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From:
Crystal Booth <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 16 Jun 2020 19:43:14 +0000
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Hi Alison,

I agree with Tim. Also, if you are testing a small amount, you can add it to a sterile diluent (such as sterile water or Fluid A, etc.) prior to filtering the entire amount.  You'd want to do a negative control of your diluent.

Kind regards,
Crystal Booth

Crystal Booth, M.M.
Regional Manager
PDASE Chapter President
PSC Biotech Corporation
700 Corporate Center Drive Pomona, CA 91768
Mobile (909) 620-0757
https://www.biotech.com/



-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Timothy Cser
Sent: Tuesday, June 16, 2020 12:24 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] Water Filtration Bioburden

[CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the sender and know the content is safe.]

Hi Alison.  How much water are you testing?  If it’s 100mL a pre-wet isn’t needed.  If it’s a small amount like 5mL, you can pre-wet with 10-20mL of sterile water/diluent.  Pre-wetting is designed to minimize any binding of the article you’re wishing to test but water isn’t a problem.

Tim Cser
MilliporeSigma
MilliporeSigma is a division of Merck KGaA, Darmstadt, Germany

> On Jun 16, 2020, at 9:18 AM, Berman, Alison <[log in to unmask]> wrote:
>
> Hi all,
> For those of you performing bioburden testing of waters using the filtration method, are you using a pre-wet, a rinse, or both a pre-wet and a rinse?
> If a study is performed showing equivalency with and without a pre-wet and/or rinse, it is acceptable to forego them?
> Thanks
>
> Alison Berman, MFS
> Supervisor
> Quality Control - Microbiology
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