Daikyo Crystal Zenith® Polymer: How does it compare to other plastic packaging material?

Part I

This is a first in a two part series dedicated to the origins and attributes of the Daikyo Crystal Zenith® Polymer 

In the early 1990s, Masamichi Sudo, founder and past president of Daikyo Seiko, Ltd., first developed the Daikyo Crystal Zenith polymer. This custom formulated cyclic olefenic polymer, available today in the Daikyo Crystal Zenith (CZ) portfolio of products offered by West, represents his lifelong ambition to improve all aspects of parenteral packaging and commitment to delivering the most precise formulation to the marketplace.

Mr. Sudo started his endeavor by creating reliable elastomeric closure solutions like B-2 lubricious coating and Flurotec® barrier film, a fluropolymer film lamination to protect both elastomer and drug product from each other. Enormously successful, these technologies led the way for Mr. Sudo to turn his attention to the nagging problems related to him by clients who were dissatisfied with glass and other vessel materials such as polypropylene and polyethylene.

Working with one of the world leading polymer suppliers, Mr. Sudo rejected formulation after formulation in a demanding search for the perfect pharmaceutical container. He sought after a material which would safely contain his clients life-saving drug products without changing it in any way. In addition, he demanded robustness so that physical damage would be a thing of the past. Just like the glass vial, rubber stopper and metal seal system replaced the glass ampoule on a grand scale, he hoped that the new material would supplant these legacy materials to the benefit of patients around the world. Finally, after years of empirical study of various polymer recipes, Mr. Sudo was satisfied with what we now know as the Daikyo Crystal Zenith polymer, or simply CZ.

Check out the West blog next week to learn more about CZ’s properties and the ways in which CZ compares to glass.

Author:
Polini Gene
Eugene Polini, Principle Program Manager, CZ Initiatives
Eugene.Polini@westpharma.com

Jennifer Ogden named West’s HBA Rising Star

Jenn Odgen

We are pleased to announce that Jennifer Ogden, Director, Global Accounts, has been recognized by the HealthCare Businesswomen’s Association (HBA) as West’s 2015 Rising Star. Jenn is a leader among the sales force and is responsible for developing and driving the execution of account strategies with West’s global biotech customers.

“Jenn is a role model within the West Sales organization and embodies the spirit of the HBA Rising Star,” said Karen Flynn, President, Pharmaceutical Packaging Systems, West. “Admired by her peers across the organization, Jenn leads by listening and working to understand the opportunities and issues in front of her, communicating the benefit of taking action and mobilizing her colleagues to ensure positive business results.”

HBA Rising Stars are professionals who contribute significantly to their organization; exemplify leadership and serve as a role model for others; assist those in subordinate or peer positions and are team players; and exhibit dedication to the healthcare industry. As a corporate member of the HBA, West is proud to honor Jenn as our first HBA Rising Star.

Jenn was officially  honored at the HBA’s 26th Woman of the Year event that took place today in New York City.

“I am proud to be part of such an elite and talented group, supporting the advancement of women in the healthcare industry,” said Jenn.  “Throughout my career, I’ve been inspired by many truly remarkable leaders, both women and men, who have encouraged my development, challenged my thinking and helped to shape my career. The Rising Star award is a tribute to these very important people in my life.”

West’s engagement with the HBA is part of the broader West WIN (Women Investing and Networking) Group initiative, which is dedicated to fostering the development of the women of West. Congratulations Jenn on this well-deserved recognition!

 

West Bolsters R&D Strategy with Global Site Expansions & Upgrades

Print

 

West today announced a multi-year investment as part of the Company’s evolving research and development strategy. To better support pharmaceutical customers around the world, West will add capabilities to all of its global Packaging Systems R&D facilities, and develop two new R&D Centers of Excellence—one in the Asia Pacific region and one in Europe—to leverage regional capabilities and expertise in parenteral drug packaging.

“For more than 90 years, West’s focus on innovation, science and service has made us a trusted partner for pharmaceutical and biopharmaceutical companies worldwide,” said Karen Flynn, President, Pharmaceutical Packaging Systems, West. “Our enhanced R&D Development Centers—in all regions of the globe—will further our commitment to our customers by providing world-class, science-based process and product development that enables us to quickly and efficiently anticipate and respond to changing market needs with new, innovative solutions.”

