Coated member and method for coating member

Abstract

This disclosure relates to coated articles having a surface, at least a portion of the surface of the article being covered by a coating, systems or kits including the coated articles, closed systems including the coated articles, and methods of coating articles.

Description

[Technical Field]

[0001] This disclosure relates to coated articles having a surface, at least a portion of the surface of the article being covered by a coating, systems or kits including the coated articles, closed systems including the coated articles, and methods of coating articles. [Background technology]

[0002] Pharmaceutical compositions for injection, such as vaccines, are usually administered to patients using a syringe.Therefore, pharmaceutical compositions can be contained in a vial and only drawn into a syringe for a few minutes before injection, or alternatively, pharmaceutical compositions can be directly filled into a syringe after production and stored in the syringe until administration.If a pharmaceutical composition is directly filled into a syringe after production, the pharmaceutical composition will be in direct contact with the inner surface of the syringe for a long time.Therefore, the pharmaceutical composition may interact with the syringe surface or air may diffuse through the syringe wall.As a result, the efficacy of the pharmaceutical composition may be reduced or it may be contaminated with extractables and leachables.In order to reduce interaction and suppress air diffusion, the surface of the syringe may be coated.However, these coatings are usually very sensitive to high or low pH values, and if the coating peels off or dissolves, it may contaminate the pharmaceutical composition itself. Summary of the Invention [Problem to be solved by the invention]

[0003] The present inventors have recognized these problems, and therefore, it is an object of the present disclosure to provide a coated member having sufficient barrier properties and improved durability, and a method for manufacturing said coated member. Improved barrier properties with respect to air, especially oxygen, Improved pH tolerance, Reduced amount of extractables, Reduced amount of leachables, · Reduction of leachable species, Reduced delamination, Improve the adhesion of coatings or coatings to decorations, and / or Improved sliding properties of coatings The object of the present invention is to provide a covering member that exhibits the following characteristics.

[0004] Furthermore, it is an object of the present disclosure to provide an improved method for producing a coated member. In particular, it is an object of the present disclosure to provide a method for producing a coated substrate, preferably a coated substrate according to any of the embodiments described herein, comprising one or more of the following: Increased application speed, Reduced costs, Increased manufacturing reliability, and / or Reduced manufacturing fluctuations The object of the present invention is to provide the method, [Means for solving the problem]

[0005] Summary of the Disclosure The claimed subject matter solves one or more of the above problems.

[0006] In one aspect, the disclosure provides a coated member having a surface, at least a portion of the surface of the member being coated with a coating, the coating comprising: · Smoothing layer (SL), Barrier layer (BL), and · Protective layer (PL) in this order, and the smoothing layer comprises a1 SL ≦[SiO + ] SL / [SiC3H9 + ] SL ≦a2 SL In the formula, a1 SL is 1.0 and a2 SL is 1 x 10 5 and [SiC3H9 + ] SLis the [SiC3H9 + ] ions and [SiO + ] SL is the [SiO + ] is the number of ions, and / or The barrier layer is a1 BL ≦[SiO + ] BL / [SiC3H9 + ] BL ≦a2 BL In the formula, a1 BL is 1 and a2 BL is 1 x 10 5 and [SiC3H9 + ] BL is the [SiC3H9 + ] is the number of ions, and [SiO + ] BL is the [SiO + ] is the number of ions, and / or The protective layer is a1 PL ≦[SiO + ] PL / [SiC3H9 + ] PL ≦a2 PL In the formula, a1 PL is 1.0 and a2 PL is 1 x 10 10 and [SiC3H9 + ] PL is the [SiC3H9 + ] is the number of ions, and [SiO + ] PL is the [SiO + ] is the number of ions, The coated member optionally has a sliding force of 0.1 to 10.0 N and / or a breaking force of 1 N to 18 N.

[0007] In combination with surface-sensitive analytical techniques, such as X-ray photoelectron spectroscopy (XPS) or secondary ion mass spectrometry (SIMS), cluster ion beams provide access to depth profiles of organic materials while preserving molecular information. In contrast to atomic ions, cluster ions do not penetrate deeply into the target material; therefore, the energy of their collisions is deposited within the first few nanometers of the surface, resulting in high sputter yields and minimal subsurface damage. This allows for the measurement of organic distribution through micrometers in industrial and medically relevant materials with depth resolution in the 10-nm range (Shard et al., Argon Cluster Ion Beams for Organic Depth Profiling: Results from a VAMAS Interlaboratory Study; Anal. Chem. 84, 2012, 7865-7873).

[0008] The coated members according to this disclosure have been characterized using cluster ion beam assays in combination with secondary ion mass spectrometry (SIMS) (see "ToF-SIMS" in the "Methods" section), which demonstrate the improved layer structure obtained by the methods according to this disclosure.

[0009] In another aspect, the disclosure provides a coated member having a surface, at least a portion of the surface of the member being coated with a coating, the coating comprising: · Smoothing layer (SL), Barrier layer (BL), and · Protective layer (PL) in this order, the smoothing layer has a thickness of 1 nm or more; and / or the barrier layer has a thickness of 1 nm or more; and / or the protective layer has a sliding force of 0.1 to 10.0 N and / or a breaking force of 1 N to 18 N, and / or The covering member has a sliding force of 0.1 to 10.0 N and / or a breaking force of 1 N to 18 N. This relates to the covering member.

[0010] It is advantageous if the coating comprises a smoothing layer (SL), a barrier layer (BL), and a protective layer (PL), because the interaction between the pharmaceutical composition and the surface of the device can be significantly reduced. The smoothing layer (SL) provides optimal contact and interaction with the (coated) device. The barrier layer (BL) is characterized by a predominance of inorganic species, which can be provided by a combination of high temperatures and oxygen used during the coating process, for example, using a plasma-generating PICVD method. The barrier layer (BL) significantly reduces the permeation rate of oxygen within and across the coating. The protective layer (PL) can be chemically similar to the smoothing layer (SL) and protects the barrier layer (BL).

[0011] In another aspect, the disclosure provides a coated member having a surface, at least a portion of the surface of the member being coated with a coating, the coating comprising: · Smoothing layer (SL), Barrier layer (BL), and · Protective layer (PL) in this order, b1 PL ≦[SiC2H + ] PL / [SiO + ] PL ≦b2 PL In the formula, b1 PL is 0.5 and b2 PL is 1 x 10 5 and [SiCH + ] PL is the [SiCH + ] is the number of ions, and [SiO + ] PL is the [SiO + ] is the number of ions, This relates to the covering member.

[0012] In another aspect, the disclosure provides a coated member having a surface, at least a portion of the surface of the member being coated with a coating, the coating comprising: · Smoothing layer (SL), Barrier layer (BL), and · Protective layer (PL) in this order, b1 BL ≦[SiO + ] BL / [SiC2H + ] BL ≦b2 BL In the formula, b1 BL is 1 and b2 BL is 1 x 10 5 and [SiCH + ] BL is the [SiCH + ] is the number of ions, and [SiO + ] BL is the [SiO + ] is the number of ions, This relates to the covering member.

[0013] In another aspect, the disclosure provides a coated member having a surface, at least a portion of the surface of the member being coated with a coating, the coating comprising: · Smoothing layer (SL), Barrier layer (BL), and · Protective layer (PL) in this order, b1 SL ≦[SiC2H + ] SL / [SiO + ] SL ≦b2 SL In the formula, b1 SL is 1.0 and b2 SL is 1 x 10 5 and [SiCH + ] SL is the [SiCH+ ] is the number of ions, and [SiO + ] SL is the [SiO + ] is the number of ions, This relates to the covering member.

[0014] In another aspect, the disclosure provides a coated member having a surface, at least a portion of the surface of the member being coated with a coating, the coating comprising: · Smoothing layer (SL), Barrier layer (BL), and · Protective layer (PL) in this order, The thickness of the smoothing layer is 1 nm to 20,000 nm, or 5 nm to 5,000, or 100 nm to 2,000 nm, or 150 nm to 1,500 nm, or 200 nm to 1,000 nm, or 250 nm to 500 nm. This relates to the covering member.

[0015] In a further aspect, the disclosure relates to a system or kit comprising a coated member according to the disclosure, said member being a syringe or cartridge, a plunger, preferably a plunger rod, and optionally a closure, preferably a tip cap and / or a needle shield.

[0016] In a further aspect, the disclosure provides: a covering member according to this disclosure, which is a syringe or cartridge; a plunger, preferably a plunger rod; Closures, preferably tip caps and / or needle shields and wherein the closed covering element passes the container integrity test in accordance with DIN EN ISO 8871-5:2016, Chapter 4.4 combined with Annex D.

[0017] In a further aspect, the present disclosure provides a method of coating a member, preferably a coated member according to the present disclosure, comprising: (1) providing a member including a surface; (2) applying a smoothing layer; (3) applying a barrier layer; (4) applying a protective layer; and (5) Optionally, applying a sliding layer each of steps (2) to (4) includes surrounding at least a portion of the surface of the component with a precursor; and Each of steps (2) to (4) includes irradiating the precursor to generate plasma using a PICVD method; Step (3) relates to the method, which includes establishing an O2 flow rate of 10 sccm or greater while irradiating the precursor.

[0018] Advantageously, the method provides a coating for a component, wherein the coated component comprises a smoothing layer, a barrier layer, a protective layer, and optionally a sliding layer, preferably in this order. Advantageously, the method allows and provides for the design and adjustment of each application step so that the smoothing layer, the barrier layer, the protective layer, and optionally the sliding layer can be physically and / or chemically distinct. The method is versatile and can be adapted, for example, so that the barrier layer can exhibit a predominantly inorganic surface portion and / or have a very low oxygen permeability, and / or so that the protective layer can protect the barrier layer and / or so that the sliding layer (if present) can exhibit a predominantly organic surface portion.

[0019] DESCRIPTION OF THE DRAWINGS 1A shows a schematic diagram of a layer structure of a covering member (CE) according to one embodiment of this disclosure, including a smoothing layer (SL), a barrier layer (BL), a protective layer (PL), and an optional sliding layer (GL), where the covering member may have a polymer substrate. Four different layers, namely, the SL, the BL, the PL, and optionally the GL, at least partially cover the covering member (CE).

[0020] Figure 1B shows the positively charged ionic species SiO+ , SiC2H + and C3H5 + A schematic diagram of TOF-SIMS data for SiO2 is shown, showing how the smoothing layer (SL), barrier layer (BL), protective layer (PL), and optional sliding layer (GL) on the coated element (CE) are designated based on this data. At the GL / PL interface, the point-to-point normalized values are calculated based on the SiO2 / PL interface. + and SiC2H + At the PL / BL interface, the point-to-point normalized values are + and SiC2H + In the BL, the point-to-point normalized values are + While the point-to-point normalized value is + In the coating material (CE), C3H5 + The species becomes dominant, i.e., the point-to-point normalized value is maximized.

[0021] Figure 1C shows the negatively charged ionic species SiCHO - , SiO 3- and C4H3 - A schematic diagram of TOF-SIMS data for SiO2 is shown, showing how the smoothing layer (SL), barrier layer (BL), protective layer (PL), and sliding layer (GL) on the coated element (CE) are designated based on this data. At the GL / PL interface, the point-to-point normalized values are 3- and SiCHO - At the PL / BL interface, the point-to-point normalized values are 3- In the BL, the point-to-point normalized values are 3- While the point-to-point normalized value is - In the coating material (CE), C4H3 - The species becomes dominant, i.e., the point-to-point normalized value is maximized.

[0022] 2A-2G show the results of Example 1 of the TOF-SIMS measurements (positive ions) described in this application, and + species (Fig. 2A), CH3 + seeds (Figure 2B), SiO + species (Figure 2C), SiCH + species (Fig. 2D), SiC2H3 + species (Figure 2E), SiC3H9 + seeds (Figure 2F), and SiO + species (Figure 2G).

[0023] 3A-3E show the results of Example 1 of the TOF-SIMS measurement (negative ions) described in this application, and C4 - species (Figure 3A), C4H3 - seeds (Figure 3B), SiC - seeds (Figure 3C), SiCHO - seeds (Figure 3D) and SiO3 - species (Figure 3E).

[0024] Detailed Description of the Disclosure Claimed embodiments In one aspect, the disclosure provides a coated member having a surface, at least a portion of the surface of the member being coated with a coating, the coating comprising: · Smoothing layer (SL), Barrier layer (BL), and · Protective layer (PL) in this order, and the smoothing layer comprises a1 SL ≦[SiO + ] SL / [SiC3H9 + ] SL ≦a2 SL In the formula, a1 SL is 1.0 and a2 SL is 1 x 10 5 and [SiC3H9 + ] SL is the [SiC3H9 + ] ions and [SiO+ ] SL is the [SiO + ] is the number of ions, and / or The barrier layer is a1 BL ≦[SiO + ] BL / [SiC3H9 + ] BL ≦a2 BL In the formula, a1 BL is 1 and a2 BL is 1 x 10 5 and [SiC3H9 + ] BL is the [SiC3H9 + ] is the number of ions, and [SiO + ] BL is the [SiO + ] is the number of ions, and / or The protective layer is a1 PL ≦[SiO + ] PL / [SiC3H9 + ] PL ≦a2 PL In the formula, a1 PL is 1.0 and a2 PL is 1 x 10 10 and [SiC3H9 + ] PL is the [SiC3H9 + ] is the number of ions, and [SiO + ] PL is the [SiO + ] is the number of ions, The covering member optionally has a sliding force of 0.1 to 10.0 N and / or a breaking force of 1 N to 18 N.

[0025] In one embodiment of the coated member, the coating is · Smoothing layer (SL), Barrier layer (BL), and · Protective layer (PL) in this order, and the smoothing layer comprises a1 SL ≦[SiO + ] SL / [SiC3H9 + ] SL ≦a2 SL In the formula, a1 SL is 1.0 and a2 SL is 1000 and [SiC3H9 + ] SL is the [SiC3H9 + ] ions and [SiO + ] SL is the [SiO + ] is the number of ions, and / or The barrier layer is a1 BL ≦[SiO + ] BL / [SiC3H9 + ] BL ≦a2 BL In the formula, a1 BL is 1 and a2 BL is 1000 and [SiC3H9 + ] BL is the [SiC3H9 + ] is the number of ions, and [SiO + ] BL is the [SiO + ] is the number of ions, and / or The protective layer is a1 PL ≦[SiO + ] PL / [SiC3H9 + ] PL ≦a2 PL In the formula, a1 PL is 1.0 and a2 PL is 1 x 10 5 and [SiC3H9 + ]PL is the [SiC3H9 + ] is the number of ions, and [SiO + ] PL is the [SiO + ] is the number of ions, The covering member optionally has a sliding force of 0.1 to 10.0 N and / or a breaking force of 1 N to 18 N.

[0026] In one embodiment of the coated member, the coating is · Smoothing layer (SL), Barrier layer (BL), and · Protective layer (PL) in this order, and the smoothing layer comprises a1 SL ≦[SiO + ] SL / [SiC3H9 + ] SL ≦a2 SL In the formula, a1 SL is 1.0 and a2 SL is 1000 and [SiC3H9 + ] SL is the [SiC3H9 + ] ions and [SiO + ] SL is the [SiO + ] is the number of ions, and / or The barrier layer is a1 BL ≦[SiO + ] BL / [SiC3H9 + ] BL ≦a2 BL In the formula, a1 BL is 1 and a2 BL is 1000 and [SiC3H9 + ] BL is the [SiC3H9 + ] is the number of ions, and [SiO+ ] BL is the [SiO + ] is the number of ions, and / or The protective layer is a1 PL ≦[SiO + ] PL / [SiC3H9 + ] PL ≦a2 PL In the formula, a1 PL is 1.0 and a2 PL is 1 x 10 5 and [SiC3H9 + ] PL is the [SiC3H9 + ] is the number of ions, and [SiO + ] PL is the [SiO + ] is the number of ions, The covering member optionally has a sliding force of 0.1 to 10.0 N and / or a breaking force of 1 N to 18 N; The smoothing layer has a thickness of 150 nm to 1500 nm, the barrier layer has a thickness of 5 nm to 500 nm, and the protective layer has a thickness of 20 nm to 1000 nm.

