Pharmaceutical — OTC Medicine Industries

Faster Product Release with Reduced Microbiological Testing Cost

BioLumix offers innovative microbiological testing solutions designed specifically for the Pharmaceutical OTC industry. We offer a comprehensive range of microbiological tests for raw materials, in process and finished products as well as environmental testing.

BioLumix Advantages:

• Simplified Microbiological testing procedures
• Expedite time to results- results in hours rather than days
• Detection limit 1 microorganism
• Ready-to-use assay vials simplify testing
• Vial structure eliminate product interference
• 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
• Help with validation including IQ, PQ and OQ
• 21 CFR Part 11 compliant with audit trail and log in/ log out
• Centralized test data automatically stored and protected

Available Assays:

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