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Validation Process for Sterilizers

11 Tips you need to know about the Validation Process for Sterilizers in relation to (AS4815)

We receive many queries from practices at Sterilizer Validation time.  There is some confusion over how to perform the biological validation after the Technician has performed the Yearly Performance Qualification testing.

MDS will carry out the biological validation upon request, otherwise we will supply the biological vials and carry out the results testing.

The 11 tips we recommend for you when preparing for the Validation of your sterilizer are:

  1. Once the Validation is booked in, organise MDS to supply and arrange delivery of the biological indicators on the booking date.
  2. Have your challenge load and challenge pack ready for the technician when he arrives. Advise the technician if the door seal or filter has been recently changed. The challenge load is the maximum amount of instruments you would ever put through your sterilizer at once.  The challenge pack is the largest package of instruments that you use which may include gauze squares or other porous material.  Pre clean, wash and dry your instruments ready for sterilization. 
  3. The technician will perform a “chamber Profile” which will give you information about the cold spot in your chamber.
  4. The penetration cycle looks at the time difference between when your sterilizer goes into sterilization at 134 deg and when the inside of your pack reaches 134 deg, this is called the penetration time. 
  5. Once the Technician has completed the performance Qualification and recordings, and you are doing the biological testing yourself, wherever possible, we recommend that you do the biological validation immediately after.  If this is not possible then it must be completed as soon as possible within the following 2 weeks.
  6. The biological validation must be completed as 3 consecutive cycles.
  7. The 7 vials should be labelled as follows –  1C, 1P; 2C, 2P; 3C, 3P; Z
  8. C= Cold Spot, P = Pack, Z = Control. 1,2 & 3 indicate which load the vials are to be put in.
  9. When putting the vials in the loads, the vial labelled C is to be put in the location that the technician identified as the Cold Spot, P is placed inside your Challenge Pack and the single vial Z is never put in the sterilizer as it acts as the Control Vial. 
  10. You can process instruments through your sterilizer at the same time as you are doing the validation but you must use the same instruments for your challenge pack to ensure consistency.  Always place the vial in the cold spot on gauze square or paper because it may melt if it is placed directly on metal.
  11. Once you have completed your 3 cycles, cool the vials to room temperature and return to  MDS for incubation.  Complete the record of the Validation test either in your own record book or on the paper work that is supplied by us.  Once MDS completes your test and forwards you the results, keep them with the test scripts from the technician so that your validation process is all together.

We hope this assists you to easily complete your Validation process on a yearly basis but feel free to contact us for assistance if required.