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May 2018

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Subject:
From:
Don English/SUF/US <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 9 May 2018 14:52:21 +0000
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Dear Maria,

If you are going to use the media in which there is a prolong standing period, you will need to have a deviation report indicating the problem and what steps that you had performed to justify the usage of the media each time that this situation occurs.  The reason is that the sterilization cycle had deviated from its normal operating parameters.

Don



Donald J. English
Head of Microbiology, Research and Development
One Avon Place, Suffern, New York 10901
Phone 1-845-369-2805
Tieline 3435
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-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Maria Ioakim
Sent: Wednesday, May 09, 2018 2:04 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] Sterilization of culture media deviation during cooling

Thank you all for the replies.
The situation here is that the autoclave showed this message "Water in the machine" and this water did not allow the unit to cool down as usually.
We did not discard the media but we performed growth promotion for investigation purposes. We will not use them for analysis. 
For TSB results were OK.
For PB there was observed a decrease (>50%) to the count of E.coli after 4h, test repeated with same result.
pH and colour were within specifications.  
We have checked the autoclave, removed any water present in the machine and we have run Instruments cycle (122°C/20min) as well as liquids cycle (121°C/15min) for media with only 3x bottles filled with water to check if the problem insists however both cycles were successful.
Thus, we used the autoclave again yesterday for sterilisation of culture media (PB, TSB, MCB) and the same problem occurred. We have then noticed a folded hose and maybe this was the issue, the supplier was also contacted for maintenance. 
The problem is that I dont have a clue if the prolonged standing (>10h) at 60-80°C can affect the media, also I cannot be sure what was actually the temperature in the chamber.
My opinion is that if we can justify effectively that the quality of media is not compromised then we can use them for analysis. "Dump it" will be the easy way! 

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The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and supported by
our sponsors as a service to the scientific community.

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]

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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