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October 2019

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Subject:
From:
Dale Kelley <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 11 Oct 2019 16:27:18 +0000
Content-Type:
text/plain
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Nicole,
What you describe sounds like a classic case of contamination through poor handling technique.
Questions to be answered include:
Are all these sampled by the same person?
Was sampler training adequate?
Are sterile gloves worn during sampling?
Are gloves frequently sanitized?
What is the sequence of sampling? (e.g. Does sampling occur in less clean areas last, first, or whenever convenient?)
Has anything changed recently? (e.g. gloves, plates, gowning materials, sampler, other personnel, equipment, facility)
Have you observed the sampling process to look for changes?

Hope this is enough to get you started,

Dale Kelley
Director
Protocol Link, Inc.
175 E. Hawthorn Parkway, Suite 210
Vernon Hills, IL 60061 USA
office +1-847-549-0390
www.protocollink.com





-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Nicole Familiari
Sent: Thursday, October 10, 2019 3:05 PM
To: [log in to unmask]
Subject: [PMFLIST] Environmental Monitoring false positives

Hello all!

Hope you are all doing well this afternoon!

My question is based on a gut feeling and I am hoping someone will have supporting literature or corrective actions. Has anyone run into colonies appearing on Environmental monitoring contact plates just along the edges?
 I have had two weeks of plates return with colonies that appear to be skin bugs along the edges of the plates, around the curve of the raised agar. This week there was even two sets of plates that similar colonies in nearly identical locations, about 10 and 2, on the edge of the contact plate. I am concerned that this is a personnel technique issue, however I am unsure how to identify the root cause . Samples are in the process of identification right now.

Thank you,
Nicole


[Carie Boyd's Prescription Shop]<http://www.carieboyd.com/> Nicole Familiari Quality Assurance Manager, Microbiologist
P:
(817) 282-9376<tel:(817)%20282-9376>
 |
F:
(817) 282-1709<tel:(817)%20282-1709>
E:
[log in to unmask]<mailto:[log in to unmask]>
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W:
www.carieboyd.com<http://www.carieboyd.com>






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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.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



Science Advisory Board https://www.scienceboard.net/

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

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

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

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

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

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

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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