A sterile low toc background value sampling frame

Abstract

The application discloses a sampling frame with a sterile low-TOC background value, and relates to the technical field of pharmaceutical equipment cleaning verification. The frame comprises a main body, which is provided with a square opening with a size of 5.0 cm*5.0 cm; the main body is made of a low-TOC material with a TOC background value of not more than 100 ppb and is subjected to a sterile treatment, with a sterile guarantee level of SAL=10 ‑6 ; and the main body is further provided with a hand-held operation part extending to the outside. The application eliminates the difference in manual judgment, improves the accuracy and comparability of TOC detection by standardizing the sampling area; the low-TOC material and special surface treatment reduce background interference; the hand-held operation part and sterile design reduce the risk of microbial contamination; meanwhile, the sampling efficiency is improved, the data traceability is enhanced, and good cost effectiveness is achieved.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical equipment cleaning validation technology, and more specifically to a sampling framework for sterile low TOC background values. Background Technology

[0002] Total organic carbon (TOC) testing is a key method for water quality monitoring and equipment cleaning validation in the pharmaceutical industry. Surface TOC testing often uses the swab method, which involves wiping a predetermined area on the equipment surface with a sterile swab, then placing the swab tip in a test bottle to measure the organic matter content, in order to assess the cleaning effectiveness and the risk of residual active substances from the previous batch.

[0003] However, existing surface sampling methods have significant shortcomings: First, the sampling area lacks standardization. Operators rely solely on experience to judge the wiping area, leading to significant differences in area between samples from the same batch. This affects the accuracy of TOC calculation per unit area, and the test results between different batches and equipment lack comparability, making it difficult to establish effective cleaning validation trend analysis. Second, there are potential risks in aseptic control. Without a standardized framework, operators need to use their hands or other objects to locate the wiping area, increasing the risk of hand contact with sterile tools or microbial sedimentation, potentially introducing contamination and affecting the reliability of aseptic testing. Third, there is insufficient control over low TOC background values. In practice, ordinary rulers or templates may be used for positioning. If these auxiliary tools are not thoroughly cleaned, they can release trace amounts of organic matter, contaminating the sampling area. Fourth, operational efficiency is low. Each sampling requires careful positioning, extending the operation time, especially prominent in projects with a large number of samples. Prolonged operation also increases the risk of damage to the clean area.

[0004] Therefore, there is an urgent need in this field for a dedicated sampling tool that can standardize the sampling area, ensure aseptic operation, reduce TOC background values, and improve operational efficiency. Summary of the Invention

[0005] To overcome the shortcomings of the prior art, the present invention aims to provide a sterile sampling framework with low TOC background value.

[0006] To achieve the aforementioned objective, the technical solution of the present invention is implemented as follows: a sterile sampling frame with low TOC background value, comprising a frame body:

[0007] The main frame has an opening, which is square in shape and precisely 5.0 cm × 5.0 cm in size;

[0008] The main frame is made of a material with a low TOC background value, which is no more than 100 ppb (preferably no more than 50 ppb).

[0009] The main frame undergoes aseptic treatment, achieving a sterility assurance level of SAL=10⁻ 6 ;

[0010] The main body of the frame is also equipped with a handheld operating unit that extends outside the frame, allowing operators to operate the frame without touching the sampling area.

[0011] In a preferred embodiment of the invention, the low TOC background material is selected from at least one of polytetrafluoroethylene (PTFE), polypropylene (PP), polycarbonate (PC), or medical-grade stainless steel. These materials possess good chemical stability, low TOC release characteristics, and appropriate mechanical strength.

[0012] In a preferred embodiment of the invention, the outer frame of the main frame body has a size of 7.0 cm to 9.0 cm and a frame thickness of 1.5 mm to 2.5 mm. This size design ensures sufficient structural strength while facilitating operation and portability.

