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 mass extraction testing on any package containing headspace, including parenteral vial packages, screw-capped bottles and flexible bags or pouches. In some cases, they can also leak test liquid packages by this approach if the threat of product formulation-clogging leak paths is addressed.
Mass extraction leak detection operates by drawing a vacuum on a sample enclosed in a chamber. The instrument monitors the airflow required to sustain a specific vacuum level. The flow required to keep the vacuum steady is proportional to the flow escaping from leaks in the sample under test.
Results are reported quantitatively, as flow rates, as well as qualitatively (Pass or Fail) according to acceptance criteria established in method development.
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.