Steam sterilization biological indicator

medicallaboratory

Biological ampoule tests are designed to verify the effectiveness of steam sterilization. Each test ampoule contains biological material. After sterilization, the survival of spores is evaluated to confirm the process efficacy. STERIM® autoclave biological test ampoules contain spores of Geobacillus stearothermophilus and a sealed portion of growth medium. Each ampoule, packed in a paper-plastic wrapper, is placed between sterilized packs inside the autoclave chamber. After the sterilization cycle, the glass ampoule is crushed, releasing the medium, and the spores undergo a 24-hour incubation test at 55–60°C. After 24 hours, bacterial growth is evaluated. If the medium changes color due to bacterial multiplication, the sterilization process was ineffective. If the medium retains its original color, it confirms successful sterilization. The biological test ampoule also includes a type 1 chemical indicator on the packaging. This indicator changes color to confirm that the sterilization cycle was performed (but does not guarantee sterility). STERIM® 24h biological test ampoules are available in multiple pack sizes to meet different user needs: - 100 ampoules per pack - 25 ampoules per pack - 10 ampoules per pack - Single ampoule option Advantages Reliable and accurate test results, Biological material can be incubated in all standard incubators, Removable label with type 1 chemical indicator on each ampoule. Technical Specifications: Sterilization method verified: steam sterilization Standards compliance: ISO 11138, EN 867-3, ANSI/AAMI ST 46:2002 Process parameters verified: biocidal efficacy of the sterilization cycle Available pack sizes: 100, 25, 10, or 1 ampoule