Posted on December 4, 2013 by West Pharma
Employees from The Tech Group’s Phoenix, Rockford, Scottsdale and Tempe West facilities raised more than $72,000 for Upward Children and Families as part of the 2013 West without Borders fundraising campaign.
Established in 1958, Upward helps children with special needs achieve their highest potential, while empowering their families to thrive. Upward is dedicated to improving the lives of children and families through education, therapy and loving care, and provides special education and childcare for children with developmental disabilities and/or medically fragile children.
Upward also offers pediatric therapies to children with disabilities in five specific disciplines: physical, speech and language, occupational, music, and feeding and swallowing.
In addition to helping beautify Upward’s facility and grounds, employees participated in several activities, including the Ragnar Relay, where volunteers ran more than 200 miles in 27 hours. Additional festivities included a motorcycle run, a dusk-to-dawn bike ride, ice cream socials, BBQ luncheon, pancake breakfast, yard sale and a variety of cooking competitions and food sales. Silent auctions and raffles also helped to add to the bottom line for Upward.
“Over the first half of 2013, West and Tech Group employees in Arizona have organized and participated in a number of fun activities to raise awareness and money for a very worthwhile cause,” said Mike Treadaway, Vice President, Tech Group. “Their generosity has helped fund critical activities at a time when funding is difficult. This year’s campaign was a phenomenal success.”
Filed under: West in the world | Tagged: philanthropy, Ragnar Relay, Tech Group, Upward Children and Families, wwb | Leave a Comment »
Posted on December 2, 2013 by West Pharma
QbD, CQA, QTPP,FEA – what does it all mean? Quality by Design (QbD) can be confusing, but it really doesn’t have to be. QbD was designed to promote an understanding of the product and manufacturing process starting with product development. When designing and developing a product using QbD principles, manufacturers must define desired product performance and identify Critical Quality Attributes (CQAs). The product and process is then designed to meet those product attributes, which leads to understanding the impact of material attributes and process parameters on the CQAs and identification and control of sources of variability. As a result of this knowledge, a company can continually monitor and update its manufacturing process to assure consistent product quality.
A Quality Target Product Profile (QTPP) is used to establish CQAs. When West decided to create a new syringe plunger it created a QTPP with a CQA for control of breakloose and glide forces. Development of the NovaPure® plunger included risk-based design inputs, Finite Element Analysis (FEA) modeling, data generation on multiple concepts, and final product performance verification with glass barrels from multiple suppliers of a 1mL long staked needle syringe. Throughout the development process QTPP served as a guideline to assure that targeted specification values for breakloose and glide force were met. Using QBD philosophy and principles can help to optimize breakloose and glide forces and significantly reduce plunger variation from part-to-part
Use of QbD principles ensures that components are developed based on science and data-driven decisions, and meet critical specification for defects, visible and sub-visible particulate and extractables consistently. In order to achieve a high-quality product, QbD components are washed and steam sterilized for optimized material compatibility and the knowledge gained throughout the process is used to maintain continuous improvement by the manufacturer. Selecting a manufacturing partner like West early in the development process can help pharmaceutical companies choose a high-quality component for use in prefillable syringe systems that will meet demands for high quality, improved total cost, and increased safety and security for the drug product.
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NovaPure® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Filed under: QbD | Tagged: CQA, FEA, NovaPure, QbD, QTPP, Quality | Leave a Comment »
Posted on November 25, 2013 by West Pharma
As biologics and other injectable drug products gain market share, greater scrutiny is being paid to the interaction between the drug product and its container closure system, including stability during shelf-life and particulate burden, among other critical quality attributes. Over the last several years, drug product recalls have increased due to quality issues, including fundamental weaknesses in primary glass containers that have resulted in problems such as breakage or delamination. Additionally, as more attention is paid to the integration of primary drug containers with devices to form combination products, finding solutions to these problems has taken on an increased urgency in order to protect patients by assuring the integrity and proper delivery of drug products.
Meet increasing high-quality demands by improving your current prefilled syringe system or designing a container closure system specifically for your sensitive drug product. Through optimized washing and validation processes, vision verification and manufacturing with quality by design (QbD) principles in mind, West works with you to answer the call for high-quality packaging components.
West’s plungers provide a packaging solution that suits both your needs and the needs of your drug product with increasing levels of quality.
Unrivaled quality…by design
·Market proven elastomeric formulations
·Ease of transition from vials to prefillable syringe systems
·Lower levels of potential extractables, a result of steam sterilization
·Reduce end-of-line drug rejections
·Reduce field complaints for particles and defects
·Prequalified and validated to global standards
·Increase quality with your current products
·High-quality components designed for biologics and sensitive drug products
·Optimized performance for use in auto-injection systems
·Patient needs drive quality
·In-depth product knowledge
Talk to West today to determine the right packaging for your drug.
Westar®, NovePure® and Envision™ are trademarks or registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Filed under: Components | Tagged: components, envision, novarpure, PFS, prefilled, QbD, syringe, westar | Leave a Comment »
Posted on November 20, 2013 by West Pharma
Component processing is a source of risk and variability, especially for loose particulate and silicone oil that can compromise quality, putting patients at risk. To simplify drug development and streamline manufacturing, pharmaceutical companies can select cartridge plungers and lined seals in a ready-to-use format.
