PMFLIST Archives

July 2020

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
Veronica Marshall <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 16 Jul 2020 13:52:18 +0000
Content-Type:
multipart/related
Parts/Attachments:
text/plain (10 kB) , image071777.gif (10 kB) , image483547.jpg (10 kB)
Dear all,

I always hesitate to say what P acnes can't do.  I have seen appear in all manner of ways,  from extremely air intolerant to very air tolerant and on TSA/TSB (unsupplemented).  The same culture adapts quite quickly between states if it has just enough resource to survive long enough to do so. 
I've also performed a study keeping it in an extremely low moisture dry powder environment.  This documented that is was able to persist in a viable state for a number of years.  If I were running an anaerobic media fill, and it is a known environmental of the facility I would include it as the in-house challenge microorganism.  


One opinion -regards,


Veronica Marshall
Sr. Manager, Quality Control
Xellia Pharmaceuticals USA, LLC
200 Northfield Road
Bedford OH USA 44146
Tel: +1 440-359-2205 Mob: +1 440-903-7905
[log in to unmask]
www.xellia.com
Main partner of:

CONFIDENTIALITY NOTICE: The information transmitted hereby is intended only for the person(s) or entity(ies) to which it is addressed and may contain confidential and/or privileged material. Any review, retransmission, dissemination, copying or other use of this information, or taking of any action in reliance upon this information, by persons or entities other than the intended recipient(s) is prohibited. If you have received this communication in error or without specific authorization, please contact the sender immediately by reply email and delete the materials and any copies from any computer. Please note that the sender of this e-mail and its attachments is solely responsible for its content if it does not concern the operations of Xellia or its subsidiaries. Thank you.
 

P Consider the environment before printing this email.
-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Vishwas Kelkar
Sent: Thursday, July 16, 2020 6:51 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] Media Fill temperature

Dear all,
I believe, General practice for Growth Promotion is as below:

1. If Media fill is done under Anaerobic condition (Nitrogen blanketing), Clostridium sporogenes (CS) is included as one of the organism. 
2. For Aerobic or An-aerobic media fill, in addition to routine organisms(SA, PA, EC, Salmonella, AB, CA,ML,BC and in-house isolates (GPR, GNR, Yeast & Mold) are also used. 
3. NMT 14 days of incubation (Either 7 days at 20-25 C followed by 7 days at 30-35 C) or 14 days at 20-35 C is a general practice. 
4. We do identify up to Species level as this is a rare occurrence and it provides additional information to identify the cause.
5. I have seen P.acne from Aseptic fill on Day-14 from FTM during sterility test. 

Thanks,
Vishwas  

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Donald English
Sent: Wednesday, July 15, 2020 10:04 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] Media Fill temperature

Dear all,

I will admit that I have been out manufacturing sterile product formulations for awhile.

I fully understand the question about incubating media fill vials at 2 temperatures.  Some things do not change in this aspect.

However, I have a question concerning this post about the test organisms used for growth promotion testing of media fills.   

Why would anyone use Cutibacterium acnes as a growth promotion test organism for a media fill? Generally, this organism is an anaerobic microorganism that is present on the skin.  I fully understand that it is possible to isolate this organism in sterility testing of a sterile product by using FTM, but it only grows in TSB that has been supplemented with defribinated sheep blood that is incubated under anaerobic conditions besides using Reinforced Clostridial Medium.  I believe that TSB is mostly used as the microbial growth medium for conducting media fills.  Is this still correct?  I assume that it is.  I can understand that it may be possible for Cutibacterium acnes to grow in sealed TSB glass ampules of a media fill. Not sure with sterile containers with a rubber stopper.

I have 2 questions for the group .  Are people using Cutibacterium acnes as a growth promotion test organism for TSB media fills?  Is it standard practice for positive media fill containers for microbial growth would be identified to the genus/species level?  I suspect that this practice has not changed over the years.   Has anyone ever isolated Cutibacterium acnes in a TSB media fill container?

Just curious.

Don

Donald J. English Microbiological Quality Consulting LLC Florham Park, New Jersey 07932

Sent from my iPhone

> On Jul 15, 2020, at 5:44 PM, Tony Cundell <[log in to unmask]> wrote:
> 
>    -
> 
>  The 2004 FDA Aseptic Processing Guidance states:
> 
>  Incubation temperature should be suitable for recovery of bioburden 
> and  environmental isolates and should at no time be outside the range 
> of 20-35  oC. Incubation temperature should be maintained within
> +2.5oC of the  target temperature.
>  -
> 
>  Incubation time should not be less than 14 days. If two temperatures 
> are  used for the incubation of the media filled units, the units 
> should be  incubated for at least 7 days at each temperature (starting 
> with the lower  temperature).
> 
>  Tony
> 
> 
>>> 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
>> ------------------
>> The PMFList is 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]
>> Steris - http://www.sterislifesciences.com/
>> Charles River Laboratories -
>> https://www2.criver.com/l/60962/2020-03-27/h6jqv6
>> Veltek Associates, Inc - http://www.sterile.com Microbiologics, Inc. 
>> - http://www.microbiologics.com BD Industrial Media - 
>> http://www.bd.com/ds/ Associates of Cape Cod, Inc. - 
>> http://www.acciusa.com/ ================================= 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 PMF or the sponsors 
>> of the list.
> 
> 
> --
> Tony Cundell, Ph. D.
> Consulting Microbiologist
> Email: [log in to unmask]
> Phone: 914 725-3947
> Cell: 914 841-0074
> 
> ------------------
> The PMFList is 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]
> 
> 
> 
> Steris - http://www.sterislifesciences.com/
> 
> Charles River Laboratories -
> https://www2.criver.com/l/60962/2020-03-27/h6jqv6
> 
> Veltek Associates, Inc - http://www.sterile.com
> 
> Microbiologics, Inc. - http://www.microbiologics.com
> 
> BD Industrial Media - http://www.bd.com/ds/
> 
> Associates of Cape Cod, Inc. - http://www.acciusa.com/
> 
> 
> =================================
> 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 PMF or the sponsors of the list.

------------------
The PMFList is 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]



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

Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

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

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

BD Industrial Media - http://www.bd.com/ds/

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


=================================
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 PMF or the sponsors of the list.

------------------
The PMFList is 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]



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

Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

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

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

BD Industrial Media - http://www.bd.com/ds/

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


=================================
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 PMF or the sponsors of the list.

------------------
The PMFList is 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]



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

Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

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

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

BD Industrial Media - http://www.bd.com/ds/

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


=================================
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 PMF or the sponsors of the list.


ATOM RSS1 RSS2