Issue: Exclusive Online Content, Posted Date: 2/1/2017

West Introduces LyoSeal® Instant Sealing Solution & NovaGuard® SA Pro Safety System

 
West Pharmaceutical Services, Inc., a global leader in innovative solutions for injectable drug administration, recently introduced two new offerings at Pharmapack Europe 2017. The LyoSeal cap, an all-plastic, instant sealing solution for lyophilized drug products, is designed to minimize risk associated with established lyophilization processes, while maintaining the necessary sealing requirements. The NovaGuard SA Pro safety system, which is pending 510(k) clearance in the United States, aids in the protection of healthcare professionals, patients who self-inject doctor-prescribed medications, and individuals who assist self-injecting patients, from accidental needlesticks. These innovations, along with West’s high-value product portfolio and leading scientific insight, were showcased at the West Pharmapack booth, February 1-2, 2017, in Paris, France.


West’s LyoSeal® cap, an all-plastic, instant sealing solution for lyophilized drug products, designed to minimize risk associated with established lyophilization processes, while maintaining the necessary sealing requirements.


“We appreciate and understand that 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,” said Karen Flynn, Senior Vice President & Chief Commercial Officer, West Pharmaceutical Services, Inc. “As part of our ongoing commitment to our customers and their patients, we’re pleased to introduce LyoSeal and NovaGuard SA Pro — two products that directly respond to market needs. We look forward to showcasing these offerings — along with West’s breadth of scientific and regulatory expertise — to attendees at Pharmapack.”

West’s NovaGuard® SA Pro safety system, which is pending 510K clearance in the United States, aids in the protection of healthcare professionals, patients who self-inject doctor-prescribed medications, and individuals who assist self-injecting patients, from accidental needlesticks.


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

 

West’s NovaGuard SA Pro safety system helps protect healthcare workers and patients from accidental needlestick injury. 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 1-mL 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.

 

In addition to sharing more about these innovative products, experts from West presented on important industry topics during scientific and educational conference sessions:

 

Solving Complex Needs During Development of a Sensitive Next-Generation Drug Product

Tibor Hlobik, Sr. Director of Product Management, Prefilled Systems & Delivery at West, hosted this learning lab and presented a case study on the approval process for a polymer prefilled syringe and how fill-finish capability was established for clinical and commercial supply.

 

The Changing Regulatory Environment Concerning Elemental Impurities & Container Closure Systems

Fran DeGrazio, Vice President of Scientific Affairs & Technical Services at West, provided 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.

 

Emergence of Plastic Caps – Market Drivers & Key Considerations for Assessment

Miriam Beyer, Global Marketing Manager, Vial Containment & Delivery at West, hosted this learning lab on assessing the external environment and internal challenges towards a change in sealing.

 

For more information on West products and services, please visit booth #H26 at Pharmapack Europe or visit us online at www.westpharma.com

 

West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world’s pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West’s 2015 sales of $1.4 billion reflect the daily use of approximately 110 million of its components and devices, which are designed to improve the delivery of healthcare to patients around the world.

 

West and the diamond logo and NovaGuard® SA Pro are registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.

 

LyoSeal® is a registered trademark of West Pharmaceutical Services Deutschland GmBH & Co KG, a subsidiary of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.

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