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April 2000


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Anthony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Mon, 10 Apr 2000 17:48:20 -0400
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 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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