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December 2015

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Subject:
From:
Tony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 18 Dec 2015 15:03:26 -0500
Content-Type:
text/plain
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text/plain (253 lines)
That is the driver of the number of air changes/hr?


According to Bill Whyte the IEST Recommended Practice CC012 for airflow
type, average air velocity and air changes per hour are:



Class

Airflow Type

Average Velocity (ft/min)

Air Changes/hr

ISO 5

Unidirectional

40-80

240-480

ISO 7

Non-unidirectional

/Mixed

10-15

60-90

ISO 8

Non-unidirectional

/Mixed

1-8

5-48



I am sure the 2004 FDA guidance document makes different recommendations


The air velocity should be sufficient to meet air cleanliness standards in
a classified area and laminarity illustrated by smoke studies a foot above
the work surface during dynamic conditions. Typically companies operate at
or above the high ranges 24/7 which adds to their energy consumption
without increase their sterility assurance.

On Fri, Dec 18, 2015 at 7:25 AM, <[log in to unmask]> wrote:

> Hi Natasha,
>
> Satisfactory particle monitoring data is not translated as sufficient air
> change rates. If you have a requirement for air change rates over time (i.e
> per hour) stated within your monitoring specification then this must be
> measured as with the other additional tests for compliance that are
> recommended and you employ.
>
> However for room classification purposes (as required by ISO) then
> particle monitoring data provides this.
>
> Regards
>
>             Darren
>
>
>
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List [mailto:
> [log in to unmask]] On Behalf Of Natasha Guss
> Sent: 18 December 2015 01:47
> To: [log in to unmask]
> Subject: [PMFLIST] Qualification of AHU's
>
> Hello Forum Members,
>
> Would the statement below be accurate in regards to qualification of air
> handling units?
>
> "Total particulate monitoring should prove the AHU units are functioning
> properly (i.e. sufficient # of air changes) to ensure room classification
> is met."
>
>
> Regards,
> Natasha
>
>
>
>
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> Please take a second to visit our sponsors' web sites and say thank you
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> Accugen Laboratories - http://accugenlabs.com
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> Associates of Cape Cod, Inc. - http://www.acciusa.com/
>
> Analytical Research Labs - http://arlok.com/
>
> Life Technologies - http://www.lifetechnologies.com/PharmaAnalytics
>
> Charles River-Endosafe and Accugenix - http://www.criver.com/emd
>
> American Type Culture Collection - http://www.atcc.org
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> ATS Labs - http://www.ats-labs.com
>
> BD Diagnostic Systems - http://www.bd.com/ds/
>
> Biolog - http://www.biolog.com
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> EMD Millipore -  http://www.emdmillipore.com/biomonitoring
>
> Microbiologics, Inc. - http://www.microbiologics.com
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> Microtest Laboratories, Inc. - http://www.microtestlabs.com
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> Nelson Labs - http://www.nelsonlabs.com
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> Steris - http://www.sterislifesciences.com/
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-- 
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

------------------
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

Accugen Laboratories - http://accugenlabs.com

Associates of Cape Cod, Inc. - http://www.acciusa.com/

Analytical Research Labs - http://arlok.com/

Life Technologies - http://www.lifetechnologies.com/PharmaAnalytics

Charles River-Endosafe and Accugenix - http://www.criver.com/emd

American Type Culture Collection - http://www.atcc.org

ATS Labs - http://www.ats-labs.com

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

Biolog - http://www.biolog.com

EMD Millipore -  http://www.emdmillipore.com/biomonitoring

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

Microtest Laboratories, Inc. - http://www.microtestlabs.com

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

Steris - http://www.sterislifesciences.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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