Pharmaceutical Package Integrity Testing
The pharmaceutical industry continues to bring breakthroughs in the field of new drugs and drug delivery systems amidst the increased scrutiny of the regulators. The packaging acts as the primary sterile barrier in drug delivery systems that safeguard the drug product through its life cycle. The efficiency of the primary sterile barrier and the functional components are of utmost importance to patient safety.
Container closure integrity is over and above a quality feature. Container closure integrity determines the safeness of the drug product at the time of use. The selection of the right CCI inspection methodology holds up to the quality standards endorsed by the pharmaceutical manufacturers. Any negligence of CCI is taken seriously by the regulatory bodies. The guidance documents stand by the deterministic, reliable test methods for measuring the industry-wide quality standards.
Pharmaceutical Package Testing
PTI insures the container closure integrity of pharmaceutical packaging formats that include parenteral products (vials, ampoules, syringes, autoinjectors) to blister packaging, induction sealed bottles and flexible packaging (pouches, sachets and suture packaging). The United States pharmacopeia released guidance in 2016 stating that deterministic methods are preferred over probabilistic test methods. Test methods offered by PTI are all deterministic and quantitative test methods that ensure the integrity of the supreme level. The PTI inspection systems for pharmaceutical packaging test methods are of the industry gold standard for sensitivity, reliability and performance. They are also non-destructive test methods that create zero waste.
PTI’s technologies are the most sensitive and most reliable solutions for pharmaceutical packaging applications where the results have a significant impact on stability studies, clinical trials, production performance and patient safety.
We offer a wide range of products and services that meet the container closure requirements of the pharmaceutical industry and regulatory agencies.