Package validation

Medical Devices Packaging System Validation as per ISO 11607

Clean room validation

Validation Activities as per ISO 14644 requirements

Residual EO/ECH Analysis

Testing activity as per ISO 10993-7

Ethylene Oxide (EO) Sterilization Validation

Testing against the following standards 

Hemocompatibility testing ISO 10993-4

Cytotoxicity testing ISO 10993-5

Intracutaneous irritation testing ISO 10993-10

Sensitization testing ISO 10993-10

Systemic toxicity testing ISO 10993-11

Packaging Accelerated Aging Studies

Packaging System Aging study as per ISO 11607 and following ASTM F1980

Ethylene Oxide (EO) Sterilization Validation

Validation Activities as per ISO 11135 requirements and AAMI TIR 15 Read more >>