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Subject:
From:
derek freeman <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 2 Nov 2018 14:06:18 +0000
Content-Type:
text/plain
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Hi Tony,

When your refer to  retaining  aseptic manipulation for small sized batches - what size would be considered  "small" in such cases . Is there  a reg / standard  I could refer to?

Thanks & Regards

Derek Freeman (PhD)

Principal DFMicro



________________________________
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> on behalf of Tony Cundell <[log in to unmask]>
Sent: 24 October 2018 22:33
To: [log in to unmask]
Subject: Re: [PMFLIST] Manufacturing of Antivenom product and clean room standard requirements

Bittu,

A valuable product. A friend was recent bitten by a copperhead snake
recently and she survived due to treatment with an anti-venom.

The process you describe is similar to sterile compounding. Is the batch
size small so you retain many aseptic manipulations? Did you conduct a
successful media fill?

Tony

On Wed, Oct 24, 2018 at 4:18 PM Bittu Dave <
[log in to unmask]> wrote:

> Dear forum member,
> The product is a antivenom   liquid immunoglobulin product undergoes a
> final 0.2 um sterile filtration inside the Grade A cabinet  ( with Grade
> C/D background) where it is filled directly into vials, stoppers inserted
> and crimp sealed with aluminium seals.     Formulation is performed
> entirely within closed disposable bags.
> The  facility was designed as a Grade D clean area but later adapted to
> include a Grade A cabinet.  There is no doubt you can conduct aseptic
> processing (filling) in such a space successfully as evidenced by  air
> quality and EM data and test results.
>
>
>
> Your view will be greatly appreciated.
>
>
> Many thanks and RegardsBittu
>
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--
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

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

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Boston Analytical http://www.bostonanalytical.com/

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