[0027] In one embodiment of the coated member, the coating is · Smoothing layer (SL), Barrier layer (BL), and · Protective layer (PL) in this order, and the smoothing layer comprises a1 SL ≦[SiO + ] SL / [SiC3H9 + ] SL ≦a2 SL In the formula, a1 SL is 1.0 and a2 SL is 1000 and [SiC3H9 + ] SL is the [SiC3H9+ ] ions and [SiO + ] SL is the [SiO + ] is the number of ions, and The barrier layer is a1 BL ≦[SiO + ] BL / [SiC3H9 + ] BL ≦a2 BL In the formula, a1 BL is 1 and a2 BL is 1000 and [SiC3H9 + ] BL is the [SiC3H9 + ] is the number of ions, and [SiO + ] BL is the [SiO + ] is the number of ions, and The protective layer is a1 PL ≦[SiO + ] PL / [SiC3H9 + ] PL ≦a2 PL In the formula, a1 PL is 1.0 and a2 PL is 1 x 10 5 and [SiC3H9 + ] PL is the [SiC3H9 + ] is the number of ions, and [SiO + ] PL is the [SiO + ] is the number of ions, The covering member optionally has a sliding force of 0.1 to 10.0 N and / or a breaking force of 1 N to 18 N; The smoothing layer has a thickness of 150 nm to 1500 nm, and / or the barrier layer has a thickness of 5 nm to 500 nm, and / or the protective layer has a thickness of 20 nm to 1000 nm.

[0028] In a further aspect, the disclosure provides a coated member having a surface, at least a portion of the surface of the member being coated with a coating, the coating comprising: · Smoothing layer (SL), Barrier layer (BL), and · Protective layer (PL) in this order, the smoothing layer has a thickness of 1 nm or more; and / or the barrier layer has a thickness of 1 nm or more; and / or the protective layer has a sliding force of 0.1 to 10.0 N and / or a breaking force of 1 N to 18 N, and / or The covering member has a sliding force of 0.1 to 10.0 N and / or a breaking force of 1 N to 18 N. The covering member is provided.

[0029] In one embodiment, the covering member comprises: · Smoothing layer (SL), Barrier layer (BL), and · Protective layer (PL) in this order, the smoothing layer has a thickness of 100 nm to 2000 nm; and / or the barrier layer has a thickness of 5 nm to 500 nm; and / or the protective layer has a sliding force of 0.1 to 10.0 N and / or a breaking force of 1 N to 18 N, and / or The covering member has a sliding force of 0.1 to 10.0 N and / or a breaking force of 1 N to 18 N.

[0030] In one embodiment, the covering member comprises: · Smoothing layer (SL), Barrier layer (BL), and · Protective layer (PL) in this order, the smoothing layer has a thickness of 100 nm to 2000 nm, the barrier layer has a thickness of 5 nm to 500 nm, and the protective layer has a thickness of 20 nm to 1000 nm; the protective layer has a sliding force of 0.1 to 10.0 N and / or a breaking force of 1 N to 18 N, and / or The covering member has a sliding force of 0.1 to 10.0 N and / or a breaking force of 1 N to 18 N.

[0031] In one embodiment, the covering member comprises: · Smoothing layer (SL), Barrier layer (BL), and · Protective layer (PL) in this order, the smoothing layer has a thickness of 100 nm to 2000 nm, and / or the barrier layer has a thickness of 5 nm to 500 nm, and / or the protective layer has a thickness of 20 nm to 1000 nm; The protective layer has a sliding force of 0.1 to 10.0 N and a breaking force of 1 N to 18 N, and / or the covering member has a sliding force of 0.1 to 10.0 N and a breaking force of 1 N to 18 N.

[0032] In one embodiment, the covering member further comprises a sliding layer (GL), the sliding layer is adjacent to the protective layer; The sliding layer is a1 GL ≦[SiC3H9 + ] GL / [SiO + ] GL ≦a2 GL In the formula, a1 GL is 1.1 and a2 GL is 1 x 10 10 and [SiC3H9 + ] GL is the [SiC3H9 + ] is the number of ions, and [SiO + ] GL is the [SiO +] is the number of ions.

[0033] In one embodiment of the coated member comprising a smoothing layer (SL), a barrier layer (BL), a protective layer (PL), and a sliding layer (GL), The smoothing layer is a1 SL ≦[SiO + ] SL / [SiC3H9 + ] SL ≦a2 SL In the formula, a1 SL is 1.0 and a2 SL is 1000 and [SiC3H9 + ] SL is the [SiC3H9 + ] ions and [SiO + ] SL is the [SiO + ] is the number of ions, and / or The barrier layer is a1 BL ≦[SiO + ] BL / [SiC3H9 + ] BL ≦a2 BL In the formula, a1 BL is 1 and a2 BL is 1000 and [SiC3H9 + ] BL is the [SiC3H9 + ] is the number of ions, and [SiO + ] BL is the [SiO + ] is the number of ions, and / or The protective layer is a1 PL ≦[SiO + ] PL / [SiC3H9 + ] PL ≦a2 PL In the formula, a1 PL is 1.0 and a2 PLis 1 x 10 5 and [SiC3H9 + ] PL is the [SiC3H9 + ] is the number of ions, and [SiO + ] PL is the [SiO + ] is the number of ions, and / or The sliding layer is a1 GL ≦[SiC3H9 + ] GL / [SiO + ] GL ≦a2 GL In the formula, a1 GL is 1.1 and a2 GL is 1 x 10 5 and [SiC3H9 + ] GL is the [SiC3H9 + ] is the number of ions, and [SiO + ] GL is the [SiO + ] is the number of ions.

[0034] In one embodiment of the coated member comprising a smoothing layer (SL), a barrier layer (BL), a protective layer (PL), and a sliding layer (GL), The smoothing layer (SL) is a1 SL ≦[SiO + ] SL / [SiC3H9 + ] SL ≦a2 SL In the formula, a1 SL is 1.0 and a2 SL is 1000 and / or The barrier layer is a1 BL ≦[SiO + ] BL / [SiC3H9 + ] BL ≦a2 BL In the formula, a1BL is 1 and a2 BL is 1000 and / or The protective layer is a1 PL ≦[SiO + ] PL / [SiC3H9 + ] PL ≦a2 PL In the formula, a1 PL is 1.0 and a2 PL is 1 x 10 5 and / or The sliding layer is a1 GL ≦[SiC3H9 + ] GL / [SiO + ] GL ≦a2 GL In the formula, a1 GL is 1.1 and a2 GL is 1 x 10 5 and The smoothing layer has a thickness of 100 nm to 2000 nm, the barrier layer has a thickness of 5 nm to 500 nm, the protective layer has a thickness of 20 nm to 1000 nm, and the sliding layer has a thickness of 30 nm to 1000 nm.

[0035] In one embodiment of the coated member comprising a smoothing layer (SL), a barrier layer (BL), a protective layer (PL), and a sliding layer (GL), The smoothing layer is a1 SL ≦[SiO + ] SL / [SiC3H9 + ] SL ≦a2 SL In the formula, a1 SL is 1.0 and a2 SL is 1000, and The barrier layer is a1 BL ≦[SiO + ] BL / [SiC3H9 + ] BL ≦a2 BL In the formula, a1 BL is 1 and a2 BLis 1000, and The protective layer is a1 PL ≦[SiO + ] PL / [SiC3H9 + ] PL ≦a2 PL In the formula, a1 PL is 1.0 and a2 PL is 1 x 10 5 and The sliding layer is a1 GL ≦[SiC3H9 + ] GL / [SiO + ] GL ≦a2 GL In the formula, a1 GL is 1.1 and a2 GL is 1 x 10 5 and The smoothing layer has a thickness of 100 nm to 2000 nm, and / or the barrier layer has a thickness of 5 nm to 500 nm, and / or the protective layer has a thickness of 20 nm to 1000 nm, and / or the sliding layer has a thickness of 30 nm to 1000 nm.

[0036] In one embodiment of the coated member comprising a smoothing layer (SL), a barrier layer (BL), a protective layer (PL), and a sliding layer (GL), The smoothing layer is a1 SL ≦[SiO + ] SL / [SiC3H9 + ] SL ≦a2 SL In the formula, a1 SL is 1.0 and a2 SL is 1000 and / or The barrier layer is a1 BL ≦[SiO + ] BL / [SiC3H9 + ] BL ≦a2 BL In the formula, a1 BL is 1 and a2 BL is 1000 and / or The protective layer is a1 PL ≦[SiO + ] PL / [SiC3H9 + ] PL ≦a2 PL In the formula, a1 PL is 1.0 and a2 PL is 1 x 10 5 and / or The sliding layer is a1 GL ≦[SiC3H9 + ] GL / [SiO + ] GL ≦a2 GL In the formula, a1 GL is 1.1 and a2 GL is 1 x 10 5 and the smoothing layer has a thickness of 100 nm to 2000 nm, the barrier layer has a thickness of 5 nm to 500 nm, the protective layer has a thickness of 20 nm to 1000 nm, and the sliding layer has a thickness of 30 nm to 1000 nm; The coefficients of both static and sliding friction are less than 10N.

[0037] In one embodiment of the coated member comprising a smoothing layer (SL), a barrier layer (BL), a protective layer (PL), and a sliding layer (GL), The smoothing layer is a1 SL ≦[SiO + ] SL / [SiC3H9 + ] SL ≦a2 SL In the formula, a1 SL is 1.0 and a2 SL is 1000 and / or The barrier layer is a1 BL ≦[SiO + ] BL / [SiC3H9 + ] BL ≦a2 BL In the formula, a1 BL is 1 and a2 BL is 1000 and / or The protective layer is a1 PL ≦[SiO + ] PL / [SiC3H9 + ] PL ≦a2 PL In the formula, a1 PL is 1.0 and a2 PL is 1 x 10 5 and / or The sliding layer is a1 GL ≦[SiC3H9 + ] GL / [SiO + ] GL ≦a2 GL In the formula, a1 GL is 1.1 and a2 GL is 1 x 10 5 and the smoothing layer has a thickness of 100 nm to 2000 nm, the barrier layer has a thickness of 5 nm to 500 nm, the protective layer has a thickness of 20 nm to 1000 nm, and the sliding layer has a thickness of 30 nm to 1000 nm; The coefficients of both static and sliding friction are between 1 and 10N.

[0038] In one embodiment, the covering member comprises, preferably consists of, glass or a polymer, preferably a polymer, more preferably a cyclic olefin copolymer (COC) and / or a cyclic olefin polymer (COP) and / or polypropylene (PP), more preferably a cyclic olefin copolymer (COC).

[0039] In the most preferred embodiment, the covering member comprises a cyclic olefin copolymer (COC) or a cyclic olefin polymer (COP).

[0040] In one embodiment of the coated member, the sliding layer satisfies one or more of the following parameters: a1 GL ≦[SiC3H9 + ] GL / [SiO + ] GL≦a2 GL , wherein a1 GL is 1.1 and a2 GL is 1 x 10 10 and [SiC3H9 + ] GL is the [SiC3H9 + ] is the number of ions, and [SiO + ] GL is the [SiO + ] is the number of ions, and b1 GL ≦[SiC2H + ] GL / [SiO + ] GL ≦b2 GL , wherein b1 GL is 1.1 and b2 GL is 1000 and [SiCH + ] GL is the [SiCH + ] is the number of ions, and [SiO + ] GL is the [SiO + ] is the number of ions.

[0041] In one embodiment of the coated member, the sliding layer satisfies one or more of the following parameters: a1 GL ≦[SiC3H9 + ] GL / [SiO + ] GL ≦a2 GL , wherein a1 GL is 1.1 and a2 GL is 1 x 10 5 and [SiC3H9 + ] GL is the [SiC3H9 + ] is the number of ions, and [SiO + ] GLis the [SiO + ] is the number of ions, and b1 GL ≦[SiC2H + ] GL / [SiO + ] GL ≦b2 GL , wherein b1 GL is 1.1 and b2 GL is 1000 and [SiCH + ] GL is the [SiCH + ] is the number of ions, and [SiO + ] GL is the [SiO + ] is the number of ions.

[0042] In one embodiment of the covering member, the protective layer satisfies one or more of the following parameters: a1 PL ≦[SiO + ] PL / [SiC3H9 + ] PL ≦a2 PL , wherein a1 PL is 1.0 and a2 PL is 1 x 10 10 and [SiC3H9 + ] PL is the [SiC3H9 + ] is the number of ions, and [SiO + ] PL is the [SiO + ] is the number of ions, and b1 PL ≦[SiC2H + ] PL / [SiO + ] PL ≦b2 PL , wherein b1 PL is 0.5 and b2 PL is 1 x 105 and [SiCH + ] PL is the [SiCH + ] PL is the number of ions, and [SiO + ] PL is the [SiO + ] is the number of ions.

[0043] In one embodiment of the covering member, the protective layer satisfies one or more of the following parameters: a1 PL ≦[SiO + ] PL / [SiC3H9 + ] PL ≦a2 PL , wherein a1 PL is 1.0 and a2 PL is 1 x 10 5 and [SiC3H9 + ] PL is the [SiC3H9 + ] is the number of ions, and [SiO + ] PL is the [SiO + ] is the number of ions, and b1 PL ≦[SiC2H + ] PL / [SiO + ] PL ≦b2 PL , wherein b1 PL is 0.5 and b2 PL is 1 x 10 5 and [SiCH + ] PL is the [SiCH + ] PL is the number of ions, and [SiO + ] PL is the [SiO +] is the number of ions.

[0044] In one embodiment of the coated article, the barrier layer meets one or more of the following parameters: a1 BL ≦[SiO + ] BL / [SiC3H9 + ] BL ≦a2 BL , wherein a1 BL is 1 and a2 BL is 1 x 10 5 and [SiC3H9 + ] BL is the [SiC3H9 + ] is the number of ions, and [SiO + ] BL is the [SiO + ] is the number of ions, and b1 BL ≦[SiO + ] BL / [SiC2H + ] BL ≦b2 BL , wherein b1 BL is 1 and b2 BL is 1 x 10 5 and [SiCH + ] BL is the [SiCH + ] is the number of ions, and [SiO + ] BL is the [SiO + ] is the number of ions.

[0045] In one embodiment of the coated article, the barrier layer meets one or more of the following parameters: a1 BL ≦[SiO + ] BL / [SiC3H9 + ] BL ≦a2 BL, wherein a1 BL is 1 and a2 BL is 1000 and [SiC3H9 + ] BL is the [SiC3H9 + ] is the number of ions, and [SiO + ] BL is the [SiO + ] is the number of ions, and b1 BL ≦[SiO + ] BL / [SiC2H + ] BL ≦b2 BL , wherein b1 BL is 1 and b2 BL is 1 x 10 5 and [SiCH + ] BL is the [SiCH + ] is the number of ions, and [SiO + ] BL is the [SiO + ] is the number of ions.

[0046] In one embodiment of the covering member, the smoothing layer satisfies one or more of the following parameters: a1 SL ≦[SiO + ] SL / [SiC3H9 + ] SL ≦a2 SL , wherein a1 SL is 1.0 and a2 SL is 1 x 10 5 and [SiC3H9 + ] SL is the [SiC3H9 + ] ions and [SiO + ] SL is the [SiO+ ] is the number of ions, and b1 SL ≦[SiC2H + ] SL / [SiO + ] SL ≦b2 SL , wherein b1 SL is 1.0 and b2 SL is 1 x 10 5 and [SiCH + ] SL is the [SiCH + ] ions and [SiO + ] SL is the [SiO + ] is the number of ions.

[0047] In one embodiment of the covering member, the smoothing layer satisfies one or more of the following parameters: a1 SL ≦[SiO + ] SL / [SiC3H9 + ] SL ≦a2 SL , wherein a1 SL is 1.0 and a2 SL is 1000 and [SiC3H9 + ] SL is the [SiC3H9 + ] ions and [SiO + ] SL is the [SiO + ] is the number of ions, and b1 SL ≦[SiC2H + ] SL / [SiO + ] SL ≦b2 SL , wherein b1 SL is 1.0 and b2 SL is 1 x 10 5 and [SiCH + ]SL is the [SiCH + ] ions and [SiO + ] SL is the [SiO + ] is the number of ions.

