Leak Detection for Finished Sterile Containers

Sponsored by: Gateway Analytical, an Aptar Pharma company

Focused on:

  • Sterile Containers
  • Leak Detection

Date: 20 July

Days to go: 37

Time: 9AM London / 1:30PM Mumbai / 4PM Beijing

Meeting the requirements of the USP <1207> Container Closure Integrity.

There is a critical need in the Pharmaceutical industry to perform leak detection testing on finished sterile containers. These defects are hidden and are not detected by visual inspection. Container Closure defects are a critical cause of the loss of sterility in sterile containers just as visible particulate matter defects are critical to the loss of quality of the parenteral medicines within them.

Leak detection, along with particulate matter defect identification, allow for on-time release of drug products that are intended for clinical trials and dosing schedules. They allow for scheduled release of commercial drug products onto the market that address critical health concerns as well as permit the urgent testing of drug product complaint samples to support field alert reports to FDA.

This webinar will provide an overview of the USP <1207> Container Closure Integrity chapter. It will also review the FDA deterministic leak detection methods that have a quantified result that can be validated over traditional probabilistic methods like blue-dye or microbial ingress. Also reviewed will be detailed case studies of common applications of leak detection in sterile liquid-filled vials and syringes, in vials stored and shipped on dry ice, and in lyophilized product vials.

Presented by

Dave Exline,

President, Gateway Analytical

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Antonio Scatena,

Director Sales and Marketing, Gateway Analytical

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Michael Gorski,

Senior Scientist, Gateway Analytical

Mike Gorski is a Scientist II at Gateway Analytical responsible for sample analysis and particle sizing and analysis for pharmaceutical projects. He has ten years of experience in the field, including a previous technical role in the testing and development of precision therapeutics. Mike is a court qualified expert in gunshot residue testimonies and a member of MAAFS and ASTEE. Mike earned a Bachelor’s Degree in Biology and a Master’s Degree in Biotechnology from Duquesne University.

Key Learning Objectives

  • Overview of the USP <1207> Container Closure Integrity chapter.
  • Learn why the FDA now prefers deterministic leak detection methods over traditional probabilistic methods.
  • Review common applications of leak detection for sterile containers.
  • Discuss our approach to CCIT projects.


  • R&D
  • Packaging
  • Project Management
  • Manufacturing
  • Quality Control
  • Quality Assurance