If it isn’t broken, doesn’t mean you shouldn’t make a change

Published: 13-Apr-2023

Despite innovative technologies and strategies, misconceptions persist about microbiological testing using rapid methods

Switching from a compendial plate count method to a rapid microbiological method (RMM) can seem scary and is perceived as time consuming, unnecessary, hard to implement, or costly. The hesitancy surrounding the use of RMMs for quality control testing has persisted for decades.

Some of the most renowned home and personal care product manufacturing companies have implemented a rapid method for product release testing with success. Regulatory agencies are familiar with rapid methods and see them as a viable replacement to the compendial plate count method with proper validation. So, why are microbiologists and quality control laboratories still having doubts? One of the big questions for microbiologists is “Are RMMs approved by regulatory authorities?”. The answer is yes, and they have been for years. The issue is that agencies don’t necessarily promote these ideas and innovations, especially if the method is not compendial. Aside from the standardised reports that are published, it’s not like they have big flashing lights on billboards that say, “You Should Probably Be Using an RMM By Now”. This, unfortunately, leads many to believe that automated testing is not being widely utilised or validated by agencies.

Another common trend we see is the “If it isn’t broken, don’t fix it” mentality in the industry. Compendial methods relying on visual and subjective confirmation of microbial contamination continue to be used because they have been considered tried and true. The compendial method is referenced in the US Pharmacopeia chapter <1223> as, “The actual limits of detection of compendial microbiological methods have never been established quantitatively, and it is understood that many variables can affect the recovery of microorganisms.” Compendial plate count is a method that microbiologists know have gaps and over the years deficiencies have begun to emerge. Shortcomings have stemmed from the subjective count with increased potential for human error, whether in the detection of contamination or in the reporting.

There are perceptions that RMMs can be difficult to validate or implement. This is not the case, especially when you choose the right vendor partner. It’s important to choose the right RMM as well as the right vendor partner who can supply robust validation protocols and data to support method suitability and equivalence when needed. Your vendor should have an implementation plan prepared for you to include installation and training. Once installed and validated, the vendor should continue to aid with ongoing technical support and additional training to provide guidance on the right validation strategy for your product portfolio.

The perceived risk of switching methods has obscured the benefits of change. Rapid methods have significant advantages over the subjective and time consuming compendial methods. RMMs reduce your time to response to a contamination event and give you a quicker time to recovery, all while reducing overall operational costs compared to the compendial method. If a company doesn’t know about the time, money, and resources they could be saving, then they won’t understand the benefits of implementing an RMM in the first place.

RMMs can play a huge role in your overall operations not just in the labs. Many companies feel as though they have streamlined production as much as possible, but one area that is frequently overlooked is microbiological testing. Even if you’re managing an efficient operation, most companies today have room for improvement. As new equipment and processes are added to the manufacturing line, a new approach to microbial contamination testing should be adopted in the lab. Think of it as an efficiency domino effect – RMMs deliver quick, definitive answers on whether your product is free from microbial contaminations. This actionable information allows you to make quick decisions and enables you to streamline manufacturing of products more quickly and get to the market faster.

Compendial methods have been around since the 1800s and that makes labs feel very comfortable using this method. A company would not even consider using a production line from the 1800s so why continue it in the lab? With the emergence of rapid technologies, it is time to consider an alternative to compendial plate count methods. How many days are your productions samples waiting in quarantine until you receive actionable microbial test results? This will vary, usually 3-5 days for home and personal care products, however a rapid method can give you a result in just 24 hours. You can also apply rapid methods to microbial testing of raw materials, which can reduce your production cycle time even more. Each compendial test micro hold will add days to your production cycle, but if using a rapid method, it does not have to be this way.

In the event of microbial contamination, companies can’t afford to wait 3-5 days for results before decisions can be made. Equally important is the early detection of a microbial contamination in addition to faster product release. Earlier detection helps to minimise the amount of product affected, accelerate corrective action, and get the facility back on track quickly. By identifying a microbial contamination event earlier, and releasing replacement lots faster, manufacturers can reduce the volume of goods that must be scrapped or recalled and can recover faster – both operationally and financially. This minimises the risk of supply chain interruptions, or worse, the risk of recalling product from the market.

Choosing the Right Rapid Method

A rapid method can improve your operational efficiencies, but you want to be sure you have a clear strategy and understanding of your needs before implementing an RMM like making sure the RMM technology matches your requirements. Different rapid methods have different capabilities. To prevent the need for labs to invest in multiple rapid methods, it’s important to ensure that the chosen method has good compatibility with the home and personal care products in your portfolio. The best RMM for your company should be able to test a wide range of products such as shampoos, lotions and creams, wipes, toothpaste, cosmetics, soaps and scrubs, gels and mousse, household cleaners, deodorant, and more. Your company will benefit from using a standardised platform replacing the compendial method with a single, harmonised testing device with unmatched sample compatibility allowing you to test a wide range of sample matrices, including varying viscosities and pH levels. Choosing the right rapid method requires the need to consider the range of potential uses including raw materials, product bulk, and finished goods testing, that can all be analysed on one system.

Realising the Value

Another misconception is that RMMs do not provide a return on investment. However, the speed to release and costs savings will greatly outweigh the initial cost to change. While the introduction of modern technology into the microbiology lab requires an investment into instrumentation and training, the initial costs are minimal in comparison to the savings and efficiencies that can be realized by the lab and supply chain operations. It makes sense that there’s value in reducing production cycle times and inventories and responding to out-of-specification results faster. That value can be measured in cost avoidance associated with microbial contamination events, and the reduction of working capital requirements necessary to fund inventories.

Those who do not understand the value that a rapid system can bring to your company may be reluctant to take the lead on internal, multi-department conversations. The financial benefits must be made clear to all internal partners and leadership. Compliant, rigorous rapid detection matters to Finance and Operations; it reduces cycle times by eliminating days of waiting time, resulting in a more streamlined, cost-effective, and responsive manufacturing facility. When you can explain to your quality control and/or operations leaders how micro testing wait times impact the bottom line, they will come to understand that making the switch to a rapid method is long overdue.

Compendial methods go against everything rapid methods stand for – they are subjective, slow, often lead to delays, and can grind your manufacturing/product release to a halt. Why take the chance on being trapped in the past when you can adapt to the way of the future to boost not just your lab, but your organization as a whole. If you needed a sign to implement an RMM into your manufacturing processes, this is a great indicator to begin moving forward. While compendial methods may not be broken, it’s about time to fix them.

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 brand reputation.

Explore our portfolio of integrated services at criver.com/personal-care-and-cosmetics.

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