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November 2018

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Subject:
From:
SHADY ABD EL-RAOUF <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 1 Nov 2018 13:01:46 +0000
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He is talking about chemical residue analysis of APIs between different pharmaceutical products where a recovery factor shall be applied to determine MACO for the API of first product to be present on manufacturing machines during the preparation of the next product.

And Adnan,

The case is different in microbial sampling, you don’t need to apply any recovery factor but you should have acceptance criteria for recovery not less than 50% of your initial inoculum.

‏‫من الـ iPhone الخاص بي‬

‫في ٠١‏/١١‏/٢٠١٨ الساعة ٧:١٣ ص، كتب/كتبت ‏Knutsen, Chris ‏<[log in to unmask]<mailto:[log in to unmask]>>:‬

I have never heard of applying a recovery factor for swabbing.  I am not sure how you would determine this.


Chris Knutsen, Ph.D.
Technical Fellow
ASO Microbiology Science and Technology
Bristol-Myers Squibb Company
1 Squibb Drive
New Brunswick, NJ 08902
Tel : +1-732-227-5375
Fax: +1-732-227-3071
Cell: +1-609-751-8362
e-mail: [log in to unmask]<mailto:[log in to unmask]>

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]<mailto:[log in to unmask]>> On Behalf Of Adnan Zahid (Head of Quality Control)
Sent: Wednesday, October 31, 2018 1:17 AM
To: [log in to unmask]<mailto:[log in to unmask]>
Subject: [PMFLIST] Recovery factor in swabbing

Dear All,
In cleaning validation while swabbing a recovery factor is applied, does same principle applies in microbial sampling of surfaces i.e. use of recovery factor in final reporting.



Regards,
Adnan Zahid

Sent from my Samsung Galaxy smartphone.


-------- Original message --------
From: Bob Friedel <[log in to unmask]<mailto:[log in to unmask]>>
Date: 31/10/2018 10:16 (GMT+05:00)
To: [log in to unmask]<mailto:[log in to unmask]>
Subject: Re: [PMFLIST] Require suggestion for Water MLT

Information Chapter USP <1231> "Water for Pharmaceutical Purposes"

Associating "Water MLT" with USP Chapters <61> and/or <62> is a mistake, as most water isolates are coming from an oligotrophic environment, favor lower temperatures, don't like copiotrophic media and require longer incubation periods.  Membrane filtration is typically used to screen larger size samples of pharmaceutical grade water vs. pour plate.

Note for Guidance on Quality of Water for Pharmaceutical Use:
https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fdocuments%2Fscientific-guideline%2Fnote-guidance-quality-water-pharmaceutical-use_en.pdf&amp;data=02%7C01%7Cchris.knutsen%40BMS.COM%7Cabc79f035b094ec580de08d63f3ada51%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C636765919334798441&amp;sdata=tJatItxQM6JMM66Kl%2BnaIjvBhSd4ktv%2B2aUJK19Luns%3D&amp;reserved=0 <https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fdocuments%2Fscientific-guideline%2Fnote-guidance-quality-water-pharmaceutical-use_en.pdf&amp;data=02%7C01%7Cchris.knutsen%40BMS.COM%7Cabc79f035b094ec580de08d63f3ada51%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C636765919334798441&amp;sdata=tJatItxQM6JMM66Kl%2BnaIjvBhSd4ktv%2B2aUJK19Luns%3D&amp;reserved=0>

Other References:

Reasoner and Geldreich (R2A)
https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC238333%2F&amp;data=02%7C01%7Cchris.knutsen%40BMS.COM%7Cabc79f035b094ec580de08d63f3ada51%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C636765919334798441&amp;sdata=T%2FVmGaetx3XDc8OjJR5AEYEeG%2FOTdrnv7CEfSDOm%2BH4%3D&amp;reserved=0 <https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC238333%2F&amp;data=02%7C01%7Cchris.knutsen%40BMS.COM%7Cabc79f035b094ec580de08d63f3ada51%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C636765919334798441&amp;sdata=T%2FVmGaetx3XDc8OjJR5AEYEeG%2FOTdrnv7CEfSDOm%2BH4%3D&amp;reserved=0>

APHA Standard Methods (R2A & NWRI)
https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Farchive.org%2Fstream%2Fgov.law.apha.method.9215.1992%2Fapha.method.9215.1992_djvu.txt&amp;data=02%7C01%7Cchris.knutsen%40BMS.COM%7Cabc79f035b094ec580de08d63f3ada51%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C636765919334798441&amp;sdata=sg%2BIIaOWPLdATc8y6fYV4QY5w1UZ%2BREQ0xMIE3x30Uk%3D&amp;reserved=0 <https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Farchive.org%2Fstream%2Fgov.law.apha.method.9215.1992%2Fapha.method.9215.1992_djvu.txt&amp;data=02%7C01%7Cchris.knutsen%40BMS.COM%7Cabc79f035b094ec580de08d63f3ada51%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C636765919334798441&amp;sdata=sg%2BIIaOWPLdATc8y6fYV4QY5w1UZ%2BREQ0xMIE3x30Uk%3D&amp;reserved=0>






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