We provide comprehensive packaging validation services for terminally sterilized medical devices, in full alignment with ISO 11607 and ISO 16775 standards. From design qualification to final packaging verification, our experts ensure sterile barrier integrity, usability, and regulatory compliance.

We guide you through every stage, from concept to execution, helping you reduce risks and ensure product safety.

 

Key Services We Offer:

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• Process validations (IQ, OQ, PQ) compliance to ISO 11607-2

• Packaging Design

• Packaging performance testing (burst, peel, dye, microbial barrier)

• Accelerated & real-time aging studies

• Sterile barrier integrity and stability evaluations

• Risk assessment and documentation support

• Test protocol creation and validation report development, etc