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July 2020

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Subject:
From:
"Polarine, Jim" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 29 Jul 2020 01:02:53 +0000
Content-Type:
text/plain
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text/plain (165 lines)
Hi Stephen and Randy:

Facilities should establish a time limit that AHU's/HVAC's shutdowns, along with pressure differential excursions, are allowed without requiring an assessment of product impact, a triple or major clean, and conformational environmental monitoring for release of the area. The decision to release a room without action should include conditions such as minimal or no traffic in the area, if doors need to remain shut, no open product, and a time limit. Most facilities should be able to withstand an AHU shutdown of 1-2 hours without having to clean and monitor as long as no personnel were in the area during the event and the environment was not breached. The duration and activities allowed would have to be supported by an environmental study. This scenario as well as other events impacting critical environments is discussed at length in our book chapter " How Issues Related to Utilities, Surfaces, and Practices Impact Cleanroom Environments" by Jim Polarine and Beth Kroeger. Source: Madsen, R.E, & Moldenhauer J. (2016). Contamination control in healthcare product manufacturing, Volume 4. River Grove, IL: Davis Healthcare International Publishing, LLC.

Warmest Regards,
Jim

Jim Polarine Jr.,  MA.
Senior Technical ServiceĀ  Manager
STERIS Corporation | Life Sciences Marketing 
7405 Page Avenue | St. Louis, MO 63133-1032 USA
440-354-2600 | 800-548-4873
Direct: 314-290-4793
Cell: 314-616-9931
Fax: 314-721-6648
Email: [log in to unmask]
Web: http://www.sterislifesciences.com/


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Stephen Dragotakes
Sent: Friday, July 24, 2020 8:33 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] Loss of Power in Aseptic Pharma. Plant

CAUTION: This email originated from outside of STERIS. Do not click links or open attachments unless you recognize the sender and know the content is safe.

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.
>
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> Steris - 
> https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.s
> terislifesciences.com%2F&amp;data=02%7C01%7Cjim_polarine%40STERIS.COM%
> 7Cdde8d3b2a80f4455b65508d8327e43ee%7C9f503db202a84bb68b64ee489d2a21c5%
> 7C0%7C0%7C637314865171807187&amp;sdata=Eo%2BTW%2BJiOKMAaPbhnOf1LnEs%2F
> Ejci8i4BcSI1lYRcWM%3D&amp;reserved=0
>
> Charles River Laboratories -
> https://urldefense.proofpoint.com/v2/url?u=https-3A__www2.criver.com_l
> _60962_2020-2D03-2D27_h6jqv6&d=DwIBaQ&c=E-bIHm3LlZHbfxnPQH77cA&r=7rxhN
> U3V93_PzOVCQGPsYqmikTdmCf892CncyfrCy0A&m=Wo3KntgdALi-JAcNvZIaob3WMQSNZ
> XBYXbrSQPd2TZ8&s=1Yh9va8a3Oj3NqFl8nEQLWZMWvam4PVIqsWDue9H8vE&e=
>
> Veltek Associates, Inc - 
> https://urldefense.proofpoint.com/v2/url?u=http-3A__www.sterile.com&d=
> DwIBaQ&c=E-bIHm3LlZHbfxnPQH77cA&r=7rxhNU3V93_PzOVCQGPsYqmikTdmCf892Cnc
> yfrCy0A&m=Wo3KntgdALi-JAcNvZIaob3WMQSNZXBYXbrSQPd2TZ8&s=MFMQgVK1doPCKD
> d1TatjfnzCYXUok-5IuQN8iJVB6Yw&e=
>
> Microbiologics, Inc. - 
> https://urldefense.proofpoint.com/v2/url?u=http-3A__www.microbiologics
> .com&d=DwIBaQ&c=E-bIHm3LlZHbfxnPQH77cA&r=7rxhNU3V93_PzOVCQGPsYqmikTdmC
> f892CncyfrCy0A&m=Wo3KntgdALi-JAcNvZIaob3WMQSNZXBYXbrSQPd2TZ8&s=bE-74Jv
> GOr6y68owwYgNv_TlMNBnTLGBAyut9GhM9Ds&e=
>
> BD Industrial Media - 
> https://urldefense.proofpoint.com/v2/url?u=http-3A__www.bd.com_ds_&d=D
> wIBaQ&c=E-bIHm3LlZHbfxnPQH77cA&r=7rxhNU3V93_PzOVCQGPsYqmikTdmCf892Cncy
> frCy0A&m=Wo3KntgdALi-JAcNvZIaob3WMQSNZXBYXbrSQPd2TZ8&s=L4wXyeHzTNusAdy
> 19ZahzybzxaTRvPRHFmL2Y7hSZoU&e=
>
> Associates of Cape Cod, Inc. - 
> https://urldefense.proofpoint.com/v2/url?u=http-3A__www.acciusa.com_&d
> =DwIBaQ&c=E-bIHm3LlZHbfxnPQH77cA&r=7rxhNU3V93_PzOVCQGPsYqmikTdmCf892Cn
> cyfrCy0A&m=Wo3KntgdALi-JAcNvZIaob3WMQSNZXBYXbrSQPd2TZ8&s=aQQlKegSdb4zn
> lza5OkPoLa2TOvzxkzEWwvJSlJ_H8w&e=
>
>
> =================================
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Steris - https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.sterislifesciences.com%2F&amp;data=02%7C01%7Cjim_polarine%40STERIS.COM%7Cdde8d3b2a80f4455b65508d8327e43ee%7C9f503db202a84bb68b64ee489d2a21c5%7C0%7C0%7C637314865171807187&amp;sdata=Eo%2BTW%2BJiOKMAaPbhnOf1LnEs%2FEjci8i4BcSI1lYRcWM%3D&amp;reserved=0

