[Case Study] Benefits of Rapid Testing

According to the FDA and Nutrition Business News, the nutraceuticals industry has grown from a $32.7 billion-a-year industry in 2000, to an $83 billion-a-year industry in 2005 – global revenue growth of nearly 150%. Nutraceuticals include herbal/natural products, dietary supplements, and functional foods such as sports drinks, energy bars and more. With a growing number of ingredients in these products, it has become increasingly important to ensure that they are free of potentially harmful microbial contaminants at the manufacturing level. 
 Founded in 1968, NOW Foods is a leader in the natural food and supplement industry. Their extensive product catalog now includes more than 1,800 vitamins, minerals, dietary supplements, natural foods, personal care and health-related products.  For nearly four decades, NOW has forged its reputation on providing natural products of exceptional quality. NOW’s efficient manufacturing practices, commitment to cutting-edge science, and industry-leading method development have kept them at the forefront of a competitive and emerging industry. 
In 1998, NOW moved their growing operations to a 209,000-square-foot facility in Bloomingdale, Illinois. This new, ultra-modern facility has maintained a consistent GMP (good manufacturing practice) A rating, and hosts an expanded Quality Control (QC) department that includes a technologically advanced microbiology lab, which conducts chemical, analytical and microbial testing.
The role of microbiology in quality control at NOW Foods includes the testing of raw materials, natural food products and dietary supplements. To further ensure the safety of all NOW Foods products, various sites throughout the Bloomingdale, Illinois manufacturing plant are carefully monitored for the presence of contaminants.
Dr. Jon Cassista, NOW Foods Microbiology Lab Manager, contacted Centrus International, Inc., with a unique challenge. His goal was to increase the level of in-house microbial testing at a pace that could support the company’s expansive growth. This was coupled with the need to maintain high levels of quality from a system capable of demonstrating a timely ROI. Centrus introduced Cassista and his microbiology staff to the Soleris™ system (previously BioSys system), a multi-functional rapid testing system known for its high level of accuracy.

PRODUCTIVITY INCREASES. In January of 2004, NOW Foods’ microbiology department leased a Soleris 32 Rapid Optical Microbiology Testing System for use in their lab. Following a positive six month trial experience, the decision was made to upgrade. This resulted in the purchase of the larger, Soleris 128 test system. The microbiology team at NOW has been using the Soleris technology for more than a year now and according to Cassista, it has clearly helped streamline their microbial testing program.
Essentially, the Soleris system enables end-users to screen raw materials, in-process and finished products or environmental samples for rapid detection of microorganisms. It features an optical monitoring instrument, ready-to-use assay vials and an advanced Windows-based software. This combination allows Cassista’s team to quickly detect and measure microbial growth with great accuracy. Functionally, the Soleris system detects microbial growth by closely monitoring pH and other biochemical reactions. As color changes occur in the liquid filled test files, they are detected by optical sensors and then recorded by a computer. This technology is sensitive enough to detect microbial growth from a single cell in the initial sample. Most results are available overnight as opposed to several days later.
Equipped with the Soleris system, NOW Foods has vastly improved its ability to screen for contaminants such as E. coli, Enterobacteriaceae, and TVC. Pre-test preparation has also been greatly enhanced. In many applications, the Soleris 128 requires only a single dilution, saving the time and material costs of serial dilutions. The optical detection system eliminates the need for time consuming colony counts, as well as manual reports.
With less time spent performing sample manipulations and processing, Dr. Cassista and his team have been able to accomplish two very advantageous tasks. First, they’ve become more productive in their sample testing. Next, and perhaps more importantly, they have greatly increased the number of tests that can be conducted.
In an industry where quality and purity ultimately govern success, the Soleris 128 has given NOW Foods an immediate edge over its competitors. “We’re very satisfied with the new {Soleris} system,” says Cassista. “It has allowed our microbiology department to keep up with the company’s growth.”

CUTTING LAB COsTS. In today’s competitive business environment, it has become increasingly important to keep all aspects of the manufacturing process as cost-efficient as possible. As mentioned, one of Cassista’s primary concerns was in generating a worthwhile and timely return on their investment. 
The Soleris system has allowed Cassista and his staff to move NOW Foods’ entire microbial testing operation in-house. Accordingly, NOW has greatly reduced the amount of time and money required to send their samples to an independent, outside testing lab. 
“When you deal with contract labs, some do not have the type of experience with nutraceuticals that our in-house lab has,” says Cassista. “It’s one thing for a chemical or analytical lab to test vitamins A or C. Looking for microbial contaminants in imported herbal components and other exotic ingredients similar to those found in many NOW products, is something else.”
According to Cassista, “Our production efficiency costs are directly affected by how much time raw materials are held up in quarantine. The Soleris has helped us cut our quarantine time from five or six days, down to approximately three days for micro testing.”    
In addition, the Soleris 128 is fully automated. Microbial tests that once required days or even weekend-long operator intervention can now be performed without supervision. This eliminates the need for costly overtime.

EASE OF USE. Based on their constant growth and high volume, ease of use was important to NOW’s microbiology staff. Centrus answered by sending a microbiologist to their Bloomingdale facility to demonstrate how easily the unit could be installed and operated. Once trained, the lead technician was able to easily train the remaining microbiology technicians on her own. 
Today, multiple users operate the Soleris 128 in NOW’s lab. This affords their lead technician more time to perform other demanding tasks, while maintaining confidence in sample test results. “The basic technology is impressive,” says Dr. Cassista. “It’s simple, straight-forward and has worked very effectively over the past six months.”