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June 2020

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Subject:
From:
Lou Fraser <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 18 Jun 2020 00:32:54 +0000
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We expected compliance with USP 60 on or soon after effective date (12-1-19) however, as of today, all are in compliance.

Lou Fraser
Sr Director Quality Assurance
16412 N. 92nd St. Suite 135
Scottsdale, AZ 85260
(O) 602-385-8892
(C) 602-319-4278
[log in to unmask]

This message (including attachments) is confidential, may contain proprietary information from Matrixx Initiatives, Inc. and is covered by professional secrecy and / or for the exclusive use by the owner of the email address to which it is directed. Matrixx Initiatives, Inc. accepts no responsibility for errors or omissions in this message or its attachments, misuse or unauthorized use of its employees, or guarantee the safety or accuracy of what is transmitted in this way because it can be intercepted, altered, delayed, lost, contain viruses or other abnormalities. Should you not be the addressee specified in this message or person authorized by it, please report immediately by fax or e-mail forwarding this message and / or attachments to their sender and destroy it kindly. Thank you very much.

Este mensaje (y anexos) es confidencial, puede contener información de propiedad exclusiva de Matrixx Initiatives, Inc. amparada por el secreto profesional y/o para el uso exclusivo por parte del titular de la dirección de correo electrónico a la que está dirigido. Matrixx Initiatives, Inc. no acepta responsabilidad alguna por errores u omisiones contenidos en este mensaje o sus anexos, uso indebido o no autorizado de sus empleados, ni garantiza la seguridad o exactitud de lo transmitido por este medio debido a que el mismo puede ser objeto de intercepción, alteración, demora, pérdida, contener virus informáticos u otras anomalías. En caso de que Ud. no sea el destinatario especificado en este mensaje o persona debidamente autorizada por el mismo, por favor comuníquelo inmediatamente vía fax o e-mail reenviando este mensaje y/o sus anexos a su emisor y tenga la amabilidad de destruirlo. Muchas gracias. 



-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of WAGER Renee
Sent: Thursday, June 4, 2020 5:28 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] USP <60> Question

Lou,

Can you tell me if you required all the manufacturers to start the testing of each product the day the USP60 Chapter became effective or was there lag time allowed before testing started?  

Thanks,

Renee

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Lou Fraser
Sent: Wednesday, June 03, 2020 3:10 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] USP <60> Question

As a sponsor of several contract manufacturers we required all oral and nasal liquid products that use PW as an ingredient to be tested for Bcc in finished product. We also instituted Bcc confirmation testing of PW for any gram negative organisms recovered during routine testing. 

Thanks,
 Lou Fraser


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Timothy Cser
Sent: Monday, June 1, 2020 12:42 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] USP <60> Question

Hi Renee.  I can't comment on what most companies are doing with regards to BCC because the guidance just came out 6 months ago.  I do know that prior to that USP chapter many (most) non-sterile MFG were monitoring their water for gram (-) bugs and some firms will ID those bugs, looking for BCC.  If purified water was a raw material in a non-sterile, aqueous product, that would be a good place to look for contamination.  The focus of the chapter is on the final product but if your purified water is a big component of that final product, it seems smart to monitor for BCC unless there's some mitigating factor.

I can't speak on the second half of your question but perhaps some MFG can offer their input.

Sincerely,

Tim Cser
MilliporeSigma

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of WAGER Renee
Sent: Monday, June 1, 2020 9:21 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] USP <60> Question

Hi Tim,

Can you tell me if you know whether most companies are testing their water on a routine basis even though it is not a requirement?  Are they using absence of BCC as the requirement for their purified water?

I am also interested in whether companies are testing all of their liquid products for BCC as a standard across the board or are they using risk assessments of their systems to determine whether this testing is required for each of their liquid products.  If companies did not initiate product testing when the USP 60 became effective, are they going back to test product from the date of effectivity?

Thanks

Renee

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Timothy Cser
Sent: Tuesday, April 21, 2020 1:55 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] USP <60> Question

Hi Renee.  I specifically asked this question at the end of the PDA Microbiology show with the FDA panel and it was very clear there is no expectation for firms to be testing their water systems on a routine basis.  This is meant for aqueous, non-sterile products only.

Sincerely,

Tim Cser
MilliporeSigma

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of WAGER Renee
Sent: Monday, April 20, 2020 9:41 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] USP <60> Question

Do you also perform this testing routinely on your water systems?

