Module 14 2022

24/03/2022

ISO 11607

Types of testing in addition to stability

● Seal Strength – Plus dye penetration testing

● Microbial challenge testing

● Light penetration testing

● Double pouching – for handling in a sterile environment

Interactive Session

The Organisation for Professionals in Regulatory Affairs

19

● US – Guidance for Industry (May 1999) “Container Closure Systems for Packaging Human Drugs and Biologics” ● EU – Ph.Eur. Monographs (3.1) on materials used for containers – Ph.Eur. Monographs (3.2) on containers – EU Note for Guidance Plastic immediate packaging materials For non-sterile products: USEFUL STANDARDS AND GUIDANCES TO CONSIDER FROM OTHER SECTORS

Interactive Session

The Organisation for Professionals in Regulatory Affairs

20

10