Product/Service

Package / Container Testing

Source: West Analytical Services
To meet client needs and regulatory requirements, West Analytical Services provides test methods that can be applied to packaging where container closure integrity or permeation rates are of concern

To meet client needs and regulatory requirements, West Analytical Services provides test methods that can be applied to packaging where container closure integrity or permeation rates are of concern. Methods available as standard testing meet client requirements for container closure integrity. These include helium leak and dye ingress/egress studies.

  • Container Closure Integrity (CCI)
    • Helium Leak detection (Quantitative)
    • Methylene Blue Dye (Qualitative)
    • Microbial Ingress – Outsourced
    • Vacuum/Pressure – Lyophilized drug products

  • Pre-Filled Syringes (PFS)
    • PTI micro Leak - Tip cap and shield
    • Break loose and extrusion
    • Tungsten Analysis

  • Functionality Testing
    • Coring
    • Spike Studies / IV applications
    • Needle penetration

  • Closure Testing
    • Ash, Micro hardness, Swelling, Sealability, Residual Seal Force
    • Karl Fisher Moisture
    • Particle sizing ad particle identification (USP <788>, Optical
    • Microscopy, FTIR Microscopy, SEM / EDS)
    • Silicone analysis

  • Biological Testing
    • USP <87> and <88> - Outsourced
    • Cytotoxicity – ISO Outsourced
    • Hemolysis

  • Elastomeric / Rubber Closure - USP <381>, EP 3.2.9, JP <59>

  • Container Testing
    • USP <661> and USP <671>
    • Container Testing - ATR / FTIR, Pyrolysis FTIR