Biological Indicators

Used to monitor the effectiveness of space sterilization such as ozone, formaldehyde and chlorine dioxide

Introduction

Features

Compliance

Applications

Download

Inquiry

They are suitable for monitoring the effectiveness of space sterilization such as ozone, formaldehyde and chlorine dioxide. Provided with staphylococcus albus 8032 and bacillus atrophaeus ATCC9372 as species. Widely used in pharmaceuticals, medical device industries and other fields.

Stainless steel strip and paper strip

Bacillus atrophaeus ATCC9372 storage 2-8℃, Staphylococcus albus 8032 storage ≤-18℃

Shelf life 12 months or 6 months

Features

Stainless steel sheet carrier, effectively avoiding false positives.
Tyvek® packaged to meet the requirements for sterilization gas penetration while avoiding external contamination.

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.