By Joseph Heinzelmann
As the need for rapid microbiological testing in various industries continues to grow, Neogen’s recent acquisition of BioLumix helps provide new resources to an already successful rapid microbiological testing product. Specifically in the nutraceutical, dietary supplement, cosmetic and pharmaceutical markets, the BioLumix system serves customers with a system supported by validation datasets, ready to use microbial tests, and Neogen’s excellent customer service. In fact, the value of the system from the perspective of some of our customer’s can be found in their testimonials and feedback. Along with great customer service, some of the key aspects that customers are able to take advantage of include 48-hour certificate of analysis and ready to use assays.
Upon reviewing both the BioLumix system and Soleris, it is apparent that both of these systems offer advantages over other methods and products. These include:
- Expedited results: most results in 12-18 hours; Yeast and mold assay in 48 hours
- Automation and connectivity allows faster product release
- Streamlined testing increases laboratory efficiencies
- Paperless laboratory: centralized test data automatically stored and protected
- Ready to use test vials
- Excellent customer support
The differences lie in the application and validation information supporting both systems. For example, the BioLumix system has submitted a DMF to help aid companies on technical and regulatory information on approvals for prescription drugs. The BioLumix system has an established protocol for preservative efficacy testing, adhering to USP Chapter <51>. Neogen also has the capability to provide services on the BioLumix system, such as suitability testing, USP Chapter <61>. The BioLumix system comes with uniquely designed validation books for nutraceutical and dietary supplements, cosmetics and toiletry, and for over the counter medication.
Similarly, the Soleris system has been for various food matrices. For
example Soleris has been validated for use in aseptically packed UHT products, dressings and sauces, and many other matrices as supported by the AOAC approvals. Because of the focus over the last few years of Soleris in food matrices, Neogen has developed various tests and applications specifically for food. For example, the 48 hours direct lactic acid vial for dressings and sauces, the orange serum broth vial for low pH and beverage applications, and the alicyclobacillus vial for beverages.
Validation strategies for both systems also varied because of market requirements. For example, in the food industry, companies seeking certain SQF level certifications require an AOAC approval on all methods used. Meaning that food testing validations were done according to the outlines and recommendations provided by AOAC International.
In addition, Neogen’s industry leading customer and technical service are now supported by the microbiological excellence of the staff from BioLumix. Both systems come with packages and programs for installation qualification, operational qualification and performance qualification. Furthermore, both systems have packages available to maintain the system through preventative maintenance programs.
Which system is right for you? It depends on the type of products manufactured, and the requirements. Neogen would be happy to help you understand the advantages of both systems and provide more information that can help you make the correct decision. You can contact Neogen by calling 800-234-5333 or emailing firstname.lastname@example.org.