Analytical & Microbiological Testing Services

Lab technician looking into microscope

Pillar5 Pharma's Analytical & Microbiological Laboratories provide the following services:

Raw Material, Packaging Component, Chemical Intermediate and Finished Product Testing

  • Compendia testing according to USP, EP & BP requirements 
  • HPLC testing with ECD, UV & Diode Array Detectors
  • GC testing, FID & FID with headspace capability
  • Operations Director, Large Pharma Company>Dissolution, TLC, UV-vis, IR
  • Efficient identity testing of raw materials by Raman Spectroscopy
  • USP Purified water testing
  • Physical testing of solid dosage forms
  • Cleaning validation testing, including residual recovery studies for API’s & detergents

Microbiological Testing of Pharmaceutical, Biological, Nutraceutical, Natural Health & Consumer Products

  • A Fully functional microbiology laboratory certified for biosafety containment Level II
  • Microbial examination of non-sterile products: USP<61> & <62>
  • Potable & purified water testing
  • Validation of Microbial Recovery
  • USP<81> Antibiotics – Microbial Assays (Cylinder-plate & Turbid metric)
  • Bioburden testing USP <1229.37>
  • Media Preparation & Growth Promotion Testing 
  • Quantitative Colorimetric Assay
  • Antimicrobial Effectiveness Testing USP <51>                
  • Total Viable Spore Count USP <55>
  • Disinfectant Efficacy Studies
  • Training system for Aseptic Processing Area Personnel

Stability Testing Required Supporting Finished Packaged & Bulk Product Stability Programs

  • Incubation conditions & stability testing as per ICH guidelines
  • Full stability data evaluation, including statistical evaluation of quantitative data
  • Report writing & data compilation for technical progress reporting, GMP reviews & for submission-ready regulatory reports & modules
  • Consulting on stability requirements for product development & post approval changes & variations