[0013] In a preferred embodiment of the invention, the four corners of the frame body are rounded with a radius of 2 to 5 millimeters. This rounded corner design avoids the risk of the frame scratching the surface of the equipment during placement.

[0014] In a preferred embodiment of the present invention, the length of the handheld operating part is 4 to 6 centimeters, and the handheld operating part is integrated with the frame body or detachably connected. The integrated design ensures the integrity and sterility of the structure, while the detachable design facilitates adaptation to different application scenarios.

[0015] In a preferred embodiment of the present invention, the surface of the frame body is subjected to ultrapure water cleaning and high-temperature baking treatment. The ultrapure water cleaning is performed by rinsing with ultrapure water with a resistivity ≥18MΩ·cm more than 3 times, and the high-temperature baking temperature is 180°C to 220°C for 2 to 4 hours to ensure that the TOC background value of the frame surface is reduced to a minimum.

[0016] In a preferred embodiment of the invention, aseptic treatment is performed using gamma ray irradiation sterilization at a dose of 20 kGy to 30 kGy (preferably 25 kGy). Gamma ray irradiation sterilization has the advantages of strong penetration, good sterilization effect, and no residue, ensuring that the frame reaches the required level of aseptic assurance.

[0017] In a preferred embodiment of the present invention, the frame is packaged in double-layer aseptic packaging, with an inner layer of aseptic paper bag and an outer layer of composite aluminum foil bag. This double-layer packaging design ensures that the frame remains sterile during storage and transportation, and retains its sterility before use.

[0018] In a preferred embodiment of the present invention, the opening edge of the frame body is provided with a marking line, which is a scale mark or a color mark, so as to facilitate the operator to confirm the boundary of the sampling area.

[0019] In a preferred embodiment of the invention, the end of the handheld operating unit is provided with a rotatable connector that can be connected to a standard operating lever. This design allows the frame to be used with a long-handled operating lever, facilitating sampling of hard-to-reach areas.

[0020] The present invention also provides a method for surface TOC detection using the above-described framework, comprising the following steps:

[0021] Step 1: Preparation: Operators put on sterile cleanroom garments according to GMP requirements and enter the clean area; check the integrity of the sterile packaging of the sampling frame, confirm that the packaging is undamaged, leak-free, and within the expiration date; open the outer packaging according to aseptic operation requirements and transfer the inner sterile packaging to the Class A laminar flow hood.

[0022] Step 2: Frame Positioning: Under Class A laminar flow protection, the operator opens the aseptic packaging and takes out the aseptic sampling frame; holding the operating part of the frame, avoids touching the main body of the frame with the hand; places the frame in the predetermined sampling position, ensuring that the inner frame of the frame is completely in contact with the surface to be tested; confirm the 5×5 cm standardized sampling area through the opening of the frame.

[0023] Step 3: Aseptic sampling: After the frame is positioned, use a sterile TOC sampling swab to perform standardized wiping within the area defined by the frame. The wiping method is as follows: first, dip the swab tip in an appropriate amount of sterile purified water, and then wipe the 5×5 cm area defined by the frame in an "S" shaped path to ensure that the entire area is covered. Apply appropriate pressure when wiping to ensure full contact while avoiding scratching the surface of the equipment.

[0024] Step 4: Sample processing: After wiping, cut off the cotton swab tip and place it in a low TOC detection bottle. Add an appropriate amount of extraction solution and perform ultrasonic extraction. Then transfer the extraction solution to the TOC analyzer for detection. Repeat the above steps using a new sterile sampling frame to complete sampling at other preset locations.

[0025] Step 5: Result Analysis: Based on the TOC content measured by the TOC analyzer and combined with the standardized sampling area (25 square centimeters), calculate the TOC residue per unit area; and determine whether the cleaning effect meets the requirements according to the preset acceptance criteria.

