Autoclave validetion

Microbiology
1

Dear Sir ,
who many sensor are required for autoclave validation according ti its size .

2

Welcome, Pankaj,

The basis of any rationale given for the quantity of temperature sensors to be used in validation studies should be to sample enough locations of the autoclave to consider representative of the usable chamber volume.

It will depend on the type of autoclave, sterilization mehtod and load characteristics, but it is generally best to consider the following recommendations:

  • Try to cover the 3 planes: length, width and height of the chamber.
  • Try to cover the corners.
  • Include a sensor in the drainage (if applicable) since it could be a cold spot or heat sink of the chamber.
  • Try to include one sensor next to the atoclave control sensors. This will help to know if there is any difference between the control sensor and the actual load temperature.
  • Enphasize in known cold and hot spots.
  • Consider results from empty and loaded chamber temperature/heat distribution studies.
  • Consider sampling locations of different materials if mixed loads are to be used.

It is a common practice, for large chambers, to use 1 additional sensor per cubic meter; and not less than 5 - 10 that are needed to cover the previous recommendations.

3 Likes
3

Dear sir,
Good morning.

  1. What should be the frequency of periodic requalification of Autoclave ?
  2. May we perform requalification with commercial load at a time ?

Thanks

4

It is generally accepted that autoclaves are verified annually by evaluating the worst case conditions, load patterns, etc. While there is no specific regulatory requirement on the frequency, some guidelines like PIC/S annex 1 of GMP suggest a 1 year verification. It must be determined from a risk assessment and documented in SOPs.

You can use a commercial load to requalify/verify but you must have controls in place to avoid its release until validation confirms process is ok. And ensure that it suits the worst case conditions you intend to verify for revalidation/verification purposes.

5

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