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December 2003

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Subject:
From:
Bhogilal Sheth <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 12 Dec 2003 09:49:01 -0600
Content-Type:
text/plain
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The basic issue is not 483s or other regulatory perspectives.  The Issue is
process validation.

Hypothetically, you can use a filter for as long as is necessary in your
process. To do this, you would need to validate the process as you wish to
use it.  That said, you should avoid what may be considered "abnormal"
extended periods. You would need to take into consideration various
parameters such as the suitability of the filter, bioburden of the product
prior to filtration, environmental status and control of the aseptic area,
personnel training, impact of process interruptions, and many other process
and equipment related issues. You would also need to have a strong
"justification" that an extended process is necessary and provides
significant benefits.

If you ask the question to a regulatory agency representative, the answer
you will most likely get is some variation of "best not to do it". But I
think extended process times are in use  in products such as contact lens
solutions. If you propose to validate  an "extended time" process, I would
suggest that you review the protocol with appropriate CDER person to clarify
any concerns and doubts.

Bhogi Sheth
[log in to unmask]
----- Original Message -----
From: "Robert Rosenlof" <[log in to unmask]>
To: <[log in to unmask]>
Sent: Friday, December 12, 2003 9:08 AM
Subject: [PMFLIST] Filter Usage


> I am interested in the forums thoughts on filter usage times.  When using
a
> 0.2um filter for a bulk in-line filtration of solution, are you aware of
use
> longer than 24 hours, 48 hours...etc.  Have any of you seen issues with
483s
> or other regulatory bodies issuing observations for using a filter longer
> than 24 hours?  Thanks for any input.
>
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