Hangzhou Winteam Scientific Instruments Co., Ltd.
THE MISSION OF WINTEAM IS PROVIDE BETTER STERILITY TEST PRODUCTION
|Place of Origin:||CHINA|
|Minimum Order Quantity:||ONE BOX|
|Packaging Details:||72sets/box,18sets/box, 48sets/box,12 sets/box|
|Supply Ability:||10000sets per day|
|Name:||Sterility Test Canister||Membrane Material:||MCE NYLON PP|
|Pakcing:||Paper Box||Needle:||304 Stainless Steel|
sterility test kit canister,
sterility testing pump
one-off membrane filtration sterility test kits EO sterilization MCE Nylon PP membrance
Sterility test method
The determination of sterility includes the use of test materials to inoculate a medium that supports microbial growth. After inoculation, the media was monitored for 14 days to observe visual signs of bacterial or fungal contamination. If growth is observed, agar plates can be used to identify and identify microorganisms. This will help you understand how the product is destroyed.
This guide details sterility testing by inoculating ethanol and soy casein digestion media with liquid thioglycolic acid. The combination of these two media was chosen to support the rapid growth of a variety of microorganisms including aerobic and anaerobic bacteria and fungi. Test substances are incorporated at low levels in typical organisms (eg aerobic bacteria Staphylococcus aureus, spore-forming bacteria, Bacillus subtilis, anaerobic bacteria Clostridium or Candida albicans Candida albicans). There is no hindrance due to potential concealment of contaminant samples to validate the test.
Sterility testing can be performed using one of two methods: membrane filtration or direct inoculation. In the case of direct inoculation, the medium can be inoculated by simply adding the test material aseptically. In the case of membrane filtration, the test substance passes through a size exclusion membrane that can hold microorganisms. The membrane can then be aseptically transferred to the medium. Membrane filtration is recommended to accommodate large amounts of test material or if the test material contains substances that can inhibit the growth of microorganisms such as antibiotics.
Characteristics of Sterility Test Canister
Membrane Filtration Method A membrane filtration method generally uses a closed membrane filter. The pore size of the membrane for sterility testing should be no more than 0.45 μm and a diameter of approximately 50 mm. The filter material is selected according to the characteristics of the test sample and its solvent. When used, the integrity of the filter before and after filtration should be guaranteed. A small amount of rinsing liquid should be filtered before the water-soluble test solution is filtered to wet the filter. For oil samples, the filter and filter should be fully dried before use. In order to maximize the filtration efficiency of the membrane, care should be taken to keep the test solution and rinse solution covering the entire surface of the membrane. After the test solution is filtered through the membrane, if it is necessary to rinse the membrane with the rinsing liquid, the amount of each membrane is usually 100 ml per flush, and the total flushing volume should not exceed 1000 ml to avoid microbial damage on the membrane.
|Schematic Diagram||Model||Inspection Style||Packing Spe.|
|Py220C||Glass Bottle Large Volume Injection||
|Ksf220C||Glass Bottle Large-Capacity Antibiotic Injection|
|Kapy220C||Ampoule Antibiotic Injection|
|Dgb220C||Vial Bottle Soluble Powder|
Vial Bottle Soluble Antibiotic Powder
|Sdy220C||Soft Bag Large Volume Injection|
|Nkf220C||Powder That Needs To Be Dissolved And Diluted|
Sterility examination should be carried out under aseptic conditions. The test environment must meet the requirements of sterility inspection. The whole process should be strictly followed by aseptic operation to prevent microbial contamination. Measures to prevent contamination should not affect the detection of microorganisms in the test sample. The unidirectional flow air zone, work surface and environment shall be regularly checked for cleanliness according to the current national standards for test methods for suspended particles, planktonic bacteria and settled bacteria in the clean room (district) of the pharmaceutical industry. The isolation system shall be verified periodically according to the relevant requirements, and the cleanliness of its internal environment shall comply with the requirements of sterility inspection. Daily testing also requires monitoring of the test environment.
USP describes three general methods for sterility testing: 1) membrane filtration, 2) direct transfer (product immersion) and 3) product rinsing.
Membrane filtration sterility test
Membrane filtration sterility testing is the method of choice for drugs, not the choice of medical devices; FDA may question the principle of using membrane filtration testing rather than direct device transfer testing. The test is for instruments containing preservatives and having bacteriostatic and/or fungal static effects under direct transfer methods. The concept of membrane filtration is that the microorganisms will accumulate on the surface of a filter having a pore size of 0.45 microns. The test medium was liquid thioglycolic acid medium (FTM) and soy casein digestion medium (SCDM), which was selected according to its ability to support anaerobic and aerobic microbial growth. The incubation time is 14 days, because a lot of operations are required, so a large number of aerobic bacteria and fungi (ie yeast and mold) are required. For sterility testing of membrane-filtered medical devices, the possibility of laboratory contamination is high, so in open systems, sterility may be higher when using this method; for drugs and small devices or combination products, A closed system is recommended. Closed using a closed system. In closed systems, the incidence of external contamination is low.
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