Coated element and method for coating an element

Abstract

The present disclosure relates to a coated element having a surface, wherein at least a portion of the element surface is coated with a coating; a system or kit comprising the coating element; a closure system comprising the coating element; and a method of coating a component.

Description

Technical Field

[0001] The present disclosure relates to a coated component having a surface, wherein at least a portion of the surface of the component is coated with a coating; a system or kit including the coated component; a closed system including the coated component; and a method of coating a component. Background Art

[0002] Pharmaceutical compositions for injection (e.g., vaccines) are usually administered to patients by means of syringes. Therefore, the pharmaceutical composition can be contained in a vial and drawn into the syringe only a few minutes before injection, or alternatively, the pharmaceutical composition is directly loaded into the syringe after production and is contained in the syringe until administration. If the pharmaceutical composition is directly loaded into the syringe after production, the pharmaceutical composition is in direct contact with the inner surface of the syringe for a long time. Therefore, the pharmaceutical composition may interact with the surface of the syringe, or air may diffuse through the wall of the syringe. Therefore, the efficacy of the pharmaceutical composition may be reduced or contaminated by extractables and leachables. In order to reduce the interaction and inhibit the diffusion of air, the surface of the syringe can be coated with a coating. However, these coatings are generally very sensitive to high or low pH values, and if the coating peels off or dissolves, it itself may contaminate the pharmaceutical composition. The inventors recognize these problems, and therefore, the purpose of the present application is to provide a coating element with sufficient barrier properties and improved resistance and a method for producing the coating element. In detail, the purpose of the present disclosure is to provide a coating element, which exhibits one or more of the following: - Improved barrier properties with respect to air (especially oxygen); - Improved pH resistance; - Reduced amount of extractables; - Reduced amount of leachables; - types of leachables reduced; - Reduce delamination; - improved adhesion of coatings or coatings and decorations; and / or - Improved coating slip properties.

[0003] In addition, the object of the present disclosure is to provide an improved method for producing a coated element. In detail, the object of the present disclosure is to provide a method for producing a coated substrate (preferably, according to any embodiment described herein), which exhibits one or more of the following: - Increased application speed; - Reduce costs; - increased production reliability; and / or - Reduced production fluctuations. Summary of the invention

[0004] The claimed subject matter addresses one or more of the above objectives.

[0005] In one aspect, the present disclosure relates to a coated element having a surface, wherein at least a portion of the surface of the element is coated with a coating, wherein the coating comprises, in the following order: - Smoothing layer (SL); - a barrier layer (BL); and - Protective layer (PL),

[0006] The smooth layer satisfies the condition a1 SL ≤[Si2O + ] SL / [SiC3H9 + ] SL ≤a2 SL , where a1 SL is 1.0, where a2 SL 1*10 5 , where [SiC3H9 + ] SL The content of [SiC3H9 in the smoothing layer measured by TOF-SIMS (Time-of-Flight Secondary-Ion-Mass-Spectrometry) + ] ion counts, among which [Si2O + ] SL The [Si2O + ] ion counts, and / or

[0007] Wherein the barrier layer satisfies condition a1 BL ≤[Si2O + ] BL / [SiC3H9 + ] BL ≤a2 BL , where a1 BL is 1, where a2 BL 1*10 5 , where [SiC3H9 + ] BL The [SiC3H9 + ] ion counts, and among them [Si2O + ] BL The [Si2O + ] ion counts, and / or

[0008] The protective layer satisfies condition a1 PL ≤[Si2O + ] PL / [SiC3H9 + ] PL ≤a2 PL , where a1 PL is 1.0, where a2 PL 1*10 10 , where [SiC3H9 + ] PL The protective layer [SiC3H9 + ] ion counts, and among them [Si2O + ] PL is the [Si2O + ] ion counts,

[0009] The coating element optionally has a sliding force of 0.1N to 10.0N and / or a static friction force of 1N to 18N.

[0010] The combination of cluster ion beams with surface-sensitive analytical techniques (such as X-ray photoelectron spectroscopy (XPS) or secondary ion mass spectrometry (SIMS)) provides a path to the depth profile of organic materials while retaining molecular information. In contrast to atomic ions, cluster ions do not penetrate deeply into the target material, and therefore, their impact energy is deposited within the first few nanometers of the surface, resulting in high sputtering yields and minimal subsurface damage. This allows the micron-scale distribution of organic materials in industrial and medical related materials to be measured with a depth resolution of around 10 nm (Shard et al., Argon Cluster Ion Beams for Organic Depth Profiling: Results from a VAMAS Interlaboratory Study; Anal. Chem. 84, 2012, 7865-7873).

[0011] The coated elements according to the present disclosure were characterized using cluster ion beam measurements in combination with secondary ion mass spectrometry (SIMS) (see "ToF-SIMS" section in the "Methods" section), which demonstrated the improved layer structure obtained according to the methods described in the present disclosure.

[0012] In another aspect, the present disclosure relates to a coated element having a surface, wherein at least a portion of the surface of the element is coated with a coating, wherein the coating comprises, in the following order: - Smoothing layer (SL); - a barrier layer (BL); and - Protective layer (PL),

[0013] wherein the thickness of the smoothing layer is 1 nm or more, and / or

[0014] wherein the thickness of the barrier layer is 1 nm or more, and / or

[0015] wherein the protective layer has a sliding force of 0.1N to 10.0N and / or a static friction force of 1N to 18N, and / or

[0016] The coating element has a sliding force of 0.1N to 10.0N and / or a static friction force of 1N to 18N.

[0017] It is advantageous if the coating comprises a smoothing layer (SL), a barrier layer (BL) and a protective layer (PL) because the interaction of the pharmaceutical composition with the surface of the element can be significantly reduced. The smoothing layer (SL) provides an optimal contact and interaction with the (coated) element. The barrier layer (BL) is characterized by being mainly inorganic, which can be provided by a combination of high temperature and oxygen employed during the coating process (e.g. using a PICVD method that generates a plasma). The barrier layer (BL) greatly reduces the oxygen permeability in and across the coating. The protective layer (PL) can be chemically similar to the smoothing layer (SL) and protects the barrier layer (BL).

[0018] In another aspect, the present disclosure relates to a coated element having a surface, wherein at least a portion of the surface of the element is coated with a coating, wherein the coating comprises, in the following order: - Smoothing layer (SL); - a barrier layer (BL); and - Protective layer (PL),

[0019] where b1 PL ≤[SiC2H + ] PL / [SiO + ] PL ≤b2 PL , where b1 PL is 0.5, where b2 PL 1*10 5 , where [SiC2H + ] PL is the [SiC2H + ] ion counts, and among them [SiO + ]PL The [SiO + ] ion counts.

[0020] In another aspect, the present disclosure relates to a coated element having a surface, wherein at least a portion of the surface of the element is coated with a coating, wherein the coating comprises, in the following order: - Smoothing layer (SL); - a barrier layer (BL); and - Protective layer (PL),

[0021] where b1 BL ≤[SiO + ] BL / [SiC2H + ] BL ≤b2 BL , where b1 BL is 1, where b2 BL 1*10 5 , where [SiC2H + ] BL is the [SiC2H + ] ion counts, among which [SiO + ] BL The [SiO + ] ion counts.

[0022] In another aspect, the present disclosure relates to a coated element having a surface, wherein at least a portion of the surface of the element is coated with a coating, wherein the coating comprises, in the following order: - Smoothing layer (SL); - a barrier layer (BL); and - Protective layer (PL),

[0023] where b1 SL ≤[SiC2H + ] SL / [SiO + ] SL ≤b2 SL , where b1 SL is 1.0, where b2 SL 1*10 5 , where [SiC2H + ] SL is the [SiC2H + ] ion counts, among which [SiO + ] SLThe [SiO + ] ion counts.

[0024] In another aspect, the present disclosure relates to a coated element having a surface, wherein at least a portion of the surface of the element is coated with a coating, wherein the coating comprises, in the following order: - Smoothing layer (SL); - a barrier layer (BL); and - Protective layer (PL),

[0025] The thickness of the smoothing layer is 1 nm to 20000 nm, or 5 nm to 5000 nm, or 100 nm to 2000 nm, or 150 nm to 1500 nm, or 200 nm to 1000 nm, or 250 nm to 500 nm.

[0026] In another aspect, the present disclosure relates to a system or kit comprising a coated element according to the present disclosure, wherein the element is a syringe or cartridge; a plunger, preferably a plunger rod; and optionally a closure, preferably a tip cap and / or a needle shield.

[0027] In another aspect, the present disclosure relates to a closed system comprising:

[0028] The coated element according to the present disclosure, wherein the element is a syringe or a cartridge;

[0029] a plunger, preferably a plunger rod; and

[0030] a closure, preferably a tip cover and / or a needle shield,

[0031] The closed coated element passes the container closure integrity test according to DIN EN ISO 8871-5:2016; Chapter 4.4 in combination with Annex D.

[0032] In another aspect, the present disclosure relates to a method of coating a component, preferably a coated component according to the present disclosure, comprising the steps of: (1) providing a component 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,

[0033] wherein each of steps (2) to (4) comprises surrounding at least a portion of the surface of the element with a precursor, and

[0034] Each of the steps (2) to (4) comprises irradiating the precursor using a PICVD method to generate a plasma,

[0035] Wherein said step (3) comprises establishing an O2 flow rate of more than 10 sccm during said irradiation of said precursor.

[0036] Advantageously, the method is provided for coating an element, wherein the coated element preferably comprises, in the following order, a smoothing layer, a barrier layer, a protective layer and optionally a sliding layer. The method advantageously allows and provides for the design and adjustment of the respective application steps, such that the smoothing layer, the barrier layer, the protective layer and optionally the sliding layer can be physically and / or chemically different. The method is versatile and can be adapted such that, for example, the barrier layer can mainly show an inorganic surface portion and / or can have a very low oxygen permeability, and / or such that, for example, the protective layer protects the barrier layer, and / or such that, for example, the sliding layer (when present) can mainly show an organic surface portion. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1A A schematic diagram of the layer structure of a coating element (CE) according to an embodiment of the present disclosure is shown, comprising a smoothing layer (SL), a barrier layer (BL), a protective layer (PL) and optionally a sliding layer (GL), wherein the coating element may have a polymer substrate. The four different layers, namely SL, BL, PL and optionally GL, at least partially cover the coating element (CE).

[0038] Figure 1B The positively charged ionic species SiO + 、SiC2H + and C3H5 + Schematic diagram of TOF-SIMS data and shows how to assign the smoothing layer (SL), barrier layer (BL), protection layer (PL) and sliding layer (GL) on the coated element (CE) based on these data. At the interface GL / PL, SiO + and SiC2H + The point-to-point normalized values ​​of the materials change significantly. At the interface PL / BL, SiO + and SiC2H + The point-to-point normalized values ​​of the materials vary significantly. In BL, SiO + The point-to-point normalized value is the largest, while SiC2H + The point-to-point normalized value of is the smallest. In the coated element (CE), the substance C3H5 + Dominant, that is, the point-to-point normalized value is the largest.

[0039] Figure 1C The negatively charged ionic species SiCH3O is shown - 、SiO 3- and C4H3 - Schematic diagram of TOF-SIMS data and shows how to assign the smoothing layer (SL), barrier layer (BL), protection layer (PL) and sliding layer (GL) on the coated element (CE) based on these data. At the interface GL / PL, SiO 3- and SiCH3O - The point-to-point normalized values ​​of the materials change significantly. At the interface PL / BL, SiO 3- The point-to-point normalized values ​​of the materials vary significantly. In BL, SiO 3- The point-to-point normalized value of SiCH3O - The point-to-point normalized value of is the smallest. In the coated element (CE), the substance C4H3 - Dominant, that is, the point-to-point normalized value is the largest.

[0040] Figures 2A to 2G The results of Example 1 of the TOF-SIMS measurement (cation) described herein are shown, showing that the species C3H5 + ( Figure 2A )、CH3 + ( Figure 2B )、Si2O + ( Figure 2C )、SiC2H + ( Figure 2D )、SiC2H3 + ( Figure 2E )、SiC3H9 + ( Figure 2F ) and SiO + ( Figure 2G ).

[0041] FIG. 3A to FIG. 3E The results of Example 1 of the TOF-SIMS measurement (anions) described herein are shown, showing that species C4 - ( Figure 3A )、C4H3 - ( Figure 3B )、SiC - ( Figure 3C )、SiCH3O - ( Figure 3D ) and SiO3 - ( Figure 3E ). DETAILED DESCRIPTION

[0042] Claimed embodiments

[0043] In one aspect, the present disclosure provides a coated element having a surface, wherein at least a portion of the surface of the element is coated with a coating, wherein the coating comprises, in the following order: - Smoothing layer (SL); - a barrier layer (BL); and - Protective layer (PL),

[0044] The smooth layer satisfies the condition a1 SL ≤[Si2O + ] SL / [SiC3H9 + ] SL ≤a2 SL , where a1 SL is 1.0, where a2 SL 1*10 5 , where [SiC3H9 + ] SL The [SiC3H9 + ] ion counts; among which [Si2O + ] SL The [Si2O + ] ion counts, and / or

[0045] The barrier layer satisfies the condition a1 BL ≤[Si2O + ] BL / [SiC3H9 + ] BL ≤a2 BL , where a1 BL is 1, where a2 BL 1*10 5 , where [SiC3H9 + ] BL The [SiC3H9 + ] ion counts, and among them [Si2O + ] BL is the [Si2O + ] ion counts, and / or

[0046] The protective layer satisfies condition a1 PL ≤[Si2O + ] PL / [SiC3H9 + ] PL ≤a2 PL , where a1 PL is 1.0, where a2PL 1*10 10 , where [SiC3H9 + ] PL The protective layer [SiC3H9 + ] ion counts, and among them [Si2O + ] PL The [Si2O + ] ion counts,

[0047] The coating element optionally has a sliding force of 0.1N to 10.0N and / or a static friction force of 1N to 18N.

