West Welcomes STEM Students throughout the Summer

STEM_july 2015

Since its inception in 2011, the Downingtown Science, Technology, Engineering and Mathematics (STEM) Academy has quickly earned the ranking as the number one high school in the state of Pennsylvania. With the STEM Academy located in the same district as West’s corporate headquarters, and a strong corporate culture of giving back to the community, a partnership between the two organizations was a natural fit.

West collaborates with the STEM academy in a variety of ways that harnesses that spirit of giving while also drawing upon the knowledge base available at West. One example is West’s work with teachers at STEM to create lesson plans that are project-driven and student-led. Additionally, West offers STEM students the opportunity to complete their 21 hours of required internship experience at the Exton headquarters over the summer months. The internship, along with 150 “Creativity, Action, and Service” hours, are required before graduation with the goal of creating well-rounded and community-oriented students.

“Having a strong technical talent pool is a requirement for West’s continued success,” said Karen Flynn, President, Pharmaceutical Packaging Systems. “If we want to ensure that students are prepared to earn advanced degrees and pursuing STEM careers, we need to support them early on.”

This year, 10 STEM students have been invited to West headquarters to fulfill their internship requirement over a four week period. The students have an opportunity to get answers to any questions they have about working in a corporate environment and are paired with a college student who is part of the West Ambassador Internship program.

On the STEM students’ first day of their internship, they attended a workshop to discuss what they wanted to gain from their experience and what was needed to develop their leadership skills further. Upon their return the following week, students were given time to shadow their mentors and learn about the projects they have been working on throughout their time at West this summer. Finally, STEM students attended a presentation that provided an overview of West’s products and the manufacturing processes involved.

“It’s very rewarding to see the STEM students engage with the Ambassador Interns, take an active role in preparing for their careers, and doing all of this while they are on summer vacation,” said Brian Stocker, Vice President, Human Resources, Americas.

West partners with the STEM Academy through their Business and Industry Advisory Board, which helps steer Academy initiatives and programs, including internships and other field experiences.

When choosing a rubber stopper for products to be marketed in the U.S. or Canada—consider Westar® Components

FAC KINS 028 West Pharm_Kinston-8296 LR

For many years, West has offered several ready-to-sterilize products that are qualified for a minimum 3-log Bacterial Endotoxin Reduction (BER). “Ready-to-sterilize” is known to West customers in Europe as “RS” quality. In other regions, such as South America or Asia, the ready-to-sterilize line of products includes our Superior Clean Product® (SCP) components and Enhanced Performance Products (EPP). These offerings reflect West’s commitment to quality components that support pharmaceuticals and biopharmaceuticals throughout the product lifecycle, while also fulfilling various regional market needs.

However, recent experience has led us to recommend Westar® RS components for our customers filing in the U.S., because of increasingly stringent requirements from the Food and Drug Administration (FDA) for extensive ongoing validation.

Customers who choose RS components select clean components that comply with applicable USP compendial standards and provide consistency of preparation from clinical trials through commercialization. Additionally, West performs a portion of the component preparation process.

Our Westar RS process is backed by an extensive and ongoing validation program employing a comprehensive matrix approach to establish coverage for a broad range of elastomeric products. This information is available to the FDA and Health Canada through our portfolio of Drug Master Files (DMFs), and it has been proven that the Agencies find this validation program to be acceptable.

Based on our experience, customers attempting to register an RS, EPP or SCP component with the FDA may have to commit to transitioning to Westar RS components in order to secure their approvals.  Especially for products marketed in the U.S. and/or Canada, consider Westar RS components. To learn more about Westar pharmaceutical stopper and syringe components, visit the value added processing section of our website.

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

Authors:

Bjoern Henze, Ph.D.
Manager, Technical Customer Support Europe
Bjoern.Henze@westpharma.com

Markus Robers, Ph.D.
Manager, Validation PPS Europe
Markus.Robers@westpharma.com

Capping: Reading Between the Guidelines

As members of the pharmaceutical community, we’re often keenly aware of regional regulatory differences. But it’s just as useful to focus on points of harmony, whether these are well-established, emerging, or implicit in regulatory and industry feedback.

