72 MANUFACTURE
Rapid microbial methods for a financial boost
Minu Youngkin – Charles River Laboratories
Personal care companies that use traditional quality control microbiological methods, also known as compendial or pour plate methods, spend more time testing their products than it takes to make them. It does not need to be that way. The best
managed companies have brought rapid testing technology into their microbiology labs to facilitate significant reductions in both production cycle times and work-in-process inventory. Additionally, when a possible microbial
contamination is detected, the increased agility gained from a rapid approach allows for an expedited, cost-effective response. While rapid micro methods cost more per test than traditional microbiological methods, the broad and sustainable benefits of faster results with superior quality enable cost savings and avoidances across multiple departments and can revolutionize your production operation now and for the future. Traditional microbiological methods are the
bottleneck to finished goods released to market. When a production run is complete, samples must be obtained from the manufacturing line and delivered to quality control labs for analytical chemistry, sensorial, and microbiology testing. While many analytical chemistry and
sensorial tests take only hours to complete, traditional microbiological methods take as long as three to five days, which can delay product disposition decisions required to release product to the market. Rapid microbial methods resolve this waiting period. By implementing a rapid microbial testing
system, that waiting period can be as short as 24 hours. Beyond the immediate-term benefits to disposition decisions, these methods enable rapid responses to potential contamination events, and improved inventory management. Rapid methods also provide long-term benefits, including lower inventory levels, which translates to reduced warehousing requirements with your current production volumes, as well as in the future as your business grows.
Modern rapid microbial methods Modern rapid microbial methods extend efficiencies beyond the micro testing lab and into production processes. For all the attention that has been given to operational efficiency for personal care manufacturing, the benefits of rapid micro methods are frequently overlooked,
PERSONAL CARE June 2023
and arguably represent the single largest opportunity for efficiency improvements in the industry today because it is possible to cut days off the production cycle time. Unlike the routine agar plate examinations
of traditional methods, rapid microbial testing systems usually include some degree of automation. They can be user-friendly, and some can be operated by the least experienced laboratory technician in the lab. More importantly, automation can improve
accuracy and consistency by providing instrument-based objectivity to results – the instrumentation determines and records the results, as opposed to the lab technician performing colony counting tasks and manually recording it. These objective and streamlined results improve your data integrity by eliminating the individual subjectivity of your testing and reporting. A rapid microbial method is only as good as
the reagents that power it. The rapid method requires more than just the instrument located in the lab; they require quality chemical reagents. Utilizing reagent kits that are compatible with a wide range of products can help replace multiple individual testing systems with a single, harmonized platform. A stable supply of reagents and consumables
from the vendor ensures that lab testing and operations remain seamless. A strong
supporting vendor is also a partner, which is necessary to ensure that your company maximizes its return on investment both now and in the future.
The need for speed Product release management systems and processes can vary in their design, speed, and agility. There are two general classes of release systems – positive release and controlled release. Regardless of the system used, there is always a high level of risk associated with any microbial contamination event if it is not detected quickly. Beyond these risks, additional challenges and costs that arise can vary between the two release systems. If a manufacturing plant is operating under
a positive release system, the production run must be held in quarantine until testing is complete, and even longer if a potential microbial contaminant is detected. With this product release system, it can be perceived that speed does not matter because product is always held in quarantine while awaiting microbial test results. However, it does matter because the longer
inventory is held in quarantine, the larger the negative impact on your free cash flow productivity. Faster microbial results can greatly accelerate product release in this scenario, driving multiple bottom-line contributions. If a manufacturing plant is operating
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