[0048] In one embodiment of the coated element, the coating comprises in the following order: - Smoothing layer (SL); - a barrier layer (BL); and - Protective layer (PL),

[0049] The smooth layer satisfies the condition a1 SL ≤[Si2O + ] SL / [SiC3H9 + ] SL ≤a2 SL , where a1 SL is 1.0, where a2 SL is 1000, where [SiC3H9 + ] SL The [SiC3H9 + ] ion counts; among which [Si2O + ] SL The [Si2O + ] ion counts, and / or

[0050] The barrier layer satisfies the condition a1 BL ≤[Si2O + ] BL / [SiC3H9 + ] BL ≤a2 BL , where a1 BL is 1, where a2 BL is 1000, where [SiC3H9 + ] BL The [SiC3H9 + ] ion counts, and among them [Si2O+ ] BL is the [Si2O + ] ion counts, and / or

[0051] The protective layer satisfies condition a1 PL ≤[Si2O + ] PL / [SiC3H9 + ] PL ≤a2 PL , where a1 PL is 1.0, where a2 PL 1*10 5 , where [SiC3H9 + ] PL The protective layer [SiC3H9 + ] ion counts, and among them [Si2O + ] PL The [Si2O + ] ion counts,

[0052] The coating element optionally has a sliding force of 0.1N to 10.0N and / or a static friction force of 1N to 18N.

[0053] In one embodiment of the coated element, the coating comprises in the following order: - Smoothing layer (SL); - a barrier layer (BL); and - Protective layer (PL),

[0054] The smooth layer satisfies the condition a1 SL ≤[Si2O + ] SL / [SiC3H9 + ] SL ≤a2 SL , where a1 SL is 1.0, where a2 SL is 1000, where [SiC3H9 + ] SL The [SiC3H9 + ] ion counts; among which [Si2O + ] SL The [Si2O + ] ion counts, and / or

[0055] The barrier layer satisfies the condition a1BL ≤[Si2O + ] BL / [SiC3H9 + ] BL ≤a2 BL , where a1 BL is 1, where a2 BL is 1000, where [SiC3H9 + ] BL The [SiC3H9 + ] ion counts, and among them [Si2O + ] BL is the [Si2O + ] ion counts, and / or

[0056] The protective layer satisfies condition a1 PL ≤[Si2O + ] PL / [SiC3H9 + ] PL ≤a2 PL , where a1 PL is 1.0, where a2 PL 1*10 5 , where [SiC3H9 + ] PL The protective layer [SiC3H9 + ] ion counts, and among them [Si2O + ] PL The [Si2O + ] ion counts,

[0057] wherein the coating element optionally has a sliding force of 0.1 N to 10.0 N and / or a static friction force of 1 N to 18 N,

[0058] The thickness of the smoothing layer is 150 nm to 1500 nm, the thickness of the blocking layer is 5 nm to 500 nm, and the thickness of the protective layer is 20 nm to 1000 nm.

[0059] In one embodiment of the coated element, the coating comprises in the following order: - Smoothing layer (SL); - a barrier layer (BL); and - Protective layer (PL),

[0060] The smooth layer satisfies the condition a1 SL ≤[Si2O+ ] SL / [SiC3H9 + ] SL ≤a2 SL , where a1 SL is 1.0, where a2 SL is 1000, where [SiC3H9 + ] SL The [SiC3H9 + ] ion counts; among which [Si2O + ] SL The [Si2O + ] ion counts, and

[0061] The barrier layer satisfies the condition a1 BL ≤[Si2O + ] BL / [SiC3H9 + ] BL ≤a2 BL , where a1 BL is 1, where a2 BL is 1000, where [SiC3H9 + ] BL The [SiC3H9 + ] ion counts, and among them [Si2O + ] BL is the [Si2O + ] ion counts, and

[0062] The protective layer satisfies condition a1 PL ≤[Si2O + ] PL / [SiC3H9 + ] PL ≤a2 PL , where a1 PL is 1.0, where a2 PL 1*10 5 , where [SiC3H9 + ] PL The protective layer [SiC3H9 + ] ion counts, and among them [Si2O + ] PL The [Si2O + ] ion counts,

[0063] wherein the coating element optionally has a sliding force of 0.1 N to 10.0 N and / or a static friction force of 1 N to 18 N,

[0064] The thickness of the smoothing layer is 150 nm to 1500 nm, and / or the thickness of the blocking layer is 5 nm to 500 nm, and / or the thickness of the protective layer is 20 nm to 1000 nm.

[0065] In another aspect, the present disclosure provides a coated element having a surface, wherein at least a portion of the surface of the element is coated with a coating, wherein the coating comprises, in the following order: - Smoothing layer (SL); - a barrier layer (BL); and - Protective layer (PL),

[0066] wherein the thickness of the smoothing layer is 1 nm or more, and / or

[0067] The thickness of the barrier layer is 1 nm or more, and / or

[0068] The protective layer has a sliding force of 0.1N to 10.0N and / or a static friction force of 1N to 18N, and / or

[0069] The coating element has a sliding force of 0.1N to 10.0N and / or a static friction force of 1N to 18N.

[0070] In one embodiment, the coating element comprises, in the following order: - Smoothing layer (SL); - a barrier layer (BL); and - Protective layer (PL),

[0071] The thickness of the smoothing layer is 100 nm to 2000 nm, and / or

[0072] The thickness of the barrier layer is 5 nm to 500 nm, and / or

[0073] The protective layer has a sliding force of 0.1N to 10.0N and / or a static friction force of 1N to 18N, and / or

[0074] The coating element has a sliding force of 0.1N to 10.0N and / or a static friction force of 1N to 18N.

[0075] In one embodiment, the coating element comprises, in the following order: - Smoothing layer (SL); - a barrier layer (BL); and - Protective layer (PL),

[0076] wherein the thickness of the smoothing layer is 100 nm to 2000 nm, wherein the thickness of the blocking layer is 5 nm to 500 nm, and wherein the thickness of the protective layer is 20 nm to 1000 nm,

[0077] The protective layer has a sliding force of 0.1N to 10.0N and / or a static friction force of 1N to 18N, and / or

[0078] The coating element has a sliding force of 0.1N to 10.0N and / or a static friction force of 1N to 18N.

[0079] In one embodiment, the coating element comprises, in the following order: - Smoothing layer (SL); - a barrier layer (BL); and - Protective layer (PL),

[0080] wherein the thickness of the smoothing layer is 100 nm to 2000 nm, and / or wherein the thickness of the blocking layer is 5 nm to 500 nm, and / or wherein the thickness of the protective layer is 20 nm to 1000 nm,

[0081] The protective layer has a sliding force of 0.1N to 10.0N and a static friction force of 1N to 18N, and / or the coating element has a sliding force of 0.1N to 10.0N and a static friction force of 1N to 18N.

[0082] In one embodiment, the coated element further comprises a sliding layer (GL),

[0083] wherein the sliding layer is adjacent to the protective layer,

[0084] The sliding layer satisfies the condition a1 GL ≤[SiC3H9 + ] GL / [Si2O + ] GL ≤a2 GL , where a1 GL is 1.1, where a2 GL 1*10 10 , where [SiC3H9 + ] GL The sliding layer [SiC3H9 + ] ion counts, and among them [Si2O + ] GL The [Si2O + ] ion counts.

[0085] In one embodiment of the coated element comprising a smoothing layer (SL), a barrier layer (BL), a protective layer (PL) and a sliding layer (GL),

[0086] The smooth layer satisfies condition a1 SL ≤[Si2O + ] SL / [SiC3H9 + ] SL ≤a2 SL , where a1 SL is 1.0, where a2 SL is 1000, where [SiC3H9 + ] SL The [SiC3H9 + ] ion counts; among which [Si2O + ] SL The [Si2O + ] ion counts, and / or

[0087] The barrier layer satisfies condition a1 BL ≤[Si2O + ] BL / [SiC3H9 + ] BL ≤a2 BL , where a1 BL is 1, where a2 BL is 1000, where [SiC3H9 + ] BL The [SiC3H9 + ] ion counts, and among them [Si2O + ] BL is the [Si2O + ] ion counts, and / or

[0088] The protective layer meets condition a1 PL ≤[Si2O + ] PL / [SiC3H9 + ] PL ≤a2 PL , where a1 PL is 1.0, where a2 PL 1*10 5 , where [SiC3H9 + ] PL The protective layer [SiC3H9 +] ion counts, and among them [Si2O + ] PL The [Si2O + ] ion counts, and / or

[0089] The sliding layer satisfies condition a1 GL ≤[SiC3H9 + ] GL / [Si2O + ] GL ≤a2 GL , where a1 GL is 1.1, where a2 GL 1*10 5 , where [SiC3H9 + ] GL The sliding layer [SiC3H9 + ] ion counts, and among them [Si2O + ] GL The [Si2O + ] ion counts.

[0090] In one embodiment of the coated element comprising a smoothing layer (SL), a barrier layer (BL), a protective layer (PL) and a sliding layer (GL),

[0091] The smooth layer satisfies condition a1 SL ≤[Si2O + ] SL / [SiC3H9 + ] SL ≤a2 SL , where a1 SL is 1.0, where a2 SL is 1000, and / or

[0092] The barrier layer satisfies condition a1 BL ≤[Si2O + ] BL / [SiC3H9 + ] BL ≤a2 BL , where a1 BL is 1, where a2 BL is 1000, and / or

[0093] The protective layer meets condition a1 PL ≤[Si2O + ] PL / [SiC3H9 + ] PL ≤a2PL , where a1 PL is 1.0, where a2 PL 1*10 5 , and / or

[0094] The sliding layer satisfies condition a1 GL ≤[SiC3H9 + ] GL / [Si2O + ] GL ≤a2 GL , where a1 GL is 1.1, where a2 GL 1*10 5 ,

[0095] The thickness of the smoothing layer is 100 nm to 2000 nm, the thickness of the barrier layer is 5 nm to 500 nm, the protective layer has a thickness of 20 nm to 1000 nm, and the thickness of the sliding layer is 30 nm to 1000 nm.

[0096] In one embodiment of the coated element comprising a smoothing layer (SL), a barrier layer (BL), a protective layer (PL) and a sliding layer (GL),

[0097] The smooth layer satisfies condition a1 SL ≤[Si2O + ] SL / [SiC3H9 + ] SL ≤a2 SL , where a1 SL is 1.0, where a2 SL is 1000, and

[0098] The barrier layer satisfies condition a1 BL ≤[Si2O + ] BL / [SiC3H9 + ] BL ≤a2 BL , where a1 BL is 1, where a2 BL is 1000, and

[0099] The protective layer meets condition a1 PL ≤[Si2O + ] PL / [SiC3H9 + ] PL ≤a2 PL , where a1 PL is 1.0, where a2 PL 1*105 ,and

[0100] The sliding layer satisfies condition a1 GL ≤[SiC3H9 + ] GL / [Si2O + ] GL ≤a2 GL , where a1 GL is 1.1, where a2 GL 1*10 5 ,

[0101] The thickness of the smoothing layer is 100 nm to 2000 nm, and / or the thickness of the barrier layer is 5 nm to 500 nm, and / or the thickness of the protective layer is 20 nm to 1000 nm, and / or the thickness of the sliding layer is 30 nm to 1000 nm.

[0102] In one embodiment of the coated element comprising a smoothing layer (SL), a barrier layer (BL), a protective layer (PL) and a sliding layer (GL),

[0103] The smooth layer satisfies condition a1 SL ≤[Si2O + ] SL / [SiC3H9 + ] SL ≤a2 SL , where a1 SL is 1.0, where a2 SL is 1000, and / or

[0104] The barrier layer satisfies condition a1 BL ≤[Si2O + ] BL / [SiC3H9 + ] BL ≤a2 BL , where a1 BL is 1, where a2 BL is 1000, and / or

[0105] The protective layer meets condition a1 PL ≤[Si2O + ] PL / [SiC3H9 + ] PL ≤a2 PL , where a1 PL is 1.0, where a2 PL 1*10 5 , and / or

[0106] The sliding layer satisfies condition a1GL ≤[SiC3H9 + ] GL / [Si2O + ] GL ≤a2 GL , where a1 GL is 1.1, where a2 GL 1*10 5 ,

[0107] wherein the thickness of the smoothing layer is 100 nm to 2000 nm, wherein the thickness of the barrier layer is 5 nm to 500 nm, wherein the thickness of the protective layer is 20 nm to 1000 nm, and wherein the thickness of the sliding layer is 30 nm to 1000 nm,

[0108] The static friction coefficient and the sliding friction coefficient are both less than 10N.

[0109] In one embodiment of the coated element comprising a smoothing layer (SL), a barrier layer (BL), a protective layer (PL) and a sliding layer (GL),

[0110] The smooth layer satisfies condition a1 SL ≤[Si2O + ] SL / [SiC3H9 + ] SL ≤a2 SL , where a1 SL is 1.0, where a2 SL is 1000, and / or

[0111] The barrier layer satisfies condition a1 BL ≤[Si2O + ] BL / [SiC3H9 + ] BL ≤a2 BL , where a1 BL is 1, where a2 BL is 1000, and / or

[0112] The protective layer meets condition a1 PL ≤[Si2O + ] PL / [SiC3H9 + ] PL ≤a2 PL , where a1 PL is 1.0, where a2 PL 1*10 5 , and / or

[0113] The sliding layer satisfies condition a1 GL≤[SiC3H9 + ] GL / [Si2O + ] GL ≤a2 GL , where a1 GL is 1.1, where a2 GL 1*10 5 ,

[0114] wherein the thickness of the smoothing layer is 100 nm to 2000 nm, wherein the thickness of the barrier layer is 5 nm to 500 nm, wherein the thickness of the protective layer is 20 nm to 1000 nm, and wherein the thickness of the sliding layer is 30 nm to 1000 nm,

[0115] The static friction coefficient and the sliding friction coefficient are both between 1N and 10N.

[0116] In one embodiment, the coating element 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 a polypropylene (PP), more preferably a cyclic olefin copolymer (COC).

[0117] In a most preferred embodiment, the coating element consists of a cyclic olefin copolymer (COC) or a cyclic olefin polymer (COP).

[0118] In one embodiment of the coated element, the sliding layer satisfies one or more of the following parameters: GL ≤[SiC3H9 + ] GL / [Si2O + ] GL ≤a2 GL , where a1 GL is 1.1, where a2 GL 1*10 10 , where [SiC3H9 + ] GL The sliding layer [SiC3H9 + ] ion counts, and among them [Si2O + ] GL The [Si2O + ] ion counts, and -b1 GL ≤[SiC2H + ] GL / [SiO + ] GL ≤b2 GL , where b1GL is 1.1, where b2 GL is 1000, where [SiC2H + ] GL is the [SiC2H + ] ion counts, and among them [SiO + ] GL is the [SiO + ] ion counts.

