Container closure integrity testing with High Voltage Leak Detection

Container closure integrity testing with High Voltage Leak Detection
There are various methods that can be used for Container Closure Integrity Testing(CCIT). Each method has its pros and cons. The choice of the CCIT-method depends on various factors such
as the material of the primary packaging and product properties.
High Voltage Leak Detection(HVLD) is an effective method. The sensitivity of the method is quite high but its is unclear
whether it can detect all the hole sizes that may entails a risk for microbial contamination.

Experience with Artificial Leaks and Dye Ingress Container Closure Integrity Testing (CCIT)

Experience with Artificial Leaks and Dye Ingress Container Closure Integrity Testing (CCIT)
Critical leak
•Void, gap, crack, hole, porosity or breach in a container closure system allowing the passage of microorganisms
•Main factor that affects critical leak size is whether or not the micro-leak is filled with liquid: microorganisms penetrate a liquid filled defect by motility or pressure differentials

Using Helium Leak Detection CCI Testing to Inform Container Closure System Design

Using Helium Leak Detection CCI Testing to Inform Container Closure System Design
Overview of Helium Leak Detection (HeLD)
 Method development for syringes
 Fixture design
 Helium charging
 Applications of Helium Leak Detection
 Determination of inherent package integrity
 Evaluation of syringe system and sub-system design
 Assessment of container closure robustness

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)