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USP 71 Sterility testing is widely used in both the medical device and pharmaceutical industries. As a USP test, it is the official procedure for testing the sterility of pharmaceutical products (USP 71). There are different methods to test the sterility of the products.
1,Direct Transfer-Immersion Sterility Testing
2,Membrane Filtrartion - open system
3,Membrane Filtrartion by Sterility test kits Method -a closed system Sterility Testing Method
The preferred method for sterility testing is the membrane filter method using a closed sterility test system, such as the new disposable sterility test system. Virtually all pharmaceutical containers and product types can be tested due to the wide range of sterility test units featuring different adapter types. We has developed the new Universal pump for sterility testing.
The sterility test canister is elaborately manufactured through more than 40 procedures, which are strictly controlled respectively. The products fully passed integrality inspection. According to requirement of ISO 9001, each test can be traced and the quality has being improved continuously. According to the various characters and packaging formats of the samples, we match many kinds of microporous filter membranes which are different in materials and structures, and then design and develop 28 kinds of incubate container which can meet all requirements in the sterility testing for all kinds of the samples.
TECHNICAL CHARACTERISTIC
1. Adopt supersonic weld,joint smoothly and fastness to be perfect airtight performance.
2. The high elasticity tube which is made compound by special material has long tensility, endure attrition, can guarantee the biggest testing capacity.
3. CE standard ETO sterilization with reliable sterile certificates, ensure sterile capability.
4. Packed by dialytic paper, keep the sterile capacity of products for long time. Can dialyse the ETO fast; the residue of it is ≤10mg/kg.
5. Each lot of canister has been inspected and supply product test report.
APPLICATION
1. Sterile pharmaceutical for injection (large volume Injection, nutrition liquid, biological goods, powder medicine, emulsion, etc)
2. The antibiotics and other medicine with bacteriostasis ingredients.
3. Sterilized medical instruments (injector, transfusion system, apparatus transfusions, venous duct, etc.)
4. Production of sterile products without particles.
5. Food and beverage industries.
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