[0119] In one embodiment of the coated element, the sliding layer satisfies one or more of the following parameters: GL ≤[SiC3H9 + ] GL / [Si2O + ] GL ≤a2 GL , where a1 GL is 1.1, where a2 GL 1*10 5 , where [SiC3H9 + ] GL The sliding layer [SiC3H9 + ] ion counts, and among them [Si2O + ] GL The [Si2O + ] ion counts, and -b1 GL ≤[SiC2H + ] GL / [SiO + ] GL ≤b2 GL , where b1 GL is 1.1, where b2 GL is 1000, where [SiC2H + ] GL is the [SiC2H + ] ion counts, and among them [SiO + ] GL is the [SiO + ] ion counts.

[0120] In one embodiment of the coated element, the protective layer satisfies one or more of the following parameters: PL ≤[Si2O + ] PL / [SiC3H9+ ] PL ≤a2 PL , where a1 PL is 1.0, where a2 PL 1*10 10 , where [SiC3H9 + ] PL The protective layer [SiC3H9 + ] ion counts, and among them [Si2O + ] PL The [Si2O + ] ion counts, and -b1 PL ≤[SiC2H + ] PL / [SiO + ] PL ≤b2 PL , where b1 PL is 0.5, where b2 PL 1*10 5 , where [SiC2H + ] PL The [SiC2H + ] ion counts, and among them [SiO + ] PL The [SiO + ] ion counts.

[0121] In one embodiment of the coated element, the protective layer satisfies one or more of the following parameters: PL ≤[Si2O + ] PL / [SiC3H9 + ] PL ≤a2 PL , where a1 PL is 1.0, where a2 PL 1*10 5 , where [SiC3H9 + ] PL The protective layer [SiC3H9 + ] ion counts, and among them [Si2O + ] PL The [Si2O + ] ion counts, and -b1 PL ≤[SiC2H + ]PL / [SiO + ] PL ≤b2 PL , where b1 PL is 0.5, where b2 PL 1*10 5 , where [SiC2H + ] PL The [SiC2H + ] ion counts, and among them [SiO + ] PL The [SiO + ] ion counts.

[0122] In one embodiment of the coated element, the barrier layer satisfies one or more of the following parameters: BL ≤[Si2O + ] BL / [SiC3H9 + ] BL ≤a2 BL , where a1 BL is 1, where a2 BL 1*10 5 , where [SiC3H9 + ] BL The [SiC3H9 + ] ion counts, and among them [Si2O + ] BL is the [Si2O + ] ion counts, and -b1 BL ≤[SiO + ] BL / [SiC2H + ] BL ≤b2 BL , where b1 BL is 1, where b2 BL 1*10 5 , where [SiC2H + ] BL is the [SiC2H + ] ion counts, among which [SiO + ] BL is the [SiO + ] ion counts.

[0123] In one embodiment of the coated element, the barrier layer satisfies one or more of the following parameters: BL ≤[Si2O + ] BL / [SiC3H9 + ] BL ≤a2 BL , where a1 BL is 1, where a2 BL is 1000, where [SiC3H9 + ] BL The [SiC3H9 + ] ion counts, and among them [Si2O + ] BL is the [Si2O + ] ion counts, and -b1 BL ≤[SiO + ] BL / [SiC2H + ] BL ≤b2 BL , where b1 BL is 1, where b2 BL 1*10 5 , where [SiC2H + ] BL is the [SiC2H + ] ion counts, among which [SiO + ] BL is the [SiO + ] ion counts.

[0124] In one embodiment of the coated element, the smoothing layer satisfies one or more of the following parameters: SL ≤[Si2O + ] SL / [SiC3H9 + ] SL ≤a2 SL , where a1 SL is 1.0, where a2 SL 1*10 5 , where [SiC3H9 + ] SL The [SiC3H9 + ] ion counts, among which [Si2O + ] SLThe [Si2O + ] ion counts, and -b1 SL ≤[SiC2H + ] SL / [SiO + ] SL ≤b2 SL , where b1 SL is 1.0, where b2 SL 1*10 5 , where [SiC2H + ] SL The [SiC2H + ] ion counts, among which [SiO + ] SL The [SiO + ] ion counts.

[0125] In one embodiment of the coated element, the smoothing layer satisfies one or more of the following parameters: SL ≤[Si2O + ] SL / [SiC3H9 + ] SL ≤a2 SL , where a1 SL is 1.0, where a2 SL is 1000, where [SiC3H9 + ] SL The [SiC3H9 + ] ion counts, among which [Si2O + ] SL The [Si2O + ] ion counts, and -b1 SL ≤[SiC2H + ] SL / [SiO + ] SL ≤b2 SL , where b1 SL is 1.0, where b2 SL 1*10 5 , where [SiC2H + ] SL The [SiC2H + ] ion counts, among which [SiO + ] SLThe [SiO + ] ion counts.

[0126] In one embodiment of the coated element, the thickness of the smoothing layer is from 1 nm to 25000 nm, or from 2 nm to 10000 nm, or from 5 nm to 5000 nm, or from 100 nm to 2000 nm, or from 150 nm to 1500 nm, or from 200 nm to 1000 nm, or from 250 nm to 500 nm.

[0127] In one embodiment of the coated element, the time required for the sputtering gun to reach the surface of the element is 0.5 minutes to 150 minutes, or 30 to 120 minutes, or 50 to 100 minutes; and / or wherein in the case of measuring cations, the time at which the sputtering gun reaches the surface of the element is when [Si2O + ] ion count is equal to [C3H5 + ] ion count; and / or in the case of measuring negative ions, the time when the sputtering gun reaches the surface of the element is when [C4H3 - ] ion count is equal to [SiO3 - ] The moment when the count of ions is obtained; and / or the count of these ions, preferably the count of these cations and anions, can be obtained by the method described in the specification.

[0128] In one embodiment of the coated element, the element is a pharmaceutical container comprising an inner surface, wherein the inner surface is coated, wherein the smooth layer is in direct contact with the coated element, wherein the slip layer, when present, is the outermost layer.

[0129] In one embodiment of the coated element, 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 ;and

[0130] Among them [SiO3 - ] GLThe [SiO3 - ] ion counts;

[0131] Among them [SiO3 - ] PL The [SiO3 - ] ion counts;

[0132] Among them [SiO3 - ] BL is the [SiO3 - ] ion counts;

[0133] Among them [SiO3 - ] SL The [SiO3 - ] ion counts.

[0134] In one aspect, the present disclosure provides a system or kit comprising: a coated element according to the present disclosure, wherein the element is a syringe or cartridge; a plunger, preferably a plunger rod; and optionally a closure, preferably a tip cap and / or a needle shield.

[0135] In one aspect, the present disclosure provides a closure system comprising: a coated element according to the present disclosure, wherein the element is a syringe or a cartridge; a plunger, preferably a plunger rod; and a closure, preferably a tip cover and / or a needle shield, wherein the closed coated element passes the container closure integrity test according to DIN EN ISO 8871-5:2016; Chapter 4.4 in combination with Appendix D.

[0136] In one embodiment, the closed system comprises a composition, preferably a pharmaceutical composition, preferably a composition comprising a biologic or mRNA.

[0137] In one aspect, the present disclosure provides a method for coating a component, preferably, a method for coating a coated component according to the present disclosure, comprising the following steps: (1) providing a component 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,

[0138] wherein each of steps (2) to (4) comprises surrounding at least a portion of the surface of the component with a precursor, and

[0139] Each of steps (2) to (4) comprises irradiating the precursor using a PICVD method to generate a plasma,

[0140] Wherein step (3) comprises establishing an O2 flow rate of greater than 10 sccm during irradiation of the precursor.

[0141] Sliding layer

[0142] In one embodiment of the coated element, the sliding layer meets the following parameters: a1 GL ≤[SiC3H9 + ] GL / [Si2O + ] GL ≤a2 GL ;

[0143] where a1 GL 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;

[0144] where a2 GL 1*10 10 , preferably 1*10 5 , more preferably 1000, more preferably 800, more preferably 600, more preferably 500;

[0145] Among them [SiC3H9 + ] GL The sliding layer [SiC3H9 + ] ion counts; and

[0146] Among them [Si2O + ] GL The [Si2O + ] ion counts.

[0147] 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 1*10 10 , preferably 1*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 1*1010 In one embodiment, a1 GL is 2, and a2 GL 1*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.

[0148] In one embodiment of the coated element, the sliding layer meets the following parameters: b1 GL ≤[SiC2H + ] GL / [SiO + ] GL ≤b2 GL ;

[0149] where b1 GL 1.1, preferably 1.2, more preferably 1.5, more preferably 1.8, more preferably 2.0, more preferably 2.3;

[0150] where b2 GL 1000, preferably 100, more preferably 10, more preferably 5, more preferably 4, more preferably 3, more preferably 2.5;

[0151] Among them [SiC2H + ] GL The [SiC2H + ] ion counts; and

[0152] Among them [SiO + ] GL The [SiO + ] ion counts.

[0153] 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. In one embodiment, b1 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, b1GL is 2.3, and b2 GL is 2.5.

[0154] In one embodiment of the coated element, the sliding layer meets the following parameters: c1 GL ≤[SiC3H9 + ] GL / [SiO + ] GL ≤c1 GL ;

[0155] where c1 GL 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;

[0156] where c2 GL 1*10 10 , preferably 1*10 5 , more preferably 1000, more preferably 800, more preferably 600, more preferably 500;

[0157] Among them [SiC3H9 + ] GL The sliding layer [SiC3H9 + ] ion counts; and

[0158] Among them [SiO + ] GL The [SiO + ] ion counts.

[0159] 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 1*10 10 , preferably 1*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 1*10 10 In one embodiment, c1 GL is 2, and c2 GL 1*10 5 In one embodiment, c1GL is 5, and c2 GL is 1000. In one embodiment, c1 GL is 400, and c2 GL is 500.

[0160] In one embodiment of the coated element, the sliding layer meets the following parameters: d1 GL ≤[SiCH3O - ] GL / [SiO3 - ] GL ≤d1 GL ;

[0161] where d1 GL 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;

[0162] where d2 GL 1*10 10 , preferably 1*10 5 , more preferably 1000, more preferably 200, more preferably 100, more preferably 50, more preferably 30;

[0163] Among them [SiCH3O - ] GL The [SiCH3O - ] ion counts; and

[0164] Among them [SiO3 - ] GL The [SiO3 - ] ion counts.

[0165] 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 1*10 10 , preferably 1*10 5 , 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 1*10 10 In one embodiment, d1 GLis 2, and d2 GL 1*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.

[0166] In one embodiment of the coated element, the sliding layer meets the following parameters: e1 GL ≤[SiCH3O2 - ] GL / [SiO3 - ] GL ≤e1 GL ;

[0167] where e1 GL 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;

[0168] where e2 GL 1*10 10 , preferably 1*10 5 , more preferably 1000, more preferably 200, more preferably 100, more preferably 50, more preferably 30;

[0169] Among them [SiCH3O2 - ] GL The [SiCH3O2 - ] ion counts; and

[0170] Among them [SiO3 - ] GL The [SiO3 - ] ion counts.

[0171] 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 1*10 10 , preferably 1*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 e2GL 1*10 10 In one embodiment, e1 GL is 2, and e2 GL 1*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.

[0172] In one embodiment of the coated element, the sliding layer has a thickness of 10 nm to 10000 nm, or 15 nm to 5000 nm, or 20 nm to 2000 nm, or 30 nm to 1000 nm, or 40 nm to 500 nm, or 50 nm to 200 nm.

[0173] Protective layer

[0174] In one embodiment of the coated element, the protective layer comprises silicone, preferably: i) linear silicone; preferably linear polydimethylsiloxane, 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 comprising any one of i) to iii).

[0175] In one embodiment of the coated element, the protective layer meets the following parameters: a1 PL ≤[Si2O + ] PL / [SiC3H9 + ] PL ≤a2 PL ;

[0176] where a1 PL 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;

[0177] where a2 PL 1*10 10 , preferably 1*105 , more preferably 100, more preferably 20, more preferably 15, more preferably 10, more preferably 7;

[0178] Among them [SiC3H9 + ] PL The protective layer [SiC3H9 + ] ion counts; and

[0179] Among them [Si2O + ] PL The [Si2O + ] ion counts.

[0180] 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. In one embodiment, a2 PL 1*10 10 , preferably 1*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 1*10 10 In one embodiment, a1 PL is 2.0, and a2 PL 1*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.

[0181] In one embodiment of the coated element, the protective layer meets the following parameters: b1 PL ≤[SiC2H + ] PL / [SiO + ] PL ≤b2 PL ;

[0182] Among them [SiC2H + ] PL The [SiC2H + ] ion counts; and

[0183] Among them [SiO+ ] PL The [SiO + ] ion counts; and

[0184] where b1 PL is 0.5, preferably 0.8, more preferably 1.0, more preferably 1.1, more preferably 1.2; and

[0185] where b2 PL 1*10 5 , preferably 100, more preferably 25, more preferably 15, more preferably 5, more preferably 2, more preferably 1.5.

[0186] 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 1*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 1*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.

[0187] In one embodiment of the coated element, the protective layer meets the following parameters: c1 PL ≤[SiO + ] PL / [SiC3H9 + ] PL ≤c1 PL ;

[0188] where c1 PL 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;

[0189] where c2 PL 1*10 5 , preferably 100, more preferably 25, more preferably 20, more preferably 15, more preferably 4, more preferably 2.5;

[0190] Among them [SiC3H9 + ]PL The protective layer [SiC3H9 + ] ion counts; and

[0191] Among them [SiO + ] PL The [SiO + ] ion counts.

[0192] 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 1*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 In one embodiment, c1 PL is 1.0, and c2 PL is 100. In one embodiment, c1 PL is 0.5, and c2 PL 1*10 5 .

[0193] In one embodiment of the coated element, the protective layer has a thickness of 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.

[0194] Barrier layer

[0195] In one embodiment of the coated element, the barrier layer meets the following parameters: a1 BL ≤[Si2O + ] BL / [SiC3H9 + ] BL ≤a2 BL ;

[0196] where a1 BL is 1, preferably 2, more preferably 4, more preferably 10, more preferably 15, more preferably 20, more preferably 25; and

[0197] where a2 BL 1*10 5, preferably 1000, more preferably 500, more preferably, 250, more preferably 150, more preferably 100, more preferably 50;

[0198] Among them [SiC3H9 + ] BL The barrier layer [SiC3H9 + ] ion counts; and

[0199] Among them [Si2O + ] BL The [Si2O + ] ion counts.

