Assure AccuFast Biological Test Pack

Last Review Date: September 2, 2020


I.  Purpose

The Getinge Assure AccuFast Biological Test Pack with Instant Readout Integrator is designed specifically 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 for that autoclave. 

II.  Policy

It is LAR policy to meet or exceed all federal, state, and local regulations and guidelines and to comply with all institutional policies and procedures as they apply to the use of animals in research.  Personnel must attend any applicable training in animal care and use, occupational health and safety, equipment operation, and SOPs prior to performing activities outlined in this SOP or work under the direct supervision of trained personnel.

III. General Information

     A.  Storage: Store test packs in a refrigerator 2-24°C

     B.  Frequency of use: once monthly

III. Assure AccuFast Biological Test Pack Information

     A.  Instant Read Integrator Record Card

           1.  Provides immediate verification that the test pack was exposed to correct
                sterilization parameters

           2.  Ink color on card changes from PURPLE (FAIL) to GREEN (PASS)

      B.  Biological Indicator

            1.  Includes a paper strip containing G. stearothermophilus inside an ampule of
                 specially formulated growth medium

            2.  Sterilization failure is noted by positive growth of the bacteria which turns 
                 the  
medium color from purple (PASS) to yellow (FAIL)

            3.  Results available in 10 hours

V.  Procedure for Using the Assure AccuFast Biological Test Pack

       A.  Remove Test Pack box containing test vial from the refrigerator in HS008

            1.  Growth medium the test pack vial should be PURPLE

            2.  Also, remove 1 control test pack box from refrigerator in HS008 and keep at room
                 temperature

       B.  Place one Test Pack box in the autoclave

            1.  Place label side up on the lowest shelf and above the drain

            2.  Do not set anything on top of Test Pack

            3.  Process the load using the "bedding" cycle

      C.  Remove the Test Pack box from autoclave at end of the cycle

            1.  Allow the vial in the box to cool for at least 15 minutes

            2.  Remove and examine the Integrator Record Card

                 a.  An ink color change on the card from PURPLE to GREEN indicates correct
                      exposure conditions of temperature, time and steam for the autoclave

                 b.  Save the card, label with date and file with other sterilization processing records
                       in Assure notebook in HS009

                 c.  Remove the Biological Indicator vial from the box and process as directed
                       below

VI.  Processing the Biological Indicator Vials

      A.  Turn on the Assure incubator 30 minutes before needed, in order to reach 60oC (Use
            caution as the metal heating block will be hot

      B.  Place the control biological indicator vial and the vial taken from the autoclaave and
           incubate in Getinge Assure 1410 Incubator (see below)

          1.  Be certain the autoclaved vial has cooled to room temperature

          2.  Insert both autoclaved and control vials into 60oC incubator

               a.  Insert (at an angle) the bottom (only) of the vial into an empty well in the
                     incubator

               b.  Ensure the bottom of the vial contacts the bottom of the well.

          3.  Pivot (snap up) the vials into the well such that the edges of the well crush the vial.

          4.  Place each crushed vial into one of the 13 holding stations

          5.  Close the incubator cover.

          6.  Incubate vials for 10 hours.

               a.  The medium in the autoclaved vial should be PURPLE (dead spores).

               b.  The medium in the control vial should be YELLOW (live spores). 

          7.  Record findings in the ASSURE record book in HS 009.

          8.  If you find a positive growth (YELLOW) in the test vial from the autoclave, inform the
               facility manager so that she may schedule a Getinge service representative and
               have the autoclave checked immediately

          9.  Before final disposal of the Biological Indicator vials, they both must be autoclaved
               one last time (30 minutes on the "Bedding" setting.