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April 2000

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Subject:
From:
"Vojt, Christine M [OCDUS]" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Thu, 13 Apr 2000 06:53:53 -0400
Content-Type:
text/plain
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I agree with your position Tony.  This type of testing may be appropriate
during validation of the fill operation however.

Christine Vojt
OCD

> -----Original Message-----
> From: Anthony Cundell [SMTP:[log in to unmask]]
> Sent: Monday, April 10, 2000 5:48 PM
> To:   [log in to unmask]
> Subject:      [PMFLIST] EM of Product Contact Parts
>
>  The PDA EM Technical Report is near completion so it may be timely to
> discuss this issue.
>
> I do not believe it is current industry practice to monitor sterile
> aseptic filling parts. Some individuals in the regulatory agencies seem to
> feel that industry should  monitor filling needles and stopper bowls.
> Sampling can lead to product contamination. This means samples must be
> taken at the end of each fill prior to equipment breakdown so a company
> needs to have a microbiologist standing by to take the samples as the end
> of a filling operation is not predictable.  Also, it is possible that the
> swab sample may  be, on infrequent occassions, contaminated due to
> manipulation and culture.   I believe that the sucessful aseptic assembly
> of these sterile parts is adequately validated during the media fill
> validation.
>
> My authority is the draft PDA Technical Report, that may be viewed as a
> consensus document, that states:
>
> "It must be recognized, however, that it may not always be practical to
> select a site at the most critical location.  One should consider whether
> crucial site monitoring would actually increase probability of product
> contamination.  Additionally, crucial sites may not be monitored if the is
> a low probability of contamination during processing (e.g., sterilized
> sites that are do manipulated)"
>
> What does everyone think.
>
> Tony Cundell
> Wyeth-Ayerst Pharmaceuticals
>
>
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