A recent article in the Wall Street Journal discusses the move by some pharmaceutical manufacturers away from traditional, batch manufacturing to a more continuous process with the goal of increasing output and reducing the risk of quality failures.
The article notes that the pharmaceutical industry has, “used cutting edge science to discover medicines but…manufactured them using techniques dating back to the steam engine.”
The new types of processes being employed by some companies in the pharma industry include the use of a, “continuously running process” much like those adopted in other industries. One of the benefits noted is that, “quality can be checked without interrupting production – with weeks shaved off production times and operating expenses cut by as much as 50%.”
Much like their manufacturing counterparts, microbial quality control struggles with the same challenges – old processes and low efficiency. With the advent of new technologies in production and the confidence that the FDA, “will support the moves”, this sort of paradigm shift creates an opportunity to upgrade the processes in microbial quality control.
With automated, rapid, non-destructive detection and enumeration, positive results can be available in hours, with final results in about half the time of traditional tests. In a continuous processing environment the ability to determine the existence of contamination earlier can significantly reduce the amount of product impacted. In addition automated methods in the lab, much like in production, can save time and resources while increasing efficiency.
The construction of a new facility or addition of a new production line creates a perfect opportunity to upgrade QC testing as part of the validation process.
As the article mentions, “The (facility) upgrades should substantially reduce the risk of quality product failures, because companies will be able to make any needed corrections throughout production, not just after batch is finished.” Automated microbial detection and enumeration can help.