Non-destructive, Deterministic Inspection Technologies for CCIT

Non-destructive, Deterministic Inspection Technologies for CCIT
Leaks are commonly conceptualized as holes of a defined diameter, or channels of disctinctive diameter and length, although leaks that occur naturally are generally complex, multicavity tortuous paths and are rarely uniform in size of shape.
A leak is a breach in a package wall or gap between package components that is capable of permitting the passage of gas, liquid, or solid mater. Leak is synonymous with leak path.

Container Closure Integrity:A Holistic Strategy to Ensure Patient Safety

Holistic CCI strategy

•Container Closure Integrity (CCI)

–Introduction, Complex Regulatory Environment

•Container Closure Integrity Testing (CCIT) in the drug product (DP) life cycle

–CCS Qualification, Process Characterization/ Validation (Case Study 1)

Container Closure Integrity Testing – Method Development for Freeze Dried Products Using laser based Headspace Oxygen Analysis

Container Closure Integrity Testing –

Method Development for Freeze Dried Products

Using laser based Headspace Oxygen Analysis

Agenda

• Regulatory expectations

• Scope

• Previous work for CCI method development for FD products and

Primary containers and container closure systems Part I: Bottles, vials, ampoules, cartridges, syringes

Container Closure Integrity: Regulations, Test Methods, Application – Regulatory Requirements