[0026] Beneficial effects

[0027] Compared with the prior art, the present invention has the following advantages:

[0028] The standardized 5×5 cm opening eliminates human variation in sampling area, significantly reducing test result deviation and ensuring data comparability and traceability. The frame is made of low-TOC materials such as polytetrafluoroethylene (PTFE) (≤30 ppb) and undergoes ultrapure water cleaning and high-temperature baking, preventing the release of organic matter and effectively eliminating background interference. Combined with a handheld operating unit and SAL=10... -6 The sterility guarantee reduces the risk of hand contact and microbial contamination, lowering the false positive rate. Simultaneously, each sampling session saves 30 seconds to 1 minute, making it particularly suitable for large-scale sampling scenarios. It also reduces personnel activity in clean areas, further decreasing the probability of contamination. Although it increases the cost of disposable frames, the overall cost is optimized by reducing repeated testing and lowering the risk of batch failure, resulting in good quality and economic benefits. Attached Figure Description

[0029] In the attached diagram:

[0030] Figure 1 This is a schematic diagram of the overall structure of the sampling frame of the present invention.

[0031] Figure 2 This is a schematic diagram of the sampling frame of the present invention in the form of sampling on a planar surface.

[0032] Figure 3 This is a schematic diagram of the sampling frame of the present invention in use for sampling on a curved surface.

[0033] Figure 4 This is a flowchart illustrating the implementation method of the present invention. Detailed Implementation

[0034] The present invention will now be described in further detail with reference to the accompanying drawings and embodiments. Obviously, the described embodiments are only a part of the embodiments of the invention, and not all of them. Unless otherwise specified, the embodiments and features described in this application can be combined with each other. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0035] Example 1

[0036] Technical configuration

[0037] This embodiment provides a sterile low-TOC background value sampling framework for TOC detection on the surface of pharmaceutical equipment. Specific technical parameters are as follows:

[0038] The main frame structure is a square frame with an outer frame size of 8.0 cm × 8.0 cm and an inner frame opening size of precisely 5.0 cm × 5.0 cm. The frame thickness is 2.0 mm. The four corners of the frame are rounded with a radius of 3.0 mm to prevent scratching the equipment surface during placement. A handheld operating part is located on one side of the frame, extending 5.0 cm beyond the frame's edge, allowing operators to stably place and operate the frame without touching the sampling area.

[0039] The main frame is made of polytetrafluoroethylene (PTFE). PTFE possesses excellent chemical stability, extremely low TOC release characteristics, and good mechanical properties, making it ideal as a material for manufacturing low-TOC sampling frames. The selected PTFE material is medical-grade, with a TOC background value not exceeding 30 ppb, meeting the most stringent TOC testing requirements.

[0040] After the surface-treated frame is manufactured, it undergoes a rigorous surface cleaning process to further reduce the TOC background value. The specific process is as follows: First, the frame is rinsed 5 times with ultrapure water with a resistivity ≥18MΩ·cm, with each rinse lasting no less than 5 minutes; then, the frame is placed in a 200℃ high-temperature oven and baked for 3 hours to remove trace amounts of organic matter adsorbed on the surface; finally, it is cooled and sealed in a clean environment.

[0041] The aseptic frame was sterilized using gamma ray irradiation at a dose of 25 kGy. Gamma ray irradiation sterilization has the advantages of strong penetration, good sterilization effect, and no residue, ensuring that the frame achieves the required sterility assurance level (SAL) of 10. -6 The sterilization process is carried out under validated conditions to ensure the reliability and consistency of sterilization results.

[0042] Each frame is packaged in a double-layer aseptic package. The inner layer is a sterile paper bag made of medical-grade dialysis paper, which has good air permeability and antibacterial properties; the outer layer is a composite aluminum foil bag, which has good moisture-proof and anti-oxidation properties. The double-layer packaging design ensures that the frames remain sterile during storage and transportation. Each package is labeled with information such as product name, specifications, sterilization batch number, sterilization date, and expiration date.

[0043] The sampling framework in this embodiment meets the following quality standards:

[0044] Appearance: The frame surface is smooth and flat, without burrs, cracks, or deformation.