[0048] In one embodiment of the coated member, the thickness of the smoothing layer is 1 nm to 25,000 nm, or 2 nm to 10,000 nm, or 5 nm to 5,000 nm, or 100 nm to 2,000 nm, or 150 nm to 1,500 nm, or 200 nm to 1,000 nm, or 250 nm to 500 nm.

[0049] In one embodiment of the coated article, the time required for the sputter gun to reach the article surface is 0.5 minutes to 150 minutes, or 30 to 120 minutes, or 50 to 100 minutes, and / or when positive ions are measured, the time at which the sputter gun reaches the article surface is [SiO + ] ions are [C3H5 + ] ions, and / or if negative ions are measured, the time when the sputter gun reaches the workpiece surface is - ] ions are [SiO3 - ] is equal to the number of ions, and / or said number of ions, preferably positive and negative ions, can be obtained by the methods described herein.

[0050] In one embodiment of the coated member, the member is a pharmaceutical container comprising an interior surface, the interior surface being coated, the smoothing layer being in direct contact with the coated member, and the sliding layer, if present, being the outermost layer.

[0051] In one embodiment of the covering member, one or more of the following conditions are met: [SiO3 - ] GL <[SiO3 - ] BL , [SiO3 - ] PL <[SiO3 - ] BL , [SiO3 - ] SL <[SiO3 - ] BL and / or [SiO3 - ] GL <[SiO3 - ] PL , is satisfied, and [SiO3 - ] GL is the [SiO3 - ] is the number of ions, [SiO3 - ] PL is the [SiO3 - ] is the number of ions, [SiO3 - ] BL is the [SiO3 - ] is the number of ions, [SiO3 - ] SL is the [SiO3 - ] is the number of ions.

[0052] In one embodiment, this disclosure provides a system or kit comprising a coating according to this disclosure, which is a syringe or cartridge, a plunger, preferably a plunger rod, and optionally a closure, preferably a tip cap and / or a needle shield.

[0053] In one embodiment, this disclosure provides a closed system comprising a covering member according to this disclosure, which is a syringe or cartridge, a plunger, preferably a plunger rod, and a closure, preferably a tip cap and / or a needle shield, wherein the closed covering member passes a container integrity test in accordance with DIN EN ISO 8871-5:2016, Chapter 4.4 combined with Annex D.

[0054] In one embodiment, the closed system comprises a composition, preferably a pharmaceutical composition, preferably a composition containing a biologic or mRNA.

[0055] In one aspect, the disclosure provides a method of coating a member, preferably a coated member according to the disclosure, comprising: (1) providing a member including a surface; (2) applying a smoothing layer; (3) applying a barrier layer; (4) applying a protective layer; and (5) Optionally, applying a sliding layer each of steps (2) to (4) includes surrounding at least a portion of the surface of the component with a precursor; and Each of steps (2) to (4) includes irradiating the precursor to generate plasma using a PICVD method; Step (3) provides the method, comprising establishing an O2 flow rate of 10 sccm or greater while irradiating the precursor.

[0056] Sliding layer In one embodiment of the covering member, the sliding layer has the following parameters: a1 GL ≦[SiC3H9 + ] GL / [SiO + ] GL ≦a2 GL In the formula, a1 GLis 1.1, preferably 2, more preferably 5, more preferably 10, more preferably 20, more preferably 50, more preferably 100, more preferably 200, more preferably 300, more preferably 400; a2 GL is 1 x 10 10 , preferably 1 x 10 5 , more preferably 1000, more preferably 800, more preferably 600, more preferably 500; [SiC3H9 + ] GL is the [SiC3H9 + ] is the number of ions, and [SiO + ] GL is the [SiO + ] is the number of ions.

[0057] In one embodiment, a1 GL is 1.1, preferably 2, more preferably 5, more preferably 10, more preferably 20, more preferably 50, more preferably 100, more preferably 200, more preferably 300, more preferably 400. In one embodiment, a2 GL is 1 x 10 10 , preferably 1 x 10 5 , more preferably 1000, more preferably 800, more preferably 600, more preferably 500. In one embodiment, a1 GL is 1.1 and a2 GL is 1 x 10 10 In one embodiment, a1 GL is 2 and a2 GL is 1 x 10 5 In one embodiment, a1 GL is 5 and a2 GL is 1000. In one embodiment, a1 GL is 10 and a2 GL is 1000.

[0058] In one embodiment of the covering member, the sliding layer has the following parameters: b1 GL ≦[SiC2H + ] GL / [SiO + ] GL ≦b2 GL In the formula, b1 GL is 1.1, preferably 1.2, more preferably 1.5, more preferably 1.8, more preferably 2.0, more preferably 2.3; b2 GL is 1000, preferably 100, more preferably 10, more preferably 5, more preferably 4, more preferably 3, more preferably 2.5, [SiC + ] GL is the [SiCH + ] is the number of ions, and [SiO + ] GL is the [SiO + ] is the number of ions.

[0059] In one embodiment, b1 GL is 1.1, preferably 1.2, more preferably 1.5, more preferably 1.8, more preferably 2.0, more preferably 2.3. In one embodiment, b2 GL is 1000, preferably 100, more preferably 10, more preferably 5, more preferably 4, more preferably 3, more preferably 2.5. GL is 1.1 and b2 GL is 1000. In one embodiment, b1 GL is 2.0 and b2 GL is 100. In one embodiment, b1 GL is 2.3 and b2 GL is 2.5.

[0060] In one embodiment of the covering member, the sliding layer has the following parameters: c1 GL ≦[SiC3H9 + ] GL / [SiO + ] GL ≦c2 GL In the formula, c1 GL is 1.1, preferably 2, more preferably 5, more preferably 10, more preferably 20, more preferably 50, more preferably 100, more preferably 200, more preferably 300, more preferably 400; c2 GL is 1 x 10 10 , preferably 1 x 10 5 , more preferably 1000, more preferably 800, more preferably 600, more preferably 500; [SiC3H9 + ] GL is the [SiC3H9 + ] is the number of ions, and [SiO + ] GL is the [SiO + ] is the number of ions.

[0061] In one embodiment, c1 GL is 1.1, preferably 2, more preferably 5, more preferably 10, more preferably 20, more preferably 50, more preferably 100, more preferably 200, more preferably 300, more preferably 400. In one embodiment, c2 GL is 1 x 10 10 , preferably 1 x 10 5 , more preferably 1000, more preferably 800, more preferably 600, more preferably 500. In one embodiment, c1 GL is 1.1 and c2 GL is 1 x 10 10 In one embodiment, c1 GL is 2 and c2 GLis 1 x 10 5 In one embodiment, c1 GL is 5 and c2 GL is 1000. In one embodiment, c1 GL is 400 and c2 GL is 500.

[0062] In one embodiment of the covering member, the sliding layer has the following parameters: d1 GL ≦[SiCH3O - ] GL / [SiO3 - ] GL ≦d2 GL In the formula, d1 GL is 1.0, preferably 1.1, more preferably 1.5, more preferably 2, more preferably 3, more preferably 5, more preferably 8, more preferably 10, more preferably 15, more preferably 20; d2 GL is 1 x 10 10 , preferably 1 x 10 5 , more preferably 1000, more preferably 200, more preferably 100, more preferably 50, more preferably 30; [SiCHO - ] GL is the [SiCHO - ] is the number of ions, and [SiO3 - ] GL is the [SiO3 - ] is the number of ions.

[0063] In one embodiment, d1 GL is 1.0, preferably 1.1, more preferably 1.5, more preferably 2, more preferably 3, more preferably 5, more preferably 8, more preferably 10, more preferably 15, more preferably 20. In one embodiment, d2 GL is 1 x 10 10 , preferably 1 x 105 , more preferably 1000, more preferably 200, more preferably 100, more preferably 50, more preferably 30. In one embodiment, d1 GL is 1.0 and d2 GL is 1 x 10 10 In one embodiment, d1 GL is 2 and d2 GL is 1 x 10 5 In one embodiment, d1 GL is 5 and d2 GL is 1×1000. In one embodiment, d1 GL is 20 and d2 GL is 30.

[0064] In one embodiment of the covering member, the sliding layer has the following parameters: e1 GL ≦[SiCH3O2 - ] GL / [SiO3 - ] GL ≦e2 GL In the formula, e1 GL is 1.0, preferably 1.1, more preferably 1.5, more preferably 2, more preferably 3, more preferably 5, more preferably 8, more preferably 10, more preferably 15, more preferably 20; e2 GL is 1 x 10 10 , preferably 1 x 10 5 , more preferably 1000, more preferably 200, more preferably 100, more preferably 50, more preferably 30; [SiCH3O2 - ] GL is the [SiCH3O2 - ] is the number of ions, and [SiO3 - ] GL is the [SiO3 - ] is the number of ions.

[0065] In one embodiment, e1 GL is 1.0, preferably 1.1, more preferably 1.5, more preferably 2, more preferably 3, more preferably 5, more preferably 8, more preferably 10, more preferably 15, more preferably 20. In one embodiment, e2 GL is 1 x 10 10 , preferably 1 x 10 5 , more preferably 1000, more preferably 200, more preferably 100, more preferably 50, more preferably 30. In one embodiment, e1 GL is 1.0 and e2 GL is 1 x 10 10 In one embodiment, e1 GL is 2 and e2 GL is 1 x 10 5 In one embodiment, e1 GL is 5 and e2 GL is 1000. In one embodiment, e1 GL is 20 and e2 GL is 30.

[0066] In one embodiment of the coated member, the thickness of the sliding layer is 10 nm to 10,000 nm, or 15 nm to 5,000 nm, or 20 nm to 2,000 nm, or 30 nm to 1,000 nm, or 40 nm to 500 nm, or 50 nm to 200 nm.

[0067] protective layer In one embodiment of the covering member, the protective layer is made of silicone, preferably i) linear silicones; preferably linear polydimethylsiloxanes, more preferably hexamethyldisiloxane (HMDSO), octamethyltrisiloxane, decamethyltetrasiloxane, and / or ii) cyclic silicones, preferably octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane, dodecamethylcyclohexasiloxane, tetramethylcyclotetrasiloxane, pentamethylcyclopentasiloxane, and / or iii) branched siloxanes, and / or iv) A copolymer containing any one of i) to iii). Includes.

[0068] In one embodiment of the covering member, the protective layer has the following parameters: a1 PL ≦[SiO + ] PL / [SiC3H9 + ] PL ≦a2 PL In the formula, a1 P is 1.0, preferably 1.1, more preferably 1.2, more preferably 1.3, more preferably 1.4, more preferably 1.5, more preferably 2.0, more preferably 3.0; a2 PL is 1 x 10 10 , preferably 1 x 10 5 , more preferably 100, more preferably 20, more preferably 15, more preferably 10, more preferably 7; [SiC3H9 + ] PL is the [SiC3H9 + ] is the number of ions, and [SiO + ] PL is the [SiO + ] is the number of ions.

[0069] In one embodiment, a1 PL is 1.0, preferably 1.1, more preferably 1.2, more preferably 1.3, more preferably 1.4, more preferably 1.5, more preferably 2.0, more preferably 3.0.PL is 1 x 10 10 , preferably 1 x 10 5 , more preferably 100, more preferably 20, more preferably 15, more preferably 10, more preferably 7. In one embodiment, a1 PL is 1.0 and a2 PL is 1 x 10 10 In one embodiment, a1 PL is 2.0 and a2 PL is 1 x 10 5 In one embodiment, a1 PL is 2.0 and a2 PL is 100. In one embodiment, a1 PL is 3.0 and a2 PL is 7.

[0070] In one embodiment of the covering member, the protective layer has the following parameters: b1 PL ≦[SiC2H + ] PL / [SiO + ] PL ≦b2 PL In the formula, [SiCH + ] PL is the [SiCH + ] is the number of ions, and [SiO + ] PL is the [SiO + ] is the number of ions, and b1 PL is 0.5, preferably 0.8, more preferably 1.0, more preferably 1.1, more preferably 1.2, and b2 PL is 1 x 10 5 , preferably 100, more preferably 25, more preferably 15, more preferably 5, more preferably 2, more preferably 1.5.

[0071] In one embodiment, b1 PL is 0.5, preferably 0.8, more preferably 1.0, more preferably 1.1, more preferably 1.2. In one embodiment, b2 PL is 1 x 10 5 , preferably 100, more preferably 25, more preferably 15, more preferably 5, more preferably 2, more preferably 1.5. In one embodiment, b1 PL is 0.5 and b2 PL is 1 x 10 5 In one embodiment, b1 PL is 0.8 and b2 PL is 100. In one embodiment, b1 PL is 1.2 and b2 PL is 1.5.

[0072] In one embodiment of the covering member, the protective layer has the following parameters: c1 PL ≦[SiO + ] PL / [SiC3H9 + ] PL ≦c2 PL In the formula, c1 PL is 0.5, preferably 0.8, more preferably 1.0, more preferably 1.5, more preferably 2.0, more preferably 2.0, more preferably 2.1; c2 PL is 1 x 10 5 , preferably 100, more preferably 25, more preferably 20, more preferably 15, more preferably 4, more preferably 2.5; [SiC3H9 + ] PL is the [SiC3H9 + ] is the number of ions, and [SiO + ] PL is the [SiO + ] is the number of ions.

[0073] In one embodiment, c1 PL is 0.5, preferably 0.8, more preferably 1.0, more preferably 1.5, more preferably 2.0, more preferably 2.0, more preferably 2.1. In one embodiment, c2 PL is 1 x 10 5 , preferably 100, more preferably 25, more preferably 20, more preferably 15, more preferably 4, more preferably 2.5. In one embodiment, c1 PL is 2.1 and c2 PL is 2.5. In one embodiment, c1 PL is 1.0 and c2 PL is 100. In one embodiment, c1 PL is 0.5 and c2 PL is 1 x 10 5 is.

[0074] In one embodiment of the coated member, the thickness of the protective layer is 1 nm to 8000 nm, or 5 nm to 5000 nm, or 10 nm to 2000 nm, or 20 nm to 1000 nm, or 30 nm to 500 nm, or 50 nm to 300 nm.

[0075] Barrier layer In one embodiment of the covering member, the barrier layer has the following parameters: a1 BL ≦[SiO + ] BL / [SiC3H9 + ] BL ≦a2 BL In the formula, a1 BL is 1, preferably 2, more preferably 4, more preferably 10, more preferably 15, more preferably 20, more preferably 25, and a2 BL is 1 x 10 5 , preferably 1000, more preferably 500, more preferably 250, more preferably 150, more preferably 100, more preferably 50; [SiC3H9 + ] BL is the [SiC3H9 + ] is the number of ions, and [SiO + ] BL is the [SiO + ] is the number of ions.

[0076] In one embodiment, a1 BL is 1, preferably 2, more preferably 4, more preferably 10, more preferably 15, more preferably 20, more preferably 25. In one embodiment, a2 BL is 1 x 10 5 , preferably 1000, more preferably 500, more preferably 250, more preferably 150, more preferably 100, more preferably 50. In one embodiment, a1 BL is 1 and a2 BL is 1 x 10 5 In one embodiment, a1 BL is 2 and a2 BL is 1000. In one embodiment, a1 BL is 4 and a2 BL is 100. In one embodiment, a1 BL is 25 and a2 BL is 50.

[0077] In one embodiment of the covering member, the barrier layer has the following parameters: b1 BL ≦[SiO + ] BL / [SiC2H + ] BL ≦b2 BL In the formula, b1 BL is 1, preferably 5, more preferably 10, more preferably 20, more preferably 30, more preferably 40, more preferably 45, and b2 BL is 1 x 105 , preferably 1000, more preferably 500, more preferably 250, more preferably 150, more preferably 100, more preferably 80; [SiC + ] BL is the [SiCH + ] is the number of ions, and [SiO + ] BL is the [SiO + ] is the number of ions.