The facility in Europe will be the Company’s Center of Excellence for drug vial and cartridge seals, plastic technology and packaging component materials development, and will be on line by the end of 2016. The Company’s location in the Asia Pacific region will serve as a Center of Excellence for innovation across all technologies specific to the emerging markets and is expected to be operational by the end of 2015.

In addition to the new facilities in the Asia Pacific region and Europe, a significant investment is being made in North America to expand the current R&D center located within the Exton, Pa. headquarters, and to upgrade the St. Petersburg, Fla. facility.

West’s comprehensive research and development global network also includes development centers for self-injection and drug delivery systems along with the Company’s contract manufacturing facilities in Tempe, Ariz., and Dublin, Ireland. A team focused on innovation in delivery systems is led from the West Innovation Center in Washington, N.J.

West’s global investment in R&D demonstrates the Company’s focus on developing the most advanced packaging and delivery systems for its customers in order to meet the growing demands of the healthcare industry.

 

West’s Diane Paskiet to Co-chair the 2015 PDA Pharmaceutical Packaging Conference

PEOP WEMP Paskiet Daine 385 LREZ

West is proud to announce that Diane Paskiet, Director, Scientific Affairs will serve as Co-chair at the upcoming PDA Packaging Conference in Baltimore, MD. In her leadership role for the meeting, Diane will moderate several sessions, including Repackaging – Problems and Solutions and The Future Direction of Devices and Patient Adherence/Compliance.

This year’s conference—an update on current challenges and future directions—promises to take on a wider breadth of topics, including human factors and systems engineering and how to leverage this data to drive patient adherence in the years to come.

“The annual packaging conference is intended to provide solutions for both pharmaceutical companies challenged with developing and manufacturing quality products to meet patients’ needs, as well packaging suppliers faced with meeting the ever-increasing standards for container closures and delivery systems,” said Diane. “I look forward to seeing decision-makers from across the industry take a deeper dive into tough regulatory and scientific issues by examining various case studies and learning about best practices from some of the biggest names in healthcare.”

Diane will be joined at the meeting by colleagues John Chippari Vice President, Regulatory Affairs and Andrea Straka, Senior Technical Account Specialist.

John’s session will raise awareness about the unique challenges related to licensing in China, compared to other developed and developing countries around the globe. “Most pharmaceutical companies don’t realize that licensing in China is a three to four year endeavor,” said John. “It is important for manufacturers and suppliers to understand this complex process from the earliest stages of development so that the timeline for commercialization is accurately defined.”

Finally, on Tuesday afternoon, Andrea will address Rubber and Seal Nonconformities – An Update and Sample of the Upcoming PDA Technical Report and provide her perspective as co-Chair for the PDA Elastomers Technical Report Taskforce focused on creating a lexicon of stopper and aluminum seal defects. Andrea has spent the last 12 years working closely with West customers to guide decisions for appropriate container closure systems, troubleshoot issues and solve complex challenges for their drug products.

For a chance to hear from West’s experts on topics that go beyond packaging and manufacturing and into the patient experience, join Diane, John and Andrea in Baltimore from May 18-19. More details can be found on the PDA website.

Join West’s Free Webinar–Unlocking the Combination: Strategies to Deliver Integrated Prefilled Solutions

combination products

How can your packaging and delivery system meet the requirements of the drug product, the expectations of the end user and the demands of regulatory agencies all at the same time?

Start with the end in mind.

By applying new technologies intended for use in auto-injectors and electronic wearable injectors, and designed with the patient in mind to ensure quality, performance and ease of use early in the drug development process, you can unlock the combination to integrated drug delivery.

Join West Pharmaceutical Services, Inc., experts Fran DeGrazio, Vice President, Global R&D, TCS and SPM, Pharmaceutical Packaging Systems and Bob Nase, Vice President of Quality Assurance for our upcoming webinar featuring insights and case studies on:

  • Market trends for self-injection
  • Fulfilling regulatory expectations
  • Integrated solutions for drug delivery
  • Wearable injectors
  • Solutions for biologics
  • And more

For more information or to register:

Contact West.Pharmaceutical.Services@westpharma.com with any questions.

