self-contained steam sterilization

AX224 is a self-contained, rapid-read biological indicator (Type 1 BI) for steam sterilization, manufactured by Axis/Kordon. It contains Geobacillus stearothermophilus spores in a sealed tube with a built-in ampoule of culture medium. It delivers results in approximately 20 minutes after incubation, combining fast confirmation with a chemical exposure indicator for immediate feedback

Description

https://hexapharmaegy.com/wp-content/uploads/2025/06/AXIS.png
https://hexapharmaegy.com/wp-content/uploads/2025/06/KORDON.png

 

 INDICATIONS:

    • Used for monitoring steam sterilization cycles—both gravity and pre-vacuum—at 121°C–135°C.

    • Ideal for time-critical environments such as surgical centers and hospital CSSDs needing rapid verification.

    • Ensures both chemical exposure and biological kill, confirming sterility before item use or release

INSTRUCTIONS FOR USE.

  • Label the AX224 vial with sterilizer ID, date, and load number.
  • Place the indicator in the most challenging location inside the sterilization load (e.g., center of a tray or pouch).
  • Run the standard steam cycle (121–135°C) in accordance with equipment validation.
  • Immediate Check: Confirm the built-in chemical indicator has changed, indicating exposure to steam.
  • Incubate: Activate the ampoule by crushing it and incubate at 60°C using a rapid-incubator like AXRD-100.

  • Read Results (~20 min):

    • No color change in the medium = Pass (successful sterilization).

    • Yellow color change = Fail (spore survival; sterilization failure)

  • Actions:

    • Pass: Document and release the load.

    • Fail: Investigate the cycle, equipment, or load configuration and reprocess.

  • Recordkeeping: Retain vials and document results (date, incubator, load ID, result) per regulatory and QA requirements.