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China, Chinese China Winteam Disposable Use Sterility Test Closed Canister PVDF Membrane Filtering1 Industrial Products Supplier Manufacturer Details, price list catalog:
China Industrial Products Supplier Manufacturer List Catalog
Pharmaceutical Filtering EquipmentSterility Test CanisterBiological Products Test
Hangzhou Winteam Scientific Instrument Co., Ltd.
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Product Description Product Description Name:Sterility Test CanisterMembrane Material:MCE NYLON PPAir Filter:0.22μmNeedle:304 Stainless SteelUsage:FilterationTube:PvcHigh Light:sterility test kit canister,sterility testing pump Features single-use closed sterile canister ChP EP JP USP 100ml for testing facility Select the Gibraltar Institute for sterility testing:Membrane filtration sterilization testThe membrane filtration sterilization test method is the best method for filtering drugs. The product was filtered through a 0.45 or 0.2 micron membrane filter according to the USP <71> sterility test method. The filter is then rinsed with a suitable USP liquid to remove the inhibitor and then transferred to liquid thioglycolic acid medium (FTM) and soy casein digestion medium (SCDM). Both media were incubated for 14 days and microbial growth was examined daily. The USP <71> sterilization test recommends the use of liquid thioglycolic acid medium (FTM) and soy casein digestion medium (SCDM). These can promote the growth of anaerobic and aerobic microorganisms. 2. Direct transfer sterilization testThe direct transfer sterilization test method is a method of selecting medical devices (such as solid dosage forms, powders, ointments, and creams) that cannot be filtered. In this sterility test method, the test article is transferred directly to liquid thioglycolic acid medium (FTM) and soybean casein digestion medium (SCDM). Both media were incubated for 14 days and microbial growth was examined daily.We are offering sterility test closed canister.Sterility test canisters are used for pharmaceutical product sterility test by the membrane filter method which produced in very strict condition. Working together with sterility test pump. Characteristics of Sterility Test Canister Quantity of Filter Cartridge: 2 or 3Pressure Resistance of Filter Cartridge: 0.5MpaVolume of Filter Cartridge: 100mlFilter Membrane: Mixed Cellulose Esters Membrane / Nylon Membrane / PP Membrane (according to different types) with diameters of 47mm and bore diameter of 0.45 μmRespirator Filter Membrane: PTFE hydrophobic membrane with diameter of 25mm and bore diameter of 0.45 μm Product Parameters Schematic DiagramModelInspection StylePacking Spe. Py220CGlass Bottle Large Volume Injection72Sets/Box18sets/Box 48 Sets/Box12sets/BoxPy330CKsf220CGlass Bottle Large-Capacity Antibiotic InjectionKsf330C Apy220CAmpoule InjectionApy330CKapy220CAmpoule Antibiotic InjectionKapy330C Dgb220CVial Bottle Soluble PowderDgb330CKdgb220C Vial Bottle Soluble Antibiotic PowderKdgb330C Sdy220CSoft Bag Large Volume InjectionSdy330C Fsy220CInsoluble LiquidFsy330C Nkf220CPowder That Needs To Be Dissolved And DilutedNkf330C The collection collection incubator is carefully manufactured by forty processes, each in strict accordance with the ISO9001 quality system and ISO14001 environmental system requirements. 100% of the products passed the integrity test, achieving continuous improvement in quality traceability and quality. According to the testing requirements of different dosage forms and packaging forms, various cups, filter materials and matching needles were selected, and various collection incubators were designed and developed to meet various sterilization tests. need. Product rinse sterility testCombination product: Product rinse sterility test is only applicable to products with hollow tubes, such as infusion and infusion sets, which are not suitable for soaking and the fluid channel is marked as sterile, this method is easy to operate and requires modification of FTM media with liquid D rinse products, The eluate was membrane filtered and placed in FTM and SCDM. This method is usually not used. Bulk drugs / biopharmaceuticalsBulk drugs (API) have been sterilised according to USP 71 prior to release to the manufacturing process. Bulk biologics are tested for sterility according to 21 CFR 610.12, which requires a medium (FTM) with sample test sizes listed in the document and a capacity of not less than 10 ml.10 Interpretation of sterility test resultsTechnicians must be trained in growth testing methods during the cultivation process. Growth is determined by observing a medium that is generally transparent and transparent with respect to the light source, and the turbid (turbid) area of the medium indicates the growth of microorganisms. Once growth is detected, the suspect container is tested to confirm that the turbidity present is due to microbes, not due to decomposition of the sample; sometimes, the sample becomes cloudy due to particle shedding or chemical reaction with the medium. After testing, return to the incubator for the remainder of the incubation period. Samples turbid in the medium were transferred and displayed for four days on the 14th day of the test. Tag:sterility testing pump,sterility test kit canister,sterility test device
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