Packaging Validation

Appropriate packaging for medical devices should ensure product integrity and protect against damage throughout the entire supply chain. The requirements for medical device packaging are very strict and must adhere to health and safety regulations across borders, highlighting the importance of compliance with packaging validation standards. At SteriPack the medical device packaging validation process is compliant with ISO 13485:2016 and  MDD 93/42/EEC, Annex II. EN-ISO 11607 Medical packing:

•  ISO 11607-1:2019 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
•  ISO 11607-2:2019 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes

All packaging processes related to the Sterile Barrier System must be validated. Validation is confirmed by the demonstration of sterile barrier integrity over the intended shelf-life and through transportation conditions. SteriPack has developed a standardized validation approach and procedures which reflect global quality requirements (ISO, ASTM and ISTA compliance). Our validation team of experts advise on all necessary tests and standards and provide comprehensive validation reports ready for submission. Tests performed for terminally sterilized medical device packaging include:

•  Packaging system integrity testing, seal strength, visual testing
•  Package integrity (ASTM F2096: Bubble test)
•  Seal integrity (ASTM F1886: Visual inspection, ASTM 1929: Dye penetration test)
•  Seal integrity (ASTM F88: Seal strength test, ASTM F1140: Burst test)
•  Accelerated aging / real aging study
•  Accelerated aging (ASTM F1980)
•  Real-time aging (a requirement to back up an accelerated aging study)
•  Performance testing / distribution simulation
•  ASTM D4169, ISTA procedures 1, 2 and 3
•  Bubble leak testing
•  Dimensional analysis (optical analysis, CMM, CT Scan)
•  Customer specific testing

Other validation tests performed by SteriPack:

•  Transportation simulation (including environmental conditioning)
•  Shelf-life testing (including accelerated aging)
•  Tooling / equipment qualification
•  Process validation, including:
  •  Sealing validation
  •  Injection molding validation
  •  Washing validation
  •  Sterilization validation

Typical validation scope for packaging services, from design phase through to production launch:

•  Validation Plan
•  Installation Qualification IQ
•  Product Testing Pre-DOE
•  Design of Experiment DOE
•  Operational Qualification OQ
•  Performance Qualification PQ
•  Final Validation Report