[0200] 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 1*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 1*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.

[0201] In one embodiment of the coated element, the barrier layer meets the following parameters: b1 BL ≤[SiO + ] BL / [SiC2H + ] BL ≤b2 BL ;

[0202] where b1 BL is 1, preferably 5, more preferably 10, more preferably 20, more preferably 30, more preferably 40, more preferably 45; and

[0203] where b2 BL 1*10 5, preferably 1000, more preferably 500, more preferably 250, more preferably 150, more preferably 100, more preferably 80;

[0204] Among them [SiC2H + ] BL The [SiC2H + ] ion counts; and

[0205] Among them [SiO + ] BL The [SiO + ] ion counts.

[0206] 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 1*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 1*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.

[0207] In one embodiment of the coated element, the barrier layer meets the following parameters: c1 BL ≤[SiO + ] BL / [SiC3H9 + ] BL ≤c1 BL ;

[0208] where c1 BL is 1, preferably 5, more preferably 10, more preferably 50, more preferably 75, more preferably 100, more preferably 110; and

[0209] where c2 BL 1*10 5, preferably 1000, more preferably 500, more preferably 400, more preferably 300, more preferably 200, more preferably 150;

[0210] Among them [SiC3H9 + ] BL The barrier layer [SiC3H9 + ] ion counts; and

[0211] Among them [SiO + ] BL The [SiO + ] ion counts.

[0212] 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 1*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 1*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.

[0213] In one embodiment of the coated element, the barrier layer has a thickness of from 1 nm to 1000 nm, or from 5 nm to 500 nm, or from 10 nm to 200 nm, or from 20 nm to 150 nm.

[0214] Smooth Layer

[0215] In one embodiment of the coated element, the smoothing layer meets the following parameters: a1 SL ≤[Si2O + ] SL / [SiC3H9 + ] SL ≤a2 SL ;

[0216] where a1 SL 1.0, preferably 2.0, preferably 4.0, more preferably 6.0, more preferably 8.0, more preferably 9.0, more preferably 10.0;

[0217] where a2 SL 1*10 5 , preferably 1000, preferably 500, more preferably 250, more preferably 100, more preferably 50, more preferably 25, more preferably 15;

[0218] Among them [SiC3H9 + ] SL For the smooth layer [SiC3H9 + ] ion counts; and

[0219] Among them [Si2O + ] SL The [Si2O + ] ion counts.

[0220] 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 1*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 1*10 5 In one embodiment, a1 SL is 2.0, and a2 SL is 1000. In one embodiment, a1 SL is 6.0, and a2 SL is 250. In one embodiment, a1 SL is 10.0, and a2 SL is 15.

[0221] In one embodiment of the coated element, the smoothing layer meets the following parameters: b1 SL ≤[SiC2H + ] SL / [SiO + ] SL ≤b2 SL ;

[0222] Among them [SiC2H + ] SL The [SiC2H + ] ion counts; and

[0223] Among them [SiO + ] SL The [SiO + ] ion counts; and

[0224] where b1 SL 1.0, preferably 2.0, more preferably 2.5, more preferably 3.0, more preferably 3.5, more preferably 4.0;

[0225] where b2 SL 1*10 5 , preferably 100, more preferably 25, more preferably 20, more preferably 15, more preferably 9, more preferably 7.

[0226] 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 1*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 1*10 5 In 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.

[0227] In one embodiment of the coated element, the smoothing layer meets the following parameters: c1 SL ≤[SiO + ] SL / [SiC3H9 + ] SL ≤c1 SL ;

[0228] where c1 SL 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;

[0229] where c2 PL 1*10 5, preferably 100, more preferably 25, more preferably 20, more preferably 15, more preferably 4, more preferably 2.5;

[0230] Among them [SiC3H9 + ] SL For the smooth layer [SiC3H9 + ] ion counts; and

[0231] Among them [SiO + ] SL The [SiO + ] ion counts.

[0232] 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 1*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 1*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.

[0233] In one embodiment of the coated element, the smoothing layer meets the following parameters: x1 SL ≤[SiC2H + ] SL / [C3H5 + ] SL ≤x2 SL ;

[0234] Among them [SiC2H + ] SL The [SiC2H + ] ion counts; and

[0235] Among them [C3H5 + ] SL The [C3H5 + ] ion counts; and

[0236] where x1 SL is 1, preferably 2, more preferably 10, more preferably 50, more preferably 100; and

[0237] where x2 SL 1*10 10 , preferably 1*10 5 , more preferably 1*10 4 , more preferably 1*10 3 .

[0238] In one embodiment, x1 SL is 1, preferably 2, more preferably 10, more preferably 50, more preferably 100. In one embodiment, x2 SL 1*10 10 , preferably 1*10 5 , more preferably 1*10 4 , more preferably 1*10 3 In one embodiment, x1 SL is 1, and x2 SL 1*10 10 In one embodiment, x1 SL is 10, and x2 SL 1*10 5 In one embodiment, x1 SL is 100, and x2 SL 1*10 3 .

[0239] In one embodiment of the coated element, the smoothing layer meets the following parameters: y1 SL ≤[Si2O + ] SL / [C3H5 + ] SL ≤y2 SL ;

[0240] Among them [Si2O + ] SL The [Si2O + ] ion counts;

[0241] Among them [C3H5 + ] SL The [C3H5 + ] ion counts;

[0242] where y1 SLis 1, preferably 5, more preferably 20, more preferably 50, more preferably 100; and

[0243] where y2 SL 1*10 10 , preferably 1*10 5 , more preferably 1*10 4 , more preferably 1*10 3 .

[0244] In one embodiment, y1 SL is 1, preferably 5, more preferably 20, more preferably 50, more preferably 100. In one embodiment, y2 SL 1*10 10 , preferably 1*10 5 , more preferably 1*10 4 , more preferably 1*10 3 In one embodiment, y1 SL is 1, and y2 SL 1*10 10 In one embodiment, y1 SL is 5, and y2 SL 1*10 5 In one embodiment, y1 SL is 100, and y2 SL 1*10 3 .

[0245] In one embodiment of the coated element, the smoothing layer meets the following parameters: z1 SL ≤[SiO + ] SL / [C3H5 + ] SL ≤z2 SL ;

[0246] Among them [SiO + ] SL The [SiO + ] ion counts;

[0247] Among them [C3H5 + ] SL The [C3H5 + ] ion counts;

[0248] where z1 SL is 1, preferably 5, more preferably 20, more preferably 50, more preferably 70; and

[0249] where z2 SL 1*10 10 , preferably 1*10 5 , more preferably 1*10 4 , more preferably 1*10 3 .

[0250] In one embodiment of the coated element, the thickness of the smoothing layer is 1 nm to 20000 nm, preferably 5 nm to 5000 nm, more preferably 100 nm to 2000 nm, more preferably 150 nm to 1500 nm, more preferably 200 nm to 1000 nm, more preferably 250 nm to 500 nm.

[0251] In one embodiment, z1 SL is 1; preferably 5, more preferably 20, more preferably 50, more preferably 70. In one embodiment, z2 SL 1*10 10 , preferably 1*10 5 , more preferably 1*10 4 , more preferably 1*10 3 In one embodiment, z1 SL is 1, and z2 SL 1*10 10 In one embodiment, z1 SL is 5, and z2 SL 1*10 5 In one embodiment, z1 SL is 70, and z2 SL 1*10 3 .

[0252] Coating components

[0253] In one embodiment of the coated element, one or both of the following equations are satisfied: R3≤t SL / t CO ; and / or t SL / t CO ≤R4;

[0254] where t SL is the time it takes for the sputtering to penetrate the smooth layer; and

[0255] where t CO is the time for the sputtering to penetrate the coating;

[0256] wherein 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

[0257] wherein 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.

[0258] In one embodiment of the coated component, the time required for the sputtering gun to reach the surface of the component is 0.5 minutes to 150 minutes, preferably 30 minutes to 120 minutes, more preferably 50 minutes to 100 minutes; and / or

[0259] In the case of measuring cations, the moment when the sputtering gun reaches the surface of the element is when [Si2O + ] ion count is equal to [C3H5 + ] the moment when the ions are counted; and / or

[0260] In the case of measuring anions, the moment when the sputtering gun reaches the surface of the element is when [C4H3 - ] ion count is equal to [SiO3 - ] the moment when the ions are counted; and / or

[0261] The counts of the ions, preferably the cations and anions, can be obtained by the methods described in the specification.

[0262] In one embodiment of the coated element, at least a portion of the element is 10% to 90%, preferably 20% to 80%, more preferably 30% to 70%, more preferably 40% to 60% of the surface of the element.

[0263] In one embodiment of the coated element, the element is a drug container comprising an inner surface, and

[0264] Wherein at least a portion of the surface comprises at least a portion of an inner surface of the drug container, preferably comprises the inner surface of the drug container, more preferably is the inner surface of the drug container.

[0265] In one embodiment of the coated component, the smoothing layer is in direct contact with the component.

[0266] In one embodiment of the coated element, the sliding layer is the outermost layer.

[0267] In one embodiment of the coated element, the element comprises a partially uncoated surface, and

[0268] One or both of the following equations are satisfied: R1≤T SL / SRz; and / or T SL / SRz≤R2;

[0269] wherein 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

[0270] wherein 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;

[0271] Where T SL is the thickness of the smoothing layer in at least a portion of the coating; and

[0272] Wherein SRz is the surface roughness depth of at least a portion of the partially uncoated surface of the element.

[0273] In one embodiment of the coated element, the roughness SRz of the partially uncoated surface of the element is 1 nm to 5000 nm, 10 nm to 3000 nm, 50 nm to 2000 nm, 70 nm to 1000 nm, or 100 nm to 500 nm. In one embodiment of the coated element, the roughness SRz of the partially uncoated surface of the element 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 element, the roughness SRz of the partially uncoated surface of the element is 5000 nm or less, 3000 nm or less, 2000 nm or less, 1000 nm or less, or 500 nm or less.

[0274] In one embodiment of the coated element, the sliding layer, protective layer, barrier layer and / or smoothing layer comprises SiO x C y ,

[0275] wherein x is from 0.3 to 3.0, preferably from 0.5 to 2.0, more preferably from 0.9 to 1.5, and / or

[0276] wherein y is from 0 to 6.0, preferably from 0.5 to 4.0, more preferably from 2.5 to 3.5.

[0277] In one embodiment of the coated element, 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 ;

[0278] Among them [SiO3 - ] GL The [SiO3 - ] ion counts;

[0279] Among them [SiO3 - ] PL The [SiO3 - ] ion counts;

[0280] Among them [SiO3 - ] BL is the [SiO3 - ] ion counts;

[0281] Among them [SiO3 - ] SL The [SiO3 - ] ion counts.

[0282] In one embodiment of the coated element, 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 ;

[0283] Among them [SiC - ] GL The [SiC - ] ion counts;

[0284] Among them [SiC - ] PL The [SiC - ] ion counts;

[0285] Among them [SiC - ] BL The [SiC - ] ion counts;

[0286] Among them [SiC - ] SL The [SiC - ] ion counts.

[0287] In one embodiment of the coated element, one or more of the following conditions are met: [SiC2H + ] BL <[SiC2H + ] SL ; [SiC2H + ] GL <[SiC2H + ] SL ; [SiC2H + ] BL <[SiC2H + ] PL ; [SiC2H + ] GL <[SiC2H + ] PL ; and / or [SiC2H + ] GL >[SiC2H + ] BL ;

[0288] Among them [SiC2H+ ] GL is the [SiC2H + ] ion counts;

[0289] Among them [SiC2H + ] PL The [SiC2H + ] ion counts;

[0290] Among them [SiC2H + ] BL is the [SiC2H + ] ion counts;

[0291] Among them [SiC2H + ] SL The [SiC2H + ] ion counts.

[0292] In one embodiment of the coated element, 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 ;

[0293] Among them [SiO + ] GL is the [SiO + ] ion counts;

[0294] Among them [SiO + ] PL The [SiO + ] ion counts;

[0295] Among them [SiO +] BL is the [SiO + ] ion counts;

[0296] Among them [SiO + ] SL The [SiO + ] ion counts.

[0297] In one embodiment of the coated element, the coating has a thickness of 1 nm to 1 mm, 10 nm to 0.5 mm, 200 nm to 2000 nm, or 500 nm to 1500 nm.

[0298] In one embodiment of the coated element, the smoothing layer, barrier layer, protective layer and / or sliding layer comprises, preferably consists of, the elements Si, O and C, measured by XPS, more preferably all layers comprise, preferably consist of, the elements Si, O and C.

[0299] In one embodiment of the coating element, the static friction of the coating element 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 coating element, the static friction of the coating element is 1 N or more, 1.5 N or more, or 2.0 N or more. In one embodiment of the coating element, the static friction of the coating element is 18 N or less, 10 N or less, 7 N or less, or 5 N or less.

[0300] In one embodiment of the coating element, the sliding force of the coating element is 0.1N to 10.0N, preferably 0.3N to 7.0N, more preferably 0.4N to 5.0N, more preferably 0.5N to 4.0N, more preferably 1.0N to 3.0N. In one embodiment of the coating element, the sliding force of the coating element is 0.1N or more, 0.3N or more, 0.4N or more, 0.5N or more, or 1.0N or more. In one embodiment of the coating element, the sliding force of the coating element is 10.0N or less, 7.0N or less, 5.0N or less, 4.0N or less, or 3.0N or less.

[0301] In one embodiment of the coated element, one or more of the following formulas are satisfied: BF7 / BF1≤bf; and / or BF28 / BF1≤bf; and / or BF28 / BF7≤bf;

[0302] Where BF1 is the static friction after 1 day,

[0303] Where BF7 is the static friction after 7 days,

[0304] Where BF28 is the static friction after 28 days,

[0305] wherein 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.

[0306] In one embodiment of the coated element, a smoothing layer, a barrier layer, a protective layer and / or a sliding layer, more preferably all layers, can be obtained according to any of the following methods.

[0307] System or Kit

[0308] In one aspect, a system or kit is provided, the system or kit comprising: The coated element according to the present disclosure, wherein the element is a syringe or a cartridge, and a plunger, preferably a plunger and a plunger rod; Preferably a closure, more preferably a tip cover and / or a needle shield.

