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March 2020

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Subject:
From:
"Housel, Mariangela" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 3 Mar 2020 13:53:33 +0000
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Hello forum- I am seeing some inconsistencies out there regarding references to USP 61 and USP 1227 for performing pre-filtration bioburden specifically for sterile pharmaceuticals such as eye care solutions.  What I am seeing for USP 61 is the chapter is being used as a guide for the actual test method as well as qualifying the method. For qualifying the pre-filtration bioburden test as I have described above, shouldn't USP 1227 be used and referenced for qualifying the method?  Method suitability would not be required in this case as per USP 61?  USP 61 can be used as a guide but an SOP should be written for conducting the routine testing? I am interested in knowing what the industry practice is for qualifying methods and application of the above mentioned USP chapters for pre-filtration bioburden testing for sterile pharmaceuticals.

Thank you for your guidance.

Angela Housel

Email: [log in to unmask]<mailto:[log in to unmask]>




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