Biological Indicators

Used to monitor EO sterilization effectiveness

Introduction

Features

Compliance

Applications

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Inquiry

They are used to monitor EO sterilization effectiveness, and re-validation of the EO sterilization equipment, which are widely used in pharmaceuticals, medical device industries and other fields.

Self-contained and paper strip type

Storage 2-25℃

Shelf life 12 months

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 EO 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
……

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.