One of the advanced, non-destructive methods for evaluating CCI is Headspace Gas Analysis (HGA). This technique leverages changes in the gaseous composition inside the container’s headspace to detect potential leaks or failures in the container closure system. What is Headspace Gas Analysis (HGA)? Headspace Gas Analysis refers to the process Lire la suite…
Container Closure Integrity Testing (CCIT) is a crucial quality control measure for pharmaceutical and medical product packaging. The Dye Ingress Test is one of the most used methods for evaluating the integrity of container closures. This article explores the principles, methodology, advantages, limitations, and regulatory considerations of the Dye Ingress Lire la suite…
Ensuring container closure integrity (CCI) is a fundamental requirement for sterile pharmaceutical products to prevent contamination and maintain product stability. The revised EU Good Manufacturing Practice (GMP) Annex 1, which provides detailed guidance on the manufacture of sterile medical products, emphasizes the necessity of container closure integrity testing (CCIT) throughout Lire la suite…
In practice, to conduct the measurement, a few elements are needed: General rules for the proper Vacuum Decay measurement The Vacuum Decay can detect leaks of gas or vapour. If the product inside the container is liquid, and the leak (the ‘hole’) is in a position on the container that Lire la suite…
Introduction and physical principle Vacuum Decay is the most widely used deterministic method for testing the Container Closure Integrity. This method has been in use for several decades, and it is offered in advanced versions both for online and bench-top applications. The Vacuum Decay finds applications in the most different Lire la suite…
Among the different techniques for Deterministic Leak Test procedures, one of the most interesting and effective is the HVLD High Voltage Leak Test. This method is known and applied for many years, at least from the early 70ies of last century, but originally it has been developed for application in Lire la suite…
The traditional methods Dye Ingress Test The most widely used in the past is certainly the Dye Ingress Test. This method is based on the concept, common also to other different fields of technology (e.g. verification of presence of cracks or pinholes in metal welding), that a strongly coloured liquid Lire la suite…
The main methods to test CCIT on pharmaceutical products are: Probabilistic methods (operator-dependant, give only a pass/fail result): Dye ingress test or Blue Ink test destructive method Water bath test (Bubble test) destructive method Microbial ingress test destructive method Deterministic methods (give a numeric value as result, not operator dependant) Lire la suite…
The Container Closure Integrity Testing (CCIT) concern the techniques to control the integrity of a closed container, that contain a product, as for example a pharmaceutical product. Integrity definition: a compliant container does not show any discontinuity on the surface that divide the outer part from the inner part of Lire la suite…
What is CCIT? Definition. For Container Closure Integrity Testing (CCIT) we mean the specific area of technology that investigates, with suitable methods and equipment, the actual integrity, that is the condition of sealing or hermetic closure, of a container, so that it is suitable for the purpose it is closed. Lire la suite…