In its current form, Annex 1 (Manufacture of Sterile Products) of the EudraLex Volume 4 Good Manufacturing Practice Guidelines has elicited its fair share of praise as “the most robust and specific guidance that we have,”¹ as well as puzzlement due to ambiguities around changing technologies and the ICH Q9 and ICH Q19 guidelines² that followed its 2008 publication. What is clear, is that Annex 1 has become an international reference standard, and that few informed discussions on clean capping requirements take place without some awareness of its provisions.

Both Annex 1 and FDA guidelines³ can be met by focusing on practical considerations such as air supply, design, process elements, and ‘clean’ process verification (Michael Baumstein, Pfizer, ISPE Tampa Conference 20104). Such approaches tend to highlight the common ground between regulatory authorities when it comes to implementation. A shared philosophy further manifests itself in regulatory feedback. While the FDA guidance, unlike Annex 1, does not spell out the need for lot to lot bio-burden control, FDA inspectors were very clear in a 2011 warning to a major manufacturer on the need to establish such controls for capping operations5. In this context, it is not surprising that West customers are asking for help in ensuring that they go beyond a narrow interpretation of local regulatory guidelines on capping. West’s Flip-Off™ Plus seals, which introduce bio-burden control at lot level, are a response to these questions and industry concerns.

FDA and EMA written guidelines may never be fully harmonized in terms of their scope and specificity. There are valid, long-standing cultural reasons for this: given the national and linguistic diversity of its stakeholders, the EMA is under more pressure to provide detailed, written frameworks. But the absence of such detail from North American guidance should not be taken to indicate divergence. Ultimately, navigating the challenges of operating successfully in an increasingly international environment comes back to the need to think in terms of overall quality and risk management rather than limited compliance goals. As Annex 1 continues to evolve through regulatory and industry consultation, contact your West representative to explore how our Flip-Off™ Plus seal offerings can meet your current and future capping needs.

Michelle Deutsch
Michelle Deutsch
Product Manager, ICS
Michelle.Deutsch@westpharma.com

 

1 West Pharmaceutical North America customer, March 18 (Working Group, 2015 PDA Annual Meeting, Las Vegas)

2 ICH Q9 Quality Risk Management, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002873.pdf

ICH Q10 Pharmaceutical Quality System http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002871.pdf

3 FDA Guidance for Industry

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070342.pdf

4 An Implementation Example of a Clean Process for Vial Capping, presented by M. Baumstein at the International Society for Pharmaceutical Engineering (ISPE) Tampa Conference, 22-25 Feburary, 2010, Tampa, Florida, USA

5 http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/UCM278641.pdf

 

Better Patient Outcomes at Your Fingertips

Technology is becoming a common component to any drug delivery mechanism. With West’s ongoing partnership with connected health expert, HealthPrize, a new course to improve patient outcomes has been charted. By connecting West drug delivery systems with the training, education and rewards from the HealthPrize model, we are addressing some of the most fundamental challenges surrounding adherence.

In a 2013 HealthPrize patient survey, 45% of patients responded that they would rather take out the trash, 27% of patients would rather get a shot, and 10% of patients would rather get a cavity filled, than take their medication. Not only do these statistics describe the patient perspective in a relatable manner, but they also show the tremendous potential for innovative solutions like those West and HealthPrize are working to bring to the marketplace.

As West continues to develop leading drug delivery systems, so too does HealthPrize continue to develop a customizable, interactive, patient model that incorporates gamification and fun into an experience that may be considered a grueling activity for many. HealthPrize understands the behavioral economics of the patient perspective on adherence for injection systems, and continues to educate patients and provide rewards for adhering to drug regimens.

Chief Medical Officer and Co-founder of HealthPrize, Katrina Firlik, MD, defines the success of HealthPrize as summarizing the short-term benefits of awarding patients with tangible rewards to encourage best practices for patients to ultimately achieve healthier, improved outcomes in patients. Together, both organizations are dedicated to help improve behaviors related to non-adherence and doing so in an easy, fun and rewarding way.

