Active Member
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Address: NO. 18 Xianxing Road Xianlin Industrial Zone Hangzhou
Contact name:wong
Hangzhou Winteam Scientific Instruments Co., Ltd. |
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single-use closed sterile canister ChP EP JP USP 100ml for testing facility
Select the Gibraltar Institute for sterility testing:
Membrane filtration sterilization test
The 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 test
The 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
parameter
| Schematic Diagram | Model | Inspection Style | Packing Spe. |
 | Py220C | Glass Bottle Large Volume Injection | 72Sets/Box 18sets/Box
48 Sets/Box 12sets/Box |
| Py330C | |||
| Ksf220C | Glass Bottle Large-Capacity Antibiotic Injection | ||
| Ksf330C | |||
 | Apy220C | Ampoule Injection | |
| Apy330C | |||
| Kapy220C | Ampoule Antibiotic Injection | ||
| Kapy330C | |||
 | Dgb220C | Vial Bottle Soluble Powder | |
| Dgb330C | |||
| Kdgb220C |
Vial Bottle Soluble Antibiotic Powder | ||
| Kdgb330C | |||
 | Sdy220C | Soft Bag Large Volume Injection | |
| Sdy330C | |||
 | Fsy220C | Insoluble Liquid | |
| Fsy330C | |||
 | Nkf220C | Powder That Needs To Be Dissolved And Diluted | |
| Nkf330C |
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 test
Combination 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 / biopharmaceuticals
Bulk 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 results
Technicians 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.