[0078] In one embodiment, b1 BL is 1, preferably 5, more preferably 10, more preferably 20, more preferably 30, more preferably 40, more preferably 45. In one embodiment, b2 BL is 1 x 10 5 , preferably 1000, more preferably 500, more preferably 250, more preferably 150, more preferably 100, more preferably 80. In one embodiment, b1 BL is 1 and b2 BL is 1 x 10 5 In one embodiment, b1 BL is 5 and b2 BL is 1000. In one embodiment, b1 BL is 10 and b2 BL is 500. In one embodiment, b1 BL is 45 and b2 BL is 80.

[0079] In one embodiment of the covering member, the barrier layer has the following parameters: c1 BL ≦[SiO + ] BL / [SiC3H9 + ] BL ≦c2 BL In the formula, c1 BLis 1, preferably 5, more preferably 10, more preferably 50, more preferably 75, more preferably 100, more preferably 110, and c2 BL is 1 x 10 5 , preferably 1000, more preferably 500, more preferably 400, more preferably 300, more preferably 200, more preferably 150; [SiC3H9 + ] BL is the [SiC3H9 + ] is the number of ions, and [SiO + ] BL is the [SiO + ] is the number of ions.

[0080] In one embodiment, c1 BL is 1, preferably 5, more preferably 10, more preferably 50, more preferably 75, more preferably 100, more preferably 110. In one embodiment, c2 BL is 1 x 10 5 , preferably 1000, more preferably 500, more preferably 400, more preferably 300, more preferably 200, more preferably 150. In one embodiment, c1 BL is 1 and c2 BL is 1 x 10 5 In one embodiment, c1 BL is 10 and c2 BL is 1000. In one embodiment, c1 BL is 110 and c2 BL is 150.

[0081] In one embodiment of the coated member, the barrier layer has a thickness of 1 nm to 1000 nm, or 5 nm to 500 nm, or 10 nm to 200 nm, or 20 nm to 150 nm.

[0082] smoothing layer In one embodiment of the covering member, the smoothing layer has the following parameters: a1 SL ≦[SiO + ] SL / [SiC3H9 + ] SL ≦a2 SL In the formula, a1 SL is 1.0, preferably 2.0, preferably 4.0, more preferably 6.0, more preferably 8.0, more preferably 9.0, more preferably 10.0, a2 SL is 1 x 10 5 , preferably 1000, preferably 500, more preferably 250, more preferably 100, more preferably 50, more preferably 25, more preferably 15; [SiC3H9 + ] SL is the [SiC3H9 + ] is the number of ions, and [SiO + ] SL is the [SiO + ] is the number of ions.

[0083] In one embodiment, a1 SL is 1.0, preferably 2.0, preferably 4.0, more preferably 6.0, more preferably 8.0, more preferably 9.0, more preferably 10.0. In one embodiment, a2 SL is 1 x 10 5 , preferably 1000, preferably 500, more preferably 250, more preferably 100, more preferably 50, more preferably 25, more preferably 15. In one embodiment, a1 SL is 1.0 and a2 SL is 1 x 10 5 In one embodiment, a1 SL is 2.0 and a2 SL is 1000. In one embodiment, a1 SLis 6.0 and a2 SL is 250. In one embodiment, a1 SL is 10.0 and a2 SL is 15.

[0084] In one embodiment of the covering member, the smoothing layer has the following parameters: b1 SL ≦[SiC2H + ] SL / [SiO + ] SL ≦b2 SL In the formula, [SiCH + ] SL is the [SiCH + ] is the number of ions, and [SiO + ] SL is the [SiO + ] is the number of ions, and b1 SL is 1.0, preferably 2.0, more preferably 2.5, more preferably 3.0, more preferably 3.5, more preferably 4.0; b2 SL is 1 x 10 5 , preferably 100, more preferably 25, more preferably 20, more preferably 15, more preferably 9, more preferably 7.

[0085] In one embodiment, b1 SL is 1.0, preferably 2.0, more preferably 2.5, more preferably 3.0, more preferably 3.5, more preferably 4.0. In one embodiment, b2 SL is 1 x 10 5 , preferably 100, more preferably 25, more preferably 20, more preferably 15, more preferably 9, more preferably 7. In one embodiment, b1 SL is 1.0 and b2 SL is 1 x 10 5In one embodiment, b1 SL is 2.0 and b2 SL is 100. In one embodiment, b1 SL is 3.0 and b2 SL is 25. In one embodiment, b1 SL is 4.0 and b2 SL is 7.

[0086] In one embodiment of the covering member, the smoothing layer has the following parameters: c1 SL ≦[SiO + ] SL / [SiC3H9 + ] SL ≦c2 SL In the formula, c1 SL is 0.5, preferably 0.8, more preferably 1.0, more preferably 1.5, more preferably 2.0, more preferably 2.0, more preferably 2.1; c2 PL is 1 x 10 5 , preferably 100, more preferably 25, more preferably 20, more preferably 15, more preferably 4, more preferably 2.5; [SiC3H9 + ] SL is the [SiC3H9 + ] is the number of ions, and [SiO + ] SL is the [SiO + ] is the number of ions.

[0087] In one embodiment, c1 SL is 0.5, preferably 0.8, more preferably 1.0, more preferably 1.5, more preferably 2.0, more preferably 2.0, more preferably 2.1. In one embodiment, c2 PL is 1 x 10 5, preferably 100, more preferably 25, more preferably 20, more preferably 15, more preferably 4, more preferably 2.5. In one embodiment, c1 SL is 0.5 and c2 PL is 1 x 10 5 In one embodiment, c1 SL is 1.0 and c2 PL is 100. In one embodiment, c1 SL is 2.1 and c2 PL is 2.5.

[0088] In one embodiment of the covering member, the smoothing layer has the following parameters: x1 SL ≦[SiC2H + ] SL / [C3H5 + ] SL ≦x2 SL In the formula, [SiCH + ] SL is the [SiCH + ] is the number of ions, and [C3H5 + ] SL is the [C3H5 + ] is the number of ions, and x1 SL is 1, preferably 2, more preferably 10, more preferably 50, more preferably 100, and x2 SL is 1 x 10 10 , preferably 1 x 10 5 , more preferably 1 × 10 4 , more preferably 1 × 10 3 is.

[0089] In one embodiment, x1 SL is 1, preferably 2, more preferably 10, more preferably 50, more preferably 100. In one embodiment, x2 SL is 1 x 1010 , preferably 1 x 10 5 , more preferably 1 × 10 4 , more preferably 1 × 10 3 In one embodiment, x1 SL is 1 and x2 SL is 1 x 10 10 In one embodiment, x1 SL is 10 and x2 SL is 1 x 10 5 In one embodiment, x1 SL is 100 and x2 SL is 1 x 10 3 is.

[0090] In one embodiment of the covering member, the smoothing layer has the following parameters: y1 SL ≦[SiO + ] SL / [C3H5 + ] SL ≦y2 SL In the formula, [SiO + ] SL is the [SiO + ] is the number of ions, [C3H5 + ] SL is the [C3H5 + ] is the number of ions, y1 SL is 1, preferably 5, more preferably 20, more preferably 50, more preferably 100, and y2 SL is 1 x 10 10 , preferably 1 x 10 5 , more preferably 1 × 10 4 , more preferably 1 × 10 3 is.

[0091] In one embodiment, y1 SLis 1, preferably 5, more preferably 20, more preferably 50, more preferably 100. In one embodiment, y2 SL is 1 x 10 10 , preferably 1 x 10 5 , more preferably 1 × 10 4 , more preferably 1 × 10 3 In one embodiment, y1 SL is 1 and y2 SL is 1 x 10 10 In one embodiment, y1 SL is 5 and y2 SL is 1 x 10 5 In one embodiment, y1 SL is 100 and y2 SL is 1 x 10 3 is.

[0092] In one embodiment of the covering member, the smoothing layer has the following parameters: z1 SL ≦[SiO + ] SL / [C3H5 + ] SL ≦z2 SL In the formula, [SiO + ] SL is the [SiO + ] is the number of ions, [C3H5 + ] SL is the [C3H5 + ] is the number of ions, z1 SL is 1, preferably 5, more preferably 20, more preferably 50, more preferably 70, and z2 SL is 1 x 10 10 , preferably 1 x 10 5 , more preferably 1 × 10 4 , more preferably 1 × 10 3 is.

[0093] In one embodiment of the coated member, the thickness of the smoothing layer is 1 nm to 20,000 nm, preferably 5 nm to 5,000, more preferably 100 nm to 2,000 nm, more preferably 150 nm to 1,500 nm, more preferably 200 nm to 1,000 nm, more preferably 250 nm to 500 nm.

[0094] In one embodiment, z1 SL is 1, preferably 5, more preferably 20, more preferably 50, more preferably 70. In one embodiment, z2 SL is 1 x 10 10 , preferably 1 x 10 5 , more preferably 1 × 10 4 , more preferably 1 × 10 3 In one embodiment, z1 SL is 1 and z2 SL is 1 x 10 10 In one embodiment, z1 SL is 5 and z2 SL is 1 x 10 5 In one embodiment, z1 SL is 70 and z2 SL is 1 x 10 3 is.

[0095] Covering material In one embodiment of the covering member, one or both of the following formulas: R3 ≤ t SL / t CO and / or t SL / t CO ≦R4 is satisfied, and in the formula: t SL is the time to sputter through the smoothing layer, and t CO is the time it takes for the sputter to penetrate the coating, R3 is 0.01, preferably 0.05, more preferably 0.10, more preferably 0.20, more preferably 0.30, more preferably 0.40, more preferably 0.50, more preferably 0.60, more preferably 0.65; and R4 is 5.00, preferably 4.00, more preferably 3.00, more preferably 2.00, more preferably 1.00, more preferably 0.80, more preferably 0.70.

[0096] In one embodiment of the coated article, the time required for the sputter gun to reach the article surface is between 0.5 minutes and 150 minutes, preferably between 30 and 120 minutes, more preferably between 50 and 100 minutes; and / or When positive ions are measured, the time when the sputter gun reaches the surface of the workpiece is [SiO + ] ions are [C3H5 + ] is equal to the number of ions, and / or When negative ions are measured, the time when the sputter gun reaches the surface of the workpiece is [C4H3 - ] ions are [SiO3 - ] is equal to the number of ions, and / or The number of said ions, preferably positive and negative ions, can be obtained by the methods described herein.

[0097] In one embodiment of the coated member, the at least part of the member is 10% to 90%, preferably 20% to 80%, more preferably 30% to 70%, more preferably 40% to 60% of the surface of the member.

[0098] In one embodiment of the covering member, the member is a pharmaceutical container comprising an interior surface; and At least a portion of the surface comprises at least a portion of an interior surface of a pharmaceutical container, preferably an interior surface of a pharmaceutical container, more preferably an interior surface of a pharmaceutical container.

[0099] In one embodiment of the coated member, the smoothing layer is in direct contact with the member.

[0100] In one embodiment of the covering member, the sliding layer is the outermost layer.

[0101] In one embodiment of the coated member, the member includes a partially uncoated surface, and One or both of the following expressions: R1≦T SL / SRz, and / or T SL / SRz≦R2 is satisfied, and in the formula: R1 [nm / nm] is 0.005, 0.01, or 0.05, or 0.1, preferably 0.2, more preferably 0.3, more preferably 0.5, more preferably 1.0, more preferably 2.0, more preferably 3.0, more preferably 4.0, more preferably 5.0, and / or R2 [nm / nm] is 20.0, preferably 18.0, more preferably 15.0, more preferably 12.0, more preferably 10.0, more preferably 8.0, more preferably 6.0; T SL is the thickness of the smoothing layer in at least a portion of the coating, and SRz is the surface roughness depth of at least a portion of the partially uncoated surface of said component.

[0102] In one embodiment of the coated member, the roughness SRz of the partially uncoated surface of the member is 1 nm to 5,000 nm, 10 nm to 3,000 nm, 50 nm to 2,000 nm, 70 nm to 1,000 nm, or 100 nm to 500 nm. In one embodiment of the coated member, the roughness SRz of the partially uncoated surface of the member is 1 nm or more, 10 nm or more, 50 nm or more, 70 nm or more, or 100 nm or more. In one embodiment of the coated member, the roughness SRz of the partially uncoated surface of the member is 5,000 nm or less, 3,000 nm or less, 2,000 nm or less, 1,000 nm or less, or 500 nm or less.

[0103] In one embodiment of the coated member, the sliding layer, the protective layer, the barrier layer, and / or the smoothing layer has a SiO 2 content measured by XPS. x C y wherein x is 0.3 to 3.0, preferably 0.5 to 2.0, more preferably 0.9 to 1.5, and / or y is 0 to 6.0, preferably 0.5 to 4.0, and more preferably 2.5 to 3.5.

[0104] In one embodiment of the covering member, one or more of the following conditions are met: [SiO3 - ] GL <[SiO3 - ] BL , [SiO3 - ] PL <[SiO3 - ] BL , [SiO3 - ] SL <[SiO3 - ] BL and / or [SiO3 - ] GL <[SiO3 - ] PL is satisfied, and in the formula: [SiO3 - ] GL is the [SiO3 - ] is the number of ions, [SiO3 - ] PL is the [SiO3 - ] is the number of ions, [SiO3 - ] BL is the [SiO3 - ] is the number of ions, [SiO3 - ] SL is the [SiO3- ] is the number of ions.

[0105] In one embodiment of the covering member, one or more of the following conditions are met: i) [SiC - ] PL > [SiC - ] BL , ii) [SiC - ] PL <[SiC - ] SL , or [SiC - ] PL > [SiC - ] SL , iii) [SiC - ] PL > [SiC - ] GL and / or iv) [SiC - ] GL > [SiC - ] BL is satisfied, and in the formula: [SiC - ] GL is the [SiC - ] is the number of ions, [SiC - ] PL is the [SiC] in the protective layer measured by TOF-SIMS. - ] is the number of ions, [SiC - ] BL is the [SiC - ] is the number of ions, [SiC - ] SL is the [SiC - ] is the number of ions.

[0106] In one embodiment of the covering member, one or more of the following conditions are met: [SiC +] BL <[SiC2H + ] SL , [SiC + ] GL <[SiC2H + ] SL , [SiC + ] BL <[SiC2H + ] PL , [SiC + ] GL <[SiC2H + ] PL and / or [SiC + ] GL > [SiC2H + ] BL is satisfied, and in the formula: [SiC + ] GL is the [SiCH + ] is the number of ions, [SiC + ] PL is the [SiCH] in the protective layer measured by TOF-SIMS. + ] is the number of ions, [SiC + ] BL is the [SiCH + ] is the number of ions, [SiC + ] SL is the [SiCH + ] is the number of ions.

[0107] In one embodiment of the covering member, one or more of the following conditions are met: [SiO + ] GL <[SiO + ] BL , [SiO + ] PL<[SiO + ] BL , [SiO + ] SL <[SiO + ] BL and / or [SiO + ] GL <[SiO + ] PL is satisfied, and in the formula: [SiO + ] GL is the [SiO + ] is the number of ions, [SiO + ] PL is the [SiO + ] is the number of ions, [SiO + ] BL is the [SiO + ] is the number of ions, [SiO + ] SL is the [SiO + ] is the number of ions.

[0108] In one embodiment of the coated member, the coating thickness is 1 nm to 1 mm, 10 nm to 0.5 mm, 200 nm to 2000 nm, or 500 nm to 1500 nm.

[0109] In one embodiment of the coated member, the smoothing layer, the barrier layer, the protective layer, and / or the sliding layer, more preferably all layers, contain, and preferably consist of, the elements Si, O, and C as measured by XPS.

[0110] In one embodiment of the covering member, the breaking strength of the covering member is 1 N to 18 N, preferably 1.5 N to 10 N, or 2.0 N to 7 N. In one embodiment of the covering member, the breaking strength of the covering member is 1 N or more, 1.5 N or more, or 2.0 N or more. In one embodiment of the covering member, the breaking strength of the covering member is 18 N or less, 10 N or less, 7 N or less, or 5 N or less.

