Container Closure Integrity Testing (CCIT) is an assay that evaluates the adequacy of container closure systems to maintain a sterile barrier against potential contaminants. Contaminants that could potentially cross a container closure barrier include microorganisms, reactive gases, and other substances (USP <1207>). Container closure systems should maintain the sterility and product quality of sterile final pharmaceutical, biological, and vaccine products throughout their shelf-life.
Container closure systems consist of primary packaging components and secondary packaging components (USP <1207>). Primary packaging components are those components that come into direct contact with the product, such as a glass vial or syringe. While, secondary packaging components are those components that are vital to ensure correct package assembly, such as aluminum caps over stoppers (USP <1207>).
Container closure integrity testing can be performed in many different ways. All of the testing methods have pros and cons. In addition, some containers, such as ampoules, require 100% integrity testing.
Contract Container Integrity Testing laboratories offer numerous state- of-the-art options for leak testing and assessing pharmaceutical package integrity per USP <1207>. Container Closure Integrity test programs have been successfully used to optimize sealing parameters, evaluate container storage temperature impact, replace sterility tests for product stability batches, screen production lots for faulty packages and support regulatory submission applications for product commercialization around the world.
Contract Analytical services providers perform laser-based headspace analysis on transparent (colorless) or semi-transparent (amber) packages. These packages must possess a minimum headspace volume and headspace path length. Our experts recommend this approach for vials, syringes, cartridges and bottles.
The Laser-based Gas Headspace Analysis is typically performed using non-contact methods, such as frequency modulation spectroscopy (White, 2012). During the assay, a near infrared diode laser light passes through the gas headspace region. The light is absorbed as a function of gas concentration and pressure (USP <1207.2> ). This absorption information is processed using phase-sensitive detection techniques (USP <1207.2>). A microprocessor analyzes the data and yields the test results (USP <1207.2>).
Analytical service providers conduct electrical conductivity / high voltage leak detection (HVLD) testing on a range of package systems, including parenteral vials, prefilled cartridges and syringes, plastic containers and plastic bags or pouches.