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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.
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.
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.
No. According to ISO 11138, BIs are defined as the only means to provide direct evidence of microbial kill. USP <1229> further clarifies that while physical and chemical monitoring provide real-time data, they are “indirect” measures.
The color change of a CI only proves that the sterilant has “reached” the area; it does not represent that microorganisms have been completely eradicated. In annual re-validations and routine batch releases, a negative BI result is an indispensable legal basis.
Yes. Tailin states that its Biological Indicators comply with multiple international standards and guidelines, including ISO 11138, USP, EP, GMP, PDA TR51, FDA 510(k), and GB18281 requirements. In addition, the spores are traceable and test reports include important validation data such as spore concentration and D-values.
The self-contained design helps reduce operator handling steps and lowers contamination risk. Tailin also uses medical-grade dialysis paper packaging that both prevents external contamination and ensures adequate steam penetration during sterilization cycles.
Yes. To ensure a precise match with various sterilization protocols and material sensitivities, we provide biological indicators in two standard temperature categories:
121°C BIs (Standard High-Pressure): Optimized for standard autoclave cycles. These are the go-to choice for validating the sterilization of robust items like stainless steel instruments, glassware, and typical laboratory loads.
115°C BIs (Low-Temperature/Sensitive): Specifically designed for low-temperature steam sterilization processes. This option is critical for heat-sensitive materials, specialized media, or delicate equipment that cannot withstand standard 121°C cycles.