 

 

West Pharmaceutical Services at INTERPHEX 2015

Interphex booth

From April 21-23, West Pharmaceutical Services joined 12,000+ global pharmaceutical and biotechnology industry professionals and 600+ suppliers at INTERPHEX—the International Pharmaceutical Expo—sponsored by the Parenteral Drug Association. Every year in New York City, the show brings together industry leaders to focus on biopharmaceutical development and manufacturing solutions that can safely and cost effectively process all dosage forms for life-enhancing drugs.

Not only did the West sales team welcome visitors to Booth #1106, but Andy Polywacz, Vice President Quality Assurance and Jen Riter, Sr. Director, Global Analytical Services, Analytical Labs, presented: Particles Causing End of Line Rejects and Drug Product Recalls: Overcoming Packaging Challenges and Need for Adequate Controls. The session provided insight into the various sources, causes and concern for particulates from primary and secondary packaging components.

Andy specifically outlined the four main contributors of foreign matter—people, equipment, environment and materials—and urged the audience to consider holistic approaches to mitigate risks associated with packaging. Among these is the adoption of standard manufacturing practices to address particulate risk that meet the needs of both the pharmaceutical industry and today’s regulatory environment.

Jen’s presentation took a deeper dive into the various methods of particle testing and explained how selecting the optimal method is dependent upon a better understanding of the particle load.  While pharmaceutical ingredients and stability issues can contribute to particle load, as does the environment and manufacturing equipment, materials used in primary and secondary packaging components are often identified.

“Events like INTERPHEX are what enable and encourage technology leaders within the industry to continue to drive forward with improvements and advancements for the betterment of the patient,” said Simon Côté, Senior Technical Support Engineer. “It gives companies like West the opportunity to share our product offerings, while at the same time learn about new and innovative technologies and build relationships within the industry.”

West Attends Girls Exploring Tomorrow’s Technology Event

Print

West team members helped to spread the word about how fun and rewarding technology careers really can be when they attended the Girls Exploring Tomorrow’s Technology (GETT) event on March 21, 2015, at the Great Valley High School in Malvern, PA. More than 530 young women attended the event, which encourages middle school and high school age girls to pursue careers in technology, sciences, engineering, and art and design. GETT is a STEM program (Science, Technology, Engineering and Math) designed to ensure students are exposed to scientific disciplines and make them aware of their career options in these fields. This program was created in response to statistics that indicate girls are shying away from these fields. The trend was highlighted in a 2012 survey from My College Options and STEMconnector, which stated, “Male students are over three times more likely to be interested in STEM majors and careers, compared to female students.”

West supported the free, fun, informational event by holding a workshop and sending a group of female employees from the company to engage with students. Attendees learned facts about how technology careers can be fulfilling, fun and rewarding personally, professionally and financially. Lauren Orme, Peggy Frandolig, Lisa Wagner and Monica Habash attended on West’s behalf, with support from Lauren Burgess, Whitney Winters, Diane Rychlak and Nicole Whitman. Karen Flynn, President, Pharmaceutical Packaging Systems, also volunteered at the daylong event.

“At West, giving back to the community is at the heart of our corporate culture,” said Peggy Frandolig, Director of Technical Customer Support. “As a company invested in developing future scientists, we were thrilled to attend the GETT event to educate these young girls about all of their possibilities in the area of STEM.”

West’s workshop activity featured a lesson about how to package an injectable medicine. The girls were instructed to place a gummy bear into the vial and go through all the steps to make sure their vial was properly packaged with a stopper and seal, and then crimped to ensure safe and sterile packaging. West employees explained how applying science, technology, engineering and math is a critical part of their day-to-day jobs.

According to Harris interactive for the American Society for Quality, 2009 “21% of girls say their parents encourage them to become an actress, while 10% of girls say their parents have encouraged them to think about an engineering career.” GETT aims to steer girls towards STEM-based career choices. More recently in 2012, The Girl Scout Research Institute stated that “more than half (57%) of all girls say that girls don’t typically consider a career in STEM.”

“Being there to influence those girls and help them realize their potential, made me think about all that they will do one day,” said Lauren Orme, Manager of Laboratory Client Services. “It was exciting to be a part of that.”

Follow

Get every new post delivered to your Inbox.

Join 1,250 other followers