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April 2017

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Subject:
From:
Rob E Warburton <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 21 Apr 2017 19:44:58 +0000
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Hi Marc,

Good questions.  

The dilution was performed in only one diluent at a time.  One attempt was performed in phosphate buffer, and after problems were encountered a separate attempt was performed in TSB w lecithin/PS20.  The diluents were not combined.  These are not enrichment tests, the powder was weighed and serial dilutions would have been performed, then a 1mL aliquot plated, so it would still be quantitative.  Sorry for the confusion in how I worded that.

Yes a manual colony counter is used with light and magnifying glass.

Thanks,
Rob



-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Marc Glogovsky
Sent: Wednesday, April 19, 2017 9:44 AM
To: [log in to unmask]
Subject: [EXTERNAL] Re: [PMFLIST] [PMFLIST] How to overcome TSA/SDA compatibility issues with a slurry for bioburden testing

Just for clarification, is the dilution 1:50 in PB and again 1:50 in TAT Broth (which is now no longer a quantitative assay)?  How much of an aliquot is being pour plated?

Is a colony counter (I.e. Quebec) or other illuminating/magnifying device being used?

Sincerely,

Marc Glogovsky, S.M. (NRCM)  |  Global Business Manager – Environmental Monitoring Division Veltek Associates, Inc.
15 Lee Boulevard<x-apple-data-detectors://6/1>  •  Malvern, PA 19355-1234 USA<x-apple-data-detectors://7/0>
C: 609.432.1314<tel:609.432.1314>   F: 609.241.0065<tel:609.241.0065>
Email: [log in to unmask]<mailto:[log in to unmask]>   Web: www.sterile.com<http://sterile.com/product-category/environmental-monitoring/>

On Apr 19, 2017, at 9:14 AM, Rob E Warburton <[log in to unmask]<mailto:[log in to unmask]>> wrote:

Hi Kerri,

It was during the B/F testing that the cloudiness was encountered.  In the most recent case at a CMO they did have problems reading the colonies through it.  From my experience in the past, and from their recent encounter, there is not an antimicrobial effect where one would not pass the B/F acceptance criteria of NLT 50%, but the problem is being able to count certain microorganisms, most notably A. brasiliensis and P. aeruginosa, through the cloudiness of the plate.

Rob


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Kerri Sturtevant
Sent: Tuesday, April 18, 2017 7:28 PM
To: [log in to unmask]<mailto:[log in to unmask]>
Subject: [EXTERNAL] Re: [PMFLIST] How to overcome TSA/SDA compatibility issues with a slurry for bioburden testing

Robert,

Has suitability of the recovery method been performed to determined if the cloudiness would prevent the recovery of microorganisms?



Kerri Sturtevant | Microbiologist

[image: .] <http://www.micromedlabs.com>

MicroMed Laboratories, Inc. | 1129 North McDowell Blvd. Petaluma, CA 94954
| Office 707-559-2447 | Email  
| [log in to unmask]<mailto:[log in to unmask]><mail
| to:[log in to unmask]> |
www.micromedlabs.com<http://www.micromedlabs.com><http://www.micromedlabs.com>

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On Tue, Apr 18, 2017 at 11:27 AM, Rob E Warburton < [log in to unmask]<mailto:[log in to unmask]><mailto:[log in to unmask]>> wrote:

Good afternoon,

I was wondering if I could solicit advice on a situation that has occurred twice now with different molecules when performing bioburden (MLT) assays.

In the latest case, a powdered API was diluted 1:50 with phosphate buffer and also with TSB containing lecithin and PS20.  The sample was added to the plate, and when the media (TSA and SDA) was added the media turned cloudy.  I have seen this in the past with only SDA, but in this instance both TSA and SDA became cloudy.

Are there any suggestions to overcome the media turning cloudy and potential cases?  It seems like something in the matrix is incompatible with the media.

Thank you,
Rob Warburton

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The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from The Microbiology Network (http://microbiologynetwork.com) and 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.


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

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

Nelson Labs - http://www.nelsonlabs.com

BD Diagnostic Systems - http://www.bd.com/ds/

Boston Analytical http://www.bostonanalytical.com/

MilliporeSigma  http://www.emdmillipore.com/

Charles River Microbial Solutions:  Endosafe, Accugenix & Celsis   - www.criver.com/micro<http://www.criver.com/micro><http://www.criver.com/micro>

Avista Pharma Solutions  http://www.avistapharma.com

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


------------------
The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from The Microbiology Network (http://microbiologynetwork.com) and 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.


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

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

Nelson Labs - http://www.nelsonlabs.com

BD Diagnostic Systems - http://www.bd.com/ds/

Boston Analytical http://www.bostonanalytical.com/

MilliporeSigma  http://www.emdmillipore.com/

Charles River Microbial Solutions:  Endosafe, Accugenix & Celsis   - www.criver.com/micro<http://www.criver.com/micro>

Avista Pharma Solutions  http://www.avistapharma.com

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


------------------
The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from The Microbiology Network (http://microbiologynetwork.com) and 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.


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

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

Nelson Labs - http://www.nelsonlabs.com

BD Diagnostic Systems - http://www.bd.com/ds/

Boston Analytical http://www.bostonanalytical.com/

MilliporeSigma  http://www.emdmillipore.com/

Charles River Microbial Solutions:  Endosafe, Accugenix & Celsis   - www.criver.com/micro

Avista Pharma Solutions  http://www.avistapharma.com

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

------------------
The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and 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.


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

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

Nelson Labs - http://www.nelsonlabs.com

BD Diagnostic Systems - http://www.bd.com/ds/

Boston Analytical http://www.bostonanalytical.com/

MilliporeSigma  http://www.emdmillipore.com/

Charles River Microbial Solutions:  Endosafe, Accugenix & Celsis   - www.criver.com/micro

Avista Pharma Solutions  http://www.avistapharma.com

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

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