[0111] In one embodiment of the coated member, the sliding force of the coated member is 0.1 N to 10.0 N, preferably 0.3 N to 7.0 N, more preferably 0.4 N to 5.0 N, more preferably 0.5 N to 4.0 N, and more preferably 1.0 N to 3.0 N. In one embodiment of the coated member, the sliding force of the coated member is 0.1 N or more, 0.3 N or more, 0.4 N or more, 0.5 N or more, or 1.0 N or more. In one embodiment of the coated member, the sliding force of the coated member is 10.0 N or less, 7.0 N or less, 5.0 N or less, 4.0 N or less, or 3.0 N or less.

[0112] In one embodiment of the covering member, one or more of the following formulas: BF7 / BF1 ≤ bf, and / or BF28 / BF1 ≤ bf, and / or BF28 / BF7≦bf is satisfied, and in the formula: BF1 is destructive power after one day, BF7 is destructive power after 7 days, BF28 stands for "28 Days Later" bf is 4.0, preferably 3.0, more preferably 2.0, more preferably 1.8, more preferably 1.6, more preferably 1.4, more preferably 1.2.

[0113] In one embodiment of the coated member, the smoothing layer, the barrier layer, the protective layer, and / or the sliding layer, more preferably all layers, can be obtained by a method according to any one of the following items.

[0114] System or Kit In one embodiment, a system or kit is provided, said system or said kit comprising: a covering member according to this disclosure, which is a syringe or cartridge; a plunger, preferably a plunger rod; Preferably it includes a closure, more preferably a tip cap and / or a needle shield.

[0115] Closed system In one embodiment, a closed system is provided, said closed system comprising: a covering member according to this disclosure, which is a syringe or cartridge; a plunger, preferably a plunger rod; Preferably, the closure, more preferably the tip cap and / or needle shield, passes the container integrity test according to DIN EN ISO 8871-5:2016, Chapter 4.4 in combination with Annex D.

[0116] In one embodiment, the closed system comprises a composition, preferably a pharmaceutical composition, more preferably a composition containing a biologic or mRNA.

[0117] method In one embodiment, there is provided a method for coating a component, preferably a method for obtaining a coated component according to this disclosure, comprising the steps of: providing a member including a surface; applying one or more layers, preferably a smoothing layer, a barrier layer, a protective layer and optionally a sliding layer, onto at least a portion of said surface by carrying out a coating process, a) surrounding at least a portion of the surface of the component with a precursor; and b) irradiating the precursor to generate plasma. the step comprising The method includes:

[0118] In one embodiment of the method, the coating process is a plasma-enhanced chemical vapor deposition (PECVD), a plasma impulse chemical vapor deposition (PICVD) or a plasma-assisted chemical vapor deposition (PACVD), preferably a plasma impulse chemical vapor deposition (PICVD).

[0119] In the most preferred embodiment of the method, the coating process is a plasma impulse chemical vapor deposition (PICVD) process.

[0120] In one embodiment of the method, the precursor comprises one or more of hexamethyldisiloxane (HMDSO), hexamethyldisilazane (HMDSN), tetramethylsilane (TMS), trimethylborazole (TMB), tri(dimethylaminosilyl)-amino-di(dimethylamino)borane (TDADB), tris(trimethylsilyl)borate (TMSB), hexamethylcyclotrisiloxane (HMCTSO), octamethylcyclotetrasiloxane (OMCTS), decamethylcyclopentasiloxane (DMCPS), dodecamethylcyclohexasiloxane (DMCHS), diacetoxy-di-t-butoxysilane (DADBS), tetraethoxysilane (TEOS), tris(trimethylsilyloxy)vinylsilane (TTMSVS), vinyltriethoxysilane (VTES), and / or combinations thereof; preferably, the precursor is HMDSO.

[0121] In one embodiment of the method, the precursor comprises, and preferably consists of, the elements Si, C, O and H.

[0122] In one embodiment of the method, for applying the smoothing layer, the barrier layer, the protective layer, and / or the sliding layer, one or more of the following conditions are met: i. the coating process is a plasma impulse chemical vapor deposition (PICVD) process; ii. the irradiation is carried out by a microwave generator, preferably the radiation of which has a frequency of 300 MHz to 300 GHz, more preferably 600 MHz to 100 GHz, more preferably 800 MHz to 10 GHz, more preferably 900 MHz to 3 GHz, more preferably 2.45 GHz; and / or iii. the input power IP, preferably the input power IP of the microwave generator, is between 100W and 10,000W, preferably between 300W and 9,000W, more preferably between 500W and 8,000W, more preferably between 700W and 6,000W, more preferably between 900W and 4,000W, more preferably between 1,100W and 2,000W; and / or iv. the precursor P comprises one or more of hexamethyldisiloxane (HMDSO), hexamethyldisilazane (HMDS), tetramethylsilane (TMS), trimethylborazole (TMB), tri(dimethylaminosilyl)-amino-di(dimethylamino)borane (TDADB), tris(trimethylsilyl)borate (TMSB), hexamethylcyclotrisiloxane (HMCTSO), octamethylcyclotetrasiloxane (OMCTS), decamethylcyclopentasiloxane (DMCPS), dodecamethylcyclohexasiloxane (DMCHS), diacetoxy-di-t-butoxysilane (DADBS), tetraethoxysilane (TEOS), tris(trimethylsilyloxy)vinylsilane (TTMSVS), vinyltriethoxysilane (VTES), and / or combinations thereof, preferably the precursor P is HMDSO; and / or In addition to said precursor P, a gas, preferably oxygen, is supplied.

[0123] It has long been recognized that the frequency at which a radio-frequency discharge is maintained significantly influences the plasma characteristics (Moisan, M., Barbeau, C., Claude, R., Ferreira, C.M., Margot, J., Paraszczak, J., Sa, A.B., Sauve, G., & Wertheimer, M.R. (1991). Radio frequency or microwave plasma reactors? Factors determining the optimum frequency of operation. Journal of Vacuum Science & Technology B: Microelectronics and Nanometer Structures Processing, Measurement, and Phenomena 9(1), 8-25). For a given radio-frequency power density injected into the plasma, the electron density generated is higher at microwave frequencies than at radio frequencies. Based on their research, the authors established that converting a plasma process from 13.56 to 2450 MHz does not necessarily lead to the maximum possible process intensification, and that optimization may require constructing a plasma reactor that allows for the excitation frequency to be varied.

[0124] The latter challenge of (re)constructing a plasma reactor that allows for variations in excitation frequency is by no means trivial and, to the applicant's knowledge, has not yet been realized or shared as publicly known.

[0125] Pulsed microwave plasmas with low pulse frequencies, e.g., about 100 Hz, and low duty cycles (D≦0.1), as used in this disclosure, are advantageous for optical and other functional coatings. In a PICVD process, a dielectric substrate can typically be placed directly on a microwave window while a very dense plasma is formed near the substrate at relatively high pressures, on the order of 1 Torr or less, during very short pulses, typically 1-100 ms in duration.

[0126] Radjef et al. (Characterizing a Custom-Built Radio Frequency PECVD Reactor to Vary the Mechanical Properties of TMDSO Films. Molecules 26, 2021, 5621) investigated radio frequency (RF) PECVD compared to microwave (MW) PECVD for depositing organosiloxane films based on TMDSO as a precursor and found that the majority of MW TMDSO films were slightly smoother than RF TMDSO films, and that the R q They found values as low as 0.4 nm. In general, increasing the O2 concentration in the system leads to greater fragmentation of the TMDSO molecule. Higher O2 concentrations lead to more efficient cleavage of the methyl groups, leaving a relatively exposed O-Si-O backbone, and such fragmentation is thought to result in a harder, more "siliceous" film with a cross-linked network of O-Si-O.

[0127] The inventors of the present disclosure have established processes and process conditions that leave the selected precursors intact to a large extent. The layer structure of the coated member comprises, in this order, a smoothing layer (SL), a barrier layer (BL), a protective layer (PL), and an optional sliding layer (GL). The coated member may be polymer-based. Each of the layers is chemically distinct and detects specific ToF-SIMS species, namely SiC in negative mode. - , C4 - , C4H3 - , SiCHO - , and SiO3 - , and C3H5 in positive mode + , SiO + , SiC2H + , SiC2H3 + , SiO + , SiC3H9 + , and CH3 +The precise qualitative and quantitative characterization depends on both the PICVD parameters used during each of the four deposition stages (1-4) in addition to the precursors selected, and the sputter and analysis parameters of the ToF-SIMS measurements (see Figure 1B and Figure 1C).

[0128] Without wishing to be bound by theory, it is believed that for all pulse durations PD LAYER All pulse pauses PP [ms] LAYER The ratio [ms / ms] of the on-off period to the off-on period is an important parameter for controlling and regulating the deposition of each of the three or four individual layers as part of the PICVD process. This parameter may alternatively be expressed as the "duty cycle" or "power cycle," which is the portion of one period that a signal or system is active. The duty cycle may be expressed as a percentage or a fraction. The period is defined as the time it takes for the signal to complete an on-off cycle.

[0129] In one advantageous embodiment of the method, the application of the smoothing layer is performed for all pulse durations PD SL All pulse pauses PP [ms] SL The ratio of [ms / ms] to [ms] was 0.01 to 0.5, and the application of the barrier layer was performed for all pulse durations PD BL All pulse pauses PP [ms] BL and / or the application of the protective layer is carried out with a ratio [ms / ms] of 0.01 to 1, preferably 0.1 to 0.8, of the total pulse duration PD PL All pulse pauses PP [ms] PL The ratio [ms / ms] to [ms] is 0.001 to 1, preferably 0.01 to 0.5.

[0130] In one embodiment of the method, to apply the smoothing layer, one or more of the following conditions are met: i. Process temperature PT SLis 15°C to 150°C, 20°C to 80°C, or 25°C to 40°C, and / or ii. Plasma pulse duration PD SL is between 0.0001 ms and 1.5 ms, between 0.1 ms and 1.2 ms, or preferably between 0.3 ms and 0.8 ms, and / or iii. Pulse pause time PP between two pulses SL is 0.01 ms to 100 ms, 0.1 ms to 70 ms, 1.0 ms to 50 ms, or 5.0 ms to 20 ms, and / or iv. Total exposure time TT SL is between 1 and 50 seconds, between 2 and 20 seconds, between 3 and 10 seconds, or between 4 and 7 seconds, and / or v. All pulse durations PD SL All pulse pauses PP [ms] SL The ratio [ms / ms] to [ms] is 0.001 to 1, 0.01 to 0.5, or 0.03 to 0.08, and / or vi. Process pressure PR SL is 0.1 mbar to 100 mbar, 0.3 mbar to 10 mbar, 0.5 to 3.0 mbar, or 0.5 to 0.8 mbar, and / or vii. the flow rate of precursor P is 1 sccm to 200 sccm, 5 sccm to 100 sccm, or 15 sccm to 30 sccm; Besides the precursor, no further substances (eg gases) are supplied.

[0131] In one embodiment of the method, to apply the barrier layer, one or more of the following conditions are met: i. Process temperature PT BL is between 15°C and 200°C, or between 25°C and 70°C, and / or ii. Plasma pulse duration PD BL is between 0.5 ms and 50 ms, between 1.0 and 10 ms, or between 1.5 ms and 2.5 ms, and / or iii. Pulse pause time PP between two pulses BLis 0.05 ms to 500 ms, 0.1 ms to 100 ms, 1.0 ms to 30 ms, or 3.0 ms to 10 ms, and / or iv. Total time of irradiation TT BL is between 1 and 50 seconds, between 3 and 30 seconds, between 5 and 15 seconds, or between 6 and 12 seconds, and / or v. All pulse durations PD BL All pulse pauses PP [ms] BL the ratio [ms / ms] to [ms] is 0.01 to 1, preferably 0.1 to 0.8, more preferably 0.3 to 0.6, and / or vi. Process pressure PR BL is between 0.01 mbar and 10 mbar, between 0.1 mbar and 5 mbar, between 0.2 mbar and 3.0 mbar, or between 0.25 mbar and 0.8 mbar; and / or vii. the flow rate of precursor P is 0.01 sccm to 20 sccm, 0.1 sccm to 5.0 sccm, or 0.3 sccm to 0.9 sccm; In addition to the precursor, oxygen gas is supplied, and the flow rate of the oxygen gas is 0.1 to 100 sccm, 5 sccm to 80 sccm, or 30 sccm to 50 sccm.

[0132] In one embodiment of the method, to apply the protective layer, one or more of the following conditions are met: i. Process temperature PT PL is 15°C to 150°C, 30°C to 100°C, or 40°C to 70°C, and / or ii. Plasma pulse duration PD PL is between 0.001 ms and 1.5 ms, between 0.01 ms and 1.0 ms, or between 0.3 ms and 0.8 ms, and / or iii. Pulse pause time PP between two pulses PL is 0.01 ms to 100 ms, 1 ms to 50 ms, 3 ms to 20 ms, 5 ms to 15 ms, or 8 ms to 12 ms, and / or iv. Total exposure time TT PLis between 0.1 seconds and 20 seconds, between 0.3 seconds and 10 seconds, between 0.7 seconds and 8 seconds, or between 0.8 seconds and 1.2 seconds, and / or v. All pulse durations PD PL All pulse pauses PP [ms] PL the ratio [ms / ms] to [ms] is 0.001 to 1, preferably 0.01 to 0.5, more preferably 0.03 to 0.08, and / or vi. Process pressure PR PL is between 0.1 mbar and 100 mbar, between 0.1 mbar and 20 mbar, between 0.3 mbar and 1.0 mbar, or between 0.5 mbar and 0.8 mbar; and / or vii. Precursor P PL the flow rate is 1 sccm to 200 sccm, 5 sccm to 40 sccm, or 10 sccm to 20 sccm; In addition to the precursor, oxygen gas is supplied, and the flow rate of the gas is 0.1 to 100, preferably 2 to 30 sccm, and more preferably 4 to 8 sccm.

[0133] In one embodiment of the method, for applying the sliding layer, one or more of the following conditions are met: i. Process temperature PT GL is 15°C to 150°C, 25°C to 100°C, or 40°C to 70°C, and / or ii. Plasma pulse duration PD GL is between 0.001 ms and 1.5 ms, between 0.01 ms and 0.8 ms, or between 0.02 ms and 0.1 ms, and / or iii. Pulse pause time PP between two pulses GL is 0.001ms to 100ms, 0.01ms to 20ms, 0.1ms to 10ms, 0.3ms to 3ms, and / or iv. Total exposure time TT GL is between 1 and 50 seconds, between 3 and 30 seconds, between 5 and 15 seconds, or between 6 and 10 seconds, and / or v. All pulse durations PD GL All pulse pauses PP [ms] GLthe ratio [ms / ms] to [ms] is 0.001 to 1, preferably 0.01 to 0.5, more preferably 0.02 to 0.08, and / or vi. Process pressure PR GL is between 0.1 mbar and 100 mbar, between 0.2 mbar and 10 mbar, between 0.3 and 1.5 mbar, or between 0.6 and 1.0 mbar; and / or vii. Precursor P GL The flow rate is 1 sccm to 200 sccm, 3 sccm to 50 sccm, or 5 sccm to 15 sccm, Besides the precursor, no further substances are provided.

[0134] Methods (Further Embodiments) In one embodiment, there is provided a method for coating a component, preferably a method for obtaining a coated component according to this disclosure, comprising the steps of: providing a member including a surface; applying a smoothing layer, a barrier layer, a protective layer and optionally a sliding layer onto at least a portion of said surface by carrying out a coating process, a) surrounding at least a portion of the surface of the component with a precursor; and b) irradiating the precursor to generate plasma. the step comprising Includes the following conditions: i. the coating process is a plasma impulse chemical vapor deposition (PICVD) process; ii. the irradiation is carried out by a microwave generator, the radiation of which has a frequency between MHz and 3 GHz, more preferably 2.45 GHz; and / or iii. The input power IP of the microwave generator is between 900W and 2000W; and / or iv. the precursor P comprises one or more of hexamethyldisiloxane (HMDSO), hexamethyldisilazane (HMDS), tetramethylsilane (TMS), trimethylborazole (TMB), tri(dimethylaminosilyl)-amino-di(dimethylamino)borane (TDADB), tris(trimethylsilyl)borate (TMSB), hexamethylcyclotrisiloxane (HMCTSO), octamethylcyclotetrasiloxane (OMCTS), decamethylcyclopentasiloxane (DMCPS), dodecamethylcyclohexasiloxane (DMCHS), diacetoxy-di-t-butoxysilane (DADBS), tetraethoxysilane (TEOS), tris(trimethylsilyloxy)vinylsilane (TTMSVS), vinyltriethoxysilane (VTES), and / or combinations thereof, preferably the precursor P is HMDSO; In addition to the precursor P, oxygen gas is supplied during the application of the barrier layer; is satisfied.

