Flip-Off® Seal Family of Products Attracts Growing Number of Pharmaceutical Manufacturers

Known for a commitment to excellence in elastomeric components, West has complemented its vial closure portfolio with the Flip-Off® seal brand. Particularly in its ability to provide solutions for aseptic and clean crimping, the Flip-Off seal demonstrates potential to become an industry standard.

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The highest quality offering is the Flip-Off® CCS seal. It is used for aseptic crimping and its name reflects the key product attributes: Clean, Certified and Sterilized (CCS). Customers crimping in an aseptic area are looking for a low specified particle level (in line with grade A classification and comparable to ISO 5 guidelines)1,2 and a pre-specified bioburden prior to sterilization. These features, combined with an optimal seal manufacturing process, give pharmaceutical manufacturers the option of smooth, clean operation within an isolator.

Flip-Off® Plus is the newest member in the Flip-Off seal portfolio and is designed to meet the needs for clean crimping outside of the aseptic core under Grade A, but under constant Grade A air supply (laminar flow)². Although less stringent regulations apply for the clean crimping process compared to crimping in an aseptic area, the Annex 1 of EMA regulations require a specified bioburden for sealing². Flip-Off Plus was launched to support fill-finish operations to comply with the needs for bioburden speciation and offer a high-quality, easy to use component for drugs marketed within the EMA jurisdiction and beyond.

For pharmaceutical customers, West delivers consistency and reliability. The same     high-quality standards are applied to all sterilized seals and elastomeric components. These offerings are ready to be processed immediately and guaranteed to meet tight component quality levels, which may reduce complexity in an already highly complex pharmaceutical manufacturing environment. Additionally, relying on West products and services can potentially reduce downtime and simplify inventory management.

To learn more about the Flip-Off seal brand, visit the West website.

foto-miriam

 
Miriam Beyer
Marketing Manager, Vial Containment & Delivery
Miriam.Beyer@westpharma.com

 

 

 

References:

  1. Remington: Essentials of Pharmaceutics; Michael J. Akers, PhD (2013), Chapter 26 Parenteral Preparations, p. 495-532
  2. EUROPEAN COMMISSION; EudraLex; The Rules Governing Medicinal Products in the European Union; Volume 4: EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use; Annex 1: Manufacture of Sterile Medicinal Products.

 

Flip-Off® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.

A Well-Deserved Celebration for West St. Petersburg

As a special thank you to this year’s Director’s Cup Award winners, Eric M. Green, President and CEO; Annette Favorite, Sr. VP and Chief HR Officer; and Tom Gribbin, VP, Operations, Americas, served a catered dinner to all three shifts at our St. Petersburg facility. This visit from leadership provided an opportunity to personally recognize everyone for their commitment to safety, quality, productivity, lean programs and community service.

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This spring, during the Annual Shareholder Meeting, St. Petersburg was awarded the Director’s Cup for setting notable records in several key metrics during 2015, including:

  • Reducing recordable safety incidences by 60% and implementing two new safety incentive programs
  • Improving several quality metrics and cutting internal reject and customer complaint rates by roughly 50%
  • Achieving all-time high records of increased accuracy on customer complaint report submissions and reduced customer complaint report turn-around times

In the true spirit of West philanthropy, all leftovers from the event were donated to the Fischer House–a local shelter for veterans and military families–and the St. Petersburg Police Department.

West’s Director’s Cup Award was established by the Board of Trustees to recognize outstanding team performance by West facilities around the world. The award is determined annually by an independent senior leadership committee.

Congratulations to our St. Petersburg facility for continuing to raise the bar, demonstrate core Company values, and evidence a commitment to delivering the best to our customers.

Taylor

 

Taylor Pendergast
Global Communications Associate Specialist
Taylor.Pendergast@westpharma.com

The 2016 Internship Program – A Summer Well Spent

West’s Global 2016 Internship Program has, once again, quickly come to a close. This year a group of over 40 interns, chosen from a pool of 1,156 applicants, provided a wealth of knowledge, new perspectives, and unique strengths and skill sets to the business. Interns were placed at our West locations around the globe.

