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.
News & Events
2023 PDA Annual Meeting
New Orleans, LA | Apr 03 - Apr 05, 2023
The PDA Annual Meeting is the premier meeting on pharmaceutical/biopharmaceutical manufacturing science and technology. The 2023 theme, Back to the Future: Learning from The Past in A Patient-Centric World, will spotlight the critical connection between our patients and the manufacturing process and enabling a patient-focused mindset on the manufacturing floor. This event provides a forum for sharing knowledge on developing new modalities and the adoption of innovative approaches and processes. See you in New Orleans! Booth 318.
Webinar
Container Closure Integrity on Parenteral Vial Systems
Wednesday, 29 March 2023 | 10 am EST
The pharmaceutical industry continuously releases new vaccines and drug products, which entails new challenges to ensure the sterility of such products during their lifespan. Parenteral packaging is critical in the development stage of a new drug. The package acts as the primary barrier to protect the drug product through its life cycle until it is administered to the patient. The efficacy of that barrier to maintain the sterility inside the container is paramount for the patient safety.
This webinar will present a review of CCI fundamentals on vial systems, regulatory considerations, the characterization of well-sealed vials (including residual seal force and leak testing), different capping systems, and the optimization of the sealing process. Attendees will gain valuable insights on the importance of package integrity over the life cycle of the product to mitigate risk of product contamination, which could impact patients’ health when administering the drug.
Aptus
Modular Vial Crimping System
The Genesis Aptus is a fully automated, servo driven, constant motion, rotary crimper. Ideal for mid to large production runs of time sensitive products such as lyophilized vaccines the Genesis Aptus is capable of sealing both large and small parenteral vials at up to 300 vials per minute.
Vera
Residual Seal Force Tester
The Genesis Vera Residual Seal Force Tester evaluate's seal tightness by measuring the Residual Seal Force in the stopper/seal combination of a parenteral package created as a result of the vial sealing process. The truth is in the details.
The FDA recognizes the use of RSF as a predictor of seal integrity.
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.
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.
