Nutraceutical & Dietary Supplement Industries

Automated 48 Hour Certificate of Analysis

Dietary supplement cGMPs require that manufacturers take steps to ensure that products are free of contamination with objectionable microorganisms. As a result, manufacturers must be prepared to test raw materials and finished products for relevant microorganisms.

BioLumix offers innovative microbiological testing solutions designed specifically for the Nutraceutical and Dietary Supplement industries. BioLumix can help internalize microbiological testing or make the existing microbial testing simpler, faster, and automated, thereby saving significant labor.

We offer a comprehensive range of microbiological tests for raw materials, in-process and finished products as well as environmental testing. The system can analyze tablets, capsules, powder, liquid and viscous material without any product interference. The software offers an Automated Certificate of Analysis within 48 hours.

BioLumix Advantages:

• Simplified Microbiological testing procedures
• Can be operated by non-microbiologist
• Ready-to-use assay vials are easy to use
• Vial structure eliminate product interference
• Detection limit of 1 microorganism
• Real-time communication for immediate action - Early warning of contaminated samples
• Completed assay results in hours rather than days
• An automated Certificate of Analysis within 48 hours including all organisms required by USP
• Validation package against USP methodology including IQ, OQ and PQ
• Allows for cost effective internalization of the microbiological assays
• 21 CFR part 11 compliant with audit trail and log in/ log out
• Centralized test data automatically stored and protected
• Specifically designed for the Nutraceutical industry

Available Assays:

• Total Aerobic Microbial Count (TAMC)
• Total Combined Molds and Yeasts Count (TCMY)
• Enterobacterial Count (Bile-Tolerant Gram-Negative Bacteria)
• Objectionable organisms
• Escherichia coli
• Pseudomonas aeruginosa
• Staphylococcus aureus
• Salmonella
• Probiotic
• Environmental monitoring