[0309] Closed system

[0310] In one aspect, there is provided a closed system comprising: The coated element according to the present disclosure, wherein the element is a syringe or a cartridge, and a plunger, preferably a plunger rod; Preferably a closure, more preferably a pointed cap and / or a needle shield; and wherein the closed coated element passes the container closure integrity test according to DIN EN ISO 8871-5:2016; Chapter 4.4 in combination with Annex D.

[0311] In one embodiment, the closed system comprises a composition, preferably a pharmaceutical composition, more preferably a composition comprising a biologic or mRNA.

[0312] method

[0313] In one aspect, there is provided a method for coating a component, preferably a method for obtaining a coated component according to the present disclosure, comprising the steps of: - providing an element comprising a surface; - applying one or more layers, preferably a smoothing layer, a barrier layer, a protective layer and optionally a sliding layer; by a coating process carried out on at least a portion of the surface, comprising the following steps: a) surrounding at least a portion of the surface of the component with a precursor; and b) irradiating the precursor to generate a plasma.

[0314] In one embodiment of the method, the coating process is a plasma enhanced chemical vapor deposition (PECVD) process, a plasma pulsed chemical vapor deposition (PICVD) process or a plasma assisted chemical vapor deposition (PACVD) process, preferably a plasma pulsed chemical vapor deposition (PICVD) process.

[0315] In a most preferred embodiment of the method, the coating process is a plasma pulsed chemical vapor deposition (PICVD) process.

[0316] In one embodiment of the method, the precursor includes hexamethyldisiloxane (HMDSO), hexamethyldisilazane (HMDSN), tetramethylsilane (TMS), trimethylboroxane (TMB), tris(dimethylaminosilyl)-amino-bis(dimethylamino)borane (TDADB), tris(trimethylsilyl)borate (TMSB), hexamethylcyclotrisiloxane (HMCTSO), octamethylcyclotetrasiloxane (OMCTS), decamethylcyclopentasiloxane (DMCPS), dodecamethylcyclohexasiloxane (DMCHS), diacetoxy-di-tert-butoxysilane (DADBS), tetraethoxysilane (TEOS), tris(trimethylsilyloxy)vinylsilane (TTMSVS), vinyltriethoxysilane (VTES) and / or a combination thereof. Preferably, the precursor is HMDSO.

[0317] In one embodiment of the method, the precursor comprises, preferably consists of, the elements Si, C, O and H.

[0318] In one embodiment of the method, with regard to the application of the smoothing layer, barrier layer, protective layer and / or sliding layer, one or more of the following conditions are met: i. wherein the coating process is a plasma pulse chemical vapor deposition (PICVD) process, ii. wherein the irradiation is performed by a microwave generator, preferably, wherein the frequency of the radiation is 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. wherein the input power IP, preferably the input power of the microwave generator, is 100 W to 10000 W, preferably 300 W to 9000 W, more preferably 500 W to 8000 W, more preferably 700 W to 6000 W, more preferably 900 W to 4000 W, more preferably 1100 W to 2000 W; and / or iv. wherein the precursor P comprises hexamethyldisiloxane (HMDSO), hexamethyldisilazane (HMDS), tetramethylsilane (TMS), trimethylboroxane (TMB), tris(dimethylaminosilyl)-amino-bis(dimethylamino)- At least one of trimethylsilyl) borane (TDADB), tris(trimethylsilyl) borate (TMSB), hexamethylcyclotrisiloxane (HMCTSO), octamethylcyclotetrasiloxane (OMCTS), decamethylcyclopentasiloxane (DMCPS), dodecamethylcyclohexasiloxane (DMCHS), diacetoxy-di-tert-butoxysilane (DADBS), tetraethoxysilane (TEOS), tris(trimethylsiloxy)vinylsilane (TTMSVS), vinyltriethoxysilane (VTES) and / or a combination thereof, preferably, the precursor P is HMDSO; and / or In addition to the precursor P, a gas, preferably oxygen, is also fed in.

[0319] It has long been accepted that the frequency of the sustained high-frequency discharge has a considerable influence on the properties of the plasma (Moisan, M., Barbeau, C., Claude, R., Ferreira, CM, Margot, J., Paraszczak, J., Sá, AB, Sauvé, G. and Wertheimer, MR (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 high-frequency power density, the electron density produced by deposition into the plasma at microwave frequencies is higher than that produced at radio frequencies. Based on their studies, the authors have determined that converting the plasma process from 13.56 MHz to 2450 MHz does not necessarily lead to the maximum possible process intensification and that optimization may require constructing the plasma reactor in a way that allows changing the excitation frequency.

[0320] The latter task of (re)configuring the plasma reactor to allow changing the excitation frequency is by no means trivial and, to the best of the applicant's knowledge, has not been performed so far nor shared as public knowledge.

[0321] Pulsed microwave plasmas with low pulse frequencies (e.g., about 100 Hz) and low duty cycles (D≤0.1) as employed in the present disclosure are advantageous for optical and other functional coatings. In the PICVD process, a dielectric substrate can typically be placed directly on a microwave window while a very dense plasma is formed near the substrate during very short pulses, typically 1 ms to 100 ms in duration, at relatively high pressures on the order of less than about 1 Torr.

[0322] Radjef et al. (Characterizing a Custom-Built Radio Frequency PECVDReactor to Vary the Mechanical Properties of TMDSO Films. Molecules 26, 2021, 5621) studied the comparison between radio frequency (RF) PECVD and microwave (MW) PECVD for the deposition of organosiloxane films based on TMDSO as a precursor, and found that most MW TMDSO films were slightly smoother than RF TMDSO films, with R q As low as 0.4nm. In general, higher concentrations of O2 in the system lead to fragmentation of larger TMDSO molecules. It is speculated that higher concentrations of O2 lead to effective cleavage of the methyl groups, leaving relatively bare O-Si-O backbones, and this fragmentation produces a harder, more "silica-like" film with a cross-linked O-Si-O network.

[0323] The inventors of the present disclosure have determined processes and process conditions that maintain the integrity of the selected precursors to a large extent. The layer structure of the coated element includes a smoothing layer (SL), a barrier layer (BL), a protective layer (PL) and optionally a sliding layer (GL) in the following order. The coated element can be a polymer substrate. Each of the layers is chemically different and is characterized by detecting specific ToF-SIMS species, namely SiC in negative ion mode. - 、C4 - 、C4H3 - 、SiCH3O - and SiO3 - , and C3H5 in positive ion mode + 、SiO + 、SiC2H + 、SiC2H3 + 、Si2O +、SiC3H9 + and CH3 + In addition to the chosen precursor, the exact qualitative and quantitative characteristics depend on the PICVD parameters adopted in each of the four deposition steps (1 to 4) and the sputtering and analysis parameters measured by ToF-SIMS (see Figure 1B and Figure 1C ).

[0324] Without being bound by theory, as part of the PICVD process, all pulse durations PD LAYER [ms] and all pulse pause time PP LAYER The ratio of [ms / ms] is an important parameter for controlling and regulating the deposition of each of the three or four individual layers. This parameter can alternatively be expressed as a "duty cycle" or "power cycle", which is the fraction of a cycle that a signal or system is active. The duty cycle can be expressed as a percentage or a ratio. The cycle is defined as the time it takes for a signal to complete an on and off cycle.

[0325] In an advantageous embodiment of the method, the smoothing layer is applied with all pulse durations PD SL [ms] and all pulse pause time PP SL The ratio [ms / ms] is 0.01 to 0.5, the blocking layer is applied for all pulse durations PD BL [ms] and all pulse pause time PP BL The ratio [ms / ms] of [ms] is 0.01 to 1, preferably 0.1 to 0.8, and / or the protective layer is applied with all pulse durations PD PL [ms] and all pulse pause time PP PL The ratio [ms / ms] of [ms] is 0.001 to 1, preferably 0.01 to 0.5.

[0326] In one embodiment of the method, for applying the smoothing layer, one or more of the following conditions are met: i. Where the process temperature PT SL 15°C to 150°C, 20°C to 80°C, or 25°C to 40°C; and / or ii. The plasma pulse duration PD SL 0.0001 ms to 1.5 ms, 0.1 ms to 1.2 ms, or preferably 0.3 ms to 0.8 ms; and / or iii. Pulse pause time PP between two pulses SL 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 irradiation time TT SL 1s to 50s, 2s to 20s, 3s to 10s, or 4s to 7s; and / or v. All pulse durations PD SL [ms] and all pulse pause time PP SL [ms] ratio [ms / ms] is 0.001 to 1, 0.01 to 0.5, or 0.03 to 0.08; and / or vi. Where process pressure PR SL L is 0.1 mbar to 100 mbar, 0.3 mbar to 10 mbar, 0.5 mbar to 3.0 mbar, or 0.5 mbar to 0.8 mbar; and / or vii. wherein the flow rate of the precursor P is 1 sccm to 200 sccm, 5 sccm to 100 sccm, or 15 sccm to 30 sccm, Therein, no further substances (such as gases) are supplied besides the precursors.

[0327] In one embodiment of the method, for applying the barrier layer, one or more of the following conditions are met: i. Where the process temperature PT BL 15°C to 200°C, or 25°C to 70°C; and / or ii. wherein the pulse duration PD of the plasma BL 0.5 ms to 50 ms, 1.0 ms to 10 ms, or 1.5 ms to 2.5 ms; and / or iii. Pulse pause time PP between two pulses BL 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 irradiation time TT BL 1s to 50s, 3s to 30s, 5s to 15s, or 6s to 12s; and / or v. All pulse durations PD BL [ms] and all pulse pause time PP BL The ratio [ms / ms] is from 0.01 to 1, preferably from 0.1 to 0.8, more preferably from 0.3 to 0.6; and / or vi. Where process pressure PR BL L is 0.01 mbar to 10 mbar, 0.1 mbar to 5 mbar, 0.2 mbar to 3.0 mbar, or 0.25 mbar to 0.8 mbar; and / or vii. wherein the flow rate of the precursor P is 0.01 sccm to 20 sccm, 0.1 sccm to 5.0 sccm, or 0.3 sccm to 0.9 sccm, wherein, in addition to the precursor, oxygen is supplied and the flow rate of oxygen is 0.1 sccm to 100 sccm, 5 sccm to 80 sccm, or 30 sccm to 50 sccm.

[0328] In one embodiment of the method, for applying the protective layer, one or more of the following conditions are met: i. Where the process temperature PT PL 15°C to 150°C, 30°C to 100°C, or 40°C to 70°C; and / or ii. The plasma pulse duration PD PL 0.001 ms to 1.5 ms, 0.01 ms to 1.0 ms, or 0.3 ms to 0.8 ms; and / or iii. Pulse pause time PP between two pulses PL 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 irradiation time TT PL 0.1s to 20s, 0.3s to 10s, 0.7s to 8s, or 0.8s to 1.2s; and / or v. All pulse durations PD PL [ms] and all pulse pause time PP PL The ratio [ms / ms] is from 0.001 to 1, preferably from 0.01 to 0.5, more preferably from 0.03 to 0.08; and / or vi. Where process pressure PR PL L is 0.1 mbar to 100 mbar, 0.1 mbar to 20 mbar, 0.3 mbar to 1.0 mbar, or 0.5 mbar to 0.8 mbar; and / or vii. Precursor P PL The flow rate of is 1 sccm to 200 sccm, 5 sccm to 40 sccm, or 10 sccm to 20 sccm, wherein oxygen is supplied in addition to the precursor, and the flow rate of the gas is 0.1 sccm to 100 sccm, preferably 2 sccm to 30 sccm, and more preferably 4 sccm to 8 sccm.

[0329] In one embodiment of the method, one or more of the following conditions are met for applying the sliding layer: i. Where the process temperature PT GL15°C to 150°C, 25°C to 100°C, or 40°C to 70°C; and / or ii. The plasma pulse duration PD GL 0.001 ms to 1.5 ms, 0.01 ms to 0.8 ms, or 0.02 ms to 0.1 ms; and / or iii. Pulse pause time PP between two pulses GL 0.001ms to 100ms, 0.01ms to 20ms, 0.1ms to 10ms, 0.3ms to 3ms; and / or iv. Total irradiation time TT GL 1s to 50s, 3s to 30s, 5s to 15s, or 6s to 10s; and / or v. All pulse durations PD GL [ms] and all pulse pause time PP GL The ratio [ms / ms] is from 0.001 to 1, preferably from 0.01 to 0.5, more preferably from 0.02 to 0.08; and / or vi. Where process pressure PR GL L is 0.1 mbar to 100 mbar, 0.2 mbar to 10 mbar, 0.3 mbar to 1.5 mbar, or 0.6 mbar to 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, In this case, apart from the precursors, no further substances are supplied.

[0330] Method (Alternative Embodiment)

[0331] In one aspect, there is provided a method for coating a component, preferably a method for obtaining a coated component according to the present disclosure, comprising the steps of: - providing an element comprising a surface; - Applying a smoothing layer, a barrier layer, a protective layer and optionally a sliding layer; by a coating process carried out on at least a portion of the surface, comprising the steps of: a) surrounding at least a portion of the surface of the component with a precursor; and b) irradiating the precursor to generate a plasma,

[0332] The following conditions are met: i. the coating process is a plasma pulse chemical vapor deposition (PICVD) process, ii. the irradiation is carried out by a microwave generator, wherein the frequency of the radiation is MHz to 3 GHz, more preferably 2.45 GHz; and / or iii. The input power IP of the microwave generator is 900W to 2000W; and / or iv. wherein the precursor P comprises at least one of hexamethyldisiloxane (HMDSO), hexamethyldisilazane (HMDS), tetramethylsilane (TMS), trimethylboroxane (TMB), tris(dimethylaminosilyl)-amino-bis(dimethylamino)borane (TDADB), tris(trimethylsilyl)borate (TMSB), hexamethylcyclotrisiloxane (HMCTSO), octamethylcyclotetrasiloxane (OMCTS), decamethylcyclopentasiloxane (DMCPS), dodecamethylcyclohexasiloxane (DMCHS), diacetoxy-di-tert-butoxysilane (DADBS), tetraethoxysilane (TEOS), tris(trimethylsiloxy)vinylsilane (TTMSVS), vinyltriethoxysilane (VTES) and / or a combination thereof, preferably, the precursor P is HMDSO, Therein, in addition to the precursor P, oxygen is supplied during the application of the barrier layer.