Charles River Laboratories - https://urldefense.proofpoint.com/v2/url?u=https-3A__www2.criver.com_l_60962_2020-2D03-2D27_h6jqv6&d=DwIBaQ&c=E-bIHm3LlZHbfxnPQH77cA&r=7rxhNU3V93_PzOVCQGPsYqmikTdmCf892CncyfrCy0A&m=Wo3KntgdALi-JAcNvZIaob3WMQSNZXBYXbrSQPd2TZ8&s=1Yh9va8a3Oj3NqFl8nEQLWZMWvam4PVIqsWDue9H8vE&e=

Veltek Associates, Inc - https://urldefense.proofpoint.com/v2/url?u=http-3A__www.sterile.com&d=DwIBaQ&c=E-bIHm3LlZHbfxnPQH77cA&r=7rxhNU3V93_PzOVCQGPsYqmikTdmCf892CncyfrCy0A&m=Wo3KntgdALi-JAcNvZIaob3WMQSNZXBYXbrSQPd2TZ8&s=MFMQgVK1doPCKDd1TatjfnzCYXUok-5IuQN8iJVB6Yw&e=

Microbiologics, Inc. - https://urldefense.proofpoint.com/v2/url?u=http-3A__www.microbiologics.com&d=DwIBaQ&c=E-bIHm3LlZHbfxnPQH77cA&r=7rxhNU3V93_PzOVCQGPsYqmikTdmCf892CncyfrCy0A&m=Wo3KntgdALi-JAcNvZIaob3WMQSNZXBYXbrSQPd2TZ8&s=bE-74JvGOr6y68owwYgNv_TlMNBnTLGBAyut9GhM9Ds&e=

BD Industrial Media - https://urldefense.proofpoint.com/v2/url?u=http-3A__www.bd.com_ds_&d=DwIBaQ&c=E-bIHm3LlZHbfxnPQH77cA&r=7rxhNU3V93_PzOVCQGPsYqmikTdmCf892CncyfrCy0A&m=Wo3KntgdALi-JAcNvZIaob3WMQSNZXBYXbrSQPd2TZ8&s=L4wXyeHzTNusAdy19ZahzybzxaTRvPRHFmL2Y7hSZoU&e=

Associates of Cape Cod, Inc. - https://urldefense.proofpoint.com/v2/url?u=http-3A__www.acciusa.com_&d=DwIBaQ&c=E-bIHm3LlZHbfxnPQH77cA&r=7rxhNU3V93_PzOVCQGPsYqmikTdmCf892CncyfrCy0A&m=Wo3KntgdALi-JAcNvZIaob3WMQSNZXBYXbrSQPd2TZ8&s=aQQlKegSdb4znlza5OkPoLa2TOvzxkzEWwvJSlJ_H8w&e=


=================================
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/


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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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