[0135] In one embodiment of the method, the following conditions are met for applying the smoothing layer: i. Process temperature PT SL is 15℃ to 150℃, ii. Plasma pulse duration PD SL is 0.0001ms to 1.5ms, iii. Pulse pause time PP between two pulses SL is 0.01ms to 100ms, iv. Total exposure time TT SL is 1 second to 50 seconds, v. All pulse duration PD SL All pulse pauses PP [ms] SL The ratio [ms / ms] to [ms] is 0.001 to 1, vi. Process pressure PR SL is 0.1 mbar to 100 mbar, vii. The flow rate of precursor P is 1 sccm to 200 sccm; Besides the precursor, no further substances (eg gases) are supplied.

[0136] In one embodiment of the method, the following conditions are met for applying the smoothing layer: i. Process temperature PT SL is 25℃ to 40℃, ii. Plasma pulse duration PD SL is 0.3ms to 0.8ms, iii. Pulse pause time PP between two pulses SL is 5.0ms to 20ms, iv. Total exposure time TT SL is 4 to 7 seconds, v. All pulse duration PD SL All pulse pauses PP [ms] SL The ratio [ms / ms] to [ms] is 0.03 to 0.08. vi. Process pressure PR SL is 0.5 to 0.8 mbar, vii. The flow rate of precursor P is 15 sccm to 30 sccm; Besides the precursor, no further substances (eg gases) are supplied.

[0137] In one embodiment of the method, the following conditions are met for applying the barrier layer: i. Process temperature PT BL is 15℃ to 200℃, ii. Plasma pulse duration PD BL is 0.5ms to 50ms, iii. Pulse pause time PP between two pulses BL is 0.05ms to 500ms, iv. Total exposure time TT BL is 1 second to 50 seconds, v. All pulse duration PD BL All pulse pauses PP [ms] BL The ratio [ms / ms] to [ms] is 0.01 to 1. vi. Process pressure PR BL is 0.01 mbar to 10 mbar, vii. The flow rate of precursor P is 0.01 sccm to 20 sccm; In addition to the precursor, oxygen gas is supplied, and the flow rate of the oxygen gas is 0.1 to 100 sccm.

[0138] In one embodiment of the method, the following conditions are met for applying the barrier layer: i. Process temperature PT BL is 25℃ to 70℃, ii. Plasma pulse duration PD BL is 1.5ms to 2.5ms, iii. Pulse pause time PP between two pulses BL is 3.0ms to 10ms, iv. Total exposure time TT BL is 6 to 12 seconds, v. All pulse durations PD BL All pulse pauses PP [ms] BL The ratio [ms / ms] to [ms] is 0.3 to 0.6, vi. Process pressure PR BL is 0.25 mbar to 0.8 mbar, vii. The flow rate of precursor P is 0.3 sccm to 0.9 sccm; In addition to the precursors, oxygen gas is supplied, and the flow rate of the oxygen gas is 30 sccm to 50 sccm.

[0139] In one embodiment of the method, the following conditions are met for applying the protective layer: i. Process temperature PT PL is 15℃ to 150℃, ii. Plasma pulse duration PD PL is 0.001ms to 1.5ms, iii. Pulse pause time PP between two pulses PL is 0.01ms to 100ms, iv. Total exposure time TT PL is 0.1 seconds to 20 seconds, v. All pulse duration PD PL All pulse pauses PP [ms] PL The ratio [ms / ms] to [ms] is 0.001 to 1, vi. Process pressure PR PL is between 0.1 mbar and 100 mbar, and vii. Precursor P PL The flow rate is 1sccm to 200sccm. In addition to the precursor, oxygen gas is supplied, and the flow rate of the gas is 0.1 to 100 sccm.

[0140] In one embodiment of the method, the following conditions are met for applying the protective layer: i. Process temperature PT PL is 40℃ to 70℃, ii. Plasma pulse duration PD PL is 0.3ms to 0.8ms, iii. Pulse pause time PP between two pulses PL is 8ms to 12ms, iv. Total exposure time TT PL is 0.8 seconds to 1.2 seconds, v. All pulse duration PD PL All pulse pauses PP [ms] PL The ratio [ms / ms] to [ms] is 0.03 to 0.08. vi. Process pressure PR PL is between 0.5 mbar and 0.8 mbar, and vii. Precursor P PL The flow rate is 10sccm to 20sccm. In addition to the precursor, oxygen gas is supplied, and the flow rate of the gas is 4 sccm to 8 sccm.

[0141] In one embodiment of the method, the following conditions are met for applying the sliding layer: i. Process temperature PT GL is 15℃ to 150℃, ii. Plasma pulse duration PD GL is 0.001ms to 1.5ms, iii. Pulse pause time PP between two pulses GL is 0.001ms to 100ms, iv. Total exposure time TT GL is 1 second to 50 seconds, v. All pulse duration PD GL All pulse pauses PP [ms] GL The ratio [ms / ms] to [ms] is 0.001 to 1, vi. Process pressure PR GL is between 0.1 mbar and 100 mbar, and vii. Precursor P GL The flow rate is 1sccm to 200sccm. Besides the precursor, no further substances are provided.

[0142] In one embodiment of the method, the following conditions are met for applying the sliding layer: i. Process temperature PT GL is 40℃ to 70℃, ii. Plasma pulse duration PD GL is 0.02ms to 0.1ms, iii. Pulse pause time PP between two pulses GL is 0.3ms to 3ms, iv. Total exposure time TT GL is 6 to 10 seconds, v. All pulse duration PD GL All pulse pauses PP [ms] GL The ratio [ms / ms] to [ms] is 0.02 to 0.08. vi. Process pressure PR GL is 0.6 to 1.0 mbar, and vii. Precursor P GLThe flow rate is 5sccm to 15sccm. Besides the precursor, no further substances are provided.

[0143] Pharmaceutical containers In one embodiment of the coated element according to this disclosure or the method according to this disclosure, said element is a pharmaceutical container, preferably a vial, ampoule, cartridge or syringe, more preferably a cartridge or syringe, most preferably a syringe.

[0144] In one embodiment, the member defines a lumen and the volume of the member to its rim is 0.1 ml to 200 ml, 0.2 ml to 100 ml, 0.4 ml to 50 ml, 0.6 ml to 20 ml, 0.8 ml to 15 ml, 1.0 ml to 10 ml, or 1.2 ml to 5 ml.

[0145] In one embodiment, the member comprises, preferably consists of, glass or a polymer, preferably a polymer. In one embodiment, the member comprises or consists of cyclic olefin copolymer (COC) and / or cyclic olefin polymer (COP) and / or polypropylene (PP). In one embodiment, the member comprises or consists of cyclic olefin copolymer (COC).

[0146] Silicone coating In one embodiment, there is provided a method for coating a component, preferably a coated component according to this disclosure, comprising: providing a member including a surface; applying one or more layers, preferably a smoothing layer and a barrier layer, onto at least a portion of said surface of said component by carrying out a first coating process to obtain a pre-coated component; performing a second coating process, x) providing a silicone-forming composition, said silicone-forming composition comprising: i) a silicone compound suitable for forming a silicone network after reaction; ii) a catalyst suitable for catalyzing the network reaction of said silicone compound; iii) an inert silicone oil that does not participate in the network reaction; and iv) Diluents wherein the diluent comprises a silicon-containing compound, and the silicone-forming composition comprises 45 to 95 wt. % diluent; y) applying said silicone-forming composition to said pre-coated member and allowing the silicone-forming composition to react; Obtaining the coated component The method includes:

[0147] In one embodiment of the method, the second coating process, i.e., step y), is carried out by curing the composition, preferably by annealing the composition to between 50°C and 300°C, or between 80°C and 120°C, and / or by applying IR radiation.

[0148] In one embodiment of the method, ie, the second coating process, ie, step x), the diluent comprises a silicon-containing organic compound having six or fewer silicon atoms.

[0149] In one embodiment of the method, ie the second coating process, ie step x), the diluent has a surface tension of 19 mN / m or less.

[0150] In one embodiment of the method, i.e., in the second coating process, i.e., in step x), the diluent is selected from the following list: Cyclic silicones, such as octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane, dodecamethylcyclohexasiloxane, tetramethylcyclotetrasiloxane, pentamethylcyclopentasiloxane, Hexamethyldisiloxane (HMDSO), Octamethyltrisiloxane, Decamethyltetrasiloxane is selected from.

[0151] In one embodiment of the method, i.e., the second coating process, i.e., step x), the silicone-forming composition has a viscosity of 0.5 to 200 mPa·s, 1 to 50 mPa·s, or 1 to 10 mPa·s at a temperature of 23° C. Viscosity can be measured using a rotational viscometer, for example, as described in DIN ISO 7884-2:1998-2.

[0152] In one embodiment of the method, i.e., second coating process, i.e., step x), the silicone-forming composition has a contact angle of 28° or less, 24° or less, 18° or less, or 5° or less, 1 second after application of the composition onto a borosilicate glass surface at a temperature of 23° C., wherein the contact angle is determined by drop shape analysis.

[0153] coated container In one embodiment according to this disclosure, a coated vessel is provided, comprising: the coated vessel includes an interior surface and an exterior surface; at least a portion of the interior surface is covered by a coating; and The coated vessel has the following formula: i / o≦d d value ([mg / cm 2 ] / [mg / cm 2 ]) 0.90, or 0.80, or 0.70, or 0.60, or 0.50, or 0.40, or 0.30, or 0.20, or 0.14, or 0.10, or 0.07 wherein i is a method L described within this application i Leaching (mg / cm) of one or more ions and / or compounds obtained by 2 ) and o is the leaching (mg / cm) of one or more ions and / or compounds of the substrate of the coated container 2 ) and / or the method L described within this application o is obtained by

[0154] In one embodiment of the coated container, the one or more ions and / or compounds are: one or more compounds containing C, preferably one or more compounds containing C excluding compounds containing Si, and / or one or more monomers, preferably norbornene, norbornane, and / or bicyclopentane, and / or one or more antioxidants, preferably phenolic antioxidants, more preferably pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate and / or dibutylhydroxytoluene (BHT); phosphite antioxidants, more preferably tris(2,4-di-tert-butylphenyl)phosphite; phosphonite antioxidants, preferably tetrakis(2,4-di-tert-butylphenyl)[1,1-biphenyl]-4,4′-diylbisphosphonite; and an antioxidant selected from the group consisting of thioether antioxidants, more preferably a phenolic antioxidant, more preferably pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate. is.

[0155] In one embodiment, the coated vessel or coated member comprises a substrate, the substrate comprising: one or more compounds containing C, preferably one or more compounds containing C excluding compounds containing Si, and / or one or more monomers, preferably norbornene, norbornane, and / or bicyclopentane, and / or one or more antioxidants, preferably phenolic antioxidants, more preferably pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate and / or dibutylhydroxytoluene (BHT); phosphite antioxidants, more preferably tris(2,4-di-tert-butylphenyl)phosphite; phosphonite antioxidants, preferably tetrakis(2,4-di-tert-butylphenyl)[1,1-biphenyl]-4,4′-diylbisphosphonite; and an antioxidant selected from the group consisting of thioether antioxidants, more preferably a phenolic antioxidant, more preferably pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate. Includes.

[0156] Method L i In one embodiment of this disclosure, the following method (Method L i ), wherein the method comprises: providing a container, preferably a coated container; If said container presents two openings, i.e. a syringe, covering the smaller opening with a closure, for example a tip cap, filling the pharmaceutical container with 0.9 x (volume to brim) of a 0.005 mol / l KOH solution (KOH: potassium hydroxide hydrate ≥ 99.995%, Suprapur® (Merck), demineralized water (ultrapure water similar to purity 1 according to DIN ISO 3696 with a resolution of ≤ 0.1 μS / cm at 25°C), closing the container with a closure seal, e.g., aluminum foil or a plug; placing the container in an autoclave (e.g., Systec, Model DX-150 (PM-CA-0001-01)); treating the container for 3 hours at 121°C and 1 bar above ambient pressure, for example 2 bar; opening the closure seal; emptying the container; filling and rinsing the container twice with deionized water; If the container is a glass container: filling the pharmaceutical container with 0.9 times (volume to brim) of a 0.1 mol / l HCl solution (hydrochloric acid 30% Suprapur® (Merck)) diluted with demineralized water (ultrapure water similar to purity 1 according to DIN ISO 3696, having a viscosity of 0.1 μS / cm or less at 25° C.), i.e. the same volume as used in the alkaline treatment, or if the container is a polymeric container: filling the pharmaceutical container with 0.9x (volume to brim) of a 0.1 mol / l HCl solution (hydrochloric acid 30% Suprapur® (Merck)) and isopropanol (1:1 / volume %:volume %) diluted with demineralized water (ultrapure water similar to purity 1 according to DIN ISO 3696, with a density of 0.1 μS / cm or less at 25° C.), i.e. the same volume as used in the alkaline treatment, closing the container with a closure seal; placing the container in an autoclave (e.g., Systec, Model DX-150 (PM-CA-0001-01)); treating the container for 6 hours at 121°C and 1 bar above ambient pressure; opening the closure seal; if the container is a glass container: analyzing the content (mg / l) of one or more ions and / or compounds, preferably [Na] ions, in the 0.1 mol / l HCl solution by FAAS analysis, for example using a Varian SpectrAA 280 FS (PE 3-004) to obtain a value (mg / l) for the leaching of one or more ions and / or compounds, preferably [Na] ions, when the container is a polymer container: analyzing the content (mg / l) of one or more ions and / or compounds, preferably antioxidants and / or organic compounds, more preferably antioxidants, in the 0.1 mol / l HCl solution using LC-MS, for example a Waters I-Class UPLC system equipped with a Waters Xevo qTOF, to obtain a value [mg / l] for the leaching of one or more ions and / or compounds, preferably antioxidants and / or organic compounds, more preferably antioxidants, The following formula: A×B / C [In the formula, A is the above value for the leaching of one or more ions and / or compounds [mg / l], B is 0.9 × the volume to the edge, and C is the wetted internal surface area of the container (cm 2 ) is] By value (mg / cm 2 ) to obtain a value [mg / cm 3 ] for the leaching of one or more ions and / or compounds, preferably Na ions or antioxidants. 2 ], i.e., obtaining the i value; Includes.

