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March 2020

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Subject:
From:
Timothy Cser <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 4 Mar 2020 17:30:33 +0000
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Hi Dina.  Thank you for the clarification.  No, I wouldn’t re-incubate because you want to get started on that investigation right away!  You could always pull a sample and return it to the incubator if you wanted but at that point, a positive is a positive.  In my single opinion, I would re-run the process out of an abundance of caution and to eliminate any questions from an auditor.  That's only my opinion and I'm sure other people may have different opinions.  I'd like to say "sure, invalidate that result"....but my gut tells me that's the wrong answer.  At a minimum, your CAPA should correct the sampling issue.

Sincerely,

Tim Cser
MilliporeSigma

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Dina Monsen
Sent: Wednesday, March 4, 2020 6:57 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] Positive aseptic simulation sample

Thank you for your response Tim.  I have added some clarity...

For full accountability of the media, we collect the media used to prime the fill needles (to get rid of any air in the lines).  This is not done for routine manufacturing.  At a previous company, the MHRA gave us an observation for not collecting this material.  The media was collected into translucent sample cups.  We were able to see turbidity by day 7.  We subcultured on Day 7 and returned it to incubation.  Was it necessary to return it?  Its not going to get more or less positive.

If this fill needle was truly contaminated, I would expect to see at least every 4th vial as positive (4 filling needles).  We didn't see any during the day 7 transfer.

The footage showed an issue with the sampling with the likely source of the contamination (glue from the sampling cup tamper evident sticker).  Do you think that coupled with this not being a routine production step is sufficient justification to not repeat (we filled about 5300 vials).

Thank you
Dina


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Timothy Cser
Sent: Tuesday, March 3, 2020 5:17 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] Positive aseptic simulation sample

Hi Dina.  I think we need some clarification.  If you have a positive purge sample, how would you know before day 7 or 14? Are  you're testing a purge sample because you think it was contaminated by the sample cup or it's just part of your SOP?  Either way, you still have a positive because the process wasn't aseptic.  That being said, depending on the size of your media fill, there is some wiggle room where you can investigate 1 positive sample if you have more than 5000 units.  An investigation is called for and you should "consider" another media fill.  Above 10,000 units you can have one positive but will definitely need to investigate, however you don't have to invalidate the run.  I have customers who don't follow this and will always redo the media fill if anything is ever positive, regardless of size.

In this case you're suggesting you have video proof of external contamination so that should help with the root cause.  In my mind, you should clean and re-run the media fill because the process wasn't aseptic and that's the point of the entire exercise, even if you don't "technically"
have any positive vials.  Imagine yourself in front of an FDA inspector trying  to justify your answer to get an idea if you feel comfortable with your decision.

Sincerely,

Tim Cser
MilliporeSigma

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Dina Monsen
Sent: Monday, March 2, 2020 12:57 PM
To: [log in to unmask]
Subject: [PMFLIST] Positive aseptic simulation sample

If you have a positive purge sample during an aseptic simulation, can it be pulled from incubation on the day of transfer and not incubated the full 14 days?  Also, if the vials are all negative, does the fill needle purge sample being positive effect the results of the media fill (camera footage shows that it was likely the sample cup).



Thank you!

Dina

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Steris - https://clicktime.symantec.com/a/1/-425HUGAkhccdaZqy7708MeEFJY16l4zeW3twV8OCQw=?d=-qvz8fUxpkHGWMPPOHE-ij3ZkrjXvmf-DD3DgsK6x-2IoL1pXQk8GoAZlFqhXc26Y_xDxS0cpPPIyqDxvGROkUjjuezc3rK1HQbLnGfCQtU7N36-hbxayayFp4jUjc7IJ14YM0yjPi5jMh74AYPTrd2l8h-DPLJtd5jv03E7cK6EiCbE3Y7TWj_NK8llCy4Aui_mn8OfgwBuO35FdaoPqd3q09P6Cvo64Hm2_tAsQaFgiPNLpA2YhVJwdNkC90DzZ7JUHdnqRhqzeRbTD1bFjvuzfhxD3RVYbFt_zijVhsjhHI9eJNRCNh-XDQJU9lGdxqCqTEvchwD2Z4pRwmDsC9luEP3p_cfuLG35O4tNdBMB9kAtESkW2ECcE5644FnqlDc0qPufFf_NorgKwMO-AF4SMBM-DpWLtBPqQzxV7QZ-6BFv1J6TGz7MEhUn_c9xaf_hiE9I8j1BbhFgBepoAxJ3zNS-R6pTZvcBz-N7WjHGc4sxub7u54LroHLwUyfjWZjQW86N1UG6FnzQDwOPaM972AVp9l7ZXrm17WIZARud3Z_TBeEr43yOBH6-ldpZ63AzJuVvwt7rNO1R6Q1yF9VL7SI6MQUiINOE3kj7IhyXnw0NaJYIvzIrvRJcex0a13JInF-qfo8wrz6LnMnvGN-r5hD_jbGSDbFgV9WCVA%3D%3D&u=http%3A%2F%2Fwww.sterislifesciences.com%2F