West’s internships give students the opportunity to delve into a wide array of disciplines and projects. These interns work alongside our industry experts and tackle projects where they have the potential to make an impact on West’s future, while increasing their own business acumen.

Priyansha Chadha, our Scottsdale facility’s Lean intern, ran a metrology staffing analysis enabling our QA team to plan for the next five years. Our Exton facility’s Analytical Lab Services interns, Keenan Pearson and Samantha Sholes, used preparative gas chromatography to test the purity of samples which will help prepare West for stricter FDA regulation guidelines. Finally, our Israel facility’s intern, Evyatar Ofir, had the chance to work on the implementation of West’s Product Lifecycle Management System.

“My time at West taught me how the design and manufacturing elements for pharmaceutical packaging and delivery systems and science come together to create a comprehensive solution,” said Exton’s Analytical Laboratory intern, Keenan Pearson. “I am excited to apply what I learned from my internship at West to my future educational and professional endeavors.”

Eric Green and Keenan Pearson

Eric M. Green, President and Chief Executive Office with Analytical Laboratory Intern, Keenan Pearson

Employees were especially impressed with the engagement from this year’s team of interns. It was evident that they gained an appreciation of West’s collaborative corporate culture, built confidence in their ability to communicate with all levels of the business, and established a concrete understanding of West’s role in the pharmaceutical industry. The 2016 interns demonstrated great proficiency in working on complex, biotechnical and biosimilar data analysis projects, strategic marketing research, and development of scientific methodology.

“We are grateful for the contributions that all of this year’s interns brought to West,” said Annette Favorite, Sr. VP and Chief Human Resources Officer. “We benefitted from their diverse skill sets and insight into important ongoing and new Company projects. We hope that this program has allowed them to expand upon what they are learning in the classroom to better prepare them for the world of work.”

Learn more about West’s Ambassador Internship Program here.

 

Taylor

 

Taylor Pendergast
Global Communications Associate Specialist
Taylor.Pendergast@westpharma.com

 

 

West Employees Race to Support Children

Fred200MileRelay

Runners – Mike Treadaway, Aaron Carrasco, Phylicia Zarnosky, Derek Roseman, Brian Meines, Mark Snyder, Erin Snyder, Kim Koning, Carson Koning, Ed Leon, Natalie Leon and Dave Morton
Van Drivers – Dan Trzybinski and Kurt Knoertzer
Team Manager – Tim Smith
Bike Support – Brandon Ellis
Catering Service – Chris Palmer

From August 5-6, 12 employees from West’s Grand Rapids facility participated in a 200 mile, overnight relay race. The Fred 200 Mile Relay spans the Fred Meijer White Pine Trail through Comstock Park and Cadillac, MI. This was the third year that our Grand Rapids, Michigan facility coordinated a team for the Relay.

The Fred 200 Mile Relay includes 36 “spurs” or legs, ranging from 2 to 9.5 miles per leg. The West team included runners, van drivers, bike support and a catering service.

Over the past three years, the team has raised over $18,000 for the Company’s employee-led fundraising campaign—West without Borders. This year the team’s fundraising efforts benefited the Children’s Healing Center in Grand Rapids, MI. The Children’s Healing Center is the first of its kind in the nation, and provides a safe, fun and healing environment, where kids living with weak immune systems and their families can connect with each other.

Congratulations team! To learn more about West without Borders visit our website.

 

Taylor

 

Taylor Pendergast
Global Communications Associate Specialist
Taylor.Pendergast@westpharma.com

 

 

 

Congratulations 2016 H.O. West Scholarship Winners

Scholarship Collage

West is pleased to congratulate the recipients of the 2016 H.O. West Foundation academic scholarships. This year the H.O. West scholarship program received 34 applications from among the many regions where West facilities are located and granted one scholarship for every four applications received.

