Laboratory Sterility Test Device EO Sterilization ISO9001 Closed Sterile Canister

Laboratory sterility test device EO sterilization ISO9001 Closed Sterile Canister

It is important to test the sterility of biopharmaceuticals to ensure safety. If not found, the contaminants can lead to life-threatening infections. There were many examples in the past, but the product was recalled because there was no guarantee of sterility (4). It is therefore important to ensure that the test procedures performed comply with regulatory guidelines. WINTEAM can provide the necessary evidence for mass production of biopharmaceuticals by ensuring that professional biosafety professionals perform the necessary sterility tests according to GMP standards.

Sterility testing of pharmaceuticals is required during sterilization validation and in routine release testing. USP requires sterility testing as a formal test to determine the suitability of a large number of products. Understanding the need for sterility testing to help design validation processes to provide adequate and reliable sterility test data is an important quality assurance issue. Sterility testing is a very cumbersome and embarrassing process that must be performed by trained and qualified laboratory personnel. Investigation of the failure of a sterility test is a process that requires attention. Environmental data and many other factors, including training and sample difficulty.

Disposable for sterility test, all closed.

For different samples, different types of canisters.
Meet the sterility testing industry benchmark
Minimize false positives: closed filtration devices reduce the risk of false positive results and avoid costly investigation and possible batch loss. There are no open containers or membrane manipulations, which could increase the risk of contamination.

Reduce false negatives: Steritest filtration devices are the right answer to the danger that false negative results pose to patients. Through specific membranes, unique sealing technology and optimized device design, the unit allows efficient elimination of bacteriostatic, fungistatic or bactericidal agents.
Easy Identification with color coding and optimized traceability.

Characteristics of Sterility Test Canister

HTY Sterility Test System is composed by SteritailinTM Closed Sterile Canister and HTY Germs Collector which regards as “GOLDEN STANDARD” during sterility testing for injection drugs.It passed ISO9001 amd ISO14001 cetificates. The united use of them keeps all process carrying out in complete closed condition, including transfer, filter and incubate, which avoid exogenic contamination. Accoring to different feature and package of the test sample, we develop corresponding types of sterility test kits to satisfy the demand on each test sample.

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.