Lynn,
Bioburden testing can be important depending on what your product is. I
use a combination of water activity and bioburden in my STB program
since my end product is protein/antigens. My rational is that water
activity can impact protein stability due to aggregation and
conformational changes that can take place above critical water activity
levels. Plus many environmental factors influence microbial growth but
the availability of water for biological process is probably the most
important because microorganisms have a limiting water activity level
below which they cannot maintain viability or proliferate.
Hope that gives you some help.
Kind regards,
Pam Cobb
Stability Coordinator
ALK
T 208 777 3365
M 509 279 5202
F 208 777 3436
E [log in to unmask]
-----Original Message-----
From: Pharmaceutical Stability Discussion Group
[mailto:[log in to unmask]] On Behalf Of Lynn Olstadt
Sent: Friday, February 25, 2011 2:51 PM
To: [log in to unmask]
Subject: [PSDGLIST] Yeast and Mold Testing
Is Yeast and Mold testing appropriate for stability studies? Why or Why
Not?
Thank you,
Lynn
SPL Scientific Protein Laboratories LLC
Lynn Olstadt
Supervisor, Quality Control
608.849.5944 x1671
[log in to unmask]<mailto:[log in to unmask]>
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Full installation, validation and spare parts also available
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Manufacturer of Quality Stability Chambers and
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