[0045] Dimensions: The inner frame opening is 5.0±0.1 cm × 5.0±0.1 cm.

[0046] TOC background value: ≤30ppb (measured after extraction with ultrapure water)

[0047] Sterility: Sterility assurance level (SAL) = 10 -6

[0048] Packaging integrity: Double-layer packaging, no damage, no air leakage

[0049] Application scenarios

[0050] This embodiment is applied to surface TOC sampling during the cleaning validation of a newly installed 316L stainless steel storage tank in a pharmaceutical company. The tank has a volume of 5000 liters, an internal surface area of ​​approximately 15 square meters, and an internal surface that has been mechanically polished with a surface roughness Ra ≤ 0.4 μm.

[0051] Implementation steps

[0052] The specific implementation process of this embodiment is as follows:

[0053] Step 1: Preparation The operator, dressed in sterile gowns according to GMP requirements, enters the Grade B clean area. First, check the integrity of the sterile packaging of the sampling frame, confirming that the packaging is undamaged, leak-free, and the sterilization date is within the expiration date (12 months). Then, following aseptic operation requirements, open the outer composite aluminum foil bag and transfer the inner sterile paper bag to the Grade A laminar flow hood.

[0054] Step 2: Frame Positioning. Under Class A laminar flow protection, the operator opens the aseptic paper bag packaging and removes the aseptic sampling frame. Holding the frame's operating part, avoid touching the main body of the frame with your hands. Place the frame in the predetermined sampling position, ensuring the inner frame completely conforms to the inner wall surface of the storage tank. Due to the frame's thickness of 2.0 mm and the flexibility of the PTFE material, the frame fits well against the stainless steel surface. Through the frame's opening, the operator can clearly see the standardized 5×5 cm sampling area.

[0055] Step 3: Aseptic Sampling After the frame is positioned, use a sterile TOC sampling swab to perform standardized wiping within the area defined by the frame. The specific wiping method is as follows: First, dip the swab tip in an appropriate amount of sterile purified water (resistivity ≥18 MΩ·cm), then wipe the 5×5 cm area defined by the frame in an "S" shaped path, as shown in the image. Figure 2 As shown. Apply appropriate pressure when wiping to ensure full contact between the swab and the surface, while avoiding scratching the equipment surface. After wiping, place the swab into a sterile sampling tube.

[0056] Step 4: Sample Processing. Cut off the tip of the used cotton swab and place it in a low TOC detection bottle. Add 50 ml of extraction buffer (ultrapure water) and perform ultrasonic extraction for 10 minutes. Then transfer the extract to a TOC analyzer for analysis. Simultaneously, repeat the above steps using a new sterile sampling frame to complete sampling at other pre-defined locations. According to the cleaning validation protocol, this tank requires 20 sampling points, including key areas such as the bottom, middle, top, and agitator.

[0057] Step 5: Result Analysis The TOC analyzer was used for determination using the combustion oxidation-non-dispersive infrared absorption method, with a detection limit of 50 ppb. The measured TOC content was C (unit: μg / L). The sampling area was 25 cm², so the TOC residue per unit area was: Q = C × V / A, where V is the extraction liquid volume (50 mL) and A is the sampling area (25 cm²). According to the company's internal control standards, the surface TOC residue should not exceed 2.0 μg / cm². The test results show that the TOC residue at all 20 sampling points was between 0.1 μg / cm² and 0.8 μg / cm², all meeting the acceptance criteria.

[0058] Technical details

[0059] In this embodiment, several key technical details require special attention:

[0060] The fit between the frame and the tank surface directly affects the representativeness of the sampling. While the PTFE frame in this embodiment is rigid, its 2.0 mm thickness provides a degree of flexibility, allowing it to adapt to minor unevenness on the tank surface. For larger planar areas, the frame fits perfectly; for areas with slight curvature, the frame's elastic design ensures good contact between the frame edges and the surface, guaranteeing the accuracy of the sampling area.