Chris Evans
Chris Evans
Vice President, Research & Innovation, PDS Proprietary Products
Chris.Evans@westpharma.com

West on the Road Episode #3: Veteran leadership keeps Jersey Shore on track

WOTR_screengrab2

In the final installment of this three-part video series on West’s Jersey Shore, PA plant, production manager Adam Wrench shares some of his background. Adam is a 10-year West veteran who started out in engineering and moved into product management and then production management. For him, the Lean-based continuous-improvement philosophy has been a constant motivator for the work in which he’s been involved.

The job now entails keeping production and quality at its highest levels in this 24-7 manufacturing facility. During the week, Wrench takes time to speak with workers on all four shifts and collaborate with them to implement quality-improvement initiatives. That teamwork led to the plant’s winning the 2014 Director’s Cup, a West award signifying operational excellence.

Wrap up your tour of the Jersey Shore plant and understand how quality is molded into every West component, and forged through teamwork and close attention to processes with a vigilant eye toward excellence in production and procurement.

The Tech Group Receives Recognition at Frost & Sullivan Manufacturing Leadership Awards Gala

Frost & Sullivan Award 2015

Earlier this month, The Tech Group, West’s global contract manufacturing solutions provider, officially received its Engineering and Production Technology Leadership award at the Frost & Sullivan Manufacturing Leadership Awards Gala in Carlsbad, California. Winners in this category were honored for embracing new design and production approaches to drive game-changing process improvements.

The award specifically recognizes The Tech Group’s innovative process monitoring strategy, an initiative known as E2: Every Machine, Every Part. This enterprise-wide initiative reviews and improves control processes by integrating a state-of-the-art process monitoring system across 300 molding machines at all seven of The Tech Group manufacturing facilities throughout North America.

The E2 initiative was launched as a pilot program in 2011 at The Tech Group’s Michigan plant. Its Process Excellence department tested manufacturing process discrepancies, including identifying sources of product variation and detecting product defects in real time. The Tech Group, heavily engaged in Six Sigma training since 2001, was able to leverage its experience in statistics and data collection, which was a critical step in the process. These findings led to new training programs, quality-focused infrastructure improvements and project management initiatives across West’s contract manufacturing facilities. Under the standardized process monitoring approach, it enhanced business processes by reducing manufacturing scrap, correcting up-time for post-injection molding assembly activities, and improving outgoing quality and on-time delivery to satisfy customers’ needs.

Several colleagues were on hand to receive the award in California. They included (as pictured above): Hector Leon, IT Manager; Shari Krusniak, Marketing Manager; Kim Koning, Site Director for The Tech Group Michigan; Bill Cowart, Engineering Manager – Process Excellence; and Mark McElfresh, Vice President of Operations, The Tech Group North America.

Congratulations to everyone at The Tech Group for their hard work and dedication that demonstrates West’s commitment to our customers.

 

West on the Road

WOTR_screengrab2

Episode #2: Meet Jersey Shore employees committed to patient health

It takes four shifts’ worth of dedication, around the clock, to produce 1.6 billion parts annually at the West Pharmaceutical Services’ manufacturing plant in Jersey Shore, PA. Production manager Adam Wrench continues the facility tour, introducing some of the diverse staff of employees who know that their efforts help make a difference in the health of the patients who receive medications packaged with the products they help create.

Continuous improvement initiatives are at the heart of the Jersey Shore plant’s processes, as Wrench describes how new gowning, goggles or molding upgrades are constantly being upgraded in the quest for higher quality. In employee interviews, workers share their personal ideals of keeping both West’s customers and the patients in mind.

They understand that we all are patients at one time or another in our lives, and the next drug packaging component they make could end up a part of your treatment, their own, or our families’. That idea fuels their drive to make the best quality products they can. This episode shows both their dedication and understanding that – while they might be working on elastomer parts in a clean environment – it’s the real-life customers and patients that ultimately matter.

 

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