Food and Pharma Manufacturing
In the pharmaceutical industry, the cost of a microbial outbreak in a production facility can be in the hundreds of thousands of dollars when considering production delays, product costs, and remediation costs. In food manufacturing, an outbreak-causing contamination can be even more expensive.
Pharmaceutical and food manufacturing facilities are required to perform periodic environmental monitoring (testing surfaces, water, air, in-process and finished products) for microbial contamination. Given that, in most cases, drugs are designed for diseased people and food manufacturing represents the ideal growth environment for many opportunistic or pathogenic microorganisms;microbial testing is globally required under Good Manufacturing Processes (GPM) for drugs manufacturing, and under Hazard Analysis Critical Control Point (HACCP) regulation for food manufacturing and processing.
The requirements for water used in manufacturing are that the total microbial load is under 100 CFU/ml and no objectionable microorganisms are detected- which are the same requirements in the healthcare list for pharmaceutical manufacturing, and much longer for food manufacturing.
Currently, pharmaceutical and food manufacturing testing is performed internally by companies’ own microbiology labs; few outsource this function to external labs due to its potential legal implications. Current testing, as described in US and EU Pharmacopeia, requires 2 to 5 days to produce results; time in which food loses its shelf life and drugs are stuck in processing operations (cannot be shipped). Given the move toward just-in-time manufacturing, this delay is a significant impediment to production scheduling. Furthermore, if a batch of product is contaminated, it requires a lengthy investigation and root cause analysis, and the product ends up being disposed of.
In the pharmaceutical industry, the cost of a microbial outbreak in a production facility can be in the hundreds of thousands of dollars when considering production delays, product costs, and remediation costs. In food manufacturing, an outbreak-causing contamination can be even more expensive. There is a significant push in the industry for real-time microbial monitoring, similar to what is done in terms of chemical composition monitoring. ExactBlue’s offerings will be part of the solution.