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November 2018

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Subject:
From:
Tony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 21 Nov 2018 09:29:49 -0500
Content-Type:
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Darren,

1.      Is this being interpreted that as part of suitability you must
check the pH of your solution an verify it has a pH of 6-8 and if it is
outside this range then you must adjust it before performing the next
steps.

Yes, this is correct.

2.      If you know the pH of your product and the pH of your buffered
solution are both within 6-8 do you still need to do this check to verify

Conducting a pH measurement is a trivial effort so why would you not do it
and record the result in the method suitability test results.
3.      If you do have to adjust the pH to comply when performing
suitability, do you also have to perform pH adjustment for the routine
testing or is it ok to test routinely with the pH outside the range.

Obviously you need to adjust the pH and check it if was outside the 6-8
range during suitability test. If it is consistently inside the range no
checking and adjustment is required.

4.      If it is only during suitability then why is it acceptable to
adjust during suitability but in routine it is not required?

Why would you suggest this as an option.

Tony

On Wed, Nov 21, 2018 at 6:37 AM Skarratt, Darren /GB <
[log in to unmask]> wrote:

> Good morning all,
> Within the EP (2.6.12 non-sterile products: microbial enumeration)
> relating to Preparation of the product, it states that after you add sample
> (1 in 10) to buffered solution or casein soya bean digest broth. ''If
> necessary, adjust the pH to 6-8''
>
> My questions are as follows:
>
> 1.      Is this being interpreted that as part of suitability you must
> check the pH of your solution an verify it has a pH of 6-8 and if it is
> outside this range then you must adjust it before performing the next steps.
>
> 2.      If you know the pH of your product and the pH of your buffered
> solution are both within 6-8 do you still need to do this check to verify
>
> 3.      If you do have to adjust the pH to comply when performing
> suitability, do you also have to perform pH adjustment for the routine
> testing or is it ok to test routinely with the pH outside the range
>
> 4.      If it is only during suitability then why is it acceptable to
> adjust during suitability but in routine it is not required?
>
>
> Regards
>
> Darren
>
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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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Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



Science Advisory Board https://www.scienceboard.net/

Sartorius https://promotions.sartorius.com/real-heroes

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

Avista Pharma Solutions  http://www.avistapharma.com

MilliporeSigma  http://www.emdmillipore.com/

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

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

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

Nelson Labs - http://www.nelsonlabs.com

BD Diagnostic Systems - http://www.bd.com/ds/

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

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


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The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.

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