Module 14 2022

24/03/2022

Suitability For Intended Use…

● COMPATIBILITY ● Could the packaging cause unacceptable changes in quality or performance of the device?

– Loss of integrity, leading to physical failure of the device

– Physicochemical Interactions … which lead onto safety concerns…

Interactive Session

The Organisation for Professionals in Regulatory Affairs

25

Suitability For Use…

SAFETY ● Potential for leaching harmful substances… ● What additional tests can you do? – USP Biological Reactivity Test – Extraction / toxicological evaluation – Set Limits on extractables – Batch to batch monitoring of extractables – Don’t forget that Ink printing and label adhesives can interact!

Interactive Session

The Organisation for Professionals in Regulatory Affairs

26

13