Quality Control is exercised throughout the manufacturing processes
at ATMI LifeSciences:

• Traceability, certification and specifications
• Compliance certifications backed with test data
• Validation and verification of product specifications using a variety of QA   methods
• European current Good Manufacturing Practices (cGMP) certified facilities
• ISO certified
• Good Packaging Practices (GPP) - A quality control system specifically for   pharmaceutical clients, inspired by the Pharmaceutical Good Manufacturing   Practices (cGMP)

Inspections

In process inspections are achieved through:
  • Visual control
  • Seal strength tests
  • Seal pinhole tests

Final inspections are achieved through:
  • Tensile strength seal tests
  • Particle cleanliness measurements

Irradiation

• Sterilization by gamma irradiation in conformity to
• EN 552 and ISO 11137
• Guaranteed dose of 25 kGy
• Delivered with certificate of sterilization