Steam sterilization biological indicator SS6-105

medicallaboratoryfor the pharmaceutical industry

Product Introduction
Biological indicators designed for steam autoclave sterilization. Used to confirm sterilizer performance, develop and validate steam sterilization cycles, and support re-validation in regulated environments such as pharmaceutical manufacturing, medical device production, public health laboratories and biosafety facilities.

Features

• Self-contained BI with patented design to limit incubation medium evaporation to typically <10%.
• Color-changing culture medium for rapid and reliable interpretation within 48 hours.
• Medical-grade dialysis paper packaging that allows steam penetration while preventing external contamination.
• Selected carriers enabling efficient microbial elution and accurate colony counting.

Compliance
Biological indicators directly monitor the lethality of a sterilization process. Test spores are traceable and product 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
• PDA TR51 — Biological Indicator for Gas and Vapor-Phase Decontamination Processes

Applications

• Sterilizer performance qualification and routine monitoring
• Process development and validation in pharmaceutical production
• Sterilization validation for medical device manufacturing
• Use in CDCs, public health and biosafety laboratories

Additional Product Details
Available formats: self-contained, carrier-type and spore suspension. Spore concentration and D-value can be configured to meet specific validation protocols. Widely used for performance confirmation, process development and re-validation in regulated facilities.

Technical specifications

• Product types: self-contained BIs, carrier-type BIs, spore suspension BIs
• Patented self-contained structure to control incubation medium evaporation
• Medium: color-changing formulation; interpretable within 48 hours
• Medium resistance: stable up to 134 °C sterilization
• Incubation evaporation: typically <10% for self-contained BIs
• Packaging: medical-grade dialysis paper to permit steam penetration and prevent contamination
• Carriers: selected for efficient microbial recovery and counting
• Traceability: spores are traceable; reports include spore concentration and D-value
• Customization: spore concentration and D-value configurable per validation needs
• Standards and guidance: ISO 11138, GB 18281, USP chapters, Ph.Eur 5.1.2, PDA TR51; FDA 510(k) compatibility referenced