Can Chemical Indicators (CIs) replace Biological Indicators (BIs) for cycle validation and batch release?

No. According to ISO 11138, BIs are defined as the only means to provide direct evidence of microbial kill. USP 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.

Are Biological Indicators compliant with international pharmaceutical and medical regulations?

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.

How can users avoid contamination during incubation or handling?

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.

Do you offer biological indicators (BIs) for different sterilization temperature ranges?

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.

Home > Solutions > Sterilization Monitoring and Validation > Biological Indicators > H2O2 Low-Temperature Plasma Biological Indicators

Ultra-Rapid Self Contained

H2O2 Low-Temperature Plasma Biological Indicators

Used to fast monitoring of low-temperature hydrogen peroxide plasma sterilization

Tailin Rapid Biological Indicator for Hydrogen Peroxide Low-Temperature Plasma Sterilization is designed for ultra-rapid monitoring of low-temperature hydrogen peroxide plasma sterilization, delivering fluorescence-based results within 15 minutes with the HTY-RBIR100 Rapid BI Reader. It is ideal for fast sterilization verification in hospital operating rooms, CSSDs, and other healthcare facilities.

Ultra-Rapid-H2O2-Low-Temperature-Plasma-Bl

Self-contained BIs for H2O2 Low-Temperature Plasma

The results can be read within 15 minutes.

Shelf Life 12 Months

Specifications

Model: PS6-023S	Organism: Geobacillus stearothermophilus ATCC 7953
Spore Population: 1×10⁶-5×10⁶	Storage: 2-25℃
Shelf Life: 12 months	Packaging: 50pcs/box

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

After sterilization, the indicators are incubated in the HTY-RBIR100 Rapid BI Reader, which determines the result based on fluorescence signal changes. Ideal for hospital operating rooms, CSSDs, and other healthcare facilitie.