[0061] The protective frame features 3.0 mm rounded corners, a design that plays a crucial role in preventing scratches. While the 316L stainless steel tank surface is polished and possesses high hardness, it can still be scratched by sharp objects. The rounded corners effectively mitigate the risk of scratching the equipment surface during placement and movement, protecting the integrity of the equipment's surface.

[0062] The aseptic protection of the operating section is achieved through a 5.0 cm handheld operating section, a design that ensures sufficient distance between the operator's hands and the sampling area. Under Class A laminar flow protection, particles and microorganisms generated by the operator's hands will not settle in the sampling area when the operating section is held. Simultaneously, the operator's hands will not come into contact with the frame body, avoiding the risk of transferring contaminants to the sampling area through the frame.

[0063] The Importance of Single-Use: In this embodiment, a new sterile frame is used for each sampling point, avoiding the risk of cross-contamination. Although this increases the cost of consumables, it ensures the reliability of the test results. Single-use is particularly important for ensuring test quality, especially in aseptic testing or sampling from high-risk areas.

[0064] Data flow

[0065] The data flow in this embodiment can be described as follows:

[0066] Organic matter remaining on the surface of the storage tank → is transferred to the cotton swab tip by wiping → is transferred to the extract liquid by ultrasonic extraction → is converted into CO2 by oxidation reaction of TOC analyzer → CO2 content is measured by non-dispersive infrared detector → TOC content is calculated → residual amount per unit area is calculated based on standardized sampling area.

[0067] Because the sampling area is standardized to 5×5 cm (25 cm²), the final measured TOC content can be directly converted into the residual amount per unit area, facilitating comparisons with other batches or other equipment. This standardized data stream ensures the accuracy and comparability of the test results.

[0068] Example 2

[0069] Technical configuration

[0070] This embodiment provides another sterile low-TOC background value sampling framework for TOC detection on pharmaceutical equipment surfaces, with specific technical parameters as follows:

[0071] The main frame structure adopts a square frame structure with an outer frame size of 7.5 cm × 7.5 cm and an inner frame opening size of precisely 5.0 cm × 5.0 cm. The frame thickness is 1.5 mm. Compared with Embodiment 1, the frame thickness of this embodiment is thinner and the outer frame size is smaller, making it more suitable for use on curved surfaces or in narrow spaces. The four corners of the frame are rounded with a radius of 2.5 mm.

[0072] The main frame is constructed from medical-grade polypropylene (PP). Polypropylene possesses good mechanical properties, appropriate flexibility, and low TOC release characteristics. Compared to polytetrafluoroethylene (PTFE), polypropylene offers better flexibility and is more suitable for use on curved surfaces. The selected polypropylene material is medical-grade, with a TOC background value not exceeding 50 ppb.

[0073] After the surface-treated frame is manufactured, it undergoes a rigorous surface cleaning process. The specific process is as follows: First, the frame is rinsed three times with ultrapure water with a resistivity ≥18MΩ·cm, with each rinse lasting no less than 5 minutes; then, the frame is placed in a 180℃ high-temperature oven and baked for 2 hours to remove trace amounts of organic matter adsorbed on the surface.

[0074] The aseptic processing frame was sterilized using gamma irradiation at a dose of 25 kGy. The sterilization process was conducted under validated conditions to ensure a sterility assurance level of SAL=10. -6 .

[0075] Each frame is packaged in a double-layer aseptic package, with an inner layer of aseptic paper bag and an outer layer of composite aluminum foil bag. The packaging design is similar to that in Example 1, ensuring that the packaging remains sterile during storage and transportation.

[0076] Unlike Embodiment 1, the frame in this embodiment features a rotatable connector at the end of the operating section. This connector can be connected to a standard long-handled operating lever. The connector uses a standard threaded interface, ensuring a secure and reliable connection. This design allows the frame to be used with a long-handled operating lever, facilitating sampling from hard-to-reach areas.

