Introduction to CCI Testing for Freeze-Dried Products

Introduction to CCI Testing for Freeze-Dried Products
Ability of a container closure system (CCS) to maintain the sterility and product
quality of sterile final pharmaceutical, biological, and vaccine products
throughout their shelf-life.
CCI strategy includes different steps:

Qualification of CCS

QC sampling (Microbial Ingress Test, Blue Dye Test,…) as release
testing

QC stability testing (testing at expiry)

100% routine testing