The evolution of technology available in pharmaceutical manufacturing has progressed over the years. Specifically, advancements in automation within quality control (QC) laboratories have played a major role in improving the microbial testing process.
With the traditional testing method, QC labs are forced to perform time consuming tasks, including manual incubation transfers and interim counts. During this time, events like product quarantines, delayed production and/or waiting for certain components to pass inspection can potentially have hefty financial costs.
However, with equipment that utilizes automated rapid microbial methods (RMM), value in various areas of a QC lab can be realized, many of which overlap or influence one another.
You’ve probably heard of some obvious benefits of automation, including fewer incubation transfer errors, integration with LIMS and rapid results. But there are several more benefits of automation that aren’t as obvious, including:
Fewer OOS Investigations
Out-of-specification (OOS) investigations can be costly. Furthermore, investigations can delay product releases, which can result in even more profit lost. Investigations caused as a result of a manual error can quickly become detrimental to a manufacturer’s bottom line and product quality.
Automation can help QC labs improve processes and efficiency. With automated RMM, microbiologists don’t have to conduct as many manual steps—ultimately reducing the possibility of errors and OOS investigations. Automation allows QC labs to quickly isolate and resolve problem areas, which means they don’t have to potentially delay manufacturing lines for days or even weeks in order to identify problems and implement solutions.
Furthermore, automation allows microbiologists to streamline their reporting process, making it easier to analyze trends. Being able to track colony counts over time can help the Quality organization implement improvement processes.
More Targeted Interventions
Whether a QC lab is using automated testing equipment, such as the Growth DirectTM System or the compendial testing method, when an out of specification sample is uncovered, microbiologists must be prepared to take action—quickly. With automation, QC labs are made aware of the sample of interest sooner than they would using the compendial method, which better enables them to drive resources to address the issue faster. In addition, a non-destructive test preserves the growing colony, reducing the time to identification.
More Efficient Lab Resources
When using the manual method, highly educated and trained microbiologists spend countless hours conducting tasks such as incubation transfers, colony counts, data entry and other repetitive activities. With automated RMM equipment such as the Growth DirectTM System, microbiologists only need to prepare samples using their current preparation techniques and load them into the system—the rest of the process is completed automatically.
By automating these tasks, the lab can focus on other activities that add value to the pharmaceutical manufacturer. Also, when the microbiology test is completed more rapidly, finished products could be released and shipped sooner.
Overall, automation can bring value to QC labs in a variety of ways—from improved process efficiencies to increased lab productivity. To discover more benefits of automation in the QC lab, check out this quick guide.