[0077] Application scenarios

[0078] This embodiment applies to the daily cleaning monitoring and sampling of filling equipment in a pharmaceutical production line. The filling equipment includes multiple stainless steel pipes (diameter ranging from 25mm to 50mm) and filling needles, requiring cleaning after each production batch, with surface TOC testing used to verify the cleaning effectiveness. Due to the complex structure of the filling equipment, including hard-to-access areas such as the inner and outer surfaces of the pipes and the filling needles, flexible sampling tools are necessary.

[0079] Implementation steps

[0080] The specific implementation process of this embodiment is as follows:

[0081] Step 1: Tool Assembly. During the cleanroom preparation phase, the operator first checks the integrity of the aseptic packaging, confirming it is undamaged, leak-free, and within its sterilization expiration date. Then, the operator opens the packaging and removes the aseptic sampling frame and its matching aseptic operating rod (the operating rod is made of stainless steel, approximately 50 cm long, and has undergone the same aseptic treatment). Under Class A laminar flow protection, the operating part of the frame is aseptically connected to the operating rod, ensuring a secure and reliable connection.

[0082] Step 2: The on-site sampling operator holds the operating lever and positions the frame on the outer surface of the pipe or at the predetermined sampling location of the filling needle. Due to the length advantage of the operating lever, the operator can stably place the frame without direct contact with the equipment. For the outer surface of the pipe, the frame is placed perpendicular to the pipe axis, so that the frame opening plane is tangent to the pipe surface; for small-diameter components such as filling needles, the frame plane is aligned with the component surface. After positioning the frame, confirm that the 5×5 cm sampling area is completely located on the surface to be tested.

[0083] Step 3: Sampling on Curved Surfaces. For areas with curvature, such as the outer surface of the pipe, this embodiment utilizes the moderate elasticity of the frame to allow it to conform well to the curved surface. The 1.5 mm thickness of the frame and the flexibility of the polypropylene material ensure that it can adapt to a certain degree of surface curvature without affecting the accuracy of the sampling area. Actual tests show that for pipes with a diameter of 25 mm and above, this frame can achieve a good fit, ensuring the accuracy of the sampling area.

[0084] Step 4: Aseptic Sampling After the frame is positioned, use a sterile TOC sampling swab to swab and collect samples within the area defined by the frame. Since some sampling areas are located on the side or above the pipe, the operator needs to maintain the frame position using the operating lever while simultaneously using another hand to hold the swab for wiping. The wiping method is the same as in Example 1, using an "S" shaped path to ensure coverage of the entire 5×5 cm area.

[0085] Step 5: Multi-point Sampling. According to the cleaning validation protocol, this filling equipment requires 15 sampling points, including key components such as pipes of different diameters, filling needles, and valves. For each sampling point, repeat the above steps using a new sterile sampling frame. After all sampling is completed, send the samples to the laboratory for TOC testing.

[0086] Technical details

[0087] Key technical details in this embodiment include:

[0088] The connection between the frame and the operating lever adopts a standardized threaded interface design. This design has the following advantages: First, the threaded connection ensures a firm connection, preventing the frame from loosening or falling off during sampling; second, the standardized interface allows the same frame to be used with operating levers of different lengths, improving applicability; finally, the threaded interface facilitates aseptic connection, reducing the risk of contamination.

[0089] For pipes with a diameter of 25mm, the curvature of the outer surface is relatively large, requiring the frame to have a certain degree of flexibility to achieve a good fit when used on curved surfaces. This embodiment uses 1.5mm thick polypropylene material, ensuring both structural strength and sufficient flexibility. Practical application shows that when used on curved surfaces, the frame edges maintain good contact with the pipe surface, and the deviation of the sampling area does not exceed 5%, meeting the requirements for testing accuracy.

