Newsletter | June 29, 2020

06.29.20 -- Considerations In Container Closure Integrity

Package Inspection Guidelines For Sterile Medical Products

Class III medical devices have a unique set of requirements and package characteristics that need a comprehensive approach to selecting the right inspection methods. A variety of inspection methods exist for medical package inspection that require a thorough understanding to ensure quality.

Container Closure Integrity Testing: The Importance Of Sensitivity, Automation, And Efficiency

This article explores the need for sensitive, reliable, and automated container closure integrity (CCI) testing technologies and how existing deterministic solutions can help achieve optimum quality assurance goals in CCI for pharmaceutical manufacturers.

Test Method Development, Experimental Design, And Positive Controls For Package Integrity

Given that the experimental design has only two conditions, leaking and non-leaking, this variable is extremely important to understand. Proper use of positive controls and knowledge of how alternative approaches are applied to challenge a test method support the validity and reliability of the method.

CCI For Combination Products: Assembling The Package Integrity Profile For Autoinjectors

Due to their complexity, combination products, specifically autoinjection systems, present unique challenges in implementing a container closure integrity (CCI) testing strategy. This is further complicated by a pervasive, though diminishing, tendency for companies to consider CCI only at the final product-package life cycle stage, an approach where combination products will highlight the pitfalls.

Dye Ingress For CCIT: A Poor Bet In A High-Stakes Game

The dye ingress test method continues to be a widely used test method for container closure integrity (CCI) within the pharmaceutical industry. Even with recent research attempting to support its use, this article explains why the dye ingress test method is not a suitable approach.

Prefilled Syringe Leak Detection With Vacuum Decay vs. HVLD Test Methods

This study addresses the common concern that vacuum decay is not a suitable test solution for detecting microleaks in parenteral containers if the product contains large molecule or proteinaceous liquids.