self-contained biological indicator
AX20 is a self-contained biological indicator (BI) for steam sterilization, classified as Type 1 according to ISO 11138. It contains Geobacillus stearothermophilus spores and an internal culture medium in a sealed ampoule. After incubation, growth (indicated by color change) confirms whether the sterilization cycle effectively killed the spores—or failed. It delivers results within 24 hours and includes a built-in chemical indicator for immediate exposure confirmation
Description
INDICATIONS:
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Routine validation of steam sterilization (gravity or pre‑vacuum) cycles at 121°C–135°C in healthcare, labs, and pharmaceutical settings
- Sterility assurance of instruments and critical items by verifying a minimum spore-log reduction.
- Regulatory and QA compliance, including pharma, hospital, and ISO standards requiring biological monitoring.
INSTRUCTIONS FOR USE.
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Preparation:
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Write sterilizer ID, load number, and date on the BI label before use.
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Load instruments as usual.
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Placement:
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Position the AX20 BI in the most challenging location (e.g., center of load or near door).
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Sterilization:
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Run a standard steam sterilization cycle (121–135 °C, gravity or pre‑vacuum).
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Immediate Chemical Check:
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After the cycle, confirm the chemical exposure indicator on the BI label has changed, showing exposure to the sterilant
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Incubation:
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Activate the BI by crushing the internal ampoule.
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Incubate at 60 °C (steam/plasma BI) using an AXDL-100 or similar incubator for up to 24 hours
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Result Interpretation:
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No color change in the medium (remains original) = negative result (sterilization successful).
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Yellow color change = positive result (growth occurred, sterilization failed)
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Actions:
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Negative: Load is sterile—document and release.
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Positive: Treat as sterilization failure—reprocess or discard load and investigate cycle issues.
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