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BIs for Hydrogen Peroxide Low Temperature Plasma

Biological Indicators

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Article

They are used to monitor the sterilizing effect of hydrogen peroxide plasma sterilizers, which are widely used in hospitals, medical device industries and other fields.

Self-contained type

Storage 2-25℃

Shelf life 12 months

Features

  • Patented structure, ensure hydrogen peroxide penetration and avoid false positives.
  • Effective controlofmedium evaporation duringincubation.
  • Color-changing medium, 48h for accurate results.
  • Selected carriers for easy counting.

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.

Pharmaceuticals

Medical Industry

Biosafety Laboratoires

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Article

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17/12/2025

The Final Guardian of Drug Safety: Ensuring Reliable Vials Sealing and Security
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21/11/2025

From FDA Warning Letters to New Pharmacopoeia Standards: Where Are the Boundaries of “Complete” Microbial Data?
News
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04/11/2025

Tailin Honored as “Advanced Committee Unit for Standardization Work” for Supporting Domestic & International Sterilization Standardization

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