“It is incredible to see such talented students from among our West family,” said Annette Favorite, Senior Vice President & Chief Human Resources Officer. “It is equally gratifying that the H. O. West Foundation can help them achieve their educational goals and career aspirations.”

The West scholarship program was established in 1972 to honor Herman O. West, the founder of West Pharmaceutical Services. Each year, the program offers the children of West’s full-time U.S. employees the opportunity to compete for a scholarship to a four-year college, two-year college or technical school. The scholarship is valued at up to $3,000 per year.

Winners were selected by West’s independent selection committee, which considered the student’s academic excellence, ACT/SAT scores, grade point average, class rank, honors and advanced placement courses, as well as an essay. All high school seniors of U.S. employees are encouraged to apply.

West commends the eight students that received the 2016 H.O. West Foundation scholarships and wishes them good luck in their educational endeavors:

  • Keri Bremigen: Williamsport, PA, Misericordia University
  • Galen Kardinal: Rockford, AZ, Coe College
  • Katherine Kornienko: Exton, PA, University of Delaware
  • Pallavi Kulkarni: Exton, PA, University of Delaware
  • Melissa Ling: Exton, PA, Penn State University Schreyer Honors College
  • William Ngo: Clearwater, FL, Carnegie Mellon University
  • Erin Snyder: Grand Rapids, MI, University of Michigan
  • Alexander Weck: Exton, PA, Duke University

 

Madison Bohn 3

 

 

Madison Bohn

Exton Communications Team Intern

West Participates in First PDA Europe Annual Meeting–Berlin, Germany

This summer, West Pharmaceutical Services was delighted to exhibit at the 1st PDA Europe Annual Meeting. PDA organized this unique conference about the future of injectables to provide participants with a first-hand opportunity to gain deeper insight into current and future advances in modern sterile manufacturing and quality oversight. West also supported the NovaPure® 1-3 mL plunger launch during the meeting. Throughout the event, attendees were given the opportunity to engage with speakers, industry peers, regulators and exhibitors.Novapure

West was actively involved by leading the course, “Development and Manufacturing of Pre-filled Syringes,” which was offered during the training workshops. The course provided an overview about practical aspects and trends of developing and processing pre-sterilized primary packaging systems and also focused on hot topics such as aseptic environments, particulates, silicone and single-use filling. Additionally, participants could learn from parallel tracks focused on areas such as Test Methods for Pre-filled Syringes, Cleaning and Disinfection, How to find the Right GMP for API’s, and Root Cause Investigation.

At the show, West showcased a range of high value products and highlighted the 1-3 mL NovaPure Plunger—an innovative, high-quality component for pre-filled delivery systems, designed to reduce particulate, ensure consistency of delivery and fit the changing needs of higher-volume injectable drug delivery systems. Technical details of the 1-3 mL NovaPure plunger were summarized in a comprehensive poster that was displayed on site.

To learn more about meeting visit their website. More information about the NovaPure brand can be found on the West website.

 

 

Author

Sabine Duda-Schaefers
Communications Specialist
Sabine.Duda-Schaefers@westpharma.com

 

 

The people of West’s Tempe, AZ Rockford plant

The American Southwest is the home of the rare and world-renowned Saguaro cactus, and also West’s Tech Group Rockford campus in Tempe, Arizona, which is equally unique in its capabilities as a contract manufacturing facility that produces drug delivery systems that are used across the world.

In the final part of our West on the Road -Tempe series, we hear from The Tech Group employees about the importance of working together as a team.

Mike Moran, Director of Operations, says that building a team to create new precision drug-delivery system starts with experience. His teams have logged years working together in the industry with a management group invested in providing them with the tools, information and training they need to perform at the highest levels.

Engineering Manager, Victor Cisneros, speaks to the collaborative nature of The Tech Group teams, who work together across departments to get things done: meeting goals, making products and serving customers’ needs.

Not only is collaboration a part of the fabric of our Rockford facility, but also the pride each employee takes in their work. That drives a dedication to quality to the products they make in the facility – as well as personally knowing people in their lives who could possibly use the life-saving and enriching products they make on any given day.