Steam sterilization bioindicator

temperaturesterilizationfor healthcare facilities

Description
The STERIM® biological indicator ampoule contains Geobacillus stearothermophilus spores sealed with a growth medium inside a glass ampoule, packaged in a paper-plastic pouch. Designed for routine validation of steam sterilization cycles, the ampoule is placed between sterilization loads and incubated after activation to verify the biological effectiveness of the cycle.

Packaging options

• 100 biological indicators per pack (includes ampoule crusher)
• 25 biological ampoule indicators per pack
• 10 biological indicators per pack
• Single biological ampoule indicator (1 pc)

How to use / Procedure
Place the ampoule, inside its paper-plastic pouch, between sterilization packs in the autoclave chamber. After the sterilization cycle, crush the inner glass ampoule to mix the culture medium with spores and incubate the test at 55–60°C for 24 hours. Assess the culture medium color after incubation: a color change indicates biological growth (sterilization failure); no color change indicates an effective sterilization cycle.

Benefits

• Confirms biological effectiveness of individual steam sterilization cycles
• Compatible with standard biological incubators
• 100‑piece pack includes an ampoule crusher for on-site activation
• Removable label with integrated Type 1 chemical process indicator for exposure confirmation

Technical information

• Spores organism: Geobacillus stearothermophilus
• Incubation: 24 hours at 55–60°C
• Sterilization method: Steam sterilization (autoclave)
• C hemical indicator: Type 1 chemical process indicator (confirms exposure but not effectiveness)
• Packaging options: 100 pcs (with crusher), 25 pcs, 10 pcs, 1 pc
• Shelf life: 2 years from date of manufacture
• Compliance: ISO 11138, EN 11140-1

Technical specifications

• Intended use: Routine biological monitoring of steam sterilization cycles
• Verified parameter: Biological inactivation of Geobacillus stearothermophilus spores
• Incubation conditions: 24 h at 55–60°C
• Storage: Follow manufacturer instructions; shelf life 2 years
• Compatibility: Standard laboratory incubators and autoclave processes
• Standards: ISO 11138, EN 11140-1