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.
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.
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.
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.
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
addition to sharing more about these innovative products, experts from West presented
on important industry topics during scientific and educational conference
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
Emergence of Plastic Caps – Market Drivers & Key Considerations for
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.
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.
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.