[0157] An alternative embodiment comprises the following steps: providing a container, preferably a coated container; If said container presents two openings, i.e. a syringe, covering the smaller opening with a closure, for example a tip cap, filling the pharmaceutical container with 0.9 x (volume to brim) of a 0.005 mol / l KOH solution (KOH: potassium hydroxide hydrate ≥ 99.995%, Suprapur® (Merck), demineralized water (ultrapure water similar to purity 1 according to DIN ISO 3696 with a resolution of ≤ 0.1 μS / cm at 25°C), closing the container with a closure seal, e.g., aluminum foil or a plug; placing the container in an autoclave (e.g., Systec, Model DX-150 (PM-CA-0001-01)); treating the container for 3 hours at 121°C and 1 bar above ambient pressure, for example 2 bar; opening the closure seal; emptying the container; filling and rinsing the container twice with deionized water; filling the pharmaceutical container with 0.9 times (volume to brim) a 0.1 mol / l HCl solution (hydrochloric acid 30% Suprapur® (Merck)) diluted with demineralized water (ultrapure water similar to purity 1 according to DIN ISO 3696, having a viscosity of less than 0.1 μS / cm at 25° C.), i.e. the same volume as used in the alkaline treatment, closing the container with a closure seal; placing the container in an autoclave (e.g., Systec, Model DX-150 (PM-CA-0001-01)); treating the container for 6 hours at 121°C and 1 bar above ambient pressure; opening the closure seal; emptying the container; filling and rinsing the container twice with deionized water; drying the container, preferably with air; filling the pharmaceutical container with 0.9 x (volume to brim) n-hexane, i.e., the same volume as used in the alkaline treatment; shaking the pharmaceutical container on an orbital shaker (80 rpm) for 30 minutes at room temperature; analyzing the content (mg / l) of one or more ions and / or compounds, preferably antioxidants and / or organic compounds, more preferably antioxidants, in said n-hexane solution using LC-MS, e.g. a Waters I-Class UPLC system equipped with a Waters Xevo qTOF, to obtain a value [mg / l] for the leaching of one or more ions and / or compounds, preferably antioxidants and / or organic compounds, more preferably antioxidants; The following formula: A×B / C [In the formula, A is the above value for the leaching of one or more ions and / or compounds [mg / l], B is 0.9 × the volume to the edge, and C is the wetted internal surface area of the container (cm 2 ) is] By value (mg / cm 2 ) to obtain a value [mg / cm 3 ] for the leaching of one or more ions and / or compounds, preferably Na ions or antioxidants. 2 ], i.e., obtaining the i value; Methods including (Method L i ) is included.

[0158] The o value can be obtained by several methods, and preferably the o value is determined as described herein. The o value is the content (mg / cm) of one or more ions and / or compounds in the substrate of the coated vessel. 2 ) and / or preferably or the method L described within the present application o more preferably, said o value is obtained by the method L described herein. o is obtained by

[0159] If an identical, but uncoated, container used to obtain the i value is available, the uncoated container can be used to obtain the o value by the method L described above. i and the content (mg / cm) of one or more ions and / or compounds in the substrate of the coated vessel. 2If the i and o values are to be obtained from only one container, the i value can be obtained by the above method L i and the o value is obtained by the following method L o Preferably, o is obtained by method L o The method L o can be used for externally coated or non-coated containers, but preferably the container is not externally coated. i and L o In the figure, the largest opening faces upward.

[0160] Method L o In one embodiment of this disclosure, the following method (Method L o ), wherein the method comprises: a container, preferably according to method L above i providing a container identical to that used for If said container presents two openings, i.e. a syringe, covering the smaller opening with a closure, for example a tip cap, filling the pharmaceutical container with 0.9×(volume to brim) of solution; closing the container with a closure seal; placing the container in a beaker, for example a stainless steel or aluminum beaker; filling the beaker with a 0.005 mol / l KOH solution (KOH: potassium hydroxide hydrate ≥ 99.995%, Suprapur® (Merck), demineralized water (ultrapure water similar to purity 1 according to DIN ISO 3696 with a density of ≤ 0.1 μS / cm at 25°C) until it reaches a liquid level identical to that in the container, closing the beaker with a closure; placing the beaker in an autoclave (e.g., Systec, Model DX-150 (PM-CA-0001-01)); treating the beaker for 3 hours at 121°C and 1 bar above ambient pressure, for example 2 bar; opening the closure of the beaker; emptying the beaker; cleaning the exterior of the container by filling and rinsing the beaker twice with deionized water and rinsing the exterior surface with deionized water; placing the container back into a beaker, for example a stainless steel or aluminum beaker; if the vessel is a glass vessel: filling the beaker with a 0.1 mol / l HCl solution (hydrochloric acid 30% Suprapur® (Merck)) diluted with demineralized water (ultrapure water similar to purity 1 according to DIN ISO 3696, having a viscosity of 0.1 μS / cm or less at 25° C.) until the same liquid level as in the vessel is reached, i.e. the same volume as used in the alkaline treatment, or if the container is a polymer container: filling the beaker with a 0.1 mol / l HCl solution (hydrochloric acid 30% Suprapur® (Merck)) and isopropanol (1:1 / volume %:volume %) diluted with demineralized water (ultrapure water similar to purity 1 according to DIN ISO 3696, with a concentration of ≦0.1 μS / cm at 25° C.) until the same liquid level as in the container is reached, i.e. the same volume as used in the alkaline treatment, closing the beaker with a closure; placing the beaker in an autoclave (e.g., Systec, Model DX-150 (PM-CA-0001-01)); treating the beaker for 6 hours at 121°C and 1 bar above ambient pressure; opening the beaker; if the container is a glass container: analyzing the content (mg / l) of one or more ions and / or compounds, preferably [Na] ions, in the 0.1 mol / l HCl solution by FAAS analysis, for example using a Varian SpectrAA 280 FS (PE 3-004) to obtain a value (mg / l) for the leaching of one or more ions and / or compounds, preferably [Na] ions, when the container is a polymer container: analyzing the content (mg / l) of one or more ions and / or compounds, preferably antioxidants and / or organic compounds, more preferably antioxidants, in the 0.1 mol / l HCl solution using LC-MS, for example a Waters I-Class UPLC system equipped with a Waters Xevo qTOF, to obtain a value [mg / l] for the leaching of one or more ions and / or compounds, preferably antioxidants and / or organic compounds, more preferably antioxidants, The following formula: A×B / C [In the formula, A is the above value for the leaching of one or more ions and / or compounds [mg / l], B is the volume of solution in the beaker, and C is the wetted external surface area of the container (cm 2 ) is] By value (mg / cm 2 ) to obtain a value [mg / cm ] for the leaching of one or more ions and / or compounds. 2 ], i.e., obtaining the o value; Includes:

[0161] Methods and Definitions ToF-SIMS (time-of-flight secondary ion mass spectrometry) The measurement method and data evaluation of specific TOF-SIMS measurements are described in detail below. + ], [C4H3 - ], [SiC2H3 + ] and [SiCHO - The values for the ions of [ ] can be obtained according to the following description.

[0162] Measurement method For the measurement, a TOF SIMS (TOF.SIMS 5, manufactured by Iontof) can be used. Unless otherwise stated, TOF-SIMS is measured in accordance with ASTM E 1829 and ASTM E 2695.

[0163] Measurements were started after establishing a vacuum of 1.0 mbar or less.

[0164] The following parameter settings were used for TOF-SIMS: About the analysis: Primary ion: Bi 3+ , Energy: 30 keV, Measurement area: 100×100μm 2 , Pattern: 128x128 random, and Bismuth analysis current: 0.3pA.

[0165] About the sputter gun (argon cluster source): Sputtered ions: Ar clusters, Energy: 10 keV, Sputtering area: 300×300μm 2 , and Sputtering current of Ar cluster source: 8.5 nA.

[0166] Further experimental details: Cycle time: 200μs, Analyzer drawer: 2462V (positive ions) and 2480V (negative ions), Analyzer detector: 9000V, Static compensation: flood gun, Primary ion time-of-flight correction: On, and Gas flooding: 9×10 -7 mbar.

[0167] A sample of the coated polymer container, e.g., half of an internally coated container cut into two pieces lengthwise, is positioned so that the centerlines of the TOF-SIMS sputter gun and the liquid metal ion gun strike the coated area of the sample, covering the entire measurement area, preferably so that the centerlines of the TOF-SIMS sputter gun and the liquid metal ion gun strike the same point on the coated area of the sample. TOF-SIMS measures either positive or negative ions. To obtain both types of ions, two measurements can be performed, each using a new area of the same sample or a new sample, e.g., the first and second halves of a coated container cut into two pieces lengthwise.

[0168] Identifying layers The layer structure of the coated member comprises, in this order, a smoothing layer (SL), a barrier layer (BL), a protective layer (PL), and an optional sliding layer (GL), where the coated member is a polymer substrate. Each of said layers is chemically distinct and detects a specific ToF-SIMS species, namely SiC in negative mode. - , C4 - , C4H3 - , SiCHO - , and SiO3 - , and C3H5 in positive mode + , SiO + , SiC2H + , SiC2H3 + , SiO + , SiC3H9 + , and CH3 + The precise qualitative and quantitative characteristics depend on both the PICVD parameters used during each of the four deposition stages (1-4) in addition to the precursor selected, as well as the sputter and analytical parameters of the ToF-SIMS measurements. Figures 1B and 1C show characteristic trends in the point-to-point normalized intensity of selected ToF-SIMS species in positive and negative modes, respectively.

[0169] Layer Boundaries The order of layers built on top of the polymer substrate is, in this order: smoothing layer (SL), barrier layer (BL), protective layer (PL), and optional sliding layer (GL). Based on Example 1 and using the above sputtering and analysis ToF-SIMS settings, the boundaries between the smoothing layer (SL), barrier layer (BL), protective layer (PL), and optional sliding layer (GL) can be found or established in one or more of the following ways: [SiCHO - ] GL / [SiO3 - ] GL >1.0, [SiCHO - ] BL / [SiO3 - ] BL <1.0, [SiC3H9 + ] GL / [SiO + ] GL >1.1, [SiC3H9 + ] PL / [SiO + ] PL <1.0, [SiO + ] BL / [SiC2H + ] BL >1.1, [SiO + ] GL / [SiC2H + ] GL <1.1, [SiO + ] PL / [SiC2H + ] PL <1.1, and [SiO + ] SL / [SiC2H + ] SL <1.1.

[0170] Once the polymer substrate is reached, i.e., after the smoothing layer (SL), barrier layer (BL), protective layer (PL), and optional sliding layer (GL) have all been sputtered away, C3H5 + and C4H3 -and C4 - becomes the dominant ToF-SIMS species in both positive and negative modes, with a point-to-point normalized intensity of >>1.0 relative to all Si-containing ToF-SIMS species.

[0171] Coating and layer thickness The thickness of the coating, as well as the thickness of the individual layers, i.e., the smoothing layer, the barrier layer, the protective layer, and the sliding layer, are estimated by TEM (Transmission Electron Microscopy). A scanning transmission electron microscope (SETM, Hitachi HF5000) is used with an acceleration voltage of 200 kV, an acquisition resolution of 1024 × 1024, and an acquisition time of 20 seconds. Further instrument settings are column mode operation (HR), DF mode (ZCM), BF mode (WAM), and STEM condenser aperture #2.

[0172] Sample preparation is performed using a cold magnetron to first sputter a 50 nm metallic titanium layer to establish conductivity and surface passivation. Subsequent steps are performed using an Auriga 40 SEM / FIB crossbeam: SEM-induced deposition of carbon using an organic precursor (to protect from Ga ions), FIB-induced deposition of Pt using an organic precursor (to protect the surface during lamella preparation), cutting the lamella with a 30 kV Ga FIB, transferring the sample to a copper grid, thinning with 30 kV Ga ions, and finally thinning with 2 kV Ga ions. This typically results in a final lamella width of 20 μm and a final titanium layer thickness of approximately 50 nm.

[0173] Roughness of the uncoated surface of the component The surface roughness depth (SRz) was determined on the uncoated interior surface of the component as well as the uncoated exterior surface of the component using a white light interferometer (WLI) in accordance with and in accordance with ISO 25178-2:2012. A Zygo WLI (model NexView) was used to measure a 400 μm × 400 μm field of view and subsequently calculated after correcting for component curvature. To obtain the SRz parameter, the surface area was analyzed by fitting a minimum encompassing rectangle and applying a 5 × 5 sampling grid for a total of 25 sampling areas. All sampling areas together constitute the evaluation area. While Rz relates to the roughness obtained from individual line scans (over five points), SRz reflects the average radial peak-to-valley area roughness on the surface; that is, the maximum half-average of many individual Rz results is determined by slicing the area data array around its center over 360 degrees. The Rz results were sorted by magnitude, and SRz was calculated by averaging the maximum 50% of the Rz values. A line generation algorithm is used to identify the actual pixel-to-pixel paths for each slice, with no interpolation between pixels. Thus, SRz covers the entire array and, thanks to its radial generation, is ray independent.

[0174] Depending on the type of vessel, several measurements were performed and averaged over a well-defined number of vessels and a well-defined number of measurement locations.

[0175] For syringes (COC, 1 ml length), 10 containers were measured at six different positions, resulting in an SRz of 132 nm ± 109 nm (mean ± standard deviation). The six different positions were measured at distances of 10 mm, 25 mm, and 40 mm from the stamp, and at opposite positions 180° apart with respect to the central axis of the syringe.

[0176] For vials (COP, 2 ml), 10 containers were measured at three different positions, resulting in an SRz of 147 nm ± 118 nm (mean ± standard deviation). The three different positions were measured at a vial height of 10 mm and at an angle of 120° relative to the central axis of the vial.

[0177] sliding force The coefficients of static and sliding friction for the sliding layer were determined by pushing a stopper V9361 FM457 / 0 FLNC2 057 from Datwyler Pharma Packaging, having an outer diameter of 6.9±0.1 mm, into a corresponding syringe at a speed of 100 mm / min. The force required for this pushing action was recorded.

[0178] The coefficients of static and sliding friction are determined by inserting a suitable stopper into the hollow body, moving it through the hollow body at a constant speed of 100 mm / min, and measuring the force required for this as a function of insertion depth. A typical static / sliding friction diagram has a linear rise in force as the stopper begins to move. As soon as the static friction force is overcome, the stopper begins to move and slides through the cylinder, and in the case of a good sliding layer, a relatively constant pushing force is required. Just before the start of the stopper's sliding movement, there is generally a maximum in the static / sliding friction diagram, which represents the static friction coefficient. The relatively constant force during the sliding movement represents the sliding friction coefficient. The static / sliding friction diagram should typically be measured using stoppers that are also used as stoppers for primary packaging of pharmaceutical products and with which a reasonable degree of leakage prevention is achieved, but without requiring significant effort.

[0179] destructive power Breaking force is to be understood as the static friction (force) measured on the surface of the coated or uncoated part.

[0180] Breaking force was measured in a 1 ml COC syringe using a siliconized stopper 257 / 2 ISAF2 from Datwyler Pharma. Breaking force was measured as the maximum force along an initial 4 mm path. After the initial path, an additional 30 mm path was monitored to obtain the average sliding force. Measurements were performed under dry conditions after the stopper had been stored in the syringe for 24 hours at a temperature of 20°C. Additional test parameters were a 100 N load cell, a test speed of 100 mm / min, and an unthreaded plunger rod. [Brief explanation of the drawings]

[0181] [Figure 1A] FIG. 2 illustrates the layer structure of a covering element (CE) according to one embodiment of the present disclosure. [Figure 1B] FIG. 1 shows TOF-SIMS data for the positively charged ionic species SiO, SiC2H and C3H5. [Figure 1C] FIG. 1 shows TOF-SIMS data for the negatively charged ionic species SiCH3O−, SiO3−, and C4H3−. [Figure 2A] FIG. 1 shows the results (C3H5 + species) of Example 1 of a TOF-SIMS measurement (positive ions) described within the present application. [Figure 2B] FIG. 1 shows the results (CH3 + species) of Example 1 of a TOF-SIMS measurement (positive ions) described within the present application. [Figure 2C] FIG. 1 shows the results (Si 2 O + species) of Example 1 of a TOF-SIMS measurement (positive ions) described within the present application. [Figure 2D] FIG. 1 shows the results (SiC2H+ species) of Example 1 of a TOF-SIMS measurement (positive ions) described within the present application. [Figure 2E] FIG. 1 shows the results (SiC2H3 + species) of Example 1 of a TOF-SIMS measurement (positive ions) described within the present application. [Figure 2F] FIG. 1 shows the results (SiC3H9 + species) of Example 1 of a TOF-SIMS measurement (positive ions) described within the present application. [Figure 2G] FIG. 1 shows the results (SiO species) of Example 1 of a TOF-SIMS measurement (positive ions) described within the present application. [Figure 3A] FIG. 1 shows the results (C4 − species) of Example 1 of the TOF-SIMS measurement (negative ions) described in the present application. [Figure 3B] FIG. 1 shows the results (C4H3 − species) of Example 1 of TOF-SIMS measurements (negative ions) described within the present application. [Figure 3C] FIG. 1 shows the results (SiC-species) of Example 1 of a TOF-SIMS measurement (negative ions) described within the present application. [Figure 3D] FIG. 1 shows the results (SiCH3O- species) of Example 1 of TOF-SIMS measurements (negative ions) described within the present application. [Figure 3E] FIG. 1 shows the results (SiO 3 − species) of Example 1 of TOF-SIMS measurements (negative ions) described in the present application. [Example]

[0182] Example 1 (Example of the present invention) A syringe (1 ml long, COC) of resin was prepared and subsequently coated in four stages without breaking the vacuum using the apparatus according to WO 2007 / 022976 A2 (Figure 1). The plasma was driven by microwave irradiation with a frequency of 2.45 GHz. The plasma reaction chamber was mainly inside the syringe, while ambient conditions prevailed outside the syringe. Before starting the film deposition, the reaction chamber was evacuated to a pressure of 0.05 mbar.

