We have seen these issues in older refrigerators where the chamber control probe was in glycerol and found (as a result of the initial mapping) that the air temperature was cycling below zero and to the top of our range and assumed that the condensation from overcooling and warming on the secondary packaging led to the mold. Additionally, the chamber continuous monitoring probe was also in the glycerol solution- slower response to changes in air temperature so we were not getting alarmed when the air temp cycled outside of the range. The refrigerators were discarded.
Regards
John Langdon
Baxter Healthcare Corporation
Round Lake Drug Delivery RLD-50
25212 W. Illinois Route 120
Round Lake, IL 60073
Stability Operations
[log in to unmask]
T. 847.270.6874
F. 847.270.3870
-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Markian S. Jaworsky, Ph.D.
Sent: Monday, September 19, 2011 10:37 AM
To: [log in to unmask]
Subject: Re: [PSDGLIST] Signs of Moulds on secondary packaging materials in 5°C_chambers
In my past lives our typial practices was not to place secondarily
packaged material on stability as we were primarily interested in effect
of the primary packaging. The packaged samples were typically placed on
metal or plastic trays. So we rarely if ever had mold issues in our
chambers. (The only times that I would have envisioned having material
in seconday packaging would have been if there was a photostability
issue that couldn't be remidied with appropriate primary packaging.)
In any event the chambers were cleaned as part of the scheduled periodic
preventive maintenance/calibration/mapping procedures.
Markian S. Jaworsky, Ph.D.
Executive Director and Owner
MSJ Analytical Consulting Services, LLC
[log in to unmask]
-------- Original Message --------
Subject: [PSDGLIST] Signs of Moulds on secondary packaging materials in
5°C_chambers
From: Thomas Vater <[log in to unmask]>
Date: Sun, September 18, 2011 7:08 am
To: [log in to unmask]
Dear Stabilitarians,
During the storage at 5°C we sometimes observe signs of moulds on
secondary
packaging materials (cartons and labels), especially when not protected
(through a coat of lacquer; the printing area of our cartons is without
lacquer). Microbial identification showed spore-forming bacillus and
conidia-forming moulds. Relative humidity is very high in the chamber
(as
expected). Microbial air-monitoring showed comparable results inside and
outside the chamber.
Do you have same experiences?
What are your measures in such cases? Regularly cleaning with sporocidal
agents? Reduction of relative humidity? Storage without cartons and
labels?
Would be interested in your opinions.
Best regards
Thomas
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Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
High quality controlled environmental walk-in rooms and reach-in chambers
Full installation, validation and spare parts also available
Environmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers and
Provider of Complete Validation & Calibration Services
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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 PSDG, or the sponsors of the list.
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The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) 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.
Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
High quality controlled environmental walk-in rooms and reach-in chambers
Full installation, validation and spare parts also available
Environmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers and
Provider of Complete Validation & Calibration Services
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