Dear Sir,
We have a Dehumidifier which we have qualified for Certain RH requirement ( NMT 35 % ). But now that area where this ACD is catering doesnt require that much RH and we are deciding to go for higer RH rate ( 60 % ).Do we neet to requalify it for higher RH requirement through change control.
Kindly explain?
Regards,
Vinod Kumbhar
Yes EXACTLY.
Do raise the change control and requalify. During requalification make sure that you will identify 5 to 8 crtical positions and record the humidities. Make sure that these recording must be done over a period of 5 to 6 hours of operation.
Make sure that humidity is attained to that level.
You also give a standing instruction by way of a new SOP - that operation in this area should begin only when the room attains certain humidity level. This must be checked and verified by Q.A
Intimate all new changes to QA, QC and Production.
Regards