[0183] Four separate subsequent coating steps were applied: In the first stage, a gas flow of 20 sccm of HMDSO was adjusted at a pressure of 0.66 mbar. Then, plasma was excited in pulse mode with an input power of 1460 W and a pulse duration of 0.5 ms and a pulse pause time of 10 ms (equivalent to a duty cycle of 4.8%). The plasma treatment was carried out for 5 seconds.

[0184] In the second stage, a gas mixture of 0.6 sccm HMDSO and 39.4 sccm oxygen was adjusted at a pressure of 0.36 mbar. Then, plasma was excited in pulse mode with an input power of 1180 W and a pulse duration of 2 ms and a pulse pause time of 5 ms (equivalent to a duty cycle of 28.6%). The plasma treatment was carried out for 9 seconds.

[0185] In the third stage, a gas mixture of 14 sccm HMDSO and 6 sccm oxygen was adjusted at a pressure of 0.66 mbar. Then, plasma was excited in pulse mode with an input power of 1420 W and a pulse duration of 0.5 ms and a pulse pause time of 10 ms (equivalent to a duty cycle of 4.8%). The plasma treatment was carried out for 1 second.

[0186] In the fourth step, a gas flow of 10 sccm of HMDSO was adjusted at a pressure of 0.84 mbar. Then, plasma was excited in pulse mode with an input power of 980 W and a pulse duration of 0.04 ms and a pulse pause time of 1 ms. The plasma treatment was carried out for 9 seconds. Finally, the reaction chamber was vented with nitrogen until atmospheric pressure was reached.

[0187] Example 2 (Example of the present invention) A resin syringe (1 ml long, COC) was prepared and coated according to Example 1, but the fourth coating step was omitted. Further coating steps were performed using the liquid coating according to Example 2 of EP 3636303 A1. The liquid coating was prepared by charging 80 g of vinyl-functionalized polydimethylsiloxane to a reaction vessel and mixing it with 640 g of hexamethyldisiloxane. Under constant stirring at 1000 rpm, 2 g of methylhydrosiloxane / dimethylsiloxane copolymer, 48 g of liquid polydimethylsiloxane, 1.1 g of 1,1,3,3-tetramethyl-1,3-divinyldisiloxane-complexed platinum, and 0.1 g of butynol as an inhibitor were added to the reaction mixture. The preparation was ready for use after 60 seconds of stirring.

[0188] The formulation was applied onto the inside of a plastic hollow body by a smearing process and cured by heating to 250° C. for 3.5 seconds. A standard size 1 ml COC syringe of "1 ml length" with an inner diameter of 6.5 mm was used as a substrate for depositing the sliding layer.

[0189] The coefficients of static and sliding friction for the cured sliding layer were then determined. This involved forcing a stopper of V9361 FM457 / 0 FLNC2 057 manufactured by Datwyler Pharma Packaging, having an outer diameter of 6.9±0.1 mm, into the syringe at a speed of 100 mm / min. The force required for this was recorded. The coefficients of both static and sliding friction were less than 10 N.

[0190] Reference example A syringe of resin (1 ml length, COC) was prepared and coated according to Example 1, but the fourth coating step was omitted.

Claims

1. A covering member having a surface, wherein at least a portion of the surface of the member is covered by a coating, and the coating is ・ Smoothing layer (SL), - Barrier layer (BL), and ・Protective layer (PL) include them in this order, and the smoothing layer is a1 SL ≦ [Si 2 O + SL / [SiC 3 H 9 + SL ≦ a2 SL satisfies the condition that in the above formula, a1 SL is 1.0, and a2 SL is 1000, and [SiC 3 H 9 + SL is the number of [SiC 3 H 9 + ions in the smoothing layer measured by TOF-SIMS, and [Si 2 O + SL is the number of [Si 2 O + ions in the smoothing layer measured by TOF-SIMS, and / or​​​​ The barrier layer is a1 BL ≤ [Si 2 O + ] BL / [SiC 3 H 9 + ] BL ≤ a² BL The conditions are met, and in the above formula, a1 BL is 1, a2 BL It is 1000, and [SiC 3 H 9 + ] BL [SiC] in the barrier layer is measured by TOF-SIMS. 3 H 9 + The number of ions, and [Si 2 O + ] BL [Si in the barrier layer is measured by TOF-SIMS] 2 O + ] The number of ions and / or The protective layer is a1 PL ≤ [Si 2 O + ] PL / [SiC 3 H 9 + ] PL ≤ a² PL The conditions are met, and in the above formula, a1 PL is 1.0, and a2 PL is 1 x 10 5 And [SiC 3 H 9 + ] PL [SiC] in the protective layer is measured by TOF-SIMS. 3 H 9 + The number of ions, and [Si 2 O + ] PL [Si in the protective layer is measured by TOF-SIMS] 2 O + This is the number of ions, The covering member optionally has a sliding force of 0.1 to 10.0 N and / or a breaking force of 1 N to 18 N.

2. A covering member having a surface, wherein at least a portion of the surface of the member is covered by a coating, and the coating is ・ Smoothing layer (SL), - Barrier layer (BL), and ・Protective layer (PL) This includes, in this order, The smoothing layer has a thickness of 100 nm to 2000 nm, and / or The barrier layer has a thickness of 5 nm to 500 nm, and / or The protective layer has a sliding force of 0.1 to 10.0 N and / or a breaking force of 1 N to 18 N, and / or The covering member has a sliding force of 0.1 to 10.0 N and / or a breaking force of 1 N to 18 N. The covering member.

3. Further comprising a sliding layer (GL), The sliding layer is adjacent to the protective layer, The sliding layer is a1 GL ≤ [SiC 3 H 9 + GL GL / [Si 2 O + GL GL ≤ a2 GL GL satisfies the condition that, in the above formula, a1 GL GL is 1.1, a2 GL GL is 1×10 5 5 [SiC 3 3 H 9 + GL GL is the number of [SiC 3 3 H 9 + ions in the sliding layer measured by TOF - SIMS, and [Si 2 2 O + GL GL is the number of [Si 2 2 O + ions in the sliding layer measured by TOF - SIMS. The covering member according to claim 1 or 2.

4. The coating member according to claim 1 or 2, wherein the member comprises glass or a polymer, preferably a polymer, more preferably a cyclic olefin copolymer (COC) and / or a cyclic olefin polymer (COP) and / or polypropylene (PP), more preferably a cyclic olefin copolymer (COC), and preferably made of the same.

5. The sliding layer has one or more of the following parameters: ・ a1 GL ≤ [SiC 3 H 9 + GL / [Si GL 2 O + GL GL ≤ a2 GL , wherein, a1 GL GL is 1.1, and a2 GL GL is 1×10 5 5 , [SiC 3 3 H 9 + GL GL is the number of [SiC 3 3 H 9 + ions in the sliding layer measured by TOF-SIMS, and [Si 2 2 O + GL GL is the number of [Si 2 2 O + ions in the sliding layer measured by TOF-SIMS, and ・ b1 GL ≤ [SiC 2 H + ] GL / [SiO + ] GL ≤ b² GL In the above formula, b1 GL 1.1 and b2 GL It is 1000, and [SiC 2 H + ] GL The [SiC] in the sliding layer is measured by TOF-SIMS. 2 H + The number of ions is [SiO + ] GL This is the [SiO2] in the sliding layer, measured by TOF-SIMS. + ] This is the number of ions, A covering member according to claim 3, satisfying the requirements.

6. The protective layer has one or more of the following parameters: a1 PL ≤ [Si 2 O + ] PL / [SiC 3 H 9 + ] PL ≤ a² PL In the above formula, a1 PL is 1.0, and a2 PL is 1 x 10 5 And [SiC 3 H 9 + ] PL [SiC] in the protective layer is measured by TOF-SIMS. 3 H 9 + The number of ions, and [Si 2 O + ] PL [Si in the protective layer is measured by TOF-SIMS] 2 O + ] is the number of ions, and ・ b1 PL ≤ [SiC 2 H + ] PL / [SiO + ] PL ≤ b² PL In the above formula, b1 PL b2 is 0.5 PL is 1 x 10 5 And [SiC 2 H + ] PL [SiC] in the protective layer is measured by TOF-SIMS. 2 H + The number of ions is [SiO + ] PL This is [SiO2] in the protective layer, as measured by TOF-SIMS. + ] This is the number of ions, A covering member according to claim 1 or 2, satisfying the requirements.

7. The barrier layer has one or more of the following parameters: a1 BL ≤ [Si 2 O + ] BL / [SiC 3 H 9 + ] BL ≤ a² BL In the above formula, a1 BL is 1, a2 BL It is 1000, and [SiC 3 H 9 + ] BL [SiC] in the barrier layer is measured by TOF-SIMS. 3 H 9 + The number of ions, and [Si 2 O + ] BL [Si in the barrier layer is measured by TOF-SIMS] 2 O + ] is the number of ions, and ・ b1 BL ≤ [SiO + ] BL / [SiC 2 H + ] BL ≤ b² BL In the above formula, b1 BL is 1, and b2 BL is 1 x 10 5 And [SiC 2 H + ] BL [SiC] in the barrier layer is measured by TOF-SIMS. 2 H + The number of ions is [SiO + ] BL This is [SiO2] in the barrier layer, as measured by TOF-SIMS. + ] This is the number of ions, A covering member according to claim 1 or 2, satisfying the requirements.

8. The smoothing layer has one or more of the following parameters: a1 SL ≤ [Si 2 O + ] SL / [SiC 3 H 9 + ] SL ≤ a² SL In the above formula, a1 SL is 1.0, and a2 SL It is 1 × 1000, and [SiC 3 H 9 + ] SL The [SiC] in the smoothing layer is measured by TOF-SIMS. 3 H 9 + The number of ions is [Si 2 O + ] SL [Si in the smoothing layer is measured by TOF-SIMS] 2 O + ] is the number of ions, and ・ b1 SL ≤ [SiC 2 H + ] SL / [SiO + ] SL ≤ b² SL In the above formula, b1 SL b2 is 1.0, SL is 1 x 10 5 And [SiC 2 H + ] SL The [SiC] in the smoothing layer is measured by TOF-SIMS. 2 H + The number of ions is [SiO + ] SL [SiO2] in the smoothing layer is measured by TOF-SIMS. + ] This is the number of ions, A covering member according to claim 1 or 2, satisfying the requirements.

9. The coating member according to claim 1 or 2, wherein the thickness of the smoothed layer is 1 nm to 20,000 nm, or 5 nm to 5,000 nm, or 100 nm to 2,000 nm, or 150 nm to 1,500 nm, or 200 nm to 1,000 nm, or 250 nm to 500 nm.

10. The time required for the sputter gun to reach the surface of the member is 0.5 minutes to 150 minutes, or 30 to 120 minutes, or 50 to 100 minutes, and / or When positive ions are measured, the point at which the sputter gun reaches the surface of the member is [Si 2 O + The number of ions is [C 3 H 5 + ] The point in time when the number of ions is equal to and / or When negative ions are measured, the point at which the sputter gun reaches the surface of the member is [C 4 H 3 - The number of ions is [SiO 3 - ] The point in time when the number of ions is equal to and / or The coating member according to claim 1 or 2, wherein the number of ions, preferably positive and negative ions, can be obtained by the method described herein.

11. The covering member according to claim 1 or 2, wherein the member is a pharmaceutical container including an inner surface, the inner surface is covered, the smoothing layer is in direct contact with the covering member, and the sliding layer, if present, is the outermost layer.

12. One or more of the following conditions: [NoO 3 - ] GL <[NoO 3 - ] BL 、 [NoO 3 - ] PL <[NoO 3 - ] BL 、 [SiO 3 - ] SL <[SiO 3 - ] BL , and / or [NoO 3 - ] GL <[NoO 3 - ] PL The condition is satisfied, and in the above formula, [SiO 3 - ] GL This is the [SiO2] in the sliding layer, as measured by TOF-SIMS. 3 - This is the number of ions, [SiO 3 - ] PL [SiO2] in the protective layer, as measured by TOF-SIMS. 3 - This is the number of ions, [SiO 3 - ] BL This is the [SiO2] in the barrier layer, as measured by TOF-SIMS. 3 - This is the number of ions, [SiO 3 - ] SL This is the [SiO2] in the smoothing layer, as measured by TOF-SIMS. 3 - ] This is the number of ions, The covering member according to claim 1 or 2.

13. A covering member according to claim 1 or 2, which is a syringe or cartridge, A plunger, preferably a plunger rod, Optionally, a closure, preferably a tip cap and / or needle shield. A system or kit that includes this.

14. A covering member according to claim 1 or 2, which is a syringe or cartridge, A plunger, preferably a plunger rod, Closure, preferably tip cap and / or needle shield A closed system comprising a closed covering member, wherein the closed covering member passes a container integrity test in accordance with DIN EN ISO 8871-5:2016, Chapter 4.4 and Annex D.

15. The closed system according to claim 14, comprising a composition, preferably a pharmaceutical composition, preferably a biological product, or a composition containing mRNA.

16. A coating method for a member, preferably a coating member according to claim 1 or 2, (1) In the step of preparing the components including the surface, (2) Steps to apply the smoothing layer, (3) At the stage of applying the barrier layer, (4) The step of applying a protective layer, and (5) Step of applying a sliding layer as desired Each of steps (2) to (4) includes surrounding at least a portion of the surface of the member with the precursor, Each of steps (2) to (4) includes irradiating the precursor using the PICCVD method to generate a plasma, Step (3) involves irradiating the precursor with 10 sccm or more of O 2 The method, comprising establishing a flow rate.

17. The PICCVD method, (i) Irradiation is performed by a microwave generator, preferably with a frequency of 300 MHz to 300 GHz, more preferably 600 MHz to 100 GHz, more preferably 800 MHz to 10 GHz, more preferably 900 MHz to 3 GHz, more preferably 2.45 GHz, and / or (ii) The input power IP, preferably the input power IP of the microwave generator, is 100W to 10000W, preferably 300W to 9000W, more preferably 500W to 8000W, more preferably 700W to 6000W, more preferably 900W to 4000W, and more preferably 1100W to 2000W. The method according to claim 16, as performed.

18. The PICCVD method, (i) Irradiation is performed by a microwave generator, the light having a frequency of 2.45 GHz, and / or (ii) The input power IP, preferably the input power IP of the microwave generator, is 900W to 4000W. The method according to claim 16, as performed.

19. The method according to claim 16, wherein the precursor is HMDSO.

20. The application of the smoothing layer ensures that the pulse duration PD is maintained throughout the entire pulse duration. SL [ms] All pulse pause times PP SL The application of the barrier layer is carried out at a ratio of [ms / ms] of 0.01 to 0.5 relative to [ms], and the application of the barrier layer is carried out for all pulse durations PD BL [ms] All pulse pause times PP BL The application of the protective layer is carried out at a ratio [ms / ms] of 0.01 to 1, preferably 0.1 to 0.8, and / or the application of the protective layer is carried out for the entire pulse duration PD. PL [ms] All pulse pause times PP PL The method according to claim 16, wherein the ratio [ms / ms] to [ms] is 0.001 to 1, preferably 0.01 to 0.5.

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