Hi Lim Forng. USP 1115 does a good job of talking about EM in non-sterile manufacturing. There are no charts like there are in aseptic manufacturing so you'll need to create your alert/action levels based on product, patient, MFG design, etc. There are other resources out there as well. Here's one from the FDA: https://www.fda.gov/media/152527/download
Sincerely,
Tim Cser
916-759-1401
MilliporeSigma
________________________________
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> on behalf of Lim Foong Choo <[log in to unmask]>
Sent: Wednesday, May 10, 2023 4:47:24 AM
To: [log in to unmask] <[log in to unmask]>
Subject: [PMFLIST] specification of settled plate of non sterile solid dosage manufacturing
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Dear PMF members,
What is the specification of settled plate (cfu/plate/4 hours) specification
of non-sterile manufacturing facility ?
Shall I know the references ?
Regards,
Lim
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