Pharmaceutical manufacturers have, like many industries, adopted lean manufacturing practices on their production lines. Unfortunately, other parts of the manufacturing process, such as microbial quality control, are just beginning to streamline their activities. Most microbial quality control labs are still using the century-old manual method for testing. While considered the “gold standard”, the traditional method is time consuming and prone to problems leading to unnecessary out-of-specification (OOS) investigations.
New technologies and innovative business practices have allowed labs to rethink their operations with an eye towards streamlining processes and gaining efficiencies. This can include the adoption of lean practices, and also the use of automation where available. Automated rapid microbial method (RMM) technologies, such as The Growth DirectTM System automate and accelerate the traditional method, reducing resource costs while providing faster results. Here are five signs your micro QC lab needs to consider replacing the compendial method with an RMM system.
1. Increasing Test Volumes
Increases in manufacturing typically mean increases in testing for the micro QC lab. With traditional testing, this can lead to resource constraints for the microbiology team. With automated RMM systems, however, incubation, enumeration and reporting are performed without human intervention. The technology is able to scale with the increases in testing, eliminating any resource issues.
2. Increased Resource Requirements
With the traditional testing method, increases in testing volume will likely drive the QC lab to bring on additional resources. Bringing new resources up to speed will inevitably require extra time and effort from more experienced staff to help with training, etc. With the automated capabilities of the Growth DirectTM System, the micro QC lab can respond to the increased test volumes using current resources, and often free microbiologists to perform higher value activities.
3. Long Travel Times from Sample Area to Lab
In the campus environment, the QC lab is often located in a separate building on the campus from the production areas. The sampling process becomes longer with the need to travel to and from the lab. Automated rapid methods do not need to be located in the lab, but can be located closer to the production area, significantly reducing the travel time.
4. High Number of Investigations
Because of the manual nature of the traditional culture method, unexpected problems can occur that lead to unnecessary out of specification investigations. These problems can be as simple as a transfer error during serial incubation or a keying error of final results into a laboratory information management (LIMs) system. Overall, most micro QC labs can realize increases in accuracy and streamlined operations by switching to an automated RMM system.
5. Long Time to Results
Finally, one of the major issues with the traditional test method is the time required to reach a final result. Manufacturers must either wait for results before releasing product for shipment or ship product “at risk”. In this competitive landscape, companies can't afford to miss out on the advantages of faster shipping times, greater labor efficiency and the same level of quality. An automated, rapid method like the Growth Direct SystemTM provides results in about half the time, with interim results available in hours.
To learn more about The Growth DirectTM System's ability to cut microbial testing times in half, download our free guide on the benefits of RMM technologies today.