In the U.S., the use of bacterial plate counting methods for water system analysis goes all the way back to a reference guide first published in 1905.
Now, 23 editions and 117 years later, manufacturers are still using similar methods to monitor the microbial health of pharma water systems, despite known inefficiencies. In fact, a recent industry survey conducted by Pharma Manufacturing and Mettler Toledo survey found that 43% of plants still rely solely on this method — using only grab samples for microbial testing of high purity waters, such as Purified Water or Water for Injection.
But our survey also revealed the true cost of sticking with antiquated methods: While the pricetag on real-time monitoring technology can be a major barrier to adoption, users who continue to only use the plate count method in their microbial monitoring process generally have more contamination investigations, higher false-positive rates and greater costs associated with extra sanitizations.