Charles River Laboratories - https://clicktime.symantec.com/a/1/g_1habvvoCjo73Oe5gddSTfXCTZFiNwvpY3dEX5KiAc=?d=-qvz8fUxpkHGWMPPOHE-ij3ZkrjXvmf-DD3DgsK6x-2IoL1pXQk8GoAZlFqhXc26Y_xDxS0cpPPIyqDxvGROkUjjuezc3rK1HQbLnGfCQtU7N36-hbxayayFp4jUjc7IJ14YM0yjPi5jMh74AYPTrd2l8h-DPLJtd5jv03E7cK6EiCbE3Y7TWj_NK8llCy4Aui_mn8OfgwBuO35FdaoPqd3q09P6Cvo64Hm2_tAsQaFgiPNLpA2YhVJwdNkC90DzZ7JUHdnqRhqzeRbTD1bFjvuzfhxD3RVYbFt_zijVhsjhHI9eJNRCNh-XDQJU9lGdxqCqTEvchwD2Z4pRwmDsC9luEP3p_cfuLG35O4tNdBMB9kAtESkW2ECcE5644FnqlDc0qPufFf_NorgKwMO-AF4SMBM-DpWLtBPqQzxV7QZ-6BFv1J6TGz7MEhUn_c9xaf_hiE9I8j1BbhFgBepoAxJ3zNS-R6pTZvcBz-N7WjHGc4sxub7u54LroHLwUyfjWZjQW86N1UG6FnzQDwOPaM972AVp9l7ZXrm17WIZARud3Z_TBeEr43yOBH6-ldpZ63AzJuVvwt7rNO1R6Q1yF9VL7SI6MQUiINOE3kj7IhyXnw0NaJYIvzIrvRJcex0a13JInF-qfo8wrz6LnMnvGN-r5hD_jbGSDbFgV9WCVA%3D%3D&u=http%3A%2F%2Fwww.criver.com%2F

Veltek Associates, Inc - https://clicktime.symantec.com/a/1/zkVpuL-d-djjCjypaO0hsLR1SjvoNrlnh60Nn8txM-4=?d=-qvz8fUxpkHGWMPPOHE-ij3ZkrjXvmf-DD3DgsK6x-2IoL1pXQk8GoAZlFqhXc26Y_xDxS0cpPPIyqDxvGROkUjjuezc3rK1HQbLnGfCQtU7N36-hbxayayFp4jUjc7IJ14YM0yjPi5jMh74AYPTrd2l8h-DPLJtd5jv03E7cK6EiCbE3Y7TWj_NK8llCy4Aui_mn8OfgwBuO35FdaoPqd3q09P6Cvo64Hm2_tAsQaFgiPNLpA2YhVJwdNkC90DzZ7JUHdnqRhqzeRbTD1bFjvuzfhxD3RVYbFt_zijVhsjhHI9eJNRCNh-XDQJU9lGdxqCqTEvchwD2Z4pRwmDsC9luEP3p_cfuLG35O4tNdBMB9kAtESkW2ECcE5644FnqlDc0qPufFf_NorgKwMO-AF4SMBM-DpWLtBPqQzxV7QZ-6BFv1J6TGz7MEhUn_c9xaf_hiE9I8j1BbhFgBepoAxJ3zNS-R6pTZvcBz-N7WjHGc4sxub7u54LroHLwUyfjWZjQW86N1UG6FnzQDwOPaM972AVp9l7ZXrm17WIZARud3Z_TBeEr43yOBH6-ldpZ63AzJuVvwt7rNO1R6Q1yF9VL7SI6MQUiINOE3kj7IhyXnw0NaJYIvzIrvRJcex0a13JInF-qfo8wrz6LnMnvGN-r5hD_jbGSDbFgV9WCVA%3D%3D&u=http%3A%2F%2Fwww.sterile.com

Microbiologics, Inc. - https://clicktime.symantec.com/a/1/Gcbr3NqTDTCp6xH1uhD7YtRbodKUInqPy4TZIx2pOfE=?d=-qvz8fUxpkHGWMPPOHE-ij3ZkrjXvmf-DD3DgsK6x-2IoL1pXQk8GoAZlFqhXc26Y_xDxS0cpPPIyqDxvGROkUjjuezc3rK1HQbLnGfCQtU7N36-hbxayayFp4jUjc7IJ14YM0yjPi5jMh74AYPTrd2l8h-DPLJtd5jv03E7cK6EiCbE3Y7TWj_NK8llCy4Aui_mn8OfgwBuO35FdaoPqd3q09P6Cvo64Hm2_tAsQaFgiPNLpA2YhVJwdNkC90DzZ7JUHdnqRhqzeRbTD1bFjvuzfhxD3RVYbFt_zijVhsjhHI9eJNRCNh-XDQJU9lGdxqCqTEvchwD2Z4pRwmDsC9luEP3p_cfuLG35O4tNdBMB9kAtESkW2ECcE5644FnqlDc0qPufFf_NorgKwMO-AF4SMBM-DpWLtBPqQzxV7QZ-6BFv1J6TGz7MEhUn_c9xaf_hiE9I8j1BbhFgBepoAxJ3zNS-R6pTZvcBz-N7WjHGc4sxub7u54LroHLwUyfjWZjQW86N1UG6FnzQDwOPaM972AVp9l7ZXrm17WIZARud3Z_TBeEr43yOBH6-ldpZ63AzJuVvwt7rNO1R6Q1yF9VL7SI6MQUiINOE3kj7IhyXnw0NaJYIvzIrvRJcex0a13JInF-qfo8wrz6LnMnvGN-r5hD_jbGSDbFgV9WCVA%3D%3D&u=http%3A%2F%2Fwww.microbiologics.com

