Grace Hopper, renowned for her contributions to computer systems and mathematics, famously cautioned against complacency with the quote: “The most dangerous phrase in the language is, ‘We’ve always done it this way.’” This mindset of preferring to stick with the familiar at the expense of innovation can be particularly restrictive in the cosmetics industry, including Quality Control microbiology, where efficiency is essential. The traditional microbial limits test method of plating relies on laboratory techniques that date back to the 1800s. Rapid microbiological detection methods offer alternative, more efficient, and dependable ways to achieve equivalent results in a fraction of the time. Alternative methods are pivotal in transforming how Quality Control is conducted and embrace innovative change over tradition. Without considering alternative methods, cosmetics and personal care industries are at risk for missing significant gains in efficiency.
Despite innovative technologies and advancements, there is still hesitation to change Quality Control testing from traditional methods to rapid microbial methods. QC labs may be comfortable with plating, but it’s not the most effective way. Switching to rapid microbial methods can seem intimidating. There are misconceptions that the equipment is unnecessary, hard to implement, raises regulatory concerns, or is too expensive. However, the truth is that investing in new rapid microbial detection technology can improve laboratory workflow, streamline training, and provide quicker and more effective contamination remediation.
Due to its familiarity and compendial status, many laboratories consider the traditional plating method “good enough.” It requires 3 to 7 days of incubation time just to say if a test has passed or failed; could we still consider this method good enough? Alternative methods of microbial detection, instead, use different technologies to assess the presence of microorganisms other than human eye confirmation. Some use advanced camera technology, lasers, and microbial indicators that can conclude viable microbial growth orders of magnitude faster than plating methods. There are many options for rapid detection technologies and, when considering the change, it’s important to assess their compatibility with your products and the workflow of the process.
In addition to speed to results, rapid microbial detection methods have a host of additional advantages that can only be realized if you change from traditional plating methods. When you think about the process, there is no automation. Plate preparation is manual and test result decisions are based off of subjective visual colony counting to determine if the product can be released or not. Rapid microbial detection methods offer a significant advantage in automation of workflow and data production. Rapid methods require less hands-on time for the microbial Quality Control technician allowing higher throughput and less human error. The increased efficiency from rapid method automation optimizes the productivity of the microbiology lab and has a positive impact on the company and laboratory’s output.
Another misconception about rapid microbial methods is that a new method is difficult to validate and implement. You can transition from the traditional microbial limits plate testing to a rapid method through method validation. Validation is proof that a method works for your needs, is a foundation of data history, and ensures consistency for the future. The work required to change to a new detection method can be reduced by making sure you have the right rapid method vendor. Vendors that offer method validation support, on-site training, and technical resources that are positioned around the world make the change significantly easier. Some vendors offer validation protocols or testing packages specific to cosmetics, home, personal care, and over-the-counter (OTC) drug products to meet a wide variety of product formulations. Validation testing and reports should be compliant with validation parameters for alternative methods such as United States Pharmacopeia (USP) <1223> and European Pharmacopoeia (Ph. Eur.) 5.1.6. Regulatory agencies are becoming more familiar with rapid microbial methods and are accepting it as a viable replacement to the compendial plate count method with proper validation. Rapid microbial methods have been approved around the globe by regulatory agencies with proper validation.
While transitioning to a rapid method requires an initial investment, both the short and long-term benefits greatly outweigh the cost. The value can be measured in cost avoidance associated with microbial contamination events and the reduction of expenses required to keep extra inventory in stock. While laboratories can acknowledge the benefits of rapid microbial methods, it can be challenging to build a business case around the budget required to implement them. What most don’t realize, is that there is an internal investment partner at your company to collaborate with, specifically the operations department. Working with operations can allow for a joint venture where both teams can realize the value of the upgrade. The Quality Control laboratory gets tangible efficiency in their workflows and the operations group sees the value in the supply chain efficiency, agility, and predictability provided by the rapid method.
As stated above, moving to a rapid method can have significant impact in both your lab and operations. Rapid microbial methods give you automated results, increased data integrity, and in case of a contamination event, faster corrective action. When you release products faster, held inventory and additional costs are reduced – saving you time and money, which are really appreciated by stakeholders and financial teams. Why waste time and money when there is a better way to get your products to market faster. Aren’t these all good reasons to understand that it’s worth the switch?
How Can Charles River Laboratories Help You?
We’ve purposely built our portfolio to bring you progressive products and services that deliver accurate, relevant, and reliable data to fuel confident decisions on product quality and contamination control. Our unique combination of Celsis® rapid microbial detection and Accugenix® microbial identification keeps your manufacturing operations running efficiently and smoothly, lowers your cost to manufacture, and protects your reputation. Explore our portfolio of integrated services at www.criver.com/cosmetics.
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