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