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Subject:
From:
April N Moore <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 18 Dec 2015 12:53:18 +0000
Content-Type:
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Natasha,

The statement is partially correct.  The only issue noticed is just because your non-viable particulates are within acceptance criteria for the ISO classification you have qualified the area to does not mean the room air change over rate is at the recommended air changes for classification.  It also may not reveal a leak in your HEPA filter.  Leak testing of HEPA filters per routine maintenance would confirm the AHU is functioning appropriately.  The non-viable particulate data only confirms you are meeting the classification you have qualified the area to.  Depending on the classification you could collect non viable data in a non classified area and still be within certain classified limit acceptance criteria.  Therefore, using non-viable particulate data alone to state The AHU is functioning appropriately is only partially correct.  You must use other controls in place associated with the AHU unit to confirm it is functioning properly.

How this helps
April 

Sent from my iPhone

> On Dec 18, 2015, at 6:40 AM, Natasha Guss <[log in to unmask]> wrote:
> 
> 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 for their support of this service.

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