TABLE III

Summary of Opportunities for Improvement within Teams

Elastomer TeamGlass TeamFill Finish Team

  • Molding

  • Cutting panels

  • Trimming

  • Cleanroom protocols

  • Contact with panel surfaces

  • Tubing supply

  • Glass cutting

  • Cleanroom protocols

  • Inspection sensitivity

  • Final packaging material handling and supply

  • Operators behavior during line setup and interventions

  • Cleanroom materials:

    • Wipes

    • Tyvec bags

    • Gowning

    • Gloves

  • Handling glass to glass contact, incl. glass breakage

  • Transport and storage of sterilized bulk material and filled containers

  • Risk in manufacturing; laminar flow, restricted access barriers, isolators .te