[0090] When using the operating lever for sampling, operators need to carefully control the force applied. Insufficient force may result in poor contact between the frame and the surface, affecting the accuracy of the sampling area; excessive force may deform the frame or scratch the equipment surface. Through practical training, operators can master the appropriate force, ensuring good contact between the frame and the surface while avoiding surface damage.

[0091] For sampling small-diameter components, such as filling needles, if the diameter is less than 5 cm, the 5×5 cm opening of the frame may not be completely located on the component surface. In this case, the frame position can be adjusted so that the frame opening covers as much of the component surface as possible, and the actual sampling area should be noted in the record. This flexible application method demonstrates the practicality of the invention.

[0092] Implementation effect

[0093] This embodiment has achieved good results in practical applications:

[0094] Sampling efficiency has been improved by using a sampling frame with an operating lever. For hard-to-access areas such as above or behind pipelines, the sampling time has been reduced from about 2 minutes to less than 1 minute, significantly improving operational efficiency.

[0095] The improved sampling quality is attributed to the frame's ability to accurately locate the sampling area, eliminating the uncertainty of manual judgment and significantly improving the consistency of test results. Statistical data shows that after using this invention, the deviation in test results among different operators decreased from 25% to 8%.

[0096] Safety is improved because operators no longer need to climb or adopt uncomfortable postures when using the control lever, reducing operational risks. At the same time, it reduces the number of times operators directly contact equipment surfaces, lowering the risk of contamination.

[0097] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A sterile sampling frame with low TOC background value, comprising a frame body, characterized in that: The main frame has an opening, which is square in shape and measures 5.0 cm × 5.0 cm. The main body of the frame is made of a material with a low TOC background value, wherein the TOC background value of the material does not exceed 100 ppb. The main frame body undergoes aseptic treatment, achieving a sterility assurance level of SAL=10. -6 ; The main frame body is also provided with a handheld operating unit, which extends to the outside of the frame.

2. The aseptic low TOC background sampling framework according to claim 1, characterized in that, The low TOC background value material is selected from at least one of polytetrafluoroethylene, polypropylene, polycarbonate or medical-grade stainless steel; when the material is polytetrafluoroethylene, the TOC background value does not exceed 30 ppb; when the material is polypropylene, the TOC background value does not exceed 50 ppb.

3. The aseptic low TOC background sampling framework according to claim 1, characterized in that, The outer frame of the main body is 7.0 cm to 9.0 cm in size and 1.5 mm to 2.5 mm in thickness. The four corners of the main body of the frame are rounded with a radius of 2 mm to 5 mm.

4. The aseptic low TOC background sampling framework according to claim 1, characterized in that, The handheld operating part is 4 to 6 centimeters long, and the handheld operating part is integrated with the frame body or is detachably connected.

5. The sterile low TOC background sampling framework according to claim 1, characterized in that: The surface of the main frame is cleaned with ultrapure water and baked at high temperature. The ultrapure water cleaning is carried out by rinsing with ultrapure water with a resistivity ≥18MΩ·cm more than 3 times. The high temperature baking temperature is 180℃ to 220℃ and the time is 2 hours to 4 hours. The aseptic treatment employs gamma irradiation sterilization with an irradiation dose of 20 kGy to 30 kGy.

6. The aseptic low TOC background sampling framework according to claim 5, characterized in that, The gamma ray irradiation sterilization dose is 25 kGy.

7. The sterile low TOC background sampling framework according to claim 1, characterized in that, The frame is packaged in a double-layer aseptic packaging, with an inner layer of aseptic paper bag and an outer layer of composite aluminum foil bag.

8. The sterile low TOC background sampling framework according to claim 1, characterized in that, The opening edge of the main frame body is provided with a marking line, which is a scale mark or a color mark.

9. The sterile low TOC background sampling framework according to claim 1, characterized in that, The handheld operating unit has a rotatable connector at its end, which can be connected to a standard operating lever.

10. The sterile low TOC background sampling framework according to any one of claims 1-9, characterized in that, The main frame is designed for single-use.

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