PLC Validation - Double Door Autoclave

GOOD VALIDATION PRACTICE (cGVP)
1

Dear Friends,

Is it required to re-validate the PLC of a double door autoclave used in microbiology department used for the sterility of media/garment etc.?

I am not in a favour of doing the re-validation since the same is not impacting the product quality and secondly during our autoclave validation we compare the PLC print outs with the Data generated by the data logger.

Hope to get a quick reply…

Ajaya

2

I am not sure of your question. Did you change something to force you to revalidate? Or are you talking about periodic review and load configuration revalidation?

3

I am talking about the re-validation of the PLC of an Autoclave.

Initially we did the validation of PLC during the OQ of the Autoclave by checking the input/output & password protection etc. Now after a period of two years is it required to re-validate the PLC of the Autoclave?

Hope my question is clear now .

4

I am not sure why you would revalidate a control system if you have not made any changes to it. Revalidation just because two years past does not make any sense to me. I can understand revalidating load patterns or some of the PQ. But OQ?

5

Thanks… I got it.