Packaging validation

Packaging validation provides evidence that the sterile barrier system and packaging configuration can protect the device throughout processing, sterilization, transport, storage and use.

SteriLandBio supports companies in defining, reviewing and documenting packaging validation strategies for new products, packaging changes, supplier changes, shelf-life extensions and requalification activities.

Our support may include the preparation or review of packaging validation protocols and reports, sterile barrier system assessments, worst-case rationale, packaging families definition, ageing strategy, transport simulation, seal integrity and strength testing rationale, deviation assessment and alignment with sterilization and stability evidence.

We help companies generate packaging validation documentation that supports product protection, sterility maintenance and compliance with applicable regulatory and technical requirements.