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Like many nutraceutical companies, Uckele Health and Nutrition (Blissfield, MI) found itself dealing with additional operating constraints this year after the Current Good Manufacturing Practices (CGMPs) for dietary supplements took effect. Among the stickier dilemmas was increased quality-control costs.
The CGMPs mandate quantitative and qualitative product tests that increased laboratory costs and, in some cases, required longer hold times for materials. Uckele needed a cost-effective yet reliable way to meet the CGMP requirements and still keep product moving out the door.
One answer that Uckele found was a microbiological testing system for both raw materials and finished products. The system keeps Uckele's overhead costs down while helping to ensure that product quality is not compromised, according to Mike Uckele, the company's CEO and president.
"[The system] paid for itself, from the first day," he says. "It not only helps me increase my turnaround time, but it validates quality."
The system, Biolumix-32 from Biolumix Inc. (Ann Arbor, MI), comprises an instrument that serves as an incubator for up to 32 vials containing a 1.5-ml product sample and 5 to 10 ml of medium.
The system automatically performs a range of functions, including assays for total aerobic count, salmonella, E. coli, Gram-negative bacteria, and Enterobacteriaceae; sanitation monitoring; sterility testing; challenge testing; microbial limits; and yeast and mold, Pseudomonas, Staphylococcus, and Thermophilic counts.
During testing, vials are placed in a desktop instrument. Once prepared, the instrument searches for various types of bacteria or organisms. Thirty-two test locations are inside each instrument. The system works quickly, and test results are available in 12 to 48 hours. The color green indicates that the raw material is clean, and red indicates that contamination has been detected.
"If you start with a contaminated raw material, then you will end with one. There is nothing that can remove it," explains Gideon Eden, a Biolumix engineer. "In just 48 hours, all of the results are there."
Biolumix says that the Biolumix-32 system can be set up to accommodate the individual needs of a business. Remote access even allows Biolumix's quality-control staff to monitor results and provide assistance immediately. Biolumix's and a company's personnel can log onto the same system and look over outcomes together.
According to Uckele, the system quickly had an impact. It discovered traces of bacteria in raw material needed to make one of the company's supplements. Uckele was able to contact the raw material supplier and get replacement material sent in time to finish the order. Retesting proved that the new material was uncontaminated, and the shipment was made on the promised date.
"There are many challenges in microbiological testing of natural products," says Ruth Eden, Biolumix's president and microbiologist. However, such technologies such as Biolumix-32 can help nutraceutical producers achieve results faster, she says.
Other options to a system such as Biolumix-32 would be standard methods that Biolumix says require time to operate and can be difficult to perform. In addition, the company adds, sending samples to an outside laboratory can take up to a week or more. They can also be expensive.
"In this business, time is money," says Uckele. "We are always looking for better ways to test and analyze our products."