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PMFLIST List Archives2024-03-29T13:42:54ZPowered by L-Soft's LISTSERV email list software
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http://www.lsoft.com/images/listserv_64x64.pngTesting of lyophilized peptide DS per USP 61
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;760220c8.2401
Hi everyone,<br><br>I am having a difficult time trying to find the answer to a fairly basic question. This is my first time sending a question to this list so I appreciate any help! I have noticed that a lyophilized peptide drug substance product is being sent and stored at -20C to a CTO for microbial limits testing per USP chapter 61. I know USP 1117 clearly states that DS should NOT be frozen prior to microbiological testing but does this apply when it is in a lyophilized state? From my understanding the DS powder is reconstituted, filtered prior to [...]
2024-01-31T22:32:43+00:00Lia Jeffreyhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;760220c8.2401Thank you Microbiologics!
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;c6823f8e.2401
The PMFList would like to thank Microbiologics for their continued support<br>of the PMF discussion group in 2024.<br><br>Microbiologics specializes in producing lyophilized QC microorganisms for<br>use in the clinical, pharmaceutical, cosmetic, dietary supplement, food,<br>water, environmental and educational industries. Microbiologics’ mission is<br>"to provide the highest quality biomaterials for a safer, healthier world".<br><br>Without the support of corporate sponsors such as Microbiologics (and the<br>others listed at the bottom of each Email from the list) this service would<br>not be possible. The Pharmaceutical Microbiology Forum is truly grateful<br>for all of our sponsors over the past 20+ years.
2024-01-31T10:08:05-05:00David Porterhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;c6823f8e.2401Swiss medic requirement
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;1e2582be.2401
I have heard that swissmedic are requiring that all aseptic manufacturing of product be performed in isolators by 2027. Does anyone have a link to where that statement may be posted?<br>Thanks<br><br>David Jones PhD<br><br>This message and any attachments are intended solely for the named addressee and may contain information that is privileged, confidential, copyrighted, and exempt from disclosure under applicable law. If the reader of this message is not the intended recipient, you are hereby notified that any dissemination, distribution or copying of this communication is strictly prohibited. If you have received this message in error, please notify [...]
2024-01-30T22:07:12+00:00David Joneshttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;1e2582be.2401