By Joe Heinzelmann
The implementation of cGMP for all manufacturers (large and small) of dietary supplements andNutraceutical productsmeans that all manufacturers must test their products for microbiology quality assurance and generate a Certificate of Analysis for each batch. Products must be tested in accordance with the methods described in USP <2021> and <2022>. This includes testing for Total Aerobic Microbial Count, Total Combined Yeast and Mold, Bile-Tolerant-Gram-Negative bacteria, and objectionable organisms (absent in 10 grams of organisms such as Salmonella, E. coli, and sometimes S. aureus). To do these tests companies either send product samples to contract laboratories for microbiological testing or test them internally.
Internal testing of products for microbiology gives the manufacturer much more control over the operation, but some manufacturers are hesitant to bring the microbiology testing in-house for fear of the complexity of testing or the need for trained microbiologist(s). Also daunting is the need for a full validation package which is required for any method that deviates from the USP methodology. Here’s the good news – BioLumix offers a solution that gives faster time to results, quicker product release, cost effective operation, and strengthens key profit drivers. This is all achieved on a single platform that is easy to use, validated to USP requirements, and doesn’t require additional skilled personnel.
At BioLumix, we don’t just offer you a simplified, rapid, automated microbiology system… we provide the Complete BioLumix Experience!
What is the Complete BioLumix Experience? It’s having, from initial contact to the completion of the installation and beyond, our commitment to providing unparalleled support and total customer satisfaction.
In 2006, Ruth & Gideon Eden established BioLumix, Inc. Today, because of their extensive backgrounds in science and technology combined with customer-oriented sales and support staff, we have raised the simplification, automation and speed of microbiology testing to a new level.
- Needs Assessment - Whether you contact us direct or through our website you can count on our sales team to respond quickly. The focus is on your needs and goals. Our BioLumix Technology Presentation provides an in depth look into how and why our system will work for you. In addition, we can quickly and easily show you the value and the ROI the system will bring to your company.
- Expertise – Knowing how the BioLumix system will work with your samples gives you peace of mind. That’s why we test samples – YOUR samples – for you at our laboratory in Ann Arbor, MI. We do this for you at no cost and at no obligation! Once completed, expect a comprehensive report from one of our expert microbiologists. That same microbiologist spends two and a half days on-site for training and installation of the system.
- Validation – If you are concerned about validation, here is more good news. We provide complete SOPs along with a customized Validation book which includes Installation Qualification (IQ), Operations Qualification (OQ) and Performance Qualification (PQ).
- Simplicity and Ease-of-Use- The easy to master BioLumix system offers a new level of productivity. Sample preparation takes less than 2 minutes; just add the sample to the diluent and mix. Pipette the appropriate amount into the vial and place it into the instrument and record the sample and assay information into the computer. The rest is totally automated. The Certificates of Analysis will automatically be generated in as little as 24-48 hours!
- Support – Our jobs center on satisfying our customers and providing unparalleled support. At BioLumix you receive 24/7 support plus a microbiologist dedicated to service you and answer your questions. What happens if you encounter a problem? Troubleshooting can be done via the internet and in most cases problems are resolved. If needed we provide a loaner instrument while your instrument is being fixed to minimize downtime. Our website provides instant access to information and resources about our technology, instruments, assays, and more. It’s also mobile-enabled to format to your handheld devices. Links to social media, white papers, blogs, videos, and other informative contact information puts everything you need at your fingertips.
- Continuous Product Improvement – At BioLumix we have an ongoing commitment to evolving and adding to our platform. One way this is achieved is through our partnership with our customers. Customer feedback, along with a desire to increase the breadth and depth of our offerings, helps us to make improvements to our media and our assays. We have recently introduced two new assays – Listeria and Bacillus cereus.
With a simplified method such as the BioLumix System we can provide a simple cost effective method to test products for microbiology.