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 seal-scan testing to identify defects such as inconsistent seals and areas of the seal in which the minimum seal width requirement is not met.
Airborne ultrasound technology, as found in the PTI Seal-Scan, presents an alternative for seal quality assessment. Using a pair of transducers located on opposing sides of a seal, ultrasound is emitted and monitored for transmittance to the opposing transducer. Areas with poor seal quality typically have gas pockets, which reduce the amount of ultrasound passing through the seal area. On the other hand, introduction of foreign material into the seal area may increase overall transmittance of ultrasound between transducers. Thus, resulting signals are indicative of seal quality. Data may be presented quantitatively, but also in the form of a qualitative “Pass”, “Warn”, or “Fail” if method development is performed. Additionally, a digital image of the seal quality may be compiled from multiple scans.
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.