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Timothy Cser
Sent: Monday, April 20, 2020 12:17 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] USP <60> Question

Hi Dennis.  The 5 organisms in the chart should be used for GP and Suitability testing.  I believe the "or" is a mistake in the chapter and perhaps Tony Cundell can confirm that.

Sincerely,

Tim Cser
MilliporeSigma

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Dennis Neeson
Sent: Monday, April 20, 2020 7:33 AM
To: [log in to unmask]
Subject: [PMFLIST] USP <60> Question

All,

USP Chapter <60>  on testing for B. cepacia references three (3) different strains of Burkholderia for Growth promotion and Suitability testing. Are your labs using all 3 of these strains each time you perform these tests (GP & Suitability) or do you select only one , such as the hardest to recover?

Thank you

--

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BD Industrial Media - https://clicktime.symantec.com/39uF2tZjuzbBnapYhsAFRqW6H2?u=http%3A%2F%2Fwww.bd.com%2Fds%2F

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Microbiologics, Inc. - https://clicktime.symantec.com/3EDdtF85Sve4kExADkVdWBW6H2?u=http%3A%2F%2Fwww.microbiologics.com

BD Industrial Media - https://clicktime.symantec.com/39uF2tZjuzbBnapYhsAFRqW6H2?u=http%3A%2F%2Fwww.bd.com%2Fds%2F

Associates of Cape Cod, Inc. - https://clicktime.symantec.com/38dSZN5uZWnejztgNmErB4n6H2?u=http%3A%2F%2Fwww.acciusa.com%2F


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This message and any attachment are confidential and may be privileged or otherwise protected from disclosure. If you are not the intended recipient, you must not copy this message or attachment or disclose the contents to any other person. If you have received this transmission in error, please notify the sender immediately and delete the message and any attachment from your system. Merck KGaA, Darmstadt, Germany and any of its subsidiaries do not accept liability for any omissions or errors in this message which may arise as a result of E-Mail-transmission or for damages resulting from any unauthorized changes of the content of this message and any attachment thereto. Merck KGaA, Darmstadt, Germany and any of its subsidiaries do not guarantee that this message is free of viruses and does not accept liability for any damages caused by any virus transmitted therewith.



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Charles River Laboratories - https://clicktime.symantec.com/34yTB2551sZPpf4cUjAknKk6H2?u=https%3A%2F%2Fwww2.criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6

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Associates of Cape Cod, Inc. - https://clicktime.symantec.com/3CNJa5bRoL34SGVW2VqWHFq6H2?u=http%3A%2F%2Fwww.acciusa.com%2F


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Charles River Laboratories - https://clicktime.symantec.com/34yTB2551sZPpf4cUjAknKk6H2?u=https%3A%2F%2Fwww2.criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6

Veltek Associates, Inc - https://clicktime.symantec.com/3VVgHEgXkXEKW4JFhRTvY8z6H2?u=http%3A%2F%2Fwww.sterile.com

Microbiologics, Inc. - https://clicktime.symantec.com/3LuZrfUjNZRNNxrwN8MZWt26H2?u=http%3A%2F%2Fwww.microbiologics.com

BD Industrial Media - https://clicktime.symantec.com/3AadzYqjpZ1b1hLatRe599g6H2?u=http%3A%2F%2Fwww.bd.com%2Fds%2F

Associates of Cape Cod, Inc. - https://clicktime.symantec.com/3CNJa5bRoL34SGVW2VqWHFq6H2?u=http%3A%2F%2Fwww.acciusa.com%2F


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This message and any attachment are confidential and may be privileged or otherwise protected from disclosure. If you are not the intended recipient, you must not copy this message or attachment or disclose the contents to any other person. If you have received this transmission in error, please notify the sender immediately and delete the message and any attachment from your system. Merck KGaA, Darmstadt, Germany and any of its subsidiaries do not accept liability for any omissions or errors in this message which may arise as a result of E-Mail-transmission or for damages resulting from any unauthorized changes of the content of this message and any attachment thereto. Merck KGaA, Darmstadt, Germany and any of its subsidiaries do not guarantee that this message is free of viruses and does not accept liability for any damages caused by any virus transmitted therewith.



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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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The PMFList is supported by our sponsors as a service to the scientific community.

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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/


=================================
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.

------------------
The PMFList is supported by our sponsors as a service to the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



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/


=================================
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.

------------------
The PMFList is supported by our sponsors as a service to the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



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/


=================================
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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