Packaging Validation

Andersen Caledonia offers a full range of validation services to validate the sterile packing barrier and shelf life claims for sterile goods. Our range of services includes accelerated aging, seal strength testing, dye penetration and sterility testing. We offer the ability to accelerate large volumes of goods up to 2 cubic metres. Our aging chambers operate at temperatures between 40°C and 50°C giving an acceleration rate of up to 8 times.

Core reference standards

(ISO 11607-1:2006)
Packaging for terminally sterilized medical devices –
Part 1: Requirements for materials, sterile barrier systems and packaging systems
 
(ISO 11607-2:2006)
Packaging for terminally sterilized medical devices –
Part 2: Validation requirements for forming, sealing and assembly processes