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July 2020

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Subject:
From:
John Lindsay <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 24 Jul 2020 18:04:57 +0000
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Years ago, during the era of "Brown-outs" in California, I performed viable and not viable air evaluations in an ISO5/7 cleanroom before, during and after a power outage. We placed sampling devices on the floor next to air returns and also at work heights on filling equipment in the middle of the room. As expected, we saw non-viable counts increase at locations in front of the air returns when the power was turned off . However, surprisingly we saw more viable counts at the filling line than near the air returns. That phenomenon occurs because the (less-clean) air inside the air returns up to the air handler collapses during a power outage, pushes out through the air returns and flows off the floor and toward the center of the room. So if you have any power outage, you run the risk of contaminating your ISO 5 area almost immediately. 

If you want to have a 5-minute rule (like when you drop a piece of candy on the floor),  you need to generate some data (airflow study and similar viable & non-viable air sampling that we performed), and write a conclusive risk assessment to defend the practice.

Best advice: Wash your hands, stand 3-6 feet away from another gowned operator, and wear a sterile mask.

		By the way, don't pick up the candy and eat it in the cleanroom!

John Lindsay
Aseptic Solutions, Inc.

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Randy Hutt, Ph.D.
Sent: Wednesday, July 22, 2020 4:54 PM
To: [log in to unmask]
Subject: [PMFLIST] Loss of Power in Aseptic Pharma. Plant

Does anyone have a time limit for loss of power (HVAC), after which you would do a 3X clean?  I was thinking 15 minutes, but some people thought 30 minutes would be acceptable.  Are there any guidance documents for this issue?

Thanks.
Randy Hutt, Ph.D.

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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.

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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