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November 2018

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Subject:
From:
"Skarratt, Darren /GB" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 21 Nov 2018 07:56:15 +0000
Content-Type:
text/plain
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text/plain (68 lines)
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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