Analytical and Microbiological Testing Services

Pillar5′s Analytical and Microbiological Laboratories provide the following services:

Raw material, packaging component, chemical intermediate and finished product testing:

  • Compendial testing according to USP, EP and BP requirements
  • HPLC testing with ECD, UV and Diode Array Detectors
  • GC testing, FID and FID with headspace capability
  • 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 and detergents

Microbiological testing of pharmaceutical, biological, nutraceutical, natural health and consumer products:

  • A fully functional microbiology laboratory certified for biosafety containment Level II
  • Microbial enumeration and pathogen testing
  • Cleaning validation and environmental monitoring
  • Potable and purified water testing
  • Validation of microbial recovery
  • USP Method suitability testing
  • Microorganism identification
  • USP antibiotic microbial assays
  • Bioburden testing

Stability testing required to support finished packaged and bulk product stability programs:

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