PMFLIST Archives

July 2020

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
Stephen Dragotakes <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 24 Jul 2020 09:33:08 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (101 lines)
Hello Randy,
This should be based on environmental recovery documentation; best defense
is actual incident monitoring ( Viables/Non Viables) correlated to actual
CFM supply/exhaust monitoring documentation during the events. It may be
quite possible to defend a 15 minute/ 30 minute safe period since most HVAC
systems have flow lags within these short time periods where the actual
flows are able to maintain control. Again should be documented/validated.
If you have historical cfm monitoring data a retrospective review of
incidents correlated with a validated historical environmental
monitoring program may give you a defensible position.
Best Regards,

Stephen C. Dragotakes RPh, BCNP, FAPhA
[log in to unmask] , 508-361-9903

Facility Manager- Molecular Cancer Imaging Facility
Dana Farber Cancer Institute
27 Drydock Ave.
Boston, MA 02210
617-582-9615
[log in to unmask]

Radiopharmaceutical Consultant
Nuclear Pharmacist, Radiopharmaceutical Scientist, Sterile Compounding
Expert
Aseptic Processing Specialist, Registered Health Physics Service Provider
 MA Dept.Public Health Radiation Control Program.

dba Dragotakes Consulting
18 Hillcrest Rd.
Medfield,MA  02052



On Fri, Jul 24, 2020 at 12:08 AM Randy Hutt, Ph.D. <[log in to unmask]>
wrote:

> 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.
>
> ------------------
> 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.

ATOM RSS1 RSS2