April 2015


Options: Use Proportional 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
Steve Parker <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Wed, 22 Apr 2015 14:11:26 +0000
text/plain (53 lines)
I am interested in obtaining feedback on the common practices followed by industry for stability chamber excursions. I am looking at the non-sterile industry specifically.

1)      What is the typical response for a temperature and/or humidity excursion <24 hours in duration?

a.       For > 24 hours?

2)      What is the response for temperature excursions that are  5 C of the set point?

a.       For  10 C?

b.      For both conditions above, when <, > 24 hours in duration?

3)      What is the response for humidity excursions that are  5% of the set point?

a.       For  10%?

b.      For both conditions above, when <, > 24 hours in duration?

4)      What are the criteria used to determine that a study is to be extended as a result of an excursion; e.g., the CRT chamber has an humidity excursion for 1 day, the contents are at various time points of their studies, and the studies are for 36 months; is there a general rule of thumb for how much time is added to each study, dependent upon the sample's current time point?

a.       What if the above is an accelerated chamber where the total study time is for 6 months?

5)      When there is an excursion ( either temperature and/or humidity) that is < 24 hours in duration, then 2 days later there is another excursion which is < 24 hours in duration, are these treated as independent occurrences or does one take the cumulative time of the excursion to determine the appropriate response?

a.       What if the excursions are 1 week apart?

b.      If the cumulative time is used in the determination and is 24 hours or greater, what is the response?

c.       If the individual excursions are 24 hours or greater, what would the response be, given the situation(s) above?
Thanks for your responses in advance.

Stephen W. Parker

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.

The PSDGList ( is operated from The Microbiology Network ( 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.

BahnsonEnvironmental Specialties -
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Stability Environments, Inc., an affiliate of Solar Light Company, Inc. -
   High quality controlled environmental walk-in rooms and reach-in chambers
   Full installation, validation and spare parts also available

Hardy Diagnostics -
    Provides a complete selection of laboratory and microbiology supplies
    for the clinical, industrial, and molecular biology research communities.