Pharmaceuticals


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Faster Product Release with Reduced Microbiological Testing Cost

BioLumix offers innovative microbiological testing solutions designed specifically for the Pharmaceutical 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

Read our white paper at American Pharmaceutical Review