Assure AccuFast Biological Test Pack

Last Review Date: May 4, 2018

I. Purpose

The Getinge Assure AccuFast BiologicalTest Pack with Instant Readout Integrator is designed specifically for biological testing of 3or 4 minutes at 132oCis specifically designed for biological testing and monitoring of 132oC in pre-vacuum steam sterilizers.  The test pack consists of a self-contained biological indicator containing Geobacillus  Stearothermophilus inside a small package of porous and nonporous materials.  When used as directed, the Integrator Record Card gives visible indication that sterilizing conditions were met. 

II. General Information

  • Storage: Store test packs in a refrigerator ranging from 2-24° C.
  • Frequency of use: once monthly.

III. Assure AccuFast Biological Test Pack

  • Instant Read Integrator Record Card.
    • Provides immediate verification that the test pack was exposed to correct sterilization parameters.
    • Ink color on card changes from PURPLE (FAIL) to GREEN (PASS)
    • Instant results 
  • Biological Indicator.
    • Includes a paper strip containing G. stearothermophilus inside an ampule of specially formulated growth medium.
    • Sterilization failure is noted by positive growth of the test strip turning the medium color from red to yellow.
    • Results in 10 hours.  YELLOW (FAIL), Purple (PASS).
  • Place one Test Pack in autoclave
    • Place label side up on the lowest shelf and above the drain.
    • Do not set anything on top of Test Pack.
    • Process the load using the "bedding" cycle.

IV.  Procedure for Using the Assure AccuFast Biological Test Pack

  • Turn Assureincubator on 30 minutes before needed in order to reach 60oC.  Use caution as the metal heating block will be hot.
  • Remove Test Pack box from the refrigerator in HS008.
    • Medium in test pack vial should be PURPLE.
    • Remove 1 control vial from refrigerator in HS008
    Place Test Pack box in an autoclave.
    • Place label side up on the lowest shelf and above the drain.
    • Do not set anything on top of Test Pack.
    • Process the load using the "bedding" cycle.
  • Remove Test Pack box from autoclave at end of the cycle.
    • Allow box to cool for at least 15 minutes.
    • Remove and examine the Integrator Record Card.  An ink color change on the card from PURPLE to GREEN indicates correct exposure conditions of temperature, time and steam.
      • Save the card, label with date and file with other sterilization processing records in Assure notebook in HS009.
    • Remove the Biological Indicator vial from the box and process as directed below.
  • Activate the Biological Indicator and incubate in Getinge Assure 1410 Incubator (see below).
    • Be certain the autoclaved vial has cooled to room temperature.
    • Insert both autoclaved and control vial into 60oC incubator.
      • Insert (at an angle) the bottom (only) of the vial into an empty well in the incubator.
      • Ensure the bottom of the vial contacts the bottom of the well.
    • Pivot (snap up) the vial into the well such that the edges of the well crush the vial.
    • Place crushed vial in one of the 13 holding stations
    • Close the incubator cover.
    • Incubate vials for 10 hours.
      • The medium in the autoclaved vial should be PURPLE (dead spores).
      • The medium in the control vial should be YELLOW (live spores). 
    • Record findings in ASSURE record book in HS 009.
    • React to positive growth (YELLOW) in the autoclaved vial by having the autoclave checked immediately by Getinge service reps.
    • Before disposal, autoclave all the vials for at least 30 minutes on the "Bedding" setting.