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Rapid Product Release Testing



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



By Cindy Lieberman, Celsis



Published June 4, 2012
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It’s no surprise that price competition is fierce these days, but competing with lower prices alone may impede economic growth. That is why savvy contract manufacturers are realizing it’s critical to bring more than just low prices to the table: you must adopt technology, such as rapid product release testing, that will help to differentiate your services in a crowded marketplace.

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 them not only survive, but thrive.

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; and
  • 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.

With traditional testing for microbial contamination, you can wait 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.

It is not difficult to detect organisms in grossly contaminated products. What can be difficult and time consuming, however, is detecting very small numbers of microorganisms in materials and products that are expected to be free of contaminants. With traditional methods, a lot of time is spent waiting to confirm that nothing is growing.

There is an alternative. Well-validated rapid screening methods are just as effective as traditional microbiological methods; more importantly, they’re faster. Rapid microbial detection offers definitive results, both positive and negative. And, since no “judgment calls” are needed to interpret the results, lab technicians are free to work on other, more valuable projects.

Adopting Rapid Release
Rapid release product screenings are being implemented by a growing number of personal care products 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, rapid release methods can provide assurance in as few as 18 hours. This translates into an average 5-year net present value (NPV) savings of $500,000 or more for a facility.


Save time and money. Utilizing rapid methods, contract manufacturers can detect contamination sooner, release in-spec product faster, shorten cash cycles, and be more responsive to customer requirements. CMs that invest in materials, equipment and/or storage on behalf of customers can reduce costs by an average of $500,000 per facility in the first five years.
































As a contract partner, the benefits of more efficient manufacturing and more automated quality processes apply to your operation as well. 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 economic benefits of a rapid detection method are doubled. The faster you start corrective action, the faster you recover, reducing the potential impact on your customer relationships and your bottom line.

The Benefits
The personal care industry is ideal for rapid screening. Manufacturing and packaging of personal care products are done under conditions today that produce products that are “clean” and safe for release 97% or more of the time. Yet traditional micro screening typically takes 3–7 days for microbial limits testing. 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. Most of the time there is nothing to identify and nothing to count. Keep in mind, however, that the system that 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—the most likely product state? The long wait time to release in-spec product can be frustrating and expensive.

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. In the 1990s, business consultants Arthur D. Little (ADL) conducted a study of the financial impact of implementing a rapid screening 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 rapid detection system at one or multiple facilities. This Financial Impact Assessment has been refined and validated by many companies over the past decade. It is available at no charge from Celsis to help companies estimate their potential savings from adopting a rapid detection system. Company-specific data can be used to customize the Impact Report.

Controlling costs and operating more efficiently are priorities for everyone in the personal care products value chain. Contract manufacturers can reap these benefits and create a sustainable, competitive advantage by offering their customers faster turnaround times thanks to rapid release product screening.

More info: Cindy Lieberman, Tel: 800-222-8260;
Email: clieberman@celsis.com; Website: www.celsis.com


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