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July 2020

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Subject:
From:
"Dr. Michael J. Miller" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 9 Jul 2020 17:19:24 -0400
Content-Type:
text/plain
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text/plain (89 lines)
You may be able to refer to the results of the PDA 2017 Aseptic Processing Survey (TR 45010) on media fill incubation parameters: 

 

Single temp in the range of 20-35: 8% of respondents

Two temps 20-25 and 30-25 in sequence: 84% of respondents

Two temps 30-35 and 20-25 in sequence: 8% of respondents

 

Michael

 

On Thu, Jul 9, 2020 at 9:51 AM Reuven Baum <[log in to unmask]> wrote:

 

We previously incubated media fills at 20-25C for 14 days.

We intend to change to 20-25C for 7 days followed by 30-35C for 7 days.

 

What level of justification is needed for this change ?

Is a risk assessment enough ?

Do we need to do a study with microorganisms  ?

 

 

Reuven

QC Microbiologist

Isotopia

 

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