Ethylene oxide sterilization biological indicator ES6-600

medicallaboratoryfor the pharmaceutical industry

Introduction
Tailin biological indicators (BIs) are designed to monitor the effectiveness of Ethylene Oxide (EO) sterilization and to support re-validation of EO sterilizers. They are intended for use in pharmaceutical manufacturing, medical device production and other institutions requiring sterilization validation.

Product Type

• Self-contained BIs
• Paper-strip (spore strip) BIs

Key Features

• Self-contained BIs feature a patented design that limits incubation evaporation to
• Color-changing readout medium for clear visual results, typically within 48 hours.
• Medical-grade dialysis paper packaging prevents external contamination while allowing EO penetration.
• Selected carriers optimized for efficient microbial elution and colony counting.

Compliance
These biological indicators provide direct monitoring of sterilization lethality and comply with major international and regional standards. Spores used are traceable and test reports include spore concentration, D-value and related data.

• ISO 11138 — Sterilization of health care products — Biological indicators
• GB 18281 — Sterilization of health care products — Biological indicator
• 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 used in the manufacture of sterile products
• PDA TR51 — Biological Indicator for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use
• Meets GMP and FDA 510(k) expectations for BI traceability and reporting

Applications
Suitable for pharmaceutical companies, medical device manufacturers, public health laboratories, biosafety facilities and other organizations performing EO sterilization validation and routine monitoring. Technical support and documentation are available from Tailin.

Storage & Shelf Life

• Storage temperature: 2-25°C
• Shelf life: 12 months

Technical specifications

• Product family: Biological Indicators for Ethylene Oxide (BIs for EO)
• Types: Self-contained BIs and paper-strip BIs
• Incubation evaporation: Patented structure reduces evaporation to
• Readout: Color-changing medium; typical results within 48 hours
• Packaging: Medical dialysis paper permitting EO penetration while preventing contamination
• Carriers: Selected for optimized microbial elution and count
• Traceability: Traceable spores; test reports include spore concentration and D-value
• Standards/Compliance: ISO 11138, GB 18281, USP (1229, 55, 1035), Ph.Eur 5.1.2, PDA TR51, GMP, FDA 510(k)
• Storage conditions: 2-25°C
• Shelf life: 12 months