West Analytical Services 
 

VeriSure™
Verified extractables. Assured control.
West’s innovative VeriSure products allow customers to accelerate the leachables testing for qualifying a drug product’s container/ closure system.

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Process Development / Problem Resolution 

West Analytical Services personnel work closely with clients to resolve problems. West’s team approach to problem resolution combines strong analytical capabilities and continuous communication to reduce down time and the cost of analysis.

  • Particle burden, foreign particulate matter and particle identification services

  • Particle counting on packaging and closures

  • Identification of unknown particles and foreign particulate matter ((Microscopy: Optical, FTIR), SEM / EDS)

  • Lypholization Services
    • Optimizing the lyophilization cycle
    • Moisture analysis of drug product and packaging
    • Compatibility and qualification for containers and closures for lyophilized drug product

  • Cleaning validation - consulting, method development, method validation, residue limits (TOC, HPLC, UV, LC/MS, GCMS, GC, ICP/MS)

  • Identifying materials, elastomers and plastics – Characterizing materials for devices, pouches, labels, multilayer packaging, etc. (TGA, DSC, ATR / FTIR, LC/MS/MS, GC/MS, Pyrolysis FTIR, Optical and FTIR Microscopy)

  • Silicone oil analysis for packaging – vial, stopper, PFS and also for determining the amount of silicone oil in drug product over time

  • Glass Analysis - wet chemical, fusion /XRF, metals, extractables, leachables

Please click here to contact us by email to discuss your needs for process development and problem resolution.

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