Newsletter | March 25, 2020

03.25.20 -- Strategies For Container Closure Integrity Testing Of Sterile Injectable Products

 
Regulatory Guidance: Designing A Strategy For Container Closure Integrity Testing Of Sterile Injectable Product
 

Container closure integrity (CCI) plays an important role in maintaining the sterility and stability of sterile injectable products. Recent regulatory guidance has triggered changes in industry best practices in the area of CCI testing (CCIT). This article summarizes the current state of container closure integrity testing in the pharmaceutical and biopharmaceutical industries and outlines possible approaches for developing a CCIT strategy.

Container Closure Integrity Test Method Development Using Headspace Gas Ingress
 

Recent regulatory guidance has made clear there is no "gold standard" container closure integrity (CCI) test. An appropriate CCI test method should be applied depending on the specific product container closure system configuration, the stage in the product life cycle, and the testing throughput required. It is therefore considered best practice to create a toolbox of CCI testing methods.

Evaluating The Container Closure Integrity Of A Vial Using Headspace Gas Ingress Methods
 

To ensure patient safety, pharmaceutical products must be kept properly packaged prior to use. Proper packaging prevents ingress of contaminants. Unfortunately, these contaminants are not always visible to the human eye and container closure integrity (CCI) tests must be performed to ensure the package has not been compromised. One way to test for proper CCI is to analyze the headspace gas composition of the vial.

CCI Test Method Validation For Prefilled Syringes
 

Regulators are paying closer attention to the proper design of robust container closure integrity (CCI) studies and the validation of CCI test methods. Learn how method validation is used to demonstrate sufficient accuracy and reproducibility of a method, in this case to detect CCI defects at the plunger seal of a prefilled syringe.

Industry Survey: Best Practices In Container Closure Integrity Testing
 

Container closure integrity (CCI) plays an important role in maintaining the sterility and stability of sterile injectable products. This article summarizes the answers to polling questions that were presented to representatives of pharmaceutical companies involved in CCIT activities.

Headspace Gas Ingress Testing For CCI
 

Imagine a blue dye test, but replace the dye with a tracer gas. Headspace gas ingress testing is a robust detection method of critical leaks. It is a rapid, nondestructive, analytical measurement and can be scientifically validated. Are you considering upgrading your blue dye test, and do you want to learn more about this approach? Watch this webinar.

Solutions
Container Closure Integrity Testing Using Gas Ingress
 

The CCI Test Vessel provides a simple means of preparing samples for container closure integrity testing (CCIT) using the highly sensitive and nondestructive laser-based headspace analysis technology. When combined with a LIGHTHOUSE FMS headspace gas analyzer, the CCI Test Vessel offers a robust solution for container integrity tests on a wide range of container types and packaging conditions.