self-contained biological indicator
AX91 is a self-contained biological indicator (BI) used for hydrogen peroxide plasma sterilization, classified as Type 1 according to ISO 11138 standards. It contains spores of Geobacillus stearothermophilus sealed with culture medium in an ampoule. After the sterilization cycle, the BI is incubated—typically at 60 °C—and observed for up to 24 hours: no color change denotes a successful sterilization (no growth), while yellow indicates spore survival (sterilization failure)
Description
INDICATIONS:
- Monitoring sterilization cycles using low-temperature hydrogen peroxide plasma (e.g., STERRAD systems).
- Verifying efficacy of sterilization on heat- or moisture-sensitive medical devices and instruments.
- Compliance and quality assurance in hospitals, clinics, labs, and pharmaceutical facilities, providing regulatory-required biological confirmation of sterilization
INSTRUCTIONS FOR USE.
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Label & Place:
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Write sterilizer ID, cycle number, and date on the BI tube.
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Place it inside each load, ideally in the most challenging location for sterilant penetration .
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Run Cycle:
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Start the hydrogen peroxide plasma sterilization cycle as per equipment (e.g., STERRAD).
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Chemical Indicator Check:
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Immediately after sterilization, check for any chemical indicator (if present) to confirm exposure—though final confirmation relies on biological testing
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Incubate:
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Crush the internal ampoule and incubate at 60 °C in an appropriate incubator (e.g., AXDL‑100) for up to 24 hours
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Interpret Results:
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No color change (medium stays original) = Sterilization successful (pass).
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Yellow color = Spore growth = sterilization failure—load must be reprocessed .
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Action & Documentation:
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Pass: Release load; document results (date, cycle, operator, pass).
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Fail: Investigate sterilizer functionality, troubleshoot, and reprocess before release.
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