Parenteral Vial Sealing & Integrity Webinar
This FREE two hour seminar will be an overview covering component design, selection and qualification, capping system optimization and seal quality evaluation. Focusing on developing robust vial packaging systems and minimizing the risk of Container/Closure Integrity failures. The seminar will include tools for evaluation, including Residual Seal Force (RSF) testing, FMEA, and x-ray tomography. Special topics will include issues, such as raised stoppers and maintaining integrity at very low temperatures.
Roger Asselta, Genesis’s Vice President of Technical Affairs and Senior Advisor will present the course. He has thirty years of experience in parenteral packaging.
When: Thursday April 9th at 10 am EST.
The Integra Laboratory Vial Crimper
Small Package, Big Performance
The Integra Laboratory Crimper is a small vial crimper that is ideal for development, pre-clinical, clinical, pilot and compounding pharmacy operations. Available in four configurations the Integra can meet your small batch size needs assuring the best possible seal integrity.
Residual Seal Force Tester
The function of the Residual Seal Force Tester is to evaluate seal tightness by measuring the Residual Seal Force in the stopper/seal combination created as a result of the sealing process.
The FDA in its Guidance for Industry Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products recognizes the usefulness of properly validated seal force testing. Most importantly, RSF is useful in the establishment, validation and control of capping machine settings.