West introduces LyoSeal instant sealing solution and NovaGuard SA pro safety system at Pharmapack Europe

Scientific and educational sessions will take place on February 1–2 in Paris

West Pharmaceutical Services, injectable drug administration company, introduced two new offerings at Pharmapack Europe 2017.

The LyoSeal cap, an all-plastic, instant sealing solution for lyophilised drug products, is designed to minimise risk associated with established lyophilisation processes, while maintaining the necessary sealing requirements.

The NovaGuard SA Pro safety system, which is pending 510(k) clearance in the US, aids the protection from accidental needlesticks. It is intended for healthcare professionals, patients who self-inject doctor-prescribed medications and individuals who assist self-injecting patients.

“We look forward to showcasing these offerings—along with West’s breadth of scientific and regulatory expertise—to attendees at Pharmapack.” said Karen Flynn, Senior Vice President & Chief Commercial Officer, West Pharmaceutical Services, Inc.

“In today’s healthcare environment, our customers are continually looking for new packaging solutions that offer manufacturing efficiencies, as well as products that provide an improved experience for healthcare providers.”

The LyoSeal cap provides a new option to help pharmaceutical companies safely and efficiently preserve and protect lyophilised drug products. Constructed of medical-grade polypropylene, the LyoSeal capenables complete container closure within the chamber and mitigates several common challenges associated with the lyophilisation process by:

• Safeguarding vacuum and headspace content through immediate vial closure in the chamber;
• Buffering between the stopper and chamber shelves to prevent stoppers sticking to the shelf
• Reducing the risk of glass breakage within the lyo chamber due to the spring force design.

The NovaGuard SA Pro system can be deployed using a single-handed technique and was designed to prevent pre-activation during handling.

The system is compatible with ISO 1mL long glass-staked needle syringes and is transparent for ease of drug inspection and delivery.

Furthermore, the device design facilitates easy assembly of a glass pre-filled syringe with very minimal change parts and changeover time to existing assembly equipment.

West will present on important industry topics during scientific and educational conference sessions:

• ”Solving Complex Needs during Development of a Sensitive Next Generation Drug Product” — Tibor Hlobik, Senior Director of Product Management, Prefilled Systems and Delivery at West, will host this learning lab and present a case study on the approval process for a polymer prefilled syringe and how fill-finish capability was established for clinical and commercial supply. (Feb 1 at 10:10 am.)
• ”The Changing Regulatory Environment Concerning Elemental Impurities and Container Closure Systems” — Fran DeGrasio, Vice President of Scientific Affairs and Technical Services at West, will provide an overview of the ICH Q3D guideline, its implication on related USP chapters and an overview of method development work completed to provide guidance to a new USP elemental impurities method. (Feb 1 at 11:00 am)
• ”Emergence of Plastic Caps – Market Drivers and Key Considerations for Assessment” — Miriam Beyer, Global Marketing Manager, Vial Containment & Delivery at West, will host this learning lab on assessing the external environment and internal challenges towards a change in sealing. (Feb 2 at 10:50 am)

Companies

• West Pharmaceutical Services