Hello,
Brief History:
In 1999-2000, our company completed the year-long qualification/ validation of
the Purified Water System. No major issues occurred for a period of
1.5 years. Since then, we were confronted with micro contamination
issues and responded by improving sampling techniques and increasing
ozone sanitization from monthly to every other week with chemical
sanitization every 6 months.
For the most part,the system is now under control with an occasional
Pseudomonas count (>1cfu/100 ml but < 20cfu/100 ml) in random sample
or use port.
After in-depth investigation, we have concluded that several external
factors were responsible for the original counts and steps have been
taken to bring the system under control and prevent further
occurrences.
My question is this: does one incident of Pseudomonas invalidate
previous qualification and validation performed?
We started daily monitoring of all ports during summer season to
further support our system was under control again. All samples were
within spec up until 2nd to last day of increased monitoring (30 day
period). One port of the 10 checked daily had 1 cfu/100 ml of
Pseudo. (no TAPC).
Our spec is <100 cfu/ml TAPC & <100 cfu/100 ml Pseudomonas for all
use ports. Is this too strict for a cold water system like ours?
Please advise...
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Ivonne Parikh
Ivonne_parikh@colpal.com
Colgate
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