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May 2018

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Subject:
From:
"Stewart, Jonathan" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 15 May 2018 17:39:13 +0000
Content-Type:
text/plain
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Girdhari,

It is not a good idea to try to validate or qualify a bad practice. I've had experience in such a situation where one HEPA was not powered during a product fill and it was decided to perform a media fill to qualify the process. The media fill failed. If there is a power loss during an active fill there should be procedures describing how to clear the fill line and recover the room prior to resuming the fill.

Best,
Jon

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Girdhari Yadav
Sent: Tuesday, May 15, 2018 7:01 AM
To: [log in to unmask]
Subject: [PMFLIST] Query regarding process simulation

Dear Team


In our existing facility ,All LAF and oRABS are connected with UPS (uninterruptible power supply) but AHU is not connected with UPS. 

As per industry practices AHU is switched off for 2-5 minute during process simulation in filling room , 

Is it necessary to switch off AHU during media-fill for worst case / non routine intervention ?  is there any rationale ?

Need your opinion on this query 

Warm Regards
Girdhari

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