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Pharma Tech Outlook | Tuesday, November 24, 2020
The QC labs are using automation so that they can improve the microbial testing processes.
FREMONT, CA: The development of technology in pharmaceutical manufacturing has advanced over the years. Mainly, the automation within the quality control (QC) laboratories has played an essential role in enhancing the microbial testing procedure.
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In the traditional testing procedure, the QC labs are forced to conduct time-consuming tasks consisting of manual incubation transfers and interim counts. During such time, practices like product quarantines, delayed production, or waiting for specific components to pass inspection can lead to massive financial costs.
With the help of equipment that uses automated rapid microbial methods (RMM), the value in several areas of a QC lab can be understood, as most of them overlap or influence one another.
There are many advantages of automation, including reduced incubation transfer errors, rapid results, and integration with LIMS. But many other benefits of automation are not obvious.
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Fewer OOS Investigations
Out-of-specification (OOS) investigations can be expensive. Product release can get delayed due to investigations that can lead to more profit lost. The investigations due to manual error can quickly become damaging to the manufacturer’s reputation and product quality.
Automation can assist the QC labs in enhancing the procedures and efficiency. With the help of automated RMM, microbiologists do not have to conduct various manual steps, decreasing the chances of errors and OOS investigations. Automation even permits the QC labs to isolate and solve the problem areas quickly. It means they do not have to delay the manufacturing lines for days or weeks to detect the problems and implement solutions. Automation also allows microbiologists to streamline their reporting procedure, due to which it becomes easier to analyze. Tracking the colony counts will also help the quality organization to apply enhancement procedures.
More Targeted Interventions
Whether the QC lab utilizes automated testing equipment or the compendial testing procedure, when an out of specification sample is discovered, the microbiologists must be ready to act rapidly. With the help of automation, the QC labs can be made aware of the sample of interest sooner than possible with the compendial process. The method helps them to drive resources to address the problem faster. A non-destructive test stores the increasing colony by decreasing the time to the identification.
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