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Biocompatibility: Materials must not release harmful substances (such as extractables and leachables), avoid reacting with pharmaceutical ingredients, and at the same time have low adsorption to prevent the loss of active pharmaceutical ingredients. Shanghai Cunjian implements strict incoming inspection for all raw materials. For example, the medical-grade PE material used in single-use storage bags must pass USP <87> (Biological Reactivity Tests, In Vitro) and USP <88> (Biological Reactivity Tests, In Vivo) to ensure no toxicity risks after long-term contact with biological agents.

Sterilizability: Materials must withstand mainstream sterilization processes (such as gamma radiation sterilization, electron beam sterilization, and ethylene oxide sterilization) and maintain stable performance after sterilization. To address the issue of material degradation that may be caused by gamma radiation sterilization, Shanghai Cunjian selects imported radiation-resistant PP or PE raw materials. Through multiple test verifications, it ensures that the materials do not crack, do not release additional impurities, and maintain good sealing performance after sterilization.

Dead-End-Free Design: For example, at the connection between the bag body and the interface of a single-use bioreactor, Shanghai Cunjian adopts an integrated injection molding process instead of the traditional bonding process, completely eliminating gaps. The bottom of the storage bag adopts a circular arc transition design, which, verified by computational fluid dynamics simulations, can control the liquid residue to below 0.1%, significantly reducing the risk of microbial growth.

Sealing Structure Optimization: The interfaces of components (such as Luer connectors and quick connectors) must have reliable sealing performance to prevent external microbial invasion during use. The connector of Shanghai Cunjian's single-use infusion tube adopts a double-sealing ring design, combined with precise dimensional tolerance control of ±0.01mm. Verified by 100,000 insertion and extraction tests, it can achieve zero leakage during liquid transportation. At the same time, the sealing ring material is medical-grade silicone rubber, which has been confirmed through compatibility tests to not react with pharmaceutical products.

Gamma Radiation Sterilization: This process has strong penetration, thorough sterilization, and no residues, making it suitable for components made of radiation-resistant materials (such as storage bags and infusion tubes). In its application, Shanghai Cunjian strictly controls the radiation dose (25-35 kGy) and retains samples for each batch to test mechanical properties, preventing material degradation due to excessive radiation and ensuring that the components still maintain stable structure and sealing performance after sterilization.

Electron Beam Sterilization: Its advantages include fast sterilization speed, no chemical residues, and minimal damage to materials. It is mainly used for components made of heat-sensitive materials (such as filters and sensors). To address the issue of weak penetration of electron beams, Shanghai Cunjian adopts a layered sterilization process to ensure thorough sterilization in areas where the component thickness is uniform. At the same time, sterility sampling tests are conducted for each batch to verify whether the sterilization effect meets the standards.

Ethylene Oxide Sterilization: It is suitable for complex-structured components that are heat-sensitive and poor in moisture resistance (such as multi-channel connectors). Shanghai Cunjian innovatively adopts a "vacuum desorption + hot air drying" process to significantly reduce the residual amount of ethylene oxide, ensuring that the final residue is ≤5 μg/g, which is far lower than the industry standard (10 μg/g), thus avoiding contamination of pharmaceutical products by residual substances.

Selection of Packaging Materials: Imported three-layer composite films of polyester/aluminum foil/polyethylene are used. Tests show that their oxygen transmission rate is ≤0.1cc/m²·24h and water vapor transmission rate is ≤0.1g/m²·24h, which have excellent barrier properties and can ensure that the components inside the packaging are not affected by the external environment after sterilization.

Integrity Testing: 100% full inspection of each batch of packaging is conducted using the vacuum decay method, and sampling verification is carried out using the dye penetration method. If the vacuum degree drops by more than 0.1mbar or dye penetration occurs, the packaging is determined to be leaking, and the components must be scrapped immediately. The packaging qualification rate of Shanghai Cunjian has long been stable above 99.99%, effectively preventing the sterility from being compromised.

Quality Objective Setting: Clear key indicators such as the Sterility Assurance Level (SAL), biocompatibility grade, sterilization resistance, and service life of the components are defined. For example, for single-use storage bags used in vaccine production, Shanghai Cunjian sets the objective of "maintaining sterility for 24 months under storage conditions of 2-8℃", which is far higher than the industry average level (18 months).

Risk Assessment: The Failure Mode and Effects Analysis (FMEA) method is adopted, and a cross-departmental assessment team (including design, production, quality, and sales departments) is established to identify potential risks in the design process (such as interface sealing failure and material degradation) and formulate preventive measures in advance. For example, in the design of the filter membrane pore size of single-use filters, Shanghai Cunjian confirms through risk assessment that "a 0.22 μm pore size can effectively retain bacteria without affecting the passage of active pharmaceutical ingredients" and conducts 3 batches of simulated production verification to avoid sterility failure or pharmaceutical loss caused by improper pore size selection.

