The pharmaceutical industry continues to drive innovation in the space for new drugs and drug delivery systems while facing the heightened scrutiny of regulators. The packaging and primary sterile barrier used in drug delivery systems protect the drug product through its life cycle to the point of use. The performance of the primary sterile barrier and the functional components are critical to patient safety.
Container Closure Integrity(CCI) is more than just a quality attribute. CCI determines the safety of the product at the time of use, and the selection of the appropriate CCI inspection method upholds the quality standards that pharmaceutical manufacturers stand by today. Regulatory bodies are pursuing oversight of CCI with greater vigilance. Guidance documents are encouraging the use of deterministic, reliable test methods to support industry-wide quality standards.
Pharmaceutical Package Testing
Package leak test methods offered by CCIT s.a. are all non-destructive, quantitative test methods with a distinct focus on the reliability of the test result, and the ability to assure integrity at the highest level. CCIT s.a. offers a range of products and services to satisfy CCI testing needs to determine the safety of all types of pharmaceutical packaging formats such as ampoules, vials, pre-filled syringes, blister packages, pouches and rigid containers.
Experimental or Feasibility studies provide clients with a deeper understanding of the container system, the inspection technology, and potentially effective solutions that can be deployed to assure the quality of container systems. Advanced testing campaigns can be leveraged to make informed decisions about container systems and bring improved inspection methods into the production environment.
The technologies that CCIT s.a. offers for pharmaceutical package quality are an industry gold standard for sensitivity, reliability, and performance. Manufactured by PTIUSA, PTI inspection systems offer the most reliable inspection solutions for the highest risk pharmaceutical applications. PTI technologies are non-destructive to both the package, product and create zero waste. When the implication of test results has a significant impact on stability studies, clinical trials, production performance and patient safety, PTI’s technologies are the most reliable inspection solution.
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