Real-time microbial detection enables you to do real process control in your water system, whether it is (U) PW or (Hot) WFI.
In 1887, Dr. Koch and Dr. Petri developed a way to efficiently monitor bacterial growth. Hence the name “Petri dish” for those characteristic lab dishes. Despite its limitations, this method of microbial detection is still used in the pharmaceutical industry. The technique is simple, but you have to admit that the results are rather questionable.
In addition, you should know that a sample is always a snapshot, you have to wait a long time for results and the results are unable to offer you any certainty. This is why the regulators, the international pharmacopoeias, are directing us to apply new methods in addition to the conventional test methods that ensure that your pharmaceutical water always meets the bioburden standard. Below are some examples:
EMA: GMP Annex 1 Q&A on production of water for injections
- "Use of alternative/rapid microbiological test methods should be employed as part of the overall control strategy for the system."
- "Use of rapid microbiological methods should be considered as part of the control strategy to aid with rapid responses to deterioration of the system."
USP: Chapter <1223>
- "Studies on the recovery of microorganisms from potable and environmental waters have demonstrated that traditional plate-count methods reporting cell count estimates as colony forming units (cfu) may recover 0.1-1% of the actual microbial cells present in a sample."
- "If the growth, nutritional, or incubation conditions presented to microorganisms are not sufficient to result in recovery and the growth of colonies, the signal may be 0 cfu, or no growth, even when viable cells are present."
The pharmaceutical industry estimates that more than 80% of the positive results are actually false positives caused by human error. Online and real-time microbial control enables you to avoid these false positives as well as false negative results. This method provides reliable results, which lead to a better understanding of the process, risk reduction and lower operational costs. In addition, real-time data is the tool for quickly intervening in case of microbial contamination in the water circuit.
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