CMs: Find your Competitive Advantage with Rapid Product Release Testing


CMs: Find your Competitive Advantage with Rapid Product Release Testing

October 2011

Contract Pharmaceuticals magazine

Shortening your production cycle time with rapid microbial screening offers significant financial benefits for you—and your customers.

It’s no surprise that price competition is fierce these days. To profitably grow your business and survive long term, contract manufacturers must bring more than low prices to the table.

Adopting rapid microbial screening for faster product release is a cost-efficient way to reduce turnaround time. It also gives contract manufacturers a strong, competitive advantage to help you not only survive, but thrive.

Options for Faster Turnaround
There are two basic ways to shorten your overall turnaround time: add capacity or increase efficiency.

Adding capacity to decrease turnaround time can be accomplished by investing in high-speed production lines. Or you can add capacity by adding a second or third shift since, theoretically, you can get more produced in 24 hours with the same equipment.

But take a close look at your manufacturing process. Increased capacity doesn't necessarily mean you will be able to release products faster. And capacity is expensive.

If your processes are laden with wait time that does not add value, your best option is to look at ways to improve efficiency and become leaner. Examine each step in production to see if there are goods or products waiting to move. 

Some symptoms of not being lean include:

  • Producing more than customers order, “just in case”
  • Stockpiling large amounts of inventory and safety stock
  • Transporting materials to offsite storage or to holding areas instead of to distribution
  • Contamination events that, although rare, cause you to scrap about a week’s worth of production.

So how do you get leaner and more efficient? In many manufacturing facilities, the limiting step for faster turnaround time is not the handoff from capping to shrink wrapping or cartoning. It's the time it takes to get the results from microbiological testing.

By testing and releasing products faster, you will shorten your production cycle, free up days' worth of inventory and the warehouse space it consumes, and shorten your cash cycle. You will also have secured a competitive advantage over your competitors.

Traditional Testing Takes Time
With traditional testing for microbial contamination, you’re waiting 3-7 days (or more) for test results on products that usually test negative for contamination. Meanwhile the Quality department is visually inspecting hundreds of Petri dishes and jars of product samples, one at a time over multiple days, monitoring them for signs of growth.

There is an alternative. Well-validated rapid methods are just as effective as traditional microbiological methods; more importantly, they’re faster.

Rapid microbial detection, such as the systems available from Celsis, offers definitive results, both positive and negative, in as few as 24 hours. The Celsis AMPiScreen™ assay delivers results quickly by using a patented enzyme reaction that amplifies signal generation and accelerates time-to-result.

The rugged yet sensitive Celsis instrument is easily programmed to assay up to 120 samples per hour. Test results are recorded objectively and presented in clear, color-coded tables and graphics. Since no “judgment calls” are needed to interpret the results, lab technicians are free to work on other, more valuable projects.

Adopting Rapid Methods
Rapid microbial methods (RMMs) are being implemented by increasing numbers of pharmaceutical companies, contract manufacturers, co-packers and contract labs to reduce turnaround time. Shortening the production cycle with faster product release screening can unlock huge operational savings. Instead of holding materials or products for several days while awaiting microbiological test results, rapid methods can provide assurance in as few as 24 hours. This translates into an average 5-year net present value (NPV) savings of $500,000 or more for your facility.

As a contract partner, the benefits of more efficient manufacturing and quality processes also apply to your operation. Taking less time to complete a customer order means you can invoice faster and get paid faster, shortening your cash cycle. Since you won’t need as much space to house product in micro hold, you’ll have extra warehouse space—increasing your capacity for additional business. Plus, you’ll gain a competitive advantage by helping your customers be more responsive to their changing market needs.

Improved efficiency also reduces recovery time in the event of a contamination. At these times, when so much is at risk, the benefits of rapid methods are doubled. The faster you start corrective action, the faster you recover, reducing the potential impact on your customer relationships and your bottom line.

Who Benefits from Rapid Screening?
Almost any company can use rapid methods, but the system you choose will determine your ability to benefit from it. For example, you will need a system with the testing capacity to keep up with full-scale operations. It's not "rapid" if it creates a bottleneck in your operation. Similarly, if the method only works on one type of material, such as water, it will be less useful than a more flexible system capable of also testing viscous and heavily pigmented samples.

Equally important, the right rapid system should be focused on giving you the information you need to ship the majority of your products to market safely. In other words, how quickly will the system confirm the absence of contamination—your most likely product state?

The pharmaceutical industry is an ideal place for rapid screening. Manufacturing and packaging of pharmaceuticals are done under conditions today that produce products to spec 99% or more of the time. Yet traditional micro screening typically takes 3–7 days for limits testing; 14 days or more for sterility. That’s a long time to wait when you have a quality manufacturing process in place that is turning out products free from bioburden almost all the time.

When a positive result is rarely expected, and there is rarely anything to count or enumerate, the wait time for product release becomes frustrating and expensive.

Regulatory Support for Rapid Methods
Transitioning pharmaceuticals and other regulated products to a rapid release method is becoming more straightforward and is, in fact, supported by many global regulatory bodies including the U.S. FDA.

The preferred approach is to “tell them what you’re going to do, do it, and then tell them that you’ve done it.” Albeit highly simplified, this is a reasonably accurate description of the FDA’s Comparability Protocol.

The centerpiece, or “do it” part, is validating the product or group of products for routine release using the rapid method. This includes side-by-side testing to ensure the rapid method is equal to or better than the traditional method. During this stage, lab staff members become more practiced and confident in the rapid system so that once the validation data is collected, the RMM is effectively implemented.

Your rapid system provider may have regulatory compliance expertise that you can tap into as well as drug master files (DMFs) accepted by the US FDA. The DMFs include data for specificity, limit of detection, robustness, ruggedness, and equivalence, and can be used to supplement or streamline the validation of your rapid system. This may save significant time in both your preparation and in the FDA’s review and approval process. 

Ask your system provider about their regulatory compliance assistance and additional resources such as white papers and validation guides.

The Economics of Rapid Methods
Rapid methods are not about costs; they are about saving money and creating a competitive advantage. While there is an increased cost for reagents, the operational and, hence, financial benefits far outweigh the expense.

  • If you store batches or products awaiting test results, you will benefit by reducing your working capital investment in inventory. 
  • By reducing your investment in inventory, you will benefit by clearing out space in your warehouse.
  • If you carry safety stock, you will further benefit from cutting it down to size.
  • If you manage a brand, you will benefit from the faster response time you can offer your distributors and from reducing the risk of contaminated product reaching consumers.
  • If you compete against other contract manufacturers, offering faster turnaround time will win you more business.

The best way to know if rapid screening will benefit your specific operation is to use a proven financial assessment tool. Business consultants Arthur D. Little (ADL) conducted a study of the financial impact of implementing the Celsis system to release finished goods faster. Based on the results of this study, ADL developed a working model to quantify the financial value of implementing a Celsis system at one or multiple facilities. The Celsis Financial and Environmental Impact Assessment is available to help companies that are evaluating a move to rapid methods in estimating their potential savings. Company-specific data can be used to customize the Impact Report.

The Opportunity of Rapid Methods
Controlling costs and operating more efficiently are priorities for everyone in the pharmaceutical value chain.

Contract manufacturers can reap these benefits and create a sustainable, competitive advantage by offering their customers faster turnaround times thanks to rapid microbial screening.

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