BD Industrial Media - https://clicktime.symantec.com/a/1/xpsJr0CWrfBYbZQUFf6GWdo3-a_95-qc-456imkO26Q=?d=-qvz8fUxpkHGWMPPOHE-ij3ZkrjXvmf-DD3DgsK6x-2IoL1pXQk8GoAZlFqhXc26Y_xDxS0cpPPIyqDxvGROkUjjuezc3rK1HQbLnGfCQtU7N36-hbxayayFp4jUjc7IJ14YM0yjPi5jMh74AYPTrd2l8h-DPLJtd5jv03E7cK6EiCbE3Y7TWj_NK8llCy4Aui_mn8OfgwBuO35FdaoPqd3q09P6Cvo64Hm2_tAsQaFgiPNLpA2YhVJwdNkC90DzZ7JUHdnqRhqzeRbTD1bFjvuzfhxD3RVYbFt_zijVhsjhHI9eJNRCNh-XDQJU9lGdxqCqTEvchwD2Z4pRwmDsC9luEP3p_cfuLG35O4tNdBMB9kAtESkW2ECcE5644FnqlDc0qPufFf_NorgKwMO-AF4SMBM-DpWLtBPqQzxV7QZ-6BFv1J6TGz7MEhUn_c9xaf_hiE9I8j1BbhFgBepoAxJ3zNS-R6pTZvcBz-N7WjHGc4sxub7u54LroHLwUyfjWZjQW86N1UG6FnzQDwOPaM972AVp9l7ZXrm17WIZARud3Z_TBeEr43yOBH6-ldpZ63AzJuVvwt7rNO1R6Q1yF9VL7SI6MQUiINOE3kj7IhyXnw0NaJYIvzIrvRJcex0a13JInF-qfo8wrz6LnMnvGN-r5hD_jbGSDbFgV9WCVA%3D%3D&u=http%3A%2F%2Fwww.bd.com%2Fds%2F

Associates of Cape Cod, Inc. - https://clicktime.symantec.com/a/1/T2-MIOOGQsTjn2PHO9QceBrNO2BVI52-O0R-QsIp0fc=?d=-qvz8fUxpkHGWMPPOHE-ij3ZkrjXvmf-DD3DgsK6x-2IoL1pXQk8GoAZlFqhXc26Y_xDxS0cpPPIyqDxvGROkUjjuezc3rK1HQbLnGfCQtU7N36-hbxayayFp4jUjc7IJ14YM0yjPi5jMh74AYPTrd2l8h-DPLJtd5jv03E7cK6EiCbE3Y7TWj_NK8llCy4Aui_mn8OfgwBuO35FdaoPqd3q09P6Cvo64Hm2_tAsQaFgiPNLpA2YhVJwdNkC90DzZ7JUHdnqRhqzeRbTD1bFjvuzfhxD3RVYbFt_zijVhsjhHI9eJNRCNh-XDQJU9lGdxqCqTEvchwD2Z4pRwmDsC9luEP3p_cfuLG35O4tNdBMB9kAtESkW2ECcE5644FnqlDc0qPufFf_NorgKwMO-AF4SMBM-DpWLtBPqQzxV7QZ-6BFv1J6TGz7MEhUn_c9xaf_hiE9I8j1BbhFgBepoAxJ3zNS-R6pTZvcBz-N7WjHGc4sxub7u54LroHLwUyfjWZjQW86N1UG6FnzQDwOPaM972AVp9l7ZXrm17WIZARud3Z_TBeEr43yOBH6-ldpZ63AzJuVvwt7rNO1R6Q1yF9VL7SI6MQUiINOE3kj7IhyXnw0NaJYIvzIrvRJcex0a13JInF-qfo8wrz6LnMnvGN-r5hD_jbGSDbFgV9WCVA%3D%3D&u=http%3A%2F%2Fwww.acciusa.com%2F


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Steris - http://www.sterislifesciences.com/

Charles River Laboratories - http://www.criver.com/

Veltek Associates, Inc - http://www.sterile.com

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

BD Industrial Media - http://www.bd.com/ds/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


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