Clean Environment Requirements: The overall production workshop meets the ISO Class 8 (static) cleanliness level, and key processes (such as component assembly and sealing) are carried out in ISO Class 7 clean rooms. High-efficiency particulate air (HEPA) filters and ultraviolet disinfection systems are equipped, and real-time monitoring of suspended particles (≤352,000 particles/m³) and microorganisms (≤10 CFU/m³) in the clean rooms is conducted to avoid microbial or particulate contamination during production.

Process Parameter Monitoring: Real-time monitoring and recording of parameters (such as temperature, pressure, and time) for key processes such as injection molding, welding, and assembly are carried out, and a Manufacturing Execution System (MES) is adopted to realize automatic alarm for parameter abnormalities. For example, in the welding process of the bag body of single-use bioreactors, Shanghai Cunjian monitors the welding temperature (180±2℃) and pressure (0.3±0.01 MPa), and samples are taken every 5 minutes to test the weld strength, avoiding insufficient weld strength or sealing failure caused by fluctuations in welding parameters.

Incoming Material Inspection: Strict inspection of raw materials (such as plastic pellets, sealing rings, and filter membranes) is conducted, including appearance, dimensions, physical properties (such as tensile strength and temperature resistance), and chemical properties (such as extractable content). All raw materials must be provided with a Certificate of Analysis (COA) by the supplier, and re-inspection is conducted by the Quality Department of Shanghai Cunjian before they can be put into storage for use. For example, for medical-grade PE pellets, the melt flow index (MI: 2.0±0.2 g/10min) and density (0.923±0.002 g/cm³) are tested to ensure stable material processing performance and avoid fluctuations in component performance caused by differences in raw material batches.

Sterilization Effect Verification: In addition to the aforementioned SAL test, Shanghai Cunjian also conducts a "microbial challenge test", in which 10⁶ CFU/piece of Bacillus subtilis var. niger spores are artificially contaminated on the component surface. After sterilization, the survival of microorganisms is detected to ensure that the sterilization process can 100% kill the target microorganisms. At the same time, records of sterilization process parameters are retained for each batch of products to facilitate subsequent traceability.

Packaging Integrity Verification: Multiple testing methods (such as the vacuum decay method and dye penetration method) are used for sampling inspection of packaging. At the same time, an "accelerated aging test" is conducted to simulate long-term storage conditions (storage at 40℃ and 75% relative humidity for 6 months) to verify the integrity of the packaging during the shelf life. The results of the accelerated aging test for packaging of Shanghai Cunjian show that the barrier performance of the packaging does not decrease significantly within the 24-month shelf life, and the sterility of the components can be stably maintained.

Transportation Process Control: Cooperation with cold chain logistics companies certified by Good Supply Practice (GSP) is carried out. The transport vehicles are equipped with temperature recorders (accuracy ±0.5℃) and shock-absorbing buffer devices. The transport temperature (2-8℃) and vibration intensity are monitored throughout the process. If the temperature exceeds the range or the vibration exceeds the set threshold, an emergency plan is activated immediately. At the same time, the transport routes avoid areas with high temperature, high humidity, or severe pollution to ensure the safe delivery of components.

Storage Condition Requirements: The warehouse of Shanghai Cunjian adopts a constant temperature and humidity design (temperature 20±5℃, relative humidity 40%-60%) and is equipped with a rack-type storage system to avoid component deformation due to pressure. The inventory management adopts the "first-in, first-out" principle, and a Warehouse Management System (WMS) is used to monitor the shelf life of the inventory in real time. Customers are reminded to prepare goods 3 months in advance to prevent components from exceeding their shelf life. For example, for components sterilized by gamma radiation, Shanghai Cunjian clearly requires that they should not be stored in an environment above 30℃ for a long time to prevent accelerated material aging and affect the sealing performance.

Pre-Use Inspection: Key points for pre-use inspection are specified in the product manual, including checking whether the component packaging is intact, whether the sterilization indicator card has changed color (to confirm sterilization), and whether the product is within its validity period. If any abnormality is found, use must be stopped immediately, and the Quality Department of Shanghai Cunjian should be contacted for handling.

Sterile Operation Specifications: A Sterile Operation Training Manual is provided to customers, guiding that the opening and connection of components should be carried out in a biosafety cabinet or sterile isolator. Operators must wear sterile gloves and sterile clothing to avoid contact with the sterile parts of the components with their hands. When connecting interfaces, the three-step method of "aligning-inserting-screwing tightly" should be followed to ensure proper sealing.

Post-Use Traceability: A unique batch number and serial number are assigned to each component. Customers can query information such as the production, sterilization, and inspection of the components through the "Product Traceability System" on the official website of Shanghai Cunjian. If pharmaceutical contamination problems occur later, the source can be quickly traced, the cause analyzed, and improvement measures taken.