Hangzhou Winteam Scientific Instruments Co., Ltd.
Hangzhou Winteam Scientific Instruments Co., Ltd. THE MISSION OF WINTEAM IS PROVIDE BETTER STERILITY TEST PRODUCTION
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Reliable sterility test kit Gamma Ray Sterilization AS cup 0.45μm membrance
Our verification program requires technicians to continuously test membrane filtration and direct immersion of 40 simulated samples under unfavorable environmental conditions without false positive results. Isolation technology is used to create conditions for a sterile environment for testing drugs. The qualification conditions for the isolator are extensive and the isolator is typically sterilized using a chemical sterilizer.
The robustness of the sterilization process involves many problems. Eligibility and maintenance of isolation and identification of sterile systems may require a significant amount of work. Isolators may not be the best cost method for solving environmental problems when testing drugs in closed systems such as winteamTM. Standard aseptic processing GMP can avoid most environmental problems. 5
Characteristics of Sterility Test Canister
100% passed the airtight performance testing;Passed the bacterial challenge experiment and sterility test, which ensures reliable of the sterility test.The united use of them keeps all process carrying out in complete closed condition, including transfer, filter and incubate, which avoids exogenous contamination.Product sterility performance has been maintained and able to dialyze the ethylene oxide quickly, its residues and packaging waste are reduced, which fully reflects the corporate philosophy of environmental protection;
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 USP <71> sterility test consists of two qualifying tests that must be performed prior to sterility testing, "adaptive testing" (promoting growth testing) and "validation testing" (antibacterial and fungal disease testing).
The suitability test is used to confirm that each growth medium used in the sterility test procedure will support the growth of less than 100 viable microorganisms, which will fail if the medium does not support the growth of the indicator organism. According to the culture parameters (time, temperature) determined by the method, a part of each medium batch must be specially sterilized, and if the medium is not sterilized, the test fails.
The verification test is used to determine whether the test sample inhibits the growth of microorganisms in the test medium. Microbiological retention means that the microorganism cannot grow and proliferate in the microbial medium, and the bacteriostatic medium does not necessarily kill the bacteria; it may It only hinders the growth and reproduction of bacteria. Each product must be tested for validation prior to and/or during the sterility test to determine if the media volume is valid for a particular product. Certain medical products contain bacteriostatic and fungistatic compounds and may require special procedures and special media for testing. This test is similar to the suitability test described above, but the product sample is placed in the medium along with the microorganisms. It was compared to a control without a test sample. If microbial growth is present in the sample and control containers, the next step is to perform an actual sterility test that allows for simultaneous suitability, validation, and sterility testing.