CCI CAMPUS

914.337.2005

CCI Consulting

PTI offers specialized Container Closure Integrity (CCI) consulting services to support clients throughout the product lifecycle. Our consulting solutions are designed to help pharmaceutical, biologics, medical devices, food, and nutrition manufacturers ensure the integrity of their packaging systems while meeting global regulatory standards. With extensive industry experience and technical expertise, PTI provides strategic guidance on establishing CCIT protocols, selecting suitable technologies, interpreting results, and resolving package integrity challenges.

Our consulting services include tailored support for R&D and clinical applications, sampling plan evaluation, and package development consulting. Whether you're designing new packaging components or scaling up to commercial production, PTI helps ensure reliable test methods and leak detection strategies that align with USP <1207> , USP 382, and Annex 1. We partner with clients to enhance quality assurance standards, optimize performance, and safeguard product sterility.

Test Method Development for Container Closure Integrity Testing

CCI Training

PTI’s Centers of Excellence in Hawthorne, New York, and St-Prex, Switzerland, offer a comprehensive suite of CCIT training programs tailored to all experience levels. Delivered by our Applications Engineering and Technical Support teams, these programs provide hands-on and classroom-based instruction covering a wide range of critical topics related to container closure integrity testing.

Training modules include regulatory requirement overviews (USP <1207>, USP 382, Annex 1, ASTM, ISO), general CCIT methodology, Maximum Allowable Leakage Limit (MALL) concepts, and method comparisons. We also offer practical system training for operators (beginner to advanced), test recipe development training for different applications, and application-specific sessions designed to address unique packaging challenges. PTI’s training empowers teams to build internal expertise, ensure method compliance, and improve system performance.

914.337.2005