Biological Indicators for Steam Sterilization in Autoclaves

Each STERIM® biological indicator ampoule contains Geobacillus stearothermophilus bacterial spores together with a sealed growth medium. The ampoule, enclosed in a paper-plastic pouch, is placed between sterilization packs inside the autoclave chamber. After completion of the sterilization cycle, the inner glass ampoule containing the culture medium is crushed, and the test is incubated for 24 hours at 55–60°C.

After the incubation period, bacterial growth is evaluated. If the bacteria continue to multiply despite sterilization, the culture medium changes color, indicating that the sterilization process was unsuccessful. If the medium retains its original color, the sterilization cycle has been effective.

The packaging of each biological indicator also includes a Type 1 chemical process indicator. Its color change confirms that the package has been exposed to a sterilization process, although it does not confirm the effectiveness of sterilization.

STERIM biological ampoule indicators are available at sterim.eu in four packaging options to meet different user needs:

• 100 biological indicators per pack,
• 25 biological ampoule indicators per pack,
• 10 biological indicators per pack,
• Single biological ampoule indicator.

Benefits of STERIM® 24-Hour Biological Ampoule Indicators

• Reliable verification of sterilization effectiveness,
• Compatible with all standard biological incubators,
• The 100-piece package includes an ampoule crusher,
• Removable label with an integrated Type 1 chemical process indicator.

Technical Specifications

• Sterilization method: Steam sterilization
• Compliance: ISO 11138, EN 11140-1
• Verified parameter: Biological effectiveness of an individual sterilization cycle
• Packaging options: 100 pcs, 25 pcs, 10 pcs, or 1 pc
• Shelf life: 2 years from the date of manufacture

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