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Rapid / Ultra-Rapid Self-contained

Autoclave Steam Biological Indicators

Used to fast monitoring of steam sterilization effectivenes

Tailin Biological Indicators for Autoclave Steam are designed for rapid verification of steam sterilization effectiveness across healthcare, pharmaceutical, medical device, and laboratory applications.

The Rapid and Ultra-Rapid Self-contained Steam BIs, supporting 121°C, 132°C, and 134°C sterilization cycles, with the Ultra-Rapid version ideal for fast release of implants and emergency surgical instruments.

Self-contained BIs for autoclave steam

Rapid version: The results can be read within 3 hours.

Ultra-Rapid Version: The results can be read within 30 minutes.

Specifications

Rapid Ultra-Rapid
Model: SS6-121R Model: SS6-121S
Organism: Geobacillus stearothermophilus ATCC 7953 Organism: Geobacillus stearothermophilus ATCC 7953
Spore Population: 1×106-5×106 Spore Population: 1×106-5×106
Storage: 2-25℃ Storage: 2-25℃
Shelf Life: 12 months Shelf Life: 12 months
Packaging: 50pcs/box Packaging: 50pcs/box
Time to Result: Within 3 hours Time to Result: Within 30 minutes

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

Rapid and ultra-rapid self-contained BIs are designed for fast monitoring of steam sterilization effectiveness. 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.

Tailin Bioengineering

Pharmaceuticals

Tailin Bioengineering

Medical Industry

Tailin Bioengineering

Biosafety Laboratoires

FAQ

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.

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