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June 2020

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Subject:
From:
"Knutsen, Chris" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 12 Jun 2020 12:37:42 +0000
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Helga:
The books and articles that Sean has suggested are pretty much invaluable. I have been involved in endotoxin testing for many years and still find myself turning to them for guidance on occasion.  They would be a wise investment.

Chris Knutsen, PhD
Technical Fellow| Microbiology Center of Excellence
Analytical Strategy and Operations

Office +1 732-227-5375
Mobile +1 609-751-8362

Bristol Myers Squibb
1 Squibb Drive
New Brunswick, NJ 08903

bms.com / LinkedIn / Twitter / Facebook / Instagram




-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of [log in to unmask]
Sent: Monday, June 8, 2020 4:04 PM
To: [log in to unmask]
Subject: [PMFLIST] BET Question

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Subject:
RE: [PMFLIST] BET question
From:
Sean Hauber <[log in to unmask]>
Date:
Thu, 4 Jun 2020 17:26:04 +0000
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Hello Helga,

The combined potential endotoxin load of the 3 components cannot exceed the endotoxin limit of, typically but not always, 350 EU/hour.  There are many variables concerning this calculation and could likely go on for paragraphs to cover just some of the potential cases.

I would highly recommend that you read Chapter 85 of the USP and the FDA Question and Answer Doc for BET.

https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2Fregulatory-information%2Fsearch-fda-guidance-documents%2Fguidance-industry-pyrogen-and-endotoxins-testing-questions-and-answers&amp;data=02%7C01%7Cchris.knutsen%40BMS.COM%7C08ed684fafb64c30e38508d80be89965%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C1%7C637272440965305835&amp;sdata=iqSKZfDsYvR6Jw2IX9h2wow9fDmbDszXtjQsNQ9iln8%3D&amp;reserved=0

Also there are two great publications concerning BET testing.

The Bacterial Endotoxins Test (A Practical Guide)  Edited by Karen Zink McCullough

Endotoxins, LAL Testing and Depyrogenation, Third Edition, Edited by Kevin L. Williams

Both are easily found on the internet (Amazon usually has them)

Also this article may be helpful:  https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.acciusa.com%2Fpdfs%2Fwhitepapers%2FEndotoxinLimits_SeanJH-PR17-012.pdf&amp;data=02%7C01%7Cchris.knutsen%40BMS.COM%7C08ed684fafb64c30e38508d80be89965%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C1%7C637272440965305835&amp;sdata=rYzz15D2e1HWSV1Yn9sJf0W%2B9wp%2BkLhT12vJJcZ60O0%3D&amp;reserved=0

You might also find some helpful information here:  https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.acciusa.com%2Ftools-and-resources%2Feducational-content%2F&amp;data=02%7C01%7Cchris.knutsen%40BMS.COM%7C08ed684fafb64c30e38508d80be89965%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C1%7C637272440965305835&amp;sdata=wQZP2ecgAIsVUP4IQVzOK0hSe6Oq0mzr3AUJWuADBZY%3D&amp;reserved=0



Best Regards,
Sean A. Hauber
Sr. Technical Product Specialist
Associates of Cape Cod
Mobile:  858-356-7600
[log in to unmask]

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Steris - http://www.sterislifesciences.com/

Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


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The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of the PMF or the sponsors of the list.

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