Container Closure Integrity Testing
Container closure integrity of parenteral products is essential to protect the product through the entire lifecycle until patient delivery. PTI’s non-destructive inspection technologies verify container closure system integrity with deterministic quantitative test methods for vials, ampoules, syringes, cartridges and auto-injectors.
Container Closure Integrity of Parenteral Products
The United States Pharmacopeia USP 1207 guidance has been revised, encouraging the preference to deterministic, quantitative, and reliable non-destructive technologies to comply with quality standards.
Parenteral products are usually packaged in several packaging formats. Most common are the following formats - Liquid-filled containers such as vials, ampoules, syringes, BFS and autoinjectors, and also containers filled with lyophilized product.
Any breach in the package can cause product deterioration from microbial contamination, exposure to gases, water vapor and loss of solvent. Therefore, container closure integrity is an essential stage in the lifecycle of a sterile drug product. Container closure integrity defects can be hazardous to the patients. Life-saving drugs can lose their efficacy or lead to fatal side effects. CCI defects can result in oxidation and have a significant impact on drug’s effectiveness and shelf-life.