Sterility test kit
HTY Sterility Test System is composed of Closed Sterile Canister and HTY Sterility Test Pump which are regarded as "GOLDEN STANDARD" of sterility testing for injection drugs.It achieved ISO9001 and ISO14001 certificates. The united use of them keeps all process carrying out in complete closed condition, including transfer, filter and incubate, which avoids exogenous contamination.According to different features and package of the test sample, we develop corresponding types of sterility test kits to satisfy the demand on each test sample.
- Ultrasonic welding process makes it smooth and firm, and at its best airtight performance;
- Special composite material made high elastic tubing, with lasting tension , wear and compression resistant, able to ensure the successful filtering of the maximum amount of testing samples;
- Introduction of the European CE standards ethylene oxide sterilizers,which help to provide reliable sterilization validation;
- U.S. advanced medical dialysis paper packaging, 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;
- 100% passed the airtight performance testing;
- Passed the bacterial challenge experiment and sterility test, which ensures reliable of the sterility test results;
- That sterilization validation procedures and process control complying with ISO11135: 2007 standards is able to ensure the sterility of product.
Details as shown in the attachment:
The product is widely used in the sterility test, including antibiotics and preparations containing antibacterial ingredients, sterile API, bulkinfusion, liquid drugs injection, sterilized medical equipment, and sterile water injection.