Nutraceutical and dietary supplements consist of vitamin and mineral supplements, amino acids, herbs, essential oils, enzymes, homeopathic remedies and other natural products. For years dietary supplements have been unregulated by the U.S. Food and Drug Administration (FDA). In 1994 the Dietary Supplement Health and Education Act (DSHEA) was enacted, which stated that dietary supplement manufacturers must ensure supplements’ safety before marketing them.1
In 2007 the FDA issued the final rule for the implementation of current good manufacturing practices (cGMP) for supplements. 2 The FDA 21 Code of Federal Regulations (CFR) Part 111 required the implementation for large manufacturers in June 2008 and that by June 2010 all dietary supplement manufacturers test their products for identity, purity, contaminants and microbiology quality assurance, like pharmaceutical companies do. 3
To meet these new requirements, dietary supplement manufacturers must test their products for microbiology quality assurance and generate a certificate of analysis for each batch. To do this they either send product samples to contract laboratories for USP microbiological testing or test them internally. To reduce the time to get results, increase efficiency and reduce expenses, BioLumix offers a fast, automated, cost effective way for nutritional and dietary supplement companies to perform USP microbiological testing. The BioLumix system is an in-house method to easily perform accurate and automated microbiology quality assurance assays on finished products, in-process and raw materials and environmental work surfaces. This system can cut quarantine time for microbial testing from 5-6 days to 35-48 hours.
Samples are placed in ready-to-use, disposable vials inserted into an instrument that determine the microbial quality of the product. The system can perform all FDA-required tests such as total aerobic count, yeast and mold count, Enterobacterial count, and objectionable organisms such as E. coli, S. aureus, Salmonella and P. aeruginosa. The BioLumix testing system also includes a step-by-step process to optimize the installation, operation and performance so that it is easy for nutraceutical and dietary supplement manufacturers to do microbiology quality assurance.
The BioLumix testing system allows for faster sample preparation plus provides automated real-time communication, fast product release and early warning of contamination via USP microbiological testing. Because the BioLumix system is automated and its software generates the results, it is not necessary to have an employee dedicated solely to running the microbiology quality assurance tests. This makes the BioLumix system a cost-effective way for dietary supplement manufacturers to meet the new FDA cGMP requirements for microbiological testing. For more information on the BioLumix cGMP USP microbiological testing system, visit http://www.mybiolumix.com or call 1-734-984-3100.
1. Dietary supplements. FDA Web site. http://www.fda.gov/food/dietarysupplements/default.htm.
2. FDA Issues Dietary Supplements Final Rule. FDA Web site.
3. FDA 21 CFR part 111. FDA Web site.
Karen F. Vieira, Ph.D.