[0333] In one embodiment of the method, the following conditions are met for applying the smoothing layer: i. Process temperature PT SL 15℃ to 150℃; ii. Plasma pulse duration PD SL 0.0001ms to 1.5ms; iii. Pulse pause time PP between two pulses SL 0.01ms to 100ms; iv. Total irradiation time TT SL 1s to 50s; v. All pulse durations PD SL [ms] and all pulse pause time PP SL The ratio [ms / ms] of [ms] is 0.001 to 1; vi. Process pressure PR SL 0.1mbar to 100mbar; vii. The flow rate of the precursor P is 1 sccm to 200 sccm, Therein, no further substances (such as gases) are supplied besides the precursors.

[0334] In one embodiment of the method, the following conditions are met for applying the smoothing layer: i. Process temperature PTSL 25℃ to 40℃; ii. Plasma pulse duration PD SL 0.3ms to 0.8ms; iii. Pulse pause time PP between two pulses SL 5.0ms to 20ms; iv. Total irradiation time TT SL 4s to 7s; v. All pulse durations PD SL [ms] and all pulse pause time PP SL The ratio [ms / ms] is 0.03 to 0.08; vi. Process pressure PR SL 0.5mbar to 0.8mbar; vii. The flow rate of the precursor P is 15 sccm to 30 sccm, Therein, no further substances (such as gases) are supplied besides the precursors.

[0335] In one embodiment of the method, for applying the barrier layer, the following conditions are met: i. Process temperature PT BL 15℃ to 200℃; ii. Plasma pulse duration PD BL 0.5ms to 50ms; iii. Pulse pause time PP between two pulses BL 0.05ms to 500ms; iv. Total irradiation time TT BL 1s to 50s; v. All pulse durations PD BL [ms] and all pulse pause time PP BL The ratio [ms / ms] of [ms] is 0.01 to 1; vi. Process pressure PR BL 0.01mbar to 10mbar; vii. The flow rate of the precursor P is 0.01 sccm to 20 sccm, Here, in addition to the precursor, oxygen gas is also supplied, and the flow rate of the oxygen gas is 0.1 sccm to 100 sccm.

[0336] In one embodiment of the method, for applying the barrier layer, the following conditions are met: i. Process temperature PT BL 25℃ to 70℃; ii. Plasma pulse duration PD BL 1.5ms to 2.5ms; iii. Pulse pause time PP between two pulses BL 3.0ms to 10ms; iv. Total irradiation time TT BL 6s to 12s; v. All pulse durations PD BL [ms] and all pulse pause time PP BL The ratio [ms / ms] is 0.3 to 0.6; vi. Process pressure PR BL 0.25mbar to 0.8mbar; vii. The flow rate of the precursor P is 0.3 sccm to 0.9 sccm, Here, in addition to the precursor, oxygen gas is also supplied, and the flow rate of the oxygen gas is 30 sccm to 50 sccm.

[0337] In one embodiment of the method, the following conditions are met for applying the protective layer: i. Process temperature PT PL 15℃ to 150℃; ii. Plasma pulse duration PD PL 0.001ms to 1.5ms; iii. Pulse pause time PP between two pulses PL 0.01ms to 100ms; iv. Total irradiation time TT PL 0.1s to 20s; v. All pulse durations PD PL [ms] and all pulse pause time PP PL The ratio [ms / ms] of [ms] is 0.001 to 1; vi. Process pressure PR PL 0.1 mbar to 100 mbar; and vii. Precursor P PL The flow rate is 1 sccm to 200 sccm, Here, oxygen gas is supplied in addition to the precursor, and the flow rate of the gas is 0.1 sccm to 100 sccm.

[0338] In one embodiment of the method, the following conditions are met for applying the protective layer: i. Process temperature PT PL 40℃ to 70℃; ii. Plasma pulse duration PD PL 0.3ms to 0.8ms; iii. Pulse pause time PP between two pulses PL 8ms to 12ms; iv. Total irradiation time TT PL 0.8s to 1.2s; v. All pulse durations PD PL [ms] and all pulse pause time PP PL The ratio [ms / ms] is 0.03 to 0.08; vi. Process pressure PR PL 0.5 mbar to 0.8 mbar; and vii. Precursor P PL The flow rate is 10 sccm to 20 sccm, Here, in addition to the precursor, oxygen gas is also supplied, and the flow rate of the gas is 4 sccm to 8 sccm.

[0339] In one embodiment of the method, the following conditions are met for applying the sliding layer: i. Process temperature PT GL 15℃ to 150℃; ii. Plasma pulse duration PD GL 0.001ms to 1.5ms; iii. Pulse pause time PP between two pulses GL 0.001ms to 100ms; iv. Total irradiation time TT GL 1s to 50s; v. All pulse durations PD GL [ms] and all pulse pause time PP GL The ratio [ms / ms] of [ms] is 0.001 to 1; vi. Process pressure PR GL 0.1 mbar to 100 mbar; and vii. Precursor P GL The flow rate is 1 sccm to 200 sccm, In this case, apart from the precursors, no further substances are supplied.

[0340] In one embodiment of the method, the following conditions are met for applying the sliding layer: i. Process temperature PT GL 40℃ to 70℃; ii. Plasma pulse duration PDGL 0.02ms to 0.1ms; iii. Pulse pause time PP between two pulses GL 0.3ms to 3ms; iv. Total irradiation time TT GL 6s to 10s; v. All pulse durations PD GL [ms] and all pulse pause time PP GL The ratio [ms / ms] is 0.02 to 0.08; vi. Process pressure PR GL 0.6 mbar to 1.0 mbar; and vii. Precursor P GL The flow rate is 5sccm to 15sccm, In this case, apart from the precursors, no further substances are supplied.

[0341] Drug Containers

[0342] In one embodiment of the coated element according to the present disclosure or the method according to the present disclosure, the element is a drug container, preferably a vial, an ampoule, a cartridge or a syringe, more preferably a cartridge or a syringe, most preferably a syringe.

[0343] In one embodiment, the element defines a lumen, wherein the brimful volume of the element 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.

[0344] In one embodiment, the element comprises, preferably consists of, glass or a polymer, preferably a polymer. In one embodiment, the element comprises or consists of cyclic olefin copolymer (COC) and / or cyclic olefin polymer (COP) and / or polypropylene (PP). In one embodiment, the element comprises or consists of cyclic olefin copolymer (COC).

[0345] Silicone coating

[0346] In one aspect, there is provided a method for coating a component, preferably a method for obtaining a coated component according to the present disclosure, comprising the steps of: - providing an element comprising a surface; - applying one or more layers, preferably a smoothing layer and a barrier layer, by a first coating process carried out on at least a portion of the surface of the component to obtain a pre-coated component, - a second coating process is performed, which comprises the steps of: x) providing a silicone-forming composition, wherein the silicone-forming composition comprises: i) a silicone compound suitable for forming a silicone network after reaction; ii) a catalyst suitable for catalyzing a network reaction of the silicone compound; iii) an inert silicone oil, wherein the inert silicone oil does not participate in the network reaction; and iv) a diluent, wherein the diluent comprises a silicon-containing compound, wherein the silicone-forming composition comprises 45 to 95 weight percent of the diluent, and y) applying the silicone-forming composition to the pre-coated element and reacting the silicone-forming composition, - Obtaining a coated element.

[0347] In one embodiment of the method, the second coating process, step y), is performed by curing the composition, preferably by annealing to 50° C. to 300° C. or 80° C. to 120° C. and / or by applying IR radiation.

[0348] In one embodiment of the method, ie the second coating process, ie step x), the diluent comprises a silicon-containing organic compound having 6 or fewer silicon atoms.

[0349] In one embodiment of the method, ie the second coating process, ie step x), the surface tension of the diluent is below 19 mN / m.

[0350] In one embodiment of the method, i.e. the second coating process, i.e. step x), the diluent is selected from the following list: - Cyclic silicones, such as octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane, dodecamethylcyclohexasiloxane, tetramethylcyclotetrasiloxane, pentamethylcyclopentasiloxane, - hexamethyldisiloxane (HMDSO), - octamethyltrisiloxane, -Decamethyltetrasiloxane.

[0351] In one embodiment of the method, i.e. the second coating process, i.e. step x), the viscosity of the silicone-forming composition at a temperature of 23° C. is from 0.5 m·Pa to 200 m·Pa, from 1 m·Pa to 50 m·Pa, or from 1 m·Pa to 10 m·Pa. The viscosity can be measured using a rotational viscometer as described in, for example, DIN ISO 7884-2:1998-2.

[0352] In one embodiment of the method, i.e., the second coating process, i.e., step x), 1 second after applying the silicone-forming composition on the borosilicate glass surface at a temperature of 23°C, the contact angle of the composition is less than 28°, less than 24°, less than 18°, or less than 5°, wherein the contact angle has been determined by drop shape analysis.

[0353] Coating container

[0354] In one aspect according to the present disclosure, a coating container is provided. wherein the coating container comprises an inner surface and an outer surface, wherein at least a portion of the interior surface is coated with a coating; and The coating container satisfies the following formula: i / o≤d Value d([mg / cm 2 ] / [mg / cm 2 ]) is 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, Where i is the number of cells of the molecule L obtained by the method described herein i Leaching of more than one type of ions and / or compounds available (mg / cm 2 );and Wherein o is the product of the method described herein. o The leaching of one or more types of ions and / or compounds of the base material of the coated container that can be obtained (mg / cm 2 ).

[0355] In one embodiment of the coated container, the one or more types of ions and / or compounds are: - one or more compounds comprising C, preferably one or more compounds comprising C other than compounds comprising Si; and / or - one or more monomers, preferably norbornene, norbornene and / or dicyclopentane; and / or - one or more antioxidants, preferably, wherein the antioxidant is selected from the group consisting of: phenolic antioxidants, more preferably pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate and / or butylated hydroxytoluene (BHT); phosphite antioxidants, more preferably tris(2,4-di-tert-butylphenyl)phosphite; phosphite antioxidants, preferably tetrakis(2,4-di-tert-butylphenyl)[1,1-biphenyl]-4,4'-diylbisphosphonite; and thioether antioxidants; more preferably, wherein the antioxidant is a phenolic antioxidant, more preferably pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate.

[0356] In one embodiment, the coating container or the coating element comprises a matrix material, wherein the matrix material comprises: - one or more compounds comprising C, preferably one or more compounds comprising C other than compounds comprising Si; and / or - one or more monomers, preferably norbornene, norbornene and / or dicyclopentane; and / or - one or more antioxidants, preferably, wherein the antioxidant is selected from the group consisting of: phenolic antioxidants, more preferably, pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate and / or butylated hydroxytoluene (BHT); phosphite antioxidants, more preferably, tris(2,4-di-tert-butylphenyl)phosphite; phosphite antioxidants, preferably, tetrakis(2,4-di-tert-butylphenyl)[1,1-biphenyl]-4,4'-diylbisphosphonite; and thioether antioxidants; more preferably, wherein the antioxidant is a phenolic antioxidant, more preferably, pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate.

[0357] Method L i

[0358] In one embodiment of the present disclosure, the following method is provided (Method L i ), comprising the steps of: - providing a container, preferably a coating container; - If the container has two openings, such as a syringe: cover the smaller opening with a closure (e.g. a pointed cap); - Fill the drug container with 0.9x (full mouth volume) of 0.005 mol / l KOH solution (KOH: potassium hydroxide hydrate ≥ 99.995%, (Merck), demineralized water (ultrapure water similar to DIN ISO 3696, purity 1, ≤ 0.1 μS / cm at 25 °C); - closing the container with a closure seal (e.g. aluminium foil or a stopper); - inserting the container in an autoclave (eg Systec, model DX-150 (PM-CA-0001-01)); - treating the container at 121° C. and 1 bar (eg 2 bar) above ambient pressure for 3 hours; - opening the closure seal; - empty the container; - Fill the container with deionized water and rinse the container twice; - If the container is a glass container: Fill the drug container with 0.9x (full volume) of 0.1 mol / l HCl solution (30% hydrochloric acid) (Merck)), which is diluted with demineralized water (ultrapure water similar to DIN ISO 3696, purity 1, ≤ 0.1 μS / cm at 25°C), i.e. the same volume as used in the alkaline treatment, or - If the container is a polymer container: Fill the drug container with 0.9x (full volume) of 0.1 mol / l HCl solution (30% hydrochloric acid) (Merck)), which was diluted with demineralized water (ultrapure water similar to DIN ISO 3696, purity 1, ≤0.1 μS / cm at 25°C) and isopropanol (1:1 / vol%:vol%), i.e. the same volumes as used in the alkaline treatment; - closing the container with a closure seal; - inserting the container in an autoclave (for example Systec, model DX-150 (PM-CA-0001-01)); - treating the container at 121° C. and 1 bar above ambient pressure for 6 hours; - opening the closure seal; - if the container is a glass container: analyzing the content (mg / l) of one or more types of ions and / or compounds (preferably [Na] ions) in a 0.1 mol / l HCl solution by FAAS analysis, for example using a Varian SpectrAA 280FS (PE3-004), to obtain a leaching value [mg / l] of one or more types of ions and / or compounds (preferably [Na] ions); - if the container is a polymer container: analyzing the content (mg / l) of one or more types of ions and / or compounds, preferably antioxidants and / or organic compounds, in a 0.1 mol / l HCl solution by LC-MS analysis, for example using a Waters I-Class UPLC system with a Waters Xevo qTOF, to obtain the leaching value [mg / l] of the one or more types of ions and / or compounds, preferably the antioxidant and / or organic compound, more preferably the antioxidant; - Calculate the value (mg / cm 2 ) to obtain leaching values ​​[mg / cm 2 ], preferably the leaching value of Na ions or antioxidants [mg / cm 2 ], i.e., the value i: A*B / C, wherein A is the leaching value [mg / l] of one or more types of ions and / or compounds as described above, wherein B is 0.9x the mouthfull volume, and Where C is the wetted inner surface of the container (in cm 2 as units).

