Fundamental Testing

Material Knowledge

West's Analytical Services laboratory understands the requirements of compendial analysis for important components in drug product packing from elastomers to glass and plastics. In addition, the West team can evaluate effects of sterilization on elastomer moisture content as well as determining the elastomer identification for compatibility.

West Analytical Laboratory offers component testing for a variety of compendial testing:

  • USP <381> Elastomeric Closures for Injections
  • USP <660> Containers - Glass
  • USP <661> Plastic Packaging Systems and Their Materials of Construction
  • Ph. Eur. 3.2.9 Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders and for Freeze-Dried Powders
  • Ph. Eur 3.2.1 Glass Containers for Pharmaceutical Use
  • JP 7.03 Test for Rubber Closure for Aqueous Infusions
  • JP 7.01 Test for Glass Containers for Injections
  • USP <381>/Ph. Eur 3.2.9 Combined Protocol

Additional component testing includes:

  • Elastomeric moisture content
  • Silicone analysis
  • Material characterization utilizing analysis such as TGA, DSC, and UV
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