The Economics of Rapid Microbial Testing

A New Best Practice for Manufacturers Whose Profitability Depends on Cycle Speed and Supply Chain Efficiency

For years now, we’ve all been seeing the world of work through cost-cutting lenses, trimming departmental expenditures no matter how incremental. This has created an automatic reflex against anything that costs money: We “just say no.” But what if it were possible to increase your budget and increase your value to the company at the same time?

If you have any influence in or over a microbial testing lab, you may have an opportunity to help your company become more profitable by effectively streamlining the manufacturing process. But there’s a catch: Your department will need to spend a little more in order to do so. However, engaging management in a conversation about the financial benefits of rapid microbial methods (RMMs) might make getting the support and funding you need easier.

About RMMs

Briefly, RMMs provide a faster alternative to the traditional and time-consuming method of culturing samples to see if microorganisms are present. It generally takes from three to five days, using specific agar-based media, for organisms to grow to levels that may be detected as colonyforming units visible to the naked eye. During this time, the individual agar plates must be examined regularly by an experienced lab worker, making the results both subjective and prone to human error. Meanwhile, manufacturing is pressuring the Quality department to release products from their microbial testing hold.

Instead, products can be incubated, tested and released in as few as 24 hours using rapid methods. RMMs can provide fast, objective results with instruments that automatically read results, drastically reducing subjectivity and the risk of human error. They often make microbial testing labs more efficient, and can require less time, materials and expertise to operate. Unlike the routine agar plate examinations of traditional methods, RMM systems usually include some automation. They can be user-friendly, and some can be operated by the least-experienced lab technician. Plus, these systems use fewer testing materials and generate less waste, so they support company sustainability initiatives.

RMMs represent a new best practice for manufacturers whose profitability can turn on cycle time speed and supply chain efficiency. For example, by identifying a contamination event earlier and releasing replacement lots faster, manufacturers can reduce the volume of goods that must be scrapped or, worse yet, recalled, and can recover faster—both operationally and financially.

Starting the conversation

While as a lab manager you approach RMMs from a scientific standpoint, your finance and operations managers approach them from an economic point of view. So the more information you can present in financial terms, the more receptive they will be to the conversation— because it’s all about the value.

Here are three examples of effective conversation starters:

“I may have a way to cut several days out of our product release time. Would you be interested in learning more?”

“Who can I work with to quantify the value of reducing our inventories and shortening the production cycle?”

“What did our last contamination event cost us overall? I know a way we can significantly reduce those expenses the next time it happens.”

Rapid detection reduces cycle times by several or more days, which reduces the amount of working capital the company has tied up in finished goods inventory and safety stock. RMMs free up warehouse space, shorten lead times and reduce the cost (and time) of recovery from contamination events. So while your department will pay more per test to use a rapid system, your company will save far more with each rapid screening your lab runs. The overall result is a more streamlined, costeffective and responsive manufacturing facility.

Choose the RMM with ROI

The four key criteria in selecting the right RMM share a common trait: a strong correlation to financial results. Without a strong value proposition, you simply won’t get the support of your finance and operations management.

The first consideration is selecting a system that gives you actionable information. In a typical controlled manufacturing facility, products pass the final microbial limits (MLTs) or sterility tests more than 99 percent of the time. A rapid test that provides a positive or negative result quickly is therefore ideal for the vast majority of your production. The less than one percent of product that tests positive in an initial screen can undergo further evaluation against your release criteria. By managing the exceptions, 99 percent of your production run is being released two to four days faster for MLTs—and even more for sterility testing—safely and cost-effectively. The second criterion is to choose a rapid method that is compatible with all products that your lab currently tests. The full economic benefits of RMMs cannot be realized if the rapid method cannot be applied to the vast majority of products. Look at the method’s sample preparation, for example. One that does not require filtration means the application will not be limited to your filterable products only.

Flexible sample preparation also allows for the effective neutralization of preservative systems or buffering of pH levels. You should not lose the flexibility that you have with traditional methods to make standard product accommodations. Further, the detection system itself should not be subject to interference by particulate matter or product pigmentation. A good choice is a system that will allow you to assay the majority, if not all, of your products. You will benefit from testing standardization and training, as well as from maximizing the financial benefits to your company through a broader application of RMMs.

Third, consider the resource efficiency of the RMM. This applies to both the system throughput—how efficient it is at screening samples—and how much staff time is freed up for other activities. Some RMMs may require multiple extra steps to prepare samples, additional labor to deal with system complexity, or multiple systems and additional lab space to handle throughput requirements. The economic benefits of “rapid” may be negated if it takes an unreasonable amount of your resources just to process the majority of samples with a rapid method. Look for a method that’s easy to use with familiar sample preparation, and a system that will minimize the potential for operator error or subjective readings. Systems that can be used by any trained employee, as opposed to only those with advanced degrees, are available and will offer more staffing flexibility.

Laboratory space is another major cost to consider. Some rapid methods, including the instrument itself and additional sample prep needed, require quite a bit of lab space, and some may require additional modules to accommodate your testing volume. So look for a system with a small footprint that can easily integrate into your existing bench space and can readily handle your throughout requirements. A plus for the environment is a system that can also reduce the amount of waste generated by the lab.

Finally, when choosing an RMM, it’s important to look beyond the instrument to the entire system, including service and support. Choosing the right RMM also means selecting a supplier with appropriate scientific, technical and regulatory support. Without this, it is difficult to obtain maximum value from your investment, because you won’t have the benefit of the accumulated experience from getting hundreds of systems up and running and many thousands of products validated. Ask what teams are available to you and where they are located. Will you have quick access to experts? You don’t want to incur costs for international flights to have someone look at your system. Finding a good team to work with will ensure a smooth implementation and a streamlined product release cycle that enables you to realize the benefits of the rapid detection technology. Some companies include a three-day on-site installation and operations qualification, and will get your team started with the validation work as part of the training. This ensures that you’ll be able to see a fast return on investment (ROI).

Get the financials for finance

Ask RMM providers about their resources to help your company project the ROI for your facility. A financial model that incorporates company-specific information will give you an accurate look at the economic value of the solution. Rapid screening systems, because they allow you to release the bulk of your products quickly, will offer strong ROI with a payback period averaging six to nine months. These systems typically free up working capital in amounts greater than $500,000 in net present value. And even if you’re not quite sure what that means, your finance department will know—and they’ll like it!

Rapid methods are also available as an outsourced service from an analytical services laboratory. Contract labs experienced in rapid methods can provide cGMP validation services and full turnkey testing. Although you will have to build in extra time to get the samples to the lab, you may still find it economically beneficial to outsource your testing to an accredited lab offering RMMs.

The key is to remember that this is not about asking for a budget increase for the microbial testing lab: It is about helping your company find new ways to save. This time, however, instead of cutting costs, you’re adding value to the bottom line. And that will let management see you, and the lab, in a different light.

About Celsis

Celsis Rapid Detection provides rapid microbial systems for detecting contamination in consumer-bound pharmaceuticals, home and personal care products, and beverages. For more information, visit www.celsis.com.