PDA/FDA Regulatory Conference
Genesis will be attending this year’s PDA/FDA Joint Regulatory Conference taking place at the Marriott Renaissance in Washington, DC from September 16th to 18th. This flagship Conference consistently provides a unique opportunity to hear from and engage with numerous regulatory and industry leaders concerning the latest manufacturing, quality, supply, and compliance issues. Consider attending and be sure top stop by Table 5.
Follow the link to see where Genesis will be over the coming year…
More Than You Think
Genesis brings to the table much more than the time-honored Westcapper® sealing technology. We bring a complete understanding of the parenteral package itself. Our technical experts maintain long-standing relationships with parenteral package component manufacturers. We know the vial package. Our expertise in the science of sealing is deep-rooted and so is our commitment to seal integrity.
The Westcapper®
The industry standard in capping for parenteral packaging, the Westcapper® offers a wide range of sizes and capabilities up to 750 vials per minute.
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 three 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.
