Speculate to accumulate
17 Jan 2012 by Evoluted New Media
Rapid microbial methods can save a laboratory time and money – but incorporating them can be a battle with management. Here is our guide to getting the money men to recognise the importance of your lab practices
For years now, we have all been seeing the world of work through cost-cutting lenses, trimming departmental expenditures no matter how incremental. It has crea ted 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 the microbiology laboratory, you have an opportunity to literally save your company millions. That is in addition to the millions you already save the company every year by ensuring product quality. The microbiology laboratory can effectively streamline the manufacturing process and make your company more profitable. However there is a catch: your department will need to spend a little more in order to do so. Yet it is easy to get the support and budget you need if you engage your manufacturing and finance colleagues in a conversation about the financial benefits of rapid microbial methods (RMMs).
[caption id="attachment_26163" align="alignright" width="300" caption="Figure 1: Contamination Recovery. Faster results from testing also improves recovery time. When there is a contamination event, the benefits of using a rapid method are doubled."]
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Rapid microbiological methods are a faster alternative to the traditional, time consuming method of culturing samples to see if microorganisms are present. It generally takes from 3-5 days, using specific agar-based media, for organisms to grow to levels that may be detected as colony-forming units visible to the naked eye. During this time the individual agar plates must be examined regularly by an experienced laboratory worker, making the results both subjective and prone to human error. Meanwhile, manufacturing is pressuring quality to release products from micro-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 microbiology laboratories 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 even the least experienced laboratory technician. In addition, they 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, you can reduce the volume of goods that must be scrapped or, worse yet, recalled, and recover faster – both operationally and financially.
[caption id="attachment_26164" align="alignleft" width="300" caption="Figure 2: Actionable Information. For products that are expected to be clean, an absence/presence test provides actionable information to get your products out the door faster."]
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While as a laboratory manager you approach RMMs from a scientific standpoint, your finance and operations people will approach them from an economic perspective. So the more information you can present in financial terms, the more receptive they will be to the conversation.
Rapid detection will matter to your finance and operations leadership. It reduces cycle times by several days or more, 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 laboratory runs. The overall result is a high quality, more streamlined, cost-effective and responsive manufacturing facility, thanks to the microbiology laboratory.
The four key criteria in selecting the right rapid method share a common trait: a strong correlation to financial results. Without a strong value proposition, you simply will not have the support of your finance and operations executives.
The first consideration is selecting a system that gives you actionable information. In a typical, controlled manufacturing facility, products pass the final microbial limits (MLT) or sterility test more than 99% 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-1% of product that tests positive in an initial screen can undergo further evaluation against your release criteria. By managing the exceptions, 99% of your production run is being released 2-4 days faster for MLT, and even more for sterility testing, safely and cost effectively.
[caption id="attachment_26165" align="alignright" width="300" caption="Figure 3: Return on Investment graph. Financial models can be used to accurately project the business value to your company of implementing rapid methods."]
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The second criterion is to choose a rapid method that is compatible with all products that you currently test. The full economic benefits of RMMs cannot be realised if the rapid method cannot be applied to the vast majority of your 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 neutralisation 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 standardisation and training, as well as from maximising the financial benefits to your company through a broader application of rapid methods.
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 labour to deal with system complexity, or multiple systems and additional laboratory 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 is easy to use with familiar sample preparation and a system that will minimise 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 preparation needed, require quite a bit of laboratory 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 laboratory.
Finally, when choosing an RMM, it is important to look beyond the instrument at the entire system including the service and support. Choosing the right RMM also means selecting a supplier with the appropriate scientific, technical and regulatory support. Without this, it is difficult to obtain maximum value from your investment, because you will not have the benefit of the accumulated experience in 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 do not 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 realise the benefits of the rapid detection technology. Some companies include a three-day, on-site installation qualification and operations qualification, and will get your team started with the validation work as part of the training. This ensures you will be able to see a ROI fast.
Ask RMM providers about their resources to help your company project the return on investment (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 6-9 months. These systems typically free up working capital in amounts greater than €500,000 in net present value. Something your finance department will like!
The key is to remember that this is not about asking for a budget increase for the microbiology laboratory, it is about helping your company find new ways to save. This time however, instead of cutting costs you are adding value to the bottom line. And that will cause management to see you, and the laboratory, in a different light.
The Author
Cindy Lieberman, vice president, joined Celsis in 2007. She brings significant manufacturing supply chain, technology and healthcare industry experience to company from her previous positions, most recently with Zebra Technologies.
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