Biological Indicators

Introduction

Features

Compliance

Applications

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Specially designed to meet the needs of the pharmaceutical, food, and medical device industries using vaporized & atomized hydrogen peroxide decontamination

Suitable for sterilization validation of vaporized & atomized hydrogen peroxide

Mature spore preparation process, purity of spores is higher than 99%

Patented design structure, easy to use, high temperature resistant culture

Features

Self-contained Bls, easy to use, press for instant inoculation.
Patented structure, less than 10% evaporates of incubation.
Tyveke® packaged to meet the requirements for hydrogen peroxide penetration while avoiding external contamination.
Waterproof to ensure safety and effectiveness in high humidity environments.

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
……

Applications

Biological indicators are suitable for pharmaceutical enterprises, medical device industries, CDC, biosafety laboratories and so on. Tailin’s biological indicators are of reliable quality and complete types, and can provide professional technical support for users.