Biological Indicators

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BIs for Autoclave Steam

They are used to confirm the performance of steam sterilization equipment, develop and establish steam sterilization processes, and re-validation of the steam sterilization equipment. They are suitable for pharmaceutical enterprises, medical device industries, CDC, biosafety laboratories and other fields.

Self-contained BIs for autoclave steam

Patented design structure, efective control of medium evaporation during cultivation

The medium is resistant to sterilization up to 134 °C

Features

Self-contained Bls with a patented structure, less than 10% evaporates of incubation.
Color-changing medium, 48h for accurate results.
Medical packaging dialysis paper aviod external contamination and allows steam penetration.
Selected carriers for easy microbial elution and count.

Compliance

Biological indicators are the ideal process indicators that directly monitor the lethality of a given sterilization process. Tailin’s biological
indicators meet the requirements of ISO 11138, GB18281, GMP, PDA TR51, FDA 510k and Pharmacopoeia (USP, EP, ChP). The spores
used are traceable and the test report includes spore concentration, D-value, and other relevant data.

ISO11138 Sterilization of health care products-Biological indicator
GB18281 Sterilization of health care products-Biological indicator
USP 1229 Sterilization of Compendial Articles
USP55 BIOLOGICAL INDICATORS-RESISTANCE PERFORMANCE TESTS
USP 1035 BIOLOGICAL INDICATORS FOR STERILIZATION
Ph.Eur5.1.2 Biological Indicators and related microbial preparations used in the manufacture of sterile products
PDA TR51 Biological Indicator for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use
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