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March 2020

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Subject:
From:
"Berman, Alison" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 4 Mar 2020 14:32:49 +0000
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Good morning,

We perform enumeration and identification on all incoming lots, per concentration, prior to use. If we use the tri-scale BIs, we do an enumeration on all three declared populations even though they are received as one lot.

Alison Berman



-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Nandhivarman
Sent: Tuesday, March 3, 2020 10:25 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] Regarding resistance performance test

[External Email] - This email is originated from outside of the organization. Do not click links or open attachments unless you recognize the sender and know the content is safe

Hi Nilay
Only spore enumeration is suggested for end user, when BI is used in accordance with the BI manufacturer's directions no D value determination is required as per USP 1229.

Regards
Nandhivarman M

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Nilay Joshi
Sent: 03 March 2020 15:42
To: [log in to unmask]
Subject: [PMFLIST] Regarding resistance performance test

Dear all,

USP general chapter 55

I just wanted to know about the industry practice regarding d value determination of BI.

Do you use BIs just by performing only enumeration or do you perform d value determination of individual lots.

Also is there any guidance for testing BI at user end.

Regards,
Nilay Joshi

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

Charles River Laboratories - http://www.criver.com/

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

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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 Microbiology Network, Inc., the PMF, or the sponsors of the list.

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