World-class cartridge components are manufactured for consistency and quality. Westar® component processing reduces the risk of variability and its potential effects on drug quality, safety and efficacy. Westar cartridge components can help reduce the risk of product loss and failures.
Westar components offer:
•Validated particle levels in specified size ranges.
•Enhanced device functionality because of the optimized silicone level on the plungers.
•Excellent re-seal properties to meet multi-dose requirements.
•Lower levels of potential extractables, a result of steam sterilization.
•The confidence that your drug cartridge components are manufactured from market-proven elastomer formulations.
Westar cartridge components are available in ready-to-use or ready-to-sterilize formats for flexibility in operations. With either choice, components are supported by detailed technical knowledge documentation packages.
Westar® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Filed under: Components | Tagged: components, PFS, westar | Leave a Comment »
Posted on November 18, 2013 by West Pharma
Employees in West’s St. Austell, Cornwall, location raised more than £4152.81 for local charity, Children’s Hospice South West (CHSW). The charity is dedicated to providing the best possible hospice care for life-limited children and their families from southwest England.
West employees took part in a sponsored cycling event on exercise bikes at Kingsley Village. Employees could choose to do a 15- or 30-minute cycle ride, which raised funds for CHSW’s Little Harbour. A sanctuary for children with life-limiting conditions and their families, Little Harbour has been open for over a year and offers a home-away-from-home environment while also giving 24-hour care and support to families. The children’s hospice is a place where families can relax and enjoy precious time with each other.
Lee Burford, West employee and participant in the cycling event said, “Everyone involved, from the organizers to the participants gave 100 percent effort and commitment, which was reflected in the generous donations and sponsorships from friends, family and public donations. It was a great event to be involved with and a pleasure to help raise funds for such a worthwhile cause.”
West Corwall has supported Children’s Hospice South West since the start of their Precious Lives Appeal to raise money for the creation of CHSW’s third hospice, Little Harbour in St Austell.
Bernadette Chambers, Corporate Fundraiser for Children’s Hospice South West said, “The amount of money raised by all the participants from West is incredible. Everyone at Little Harbour is so grateful for all donations that were made for the cycling event.”
To learn more about Little Harbour or Children’s Hospice South West, visit www.chsw.org.uk.
West without Borders is not affiliated with Doctors Without Borders®, which is a registered service mark of Bureau International de Médecins Sans Frontières.
Filed under: West in the world | Tagged: west without borders, wwb | Leave a Comment »
Posted on November 15, 2013 by West Pharma
Diane Paskiet will speak at the U.S. Pharmcopeial Convention’s “Suitability and Compatibility for Packaging and Delivery Systems: Extractables and Leachables” Conference, which will be held at USP Headquarters in Rockville, Maryland, on December 9-10, 2013.
Diane serves as a session chair for the “Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems” and “Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product” programs. She is chair of the PCRI/PODP Leachables and Extractables Working Group and will discuss the goals and objectives of the group at a session on Tuesday, December 10.
Additional topics include:
USP General Chapter <661> Plastic Packaging Systems and Their Materials of Construction
<661.1> Plastic Materials of Construction
<661.2> Plastic Packaging Systems for Pharmaceutical Use
<1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems
<1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems
<1664.1> Orally Inhaled and Nasal Drug Products
PQRI safety thresholds and best practices for extractables and leachables in parenterals and ophthalmic drug products
For more information or to register to attend, visit http://www.usp.org/meetings-courses/workshops/suitability-and-compatibility-packaging-and-delivery-systems-extractables-and-leachables
Filed under: Extractables and Leachables | Tagged: extractables, leachables, PQRI, USP | Leave a Comment »
Posted on November 12, 2013 by West Pharma
Cartridge-based administration using injection device systems has dominated the insulin market for many years. In 2011, the insulin market for cartridge-based container closure systems was at an estimated 1 billion units. Additional applications for cartridge-based container systems include dental, at more than 450 million units per year, and therapies such as human growth hormone, interferon and epinephrine. In fact, thanks to lower production costs when compared to vial and syringe systems, cartridge-based delivery has found a widespread and growing market.
As the healthcare market continues to evolve and administration in the home care setting increases, cartridge-based delivery has made inroads into a variety of markets. Today, systems are in use or are under consideration for use with such therapeutic categories as anemia, rheumatoid arthritis, dermatology, oncology and hepatitis. In addition, insulin use is increasing due to the growth in population and higher demand in emerging countries, so the diabetes care market is evolving to provide more accurate and reproducible dosing. Insulin pen injectors, which commonly employ a 3.0mL cartridge, provide convenience and ease of use to patients, which may in turn help to improve patient compliance.
As the global market moves toward home-based care and multi-dose delivery systems for select therapeutic categories, pharmaceutical manufacturers are now seeking sterile components, including cartridges, plungers and other high-quality components, that are capable of offering ready-to-use quality and high functional performance in a variety of delivery systems and devices. Such quality is essential to the functionality, safety and efficacy of pens, injection devices and cartridge-based delivery systems.
West offers high-quality, ready-to-use cartridge components. Our industry-proven Westar® component processing reduces the risk of variability and its potential effects on drug quality, safety and efficacy.
By Tibor Hlobik
Global Director, Marketing PFS Platform
Filed under: Uncategorized | Leave a Comment »