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Filter Validation (microbial Challenge)

Dear all,
I am working at a company manufacturing sterile solutions -human use. I was asked to prepare a validation protocol for Filter validation by means of microbial challenge.

Could you please advise on which steps - tests should the protocol be based on, what parameters should be included, is there any proposition layout by you etc.

Thank you in advance…:smiley:

Dear Cooly,
Normally the filter validation with respect to microbiological challenge is joint effort of the user and the filter manufacturer and is performed in the lab of the filter manufacturer. I don’t think it is performed by the user, or this may be very rare.
The filter manufacturer and the user discuss the protocol and finally approved by the user. Just check with your filter supplier.
Regards,
Jasbindersingh
(kamal.consultants@hotmail.com)

Please give feed back that if we are the cartilge filter has same input nozzle and increase the diameter of output nozzle it can affect the qulaity of product or what effect it can cause???
Thank you