Standard Operating Procedures

BIOSIGN SSI Test Pack

Last updated: January 5, 2012


I. Purpose
The Getinge BIOSIGN SSI Test Pack is specifically designed for biological testing and monitoring of 132^oC pre-vacuum steam sterilization cycles.  The product gives the user instant reassurance based on a result from a steam integrator card, and after biological indicator incubation, even greater assurance that the sterilizer operated at proper sterilization parameters.

II. General Information

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

III. BIOSIGN SSI Test Pack

• BIOSIGN 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 
• BIOSIGN 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 24 hours.  YELLOW (FAIL), RED (PASS).
• Place one Test Pack in autoclave
  • Place window side up on the lowest shelf and above the drain.
  • Do not set any thing on top of Test Pack.
  • Process the load using the "bedding" cycle.

IV.  Procedure for Using the BIOSIGN SSI Test Pack

• Turn Biosign incubator on 45 minutes before needed in order to reach 55^oC.  Use caution as the metal heating block will be hot.
• Remove 2 Test Packs box from refrigerator in HS009.
  • One will be autoclaved, the other kept as a control.
  • Medium in test pack vial should be RED.
• Place 1 Test Pack box in autoclave.
  • Place window 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 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.
  • Remove the Biological Indicator vial from the box and process as directed below.
• Activate the Biological Indicator and incubate in Biosign Incubator (see below).
  • Be certain the autoclaved vial has cooled to room temperature.
  • Insert both autoclaved and control vials into 55^oC incubator.
    • Insert (at an angle) the bottom (only) of 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.
  • Close the incubator cover.
  • Incubate vials for 24 hours.
    • The medium in the autoclaved vial should be RED (dead spores).
    • The medium in the control vial should be YELLOW (live spores). 
  • Record findings in BIOSIGN record book in HSB 016.
  • React to positive growth (YELLOW) in the autoclaved vial by having the autoclave checked immediately.
  • Before disposal, autoclave all the vials for at least 30 minutes on the "Bedding" setting.