Hydrogen peroxide sterilization biological indicator PS6-023

medicallaboratoryfor the pharmaceutical industry

Product Introduction
Self-contained biological indicators designed to monitor the sterilizing effect of hydrogen peroxide low-temperature plasma sterilizers. Commonly used in hospitals, medical device manufacturing, pharmaceutical production and biosafety laboratories for routine sterilization validation and process control.

Features

• Patented carrier structure ensuring hydrogen peroxide penetration and reducing false positives.
• Designed to control medium evaporation during incubation for reliable results.
• Color-changing medium: incubation results available in approximately 48 hours.
• Optimized carriers for clear, easy colony counting.

Compliance
Biological indicators provide direct monitoring of sterilization lethality. Tailin’s biological indicators comply with major industry standards and pharmacopeias; spores are traceable and the test report includes spore concentration, D-value and related data.

• ISO 11138 — Sterilization of health care products — Biological indicators
• GB 18281 — Sterilization of health care products — Biological indicators
• USP 1229 — Sterilization of Compendial Articles
• USP 55 — Biological Indicators — Resistance Performance Tests
• USP 1035 — Biological Indicators for Sterilization
• Ph. Eur. 5.1.2 — Biological indicators and related microbial preparations
• PDA TR51 — Biological Indicator for Gas and Vapor-Phase Decontamination Processes

Applications
Suitable for pharmaceutical companies, medical device manufacturers, infection control departments, CDCs and biosafety laboratories requiring sterilization validation and routine monitoring. Available in multiple formats and supported by technical data and traceable spore information.

Download
Product-related validation and sterilization monitoring documents available for download.

Technical specifications

• Type: Self-contained biological indicator
• Intended sterilant: Hydrogen peroxide low-temperature plasma (also compatible with vaporized/atomized hydrogen peroxide validation)
• Medium: Color-changing medium (results in ~48 h)
• Design: Patented carrier structure to ensure H2O2 penetration and avoid false positives
• Evaporation control: Effective control of medium evaporation during incubation
• Counting: Selected carriers for easy colony counting
• Spores: Traceable spores; test report includes spore concentration and D-value
• Storage conditions: 2-25 °C
• Shelf life: 12 months
• Compliance / Standards: ISO 11138, GB 18281, GMP, PDA TR51, FDA 510(k), Pharmacopoeias (USP, EP, ChP)