[0359] An alternative embodiment comprises a method (Method L i ), which comprises the steps of: - providing a container, preferably a coating container; - if the container has two openings, e.g. a syringe: cover the smaller opening with a closure (e.g. a pointed cap); - Fill the drug container with 0.9x (full mouth volume) of 0.005 mol / l KOH solution (KOH: potassium hydroxide hydrate ≥ 99.995%, (Merck), demineralized water (similar to DIN ISO 3696, ultrapure water with purity 1, ≤0.1 μS / cm at 25°C); - closing the container with a closure seal (e.g. aluminium foil or a stopper); - inserting the container in an autoclave (e.g. Systec, model DX-150 (PM-CA-0001-01)); - treating the container at 121° C. and 1 bar (e.g. 2 bar) above ambient pressure for 3 hours; - opening the closing seal; - empty the container; - Fill the container with deionized water and rinse the container twice; - Fill the drug container with 0.9x (mouthfull volume) of 0.1 mol / l HCl solution (30% hydrochloric acid (Merck)), which was diluted with demineralized water (ultrapure water similar to DIN ISO 3696, purity 1, ≤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; - inserting the container in an autoclave (for example Systec, model DX-150 (PM-CA-0001-01)); - treating the container at 121° C. and 1 bar above ambient pressure for 6 hours; - opening the closure seal; - empty the container; - Fill and rinse the container twice with deionized water; - drying the container, preferably with air; - Fill the drug container with 0.9x (full volume) of n-hexane, i.e. the same volume as used in the alkaline treatment; - Shake the drug container on an orbital shaker (80 rpm) for 30 min at room temperature; - analyzing the content (mg / l) of one or more types of ions and / or compounds, preferably antioxidants and / or organic compounds, in the n-hexane solution by LC-MS analysis, for example using a Waters I-Class UPLC system with a Waters Xevo qTOF, to obtain a leaching value [mg / l] of one or more types of ions and / or compounds, preferably antioxidants and / or organic compounds, more preferably antioxidants; - Calculate the value (mg / cm 2 ), to obtain leaching values ​​[mg / cm 2 ], preferably the leaching value of Na ions or antioxidants [mg / cm 2 ], i.e., the value i: A*B / C, wherein A is the leaching value [mg / l] of one or more types of ions and / or compounds as described above, wherein B is 0.9x the mouthfull volume, and Where C is the wetted inner surface of the container (in cm 2 as units).

[0360] The value o can be obtained by a variety of methods, and preferably, the value o is determined as described herein. The value o is the content (mg / cm 2 ), and / or, preferably or by a method as described herein L o Obtainable, more preferably by the method described herein o Get the value o.

[0361] If an uncoated container identical to the one used to obtain the value i is available, then the method L described above can be used. i , using the uncoated container to obtain the value o, to obtain the content of one or more types of ions and / or compounds of the matrix material of the coated container (mg / cm 2 ). If the values ​​i and o are to be obtained via only one container, the value i can be obtained via the above method L i Obtained, and the value o can be obtained by the following method L o Preferably, o can be obtained by method L o Get. Method L o It can be used for containers that are coated or uncoated on the outside, however, preferably, the container is uncoated on the outside. Preferably, in method L i and L o , with the largest opening facing upward.

[0362] Method L o

[0363] In one embodiment of the present disclosure, the following method is provided (Method L o ), which comprises the steps of: - providing a container, preferably, with the above method L i Same container; - if the container has two openings, e.g. a syringe: cover the smaller opening with a closure (e.g. a pointed cap); -Fill the medication container with 0.9x (mouthfull) of solution; - closing the container with a closure seal; - inserting the container into a beaker, such as a stainless steel or aluminum beaker; - Place 0.005 mol / l KOH solution (KOH: potassium hydroxide hydrate ≥ 99.995%) in a beaker. (Merck), demineralized water (ultrapure water similar to DIN ISO 3696, purity 1, ≤ 0.1 μS / cm at 25°C)) until the water level reaches the same level as in the vessel; - 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 at 121° C. and 1 bar (e.g. 2 bar) above ambient pressure for 3 hours; - opening the closure of the beaker; - empty the beaker; - filling the beaker with deionized water and rinsing the beaker twice, and washing the outside of the container by rinsing the outer surface with deionized water; - inserting the container into the beaker, for example a stainless steel or aluminum beaker; - If the container is a glass container: Fill the beaker with 0.1 mol / l HCl solution (30% hydrochloric acid (Merck)), which is diluted with demineralized water (ultrapure water similar to DIN ISO 3696, purity 1, ≤ 0.1 μS / cm at 25°C) until the water level reaches the same level as in the vessel, i.e. the same volume as used in the alkaline treatment, or - If the container is a polymer container: Fill the beaker with 0.1 mol / l HCl solution (30% hydrochloric acid (Merck)), which was diluted with demineralized water (ultrapure water similar to DIN ISO 3696, purity 1, ≤0.1 μS / cm at 25°C) and isopropanol (1:1 / vol%:vol%) until the water level reached the same level as in the vessel, 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 at 121° C. and 1 bar above ambient pressure for 6 hours; - Open the beaker; - if the container is a glass container: analyzing the content (mg / l) of one or more types of ions and / or compounds (preferably [Na] ions) in a 0.1 mol / l HCl solution by FAAS analysis, for example using a Varian SpectrAA 280FS (PE3-004), to obtain a leaching value [mg / l] of one or more types of ions and / or compounds (preferably [Na] ions); - if the container is a polymer container: analyzing the content (mg / l) of one or more types of ions and / or compounds (preferably antioxidants and / or organic compounds) in a 0.1 mol / l HCl solution by LC-MS analysis, for example using a Waters I-Class UPLC system with a Waters Xevo qTOF, to obtain a leaching value [mg / l] of one or more types of ions and / or compounds, preferably an antioxidant and / or an organic compound, more preferably an antioxidant; - Calculate the value (mg / cm 2 ), to obtain leaching values ​​[mg / cm 2 ], that is, the value o: A*B / C, Where A is the leaching value [mg / l] of one or more types of ions and / or compounds mentioned above, where B is the volume of the solution in the beaker, and Where C is the wetted outer surface of the container (in cm 2 as units).

[0364] Methods and definitions

[0365] ToF-SIMS (Time of Flight Secondary Ion Mass Spectrometry)

[0366] The measurement method and data evaluation of a specific TOF-SIMS measurement are explained in detail below. According to the following description, ions (e.g., ions [C3H5 + ]、[C4H3 - ]、[SiC2H3 + ] and [SiCH3O - ])'s value.

[0367] Measurement method

[0368] For the measurement, TOF SIMS (TOF.SIMS 5 of Iontof) can be used. If not otherwise specified, TOF-SIMS is measured according to ASTM E 1829 and ASTM E 2695.

[0369] The measurement was started after a vacuum below 1.0 mbar had been established.

[0370] The following parameter settings were used for TOF-SIMS: For analysis: Primary ion: Bi 3+ ; Energy: 30keV; Measuring area: 100 x 100 μm 2 ; Pattern: 128 x 128 random; and Bismuth analysis current: 0.3pA. For sputtering guns (argon cluster source): Sputtering ions: Ar cluster; Energy: 10keV; Sputtering area: 300 x 300 μm 2 ;and Sputtering current of Ar cluster source: 8.5 nA. Additional experimental details: Cycle time: 200μs Analyzer Extractor: 2462V (cation) and 2480V (anion); Analyzer Detector: 9000V; Charge compensation: flooded electron gun; Primary Ion Time of Flight Correction: On; and Gas flooding: 9x 10 -7 mbar.

[0371] A sample of the coated polymer container (e.g. half of the inner coated container cut in two longitudinally) is placed in such a way that the center line of the sputtering gun and the center line of the liquid metal ion gun of the TOF-SIMS hit the coated area of ​​the sample, thereby making the sputtering area cover the entire measurement area, preferably, the center line of the sputtering gun and the center line of the liquid metal ion gun of the TOF-SIMS hit the same point of the coated area of ​​the sample. TOF-SIMS measures cations or anions. In order to obtain both ions, two measurements can be performed, each measurement using a new area of ​​the same sample or a new sample, for example, the first half and the second half of the coated container cut in two longitudinally.

[0372] Determination of layer

[0373] The layer structure of the coated element comprises in the following order a smoothing layer (SL), a barrier layer (BL), a protective layer (PL) and optionally a sliding layer (GL), wherein the coated element has a polymer substrate. Each of the layers is chemically different and is detected by specific ToF-SIMS substances, i.e. by SiC in negative ion mode. - 、C4 - 、C4H3 - 、SiCH3O - and SiO3 - and C3H5 in positive ion mode + 、SiO + 、SiC2H + 、SiC2H3 + 、Si2O + 、SiC3H9 + and CH3 + The exact qualitative and quantitative characteristics also depend on: the PICVD parameters employed during each of the four deposition steps (1 to 4) in addition to the selected precursor; and the sputtering and analysis parameters of the ToF-SIMS measurement. Figure 1B and Figure 1C Characteristic trends of the point-to-point normalized intensity of selected ToF-SIMS species in positive and negative ion modes are shown, respectively.

[0374] Layer boundaries

[0375] The order of layers built up on the polymer substrate is in the following order: smoothing layer (SL), barrier layer (BL), protective layer (PL) and optionally sliding layer (GL). Based on Example 1, and using the sputtering and analytical ToF-SIMS setup described above, the boundaries between the smoothing layer (SL), barrier layer (BL), protective layer (PL) and optionally sliding layer (GL) can be found or established according to one or more of the following criteria: [SiCH3O - ] GL / [SiO3 - ] GL >1.0; [SiCH3O - ] 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.

[0376] Once on the polymer substrate, i.e. after sputtering away all smoothing layers (SL), barrier layers (BL), protective layers (PL) and optionally sliding layers (GL), C3H5 + and C4H3 - and C4 -Became the dominant ToF-SIMS species in both positive and negative ion modes, with a site-to-site normalization (intensity) >> 1.0 compared to all Si-containing ToF-SIMS species.

[0377] The thickness of the coating and its layers

[0378] The thickness of the coating and each layer (i.e., smoothing layer, barrier layer, protective layer and sliding layer) was estimated by TEM (transmission electron microscopy). A scanning transmission electron microscope (SETM; Hitachi HF5000) was used at an accelerating voltage of 200 kV, a capture resolution of 1024 x 1024 and a collection time of 20 seconds. Other instrument settings were: column mode operation (HR), DF mode (ZCM), BF mode (WAM) and STEM condenser aperture #2.

[0379] First, the sample was prepared by sputtering a 50 nm metallic titanium layer using a cold magnetron to establish conductivity and surface protection. Subsequent steps were performed using an Auriga 40 SEM / FIB cross beam: SEM-induced carbon deposition using an organic precursor (to prevent Ga ions), FIB-induced Pt deposition using an organic precursor (to protect the surface during thin-section preparation), thin sections were cut at 30 kV Ga FIB, the sample was transferred to a copper grid, ion thinned with 30 kV Ga, and finally ion thinned with 2 kV Ga. This typically resulted in a final thin section width of 20 μm and a final thickness of the titanium layer of about 50 nm.

[0380] Roughness of the uncoated surface of the component

[0381] The surface roughness depth SRz has been determined using a white light interferometer (WLI) on the uncoated inner surface of the element and the uncoated outer surface of the element based on and according to ISO 25178-2:2012. Using Zygo's WLI (NexView type), and before any subsequent calculations, a field of view of 400μm x 400μm is measured and the curvature of the element is corrected. In order to obtain the SRz parameter, the surface area is analyzed by fitting the minimum circumscribed rectangle and applying a 5x 5 sampling grid, totaling 25 sampling areas. All sampling areas together constitute the evaluation area. However, Rz refers to the roughness obtained from a single line scan (across 5 points), and SRz reflects the average radial peak-to-valley area roughness on the surface, that is, the average of the largest half of many individual Rz results is determined by dividing the regional data array 360 degrees around its center. The Rz results are classified by amplitude, and SRz is calculated by averaging the largest 50% of the Rz values. The actual pixel-to-pixel path for each slice is determined using a line generation algorithm, and there is no interpolation between pixels. Therefore, SRz covers the entire array and is position-independent due to its radial generation.

[0382] Depending on the type of container, several measurements are taken at a well-defined number of containers and a well-defined number of measuring locations and averaged.

[0383] For the syringe (COC, 1 ml length), 6 different positions of 10 containers were measured, resulting in a SRz of 132 nm ± 109 nm (mean ± standard deviation). These 6 different positions were measured at 10 mm, 25 mm and 40 mm from the die and at a relative position of 180° relative to the central axis of the syringe.

[0384] For small bottles (COP, 2 ml), 3 different positions of 10 containers were measured, resulting in a SRz of 147 nm ± 118 nm (mean ± standard deviation). The 3 different positions were measured at a bottle height of 10 mm and at an angular position of 120° relative to the central axis of the bottle.

[0385] Sliding force

[0386] The static and sliding friction coefficients of the sliding layer were determined by pressing a V9361 FM457 / 0FLNC2 057 stopper (outer diameter 6.9±0.1 mm) from Datwyler Pharma Packaging into the corresponding syringe at a speed of 100 mm / min. The force required for this pressing action was recorded.

[0387] The coefficients of static friction and sliding friction are determined by moving a suitable stopper through the hollow body at a constant speed of 100 mm / min immediately after it has been inserted into the hollow body and measuring the force required as a function of the insertion depth. A typical static / sliding friction diagram shows a linear increase in force when the stopper starts to move. As soon as the static friction force is overcome, the stopper starts to move and the stopper slides through the cylinder, which requires a relatively constant thrust in the case of a good sliding layer. There is usually a maximum in the static / sliding friction diagram just before the stopper starts to slide, which represents the coefficient of static friction. The relatively constant force during the sliding movement represents the coefficient of sliding friction. Static / sliding friction diagrams are usually measured with stoppers, which are also used as stoppers for primary pharmaceutical packaging and which can achieve corresponding compactness without much effort.

[0388] Static friction (breaking force)

[0389] Static friction is understood to be the static friction measured on the surface of a coated or uncoated component.

[0390] Static friction was measured in a 1 ml long COC syringe with a siliconized stopper from Datwyler Pharma 257 / 2ISAF2. Static friction was measured as the maximum force along the initial path of 4 mm. After the initial path, the average sliding force was obtained by monitoring the additional 30 mm path. The stopper was measured under dry conditions after being stored in the syringe for 24 hours at a temperature of 20°C. Additional test parameters were: 100 N load cell, 100 mm / min test speed, non-threaded plunger rod.

