Moist Heat Biological Indicators

Used to monitor the sterilization performance of moist heat sterilizer

Introduction

Features

Compliance

Applications

Download

Inquiry

Tailin Moist Heat Biological Indicators (Spore Suspensions) are used to validate, monitor, and requalify moist heat sterilization processes. They provide a reliable means of verifying sterilization effectiveness, particularly for liquid product sterilization, while supporting compliance with ISO 11138 and global regulatory requirements.

Self-developed medium formula, sterilized at 134℃ for 2h without fading

Provide products with suitable parameters for different sterilization time at 121°C

Customized service for spores concentration and D value

Features

Color-changing medium, 48h for accurate results.
High strength ampoules, not easily broken.
Special production process, stable performance of spores during shelf life.
The capsule vial is more compact, suitable for monitoring the sterilization effect of specific materials such as medical device.

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.