eBook: TOC and Microbial Detection Monitoring - 30

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Hot Water For Injection
Biofilm, Endotoxins and Their Relationship
The mechanism of sanitization and
the development and existence
of bioburden in pharmaceutical
water systems is often misunderstood. Microorganisms, especially
in water and water systems, are
always present and have the ability to adapt to their environment.
While the industry makes every
effort to control and eliminate
bioburden, traditional sanitization
methods are not one-hundredpercent effective at accomplishing
this objective. The discussion
below looks at the effectivity of Hot
Water For Injection (WFI) systems
and the relationship between the
continued existence of bioburden
and the detectability of endotoxins
even with no growth of microbial
colonies.
Microbial test methods
For decades, the pharmaceutical industry has been
searching for Rapid Microbial Methods, and in recent
years several new rapid tests have been introduced
for sterility, air and pharmaceutical water.
Adoption of new Rapid Microbial Methods in the pharmaceutical industry requires not only the acceptance
of the tests, but an understanding that the new tests
provide real-time data for improved process control.

The current test method to determine the presence
of microorganisms in water requires incubation of
a sample for 5 or more days. This test underreports the presence of viable organisms and may,
as stated in USP <1223>, recover only 0.1% to
1.0% of actual viable microbial cells present in a
sample. Another challenge with traditional testing
is the myth or belief that a Hot WFI system does
not contain any biofilm.

eBook: TOC and Microbial Detection Monitoring

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