[0391] Example

[0392] Embodiment 1 (embodiment of the present invention)

[0393] A resin syringe (1 ml long COC) was provided and then coated in four steps without vacuum break using the apparatus described in WO 2007 / 022976A2 (Fig. 1). The plasma was driven by microwave irradiation at a frequency of 2.45 GHz. The plasma reaction chamber was mainly inside the syringe and the outside of the syringe was mainly ambient conditions. Before starting film deposition, the reaction chamber was evacuated until a gas pressure of 0.05 mbar was reached.

[0394] Four separate and consecutive coating steps are applied:

[0395] In the first step, a gas flow of 20 sccm HMDSO was adjusted at a pressure of 0.66 mbar. Subsequently, the plasma was ignited in pulse mode with an input power of 1460 W, with a pulse duration of 0.5 ms and a pulse pause time of 10 ms, which is equivalent to a duty cycle of 4.8%. The plasma treatment was carried out for 5 seconds.

[0396] In the second step, a gas mixture of 0.6 sccm HMDSO and 39.4 sccm oxygen was adjusted at a pressure of 0.36 mbar. Subsequently, the plasma was ignited in pulse mode with an input power of 1180 W, with a pulse duration of 2 ms and a pulse pause time of 5 ms, which is equivalent to a duty cycle of 28.6%. The plasma treatment was carried out for 9 seconds.

[0397] In the third step, a gas mixture of 14 sccm HMDSO and 6 sccm oxygen was adjusted at a pressure of 0.66 mbar. Subsequently, the plasma was ignited with an input power of 1420 W in pulse mode with a pulse duration of 0.5 ms and a pulse pause time of 10 ms, which is equivalent to a duty cycle of 4.8%. The plasma treatment was carried out for 1 second.

[0398] In the fourth step, a gas flow of 10 sccm HMDSO was adjusted at a pressure of 0.84 mbar. Subsequently, the plasma was ignited in pulse mode with an input power of 980 W, with 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 evacuated with nitrogen until atmospheric pressure was reached.

[0399] Embodiment 2 (embodiment of the present invention)

[0400] A resin syringe (1 ml long COC) is provided and, except that the fourth coating step is omitted, coating is carried out according to Example 1. Additional coating is carried out by adopting the liquid coating according to Example 2 of EP 3636303 A1. Liquid coating is prepared by loading 80 g of vinyl functionalized polydimethylsiloxane into a reaction vessel and mixing with 640 g of hexamethyldisiloxane. Under constant stirring at 1000 rpm, 2 g of methylhydrogensiloxane / dimethylsiloxane copolymer, 48 g of liquid polydimethylsiloxane, 1.1 g of 1,1,3,3-tetramethyl-1,3-divinyldisiloxane platinum complex and 0.1 g of butynol as an inhibitor are added to this reaction mixture. The preparation can be used after stirring for 60 s.

[0401] The formulation was applied to the inside of the plastic hollow body by a wiping process and cured by heating to 250° C. for 3.5 seconds. A 1-ml COC syringe of standard size "1-ml long" with an inner diameter of 6.5 mm was used as a substrate for depositing the sliding layer.

[0402] Subsequently, the static friction coefficient and the sliding friction coefficient of the cured sliding layer were determined. This involved pressing a V9361 FM457 / 0FLNC2 057 stopper of Datwyler Pharma Packaging with an outer diameter of 6.9±0.1 mm into a syringe at a speed of 100 mm / min. The force required for this was recorded. Both the static friction coefficient and the sliding friction coefficient were less than 10 N.

[0403] Reference Examples

[0404] A resin syringe (1 ml long COC) was provided and coating was performed according to Example 1 except that the fourth coating step was omitted.

Claims

1. A coated element having a surface, wherein at least a portion of the surface of the element is coated with a coating, wherein the coating comprises, in the following order: - Smoothing layer (SL); - a barrier layer (BL); and - Protective layer (PL), The smooth layer satisfies the condition a1 SL ≤[Si2O + ] SL / [SiC3H9 + ] SL ≤a2 SL , where a1 SL is 1.0, where a2 SL is 1000, where [SiC3H9 + ] SL The [SiC3H9 + ] ion counts; among which [Si2O + ] SL The [Si2O + ] ion counts, and / or The barrier layer satisfies condition a1 BL ≤[Si2O + ] BL / [SiC3H9 + ] BL ≤a2 BL , where a1 BL is 1, where a2 BL is 1000, where [SiC3H9 + ] BL The [SiC3H9 + ] ion counts, and among them [Si2O + ] BL The [Si2O + ] ion counts, and / or The protective layer satisfies condition a1 PL ≤[Si2O + ] PL / [SiC3H9 + ] PL ≤a2 PL , where a1 PL is 1.0, where a2 PL 1*10 5 , where [SiC3H9 + ] PL The protective layer [SiC3H9 + ] ion counts, and among them [Si2O + ] PL is the [Si2O + ] ion counts, The coating element optionally has a sliding force of 0.1N to 10.0N and / or a static friction force of 1N to 18N.

2. A coated element having a surface, wherein at least a portion of the surface of the element is coated with a coating, wherein the coating comprises, in the following order: - Smoothing layer (SL); - a barrier layer (BL); and - Protective layer (PL), wherein the thickness of the smoothing layer is 100 nm to 2000 nm, and / or The thickness of the barrier layer is 5 nm to 500 nm, and / or wherein the protective layer has a sliding force of 0.1N to 10.0N and / or a static friction force of 1N to 18N, and / or The coating element has a sliding force of 0.1N to 10.0N and / or a static friction force of 1N to 18N.

3. The coated element according to claim 1 or claim 2, further comprising a sliding layer (GL), wherein the sliding layer is adjacent to the protective layer, The sliding layer satisfies the condition a1 GL ≤[SiC3H9 + ] GL / [Si2O + ] GL ≤a2 GL , where a1 GL is 1.1, where a2 GL 1*10 5 , where [SiC3H9 + ] GL The sliding layer [SiC3H9 + ] ion counts, and among them [Si2O + ] GL The [Si2O + ] ion counts.

4. A coated element according to any one of claims 1 to 3, wherein the element comprises, preferably consists of: Glass or polymer, preferably polymer, more preferably cycloolefin copolymer (COC) and / or cycloolefin polymer (COP) and / or polypropylene (PP), more preferably cycloolefin copolymer (COC).

5. The coated element according to claim 3 or 4, wherein the sliding layer meets one or more of the following parameters: -a1 GL ≤[SiC3H9 + ] GL / [Si2O + ] GL ≤a2 GL , where a1 GL is 1.1, where a2 GL 1*10 5 , where [SiC3H9 + ] GL The sliding layer [SiC3H9 + ] ion counts, and among them [Si2O + ] GL The [Si2O + ] ion counts, and -b1 GL ≤[SiC2H + ] GL / [SiO + ] GL ≤b2 GL , where b1 GL is 1.1, where b2 GL is 1000, where [SiC2H + ] GL is the [SiC2H + ] ion counts, and among them [SiO + ] GL The [SiO + ] ion counts.

6. The coated element according to any one of the preceding claims, wherein the protective layer satisfies one or more of the following parameters: -a1 PL ≤[Si2O + ] PL / [SiC3H9 + ] PL ≤a2 PL , where a1 PL is 1.0, where a2 PL 1*10 5 , where [SiC3H9 + ] PL The protective layer [SiC3H9 + ] ion counts, and among them [Si2O + ] PL is the [Si2O + ] ion counts, and -b1 PL ≤[SiC2H + ] PL / [SiO + ] PL ≤b2 PL , where b1 PL is 0.5, where b2 PL 1*10 5 , where [SiC2H + ] PL is the [SiC2H + ] ion counts, and among them [SiO + ] PL The [SiO + ] ion counts.

7. A coated element according to any one of the preceding claims, wherein the barrier layer meets one or more of the following parameters: -a1 BL ≤[Si2O + ] BL / [SiC3H9 + ] BL ≤a2 BL , where a1 BL is 1, where a2 BL is 1000, where [SiC3H9 + ] BL The [SiC3H9 + ] ion counts, and among them [Si2O + ] BL The [Si2O + ] ion counts, and -b1 BL ≤[SiO + ] BL / [SiC2H + ] BL ≤b2 BL , where b1 BL is 1, where b2 BL 1*10 5 , where [SiC2H + ] BL is the [SiC2H + ] ion counts, among which [SiO + ] BL The [SiO + ] ion counts.

8. The coated element according to any one of the preceding claims, wherein the smoothing layer satisfies one or more of the following parameters: -a1 SL ≤[Si2O + ] SL / [SiC3H9 + ] SL ≤a2 SL , where a1 SL is 1.0, where a2 SL is 1*1000, where [SiC3H9 + ] SL The [SiC3H9 + ] ion counts, among which [Si2O + ] SL The [Si2O + ] ion counts, and -b1 SL ≤[SiC2H + ] SL / [SiO + ] SL ≤b2 SL , where b1 SL is 1.0, where b2 SL 1*10 5 , where [SiC2H + ] SL is the [SiC2H + ] ion counts, among which [SiO + ] SL The [SiO + ] ion counts.

9. The coated element according to any one of the preceding claims, wherein the thickness of the smoothing layer is from 1 nm to 20000 nm, or from 5 nm to 5000 nm, or from 100 nm to 2000 nm, or from 150 nm to 1500 nm, or from 200 nm to 1000 nm, or from 250 nm to 500 nm.

10. A coating element according to any one of the preceding claims, The time required for the sputtering gun to reach the surface of the component is 0.5 to 150 minutes, or 30 to 120 minutes, or 50 to 100 minutes; and / or In the case of measuring cations, the moment when the sputtering gun reaches the surface of the element is when [Si2O + ] ion count is equal to [C3H5 + ] the time at which the ions are counted; and / or In the case of measuring anions, the moment when the sputtering gun reaches the surface of the element is when [C4H3 - ] ion count is equal to [SiO3 - ] the time at which the ions are counted; and / or The counts of the ions, preferably the cations and the anions, can be obtained by the method described in the specification.

11. A coating element according to any one of the preceding claims, wherein the element is a drug container comprising an inner surface, wherein the inner surface is coated, wherein the smoothing layer is in direct contact with the coating element, When the sliding layer is present, the sliding layer is the outermost layer.

12. A coating element according to any one of the preceding claims, One or more of the following conditions are met: <h2 style=";text-align:left;direction:ltr">[SiO3<h2 style=";text-align:left;direction:ltr"> - <h2 style=";text-align:left;direction:ltr"> ]<h2 style=";text-align:left;direction:ltr"> GL <h2 style=";text-align:left;direction:ltr"> <[SiO3<h2 style=";text-align:left;direction:ltr"> - <h2 style=";text-align:left;direction:ltr"> ]<h2 style=";text-align:left;direction:ltr"> BL <h2 style=";text-align:left;direction:ltr"> ; <h2 style=";text-align:left;direction:ltr">[SiO3<h2 style=";text-align:left;direction:ltr"> - <h2 style=";text-align:left;direction:ltr"> ]<h2 style=";text-align:left;direction:ltr"> PL <h2 style=";text-align:left;direction:ltr"> <[SiO3<h2 style=";text-align:left;direction:ltr"> - <h2 style=";text-align:left;direction:ltr"> ]<h2 style=";text-align:left;direction:ltr"> BL <h2 style=";text-align:left;direction:ltr"> ; [SiO3 - ] SL <[SiO3 - ] BL ; and / or <h2 style=";text-align:left;direction:ltr">[SiO3<h2 style=";text-align:left;direction:ltr"> - <h2 style=";text-align:left;direction:ltr"> ]<h2 style=";text-align:left;direction:ltr"> GL <h2 style=";text-align:left;direction:ltr"> <[SiO3<h2 style=";text-align:left;direction:ltr"> - <h2 style=";text-align:left;direction:ltr"> ]<h2 style=";text-align:left;direction:ltr"> PL <h2 style=";text-align:left;direction:ltr"> , Among them [SiO3 - ] GL is the [SiO3 - ] ion counts; Among them [SiO3 - ] PL is the [SiO3 - ] ion counts; Among them [SiO3 - ] BL is the [SiO3 - ] ion counts; Among them [SiO3 - ] SL is the [SiO3 - ] ion counts.

13. A system or kit comprising: A coated element according to any one of the preceding claims, wherein the element is a syringe or a cartridge; a plunger, preferably a plunger rod; and Optionally a closure, preferably a tip cover and / or a needle shield.

14. A closed system comprising: The coating element according to any one of claims 1 to 12, wherein the element is a syringe or a cartridge; a plunger, preferably a plunger rod; and a closure, preferably a tip cover and / or a needle shield, The closed coated element passes the container closure integrity test according to DIN EN ISO 8871-5:2016; Chapter 4.4 in combination with Appendix D.

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

16. A method for coating a component, preferably a coated component according to any one of claims 1 to 12, comprising the steps of: (1) providing a component 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, wherein each of steps (2) to (4) comprises surrounding at least a portion of the surface of the element with a precursor, and Each of the steps (2) to (4) comprises irradiating the precursor using a PICVD method to generate a plasma, Wherein said step (3) comprises establishing an O2 flow rate of more than 10 sccm during said irradiation of said precursor.

17. The method according to claim 16, wherein the PICVD method is performed in such a way that: (i) the irradiation is performed by a microwave generator, preferably, wherein the frequency of the radiation is 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) wherein the input power IP, preferably, the input power of the microwave generator is 100 W to 10000 W, preferably 300 W to 9000 W, more preferably 500 W to 8000 W, more preferably 700 W to 6000 W, more preferably 900 W to 4000 W, more preferably 1100 W to 2000 W.

18. The method according to claim 16 or 17, wherein the PICVD method is performed in such a way that: (i) the irradiation is performed by a microwave generator, wherein the frequency of the radiation is 2.45 GHz; and / or (ii) Wherein the input power IP, preferably, the input power IP of the microwave generator is 900W to 4000W.

19. The method according to any one of claims 16 to 18, wherein the precursor is HMDSO.

20. The method according to any one of claims 16 to 19, wherein the application of the smoothing layer is performed during all pulse durations PD SL [ms] and all pulse pause time PP SL The blocking layer is applied at a ratio [ms / ms] of 0.01 to 0.5 for all pulse durations PD BL [ms] and all pulse pause time PP BL [ms] ratio [ms / ms] of 0.01 to 1, preferably 0.1 to 0.8, and / or the applying of the protective layer is carried out at all pulse durations PD PL [ms] and all pulse pause time PP PL The reaction is carried out at a ratio [ms / ms] of 0.001 to 1, preferably 0.01 to 0.5.

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