Requalification cycles

Can somebody tell me what requlative we use for requalification of autoclave or filling line or similiar equipment which include sterilization? My question is how many successful runs must we perform for requalification? We have fixed load and we have done 3 runs in PQ and do we need to repeat 3 runs in requalification or one run is just enough for every load?

Reply to this question is Yes 3 Runs and No it is not.

In the above case you are talking about equipment or series of equipments in which Sterility Assurance levels cannot be compromised.

Simple solution is that you must requalify till you have proper Sterility Assurance Levels confirmed by scientific evidence which are inline with regulatory requirements in your country.It may take 3 runs or more. You must be sure that all the parameters must be with in the limits of your earlier Validation runs. Any deviations may force you to conduct more runs.The reason is that this equipments are not new.They are under regular usage and any equipment or parts of equipment may get worn out.


Would disagree with that responce for autoclaves anyway, not sure about filling lines, if you have a number of different loads in an autoclave you can take a risk based approach, i.e. identify your worst case loads, which have to have a full requalification each year (3 runs minimum) however for other loads you can take a number of representative loads (1/2 depending on how many loads you have) and perform one run to requalify this. I have been through inspections by the FDA and the EMEA with this approach, and have not received any negative feedback on it!

however I will point out we were using a 12 log reduction for sterility in these autoclaves I wouldn’t try this unless your using an overkill approach

For Requalification of sterilizer “ONE CYCLE” shall be taken as part of validation.
validation data should meet with the result of initial qualification.

Reference- PDA Page No. 96

“one cycle”

reference- pda page no. 96

pushpraj singh

[b]Cbyerne – Look my statement in the 3rd Paragraph

As per PDA Technical Report -1 Revised 2007
Requalification period is every 12 months once …
Page Number 49
"The most difficult-to-sterlize runs should be included in requalification runs.Section 5.4 also talks about reduction of requalification activity.[/b]