William Knaup Nominated by the Philadelphia Business Journal for “Veterans of Influence” Award

Last night, The Philadelphia Business Journal honored 20 individuals from the Greater Philadelphia area with a “Veterans of Influence” award. West’s William Knaup, Engineering Technician, Exton, was among the recipients who were recognized for their ability to capitalize on their unique skills in order to transition from military to civilian life and further advance their careers.

Bill Knaup

Bill served as a Senior Airman in the United States Air Force for 6 years–three active and three inactive. He was honorably discharged in 1976. For the last 24 years, Bill has played an important role in West’s success. More specifically, Bill was instrumental in completing the packaging validation work necessary to make West’s SmartDose® technology platform ready for launch.

Bill and his team continue to support patients with high-quality products that address current and future healthcare challenges. He has shown the work ethic, determination, selflessness and teamwork exhibited by the many veterans employed by West, and continues to serve as an example to everyone with whom he works.

Bill is passionate about a wide array of national and local philanthropic endeavors. He is actively involved in the healthcare community through St. Jude’s Hospital. Bill is also an active member of the American Cancer Society, having participated and assisted in local “Walk for Life” and “Bark for Life” events for nearly 10 years. Bill also serves as Junior Vice Commander of American Legion Post 471 (Boyertown, Pa.), is a member of the post’s Color Guard and is a gunner in his town’s annual Memorial Day Parade.

Congratulations Bill and thank you for your service and contributions to West.

West on the Road: Tempe, AZ – Part 2

West’s continuous quality improvement under Arizona skies

In the second part of West on the Road – Tempe series, we take a look at how quality is a part of everything that we do at West.

Quality is integral to the safety and efficacy of a drug delivery system. Quality is also the ultimate metric for success for every component produced by The Tech Group’s Rockford facility in Tempe, Arizona.

The quality program for each component West makes in Tempe, according to Maria Barajas, Engineering Program Director, can’t be over-complicated. It must be efficient and unobtrusive in order for workers to follow its principles while the machines are up and running.

The process of ensuring quality is different for medical device manufacturing than, say for the auto industry. While syringes may be slightly less complicated than rolling an entire automobile off an assembly line, Engineering Manager, Victor Cisneros, highlights that making a car is often easier. In drug containment and delivery, pharmaceutical companies – and drug packaging and delivery manufacturers – must adhere to strict regulatory standards.

But the employees at West’s Tech Group plant take such rules in stride, and add them to their own stringent quality assurance program, because they know that patient safety is paramount.

West Interns Tour Jersey Shore

Jersey Shore2

Last month, interns from Exton and the Washington, New Jersey Innovation Center, journeyed to West’s Jersey Shore manufacturing plant—that everyone soon learned was not at the beach. The visit provided an ideal opportunity to witness the operations of West’s manufacturing business. Upon arrival, interns completed the gowning process in order to adhere to the plant’s safety and quality standards. Then, after listening to a brief presentation on the history and differentiating capabilities of the facility, began the tour.

Two returning summer interns had the opportunity to gown further for access to the lab. The remaining group learned about the processes required for compression rubber molding, FluroTec® lamination, B2-coating, and Westar® washing and sterilization. Additionally, the group saw how the actual components are made.

“Getting a firsthand look at processes helped to better understand the intricacies of the machines,” said returning intern, Alex Wait. “All of these details pulled the entire scope of the manufacturing process together and we were able to see how West can meet the various specifications.”

Intern Patrick Vincent commented on his experience stating, “A more in-depth look of the plant’s processes connected the dots for me. Being on the floor really gave a sense of the complex work that West operators do on a daily basis.”

Finally, the visit the provided a forum for interns to ask questions ranging from career advice to Six Sigma/LEAN training. Additionally, the experience at Jersey Shore provided the interns with the opportunity to apply the knowledge that they have garnered so far during their summer internship. It provided a useful view of West Pharmaceutical Services beyond the walls of the global headquarters.

To learn more about our Jersey Shore facility, check out West On the Road.

 

Authors:

Marketing Intern Caroline Hall

 

 

Caroline Hall
Exton Marketing Intern

 

 

Communications Intern

 

Madison Bohn
Exton Communication Intern

 

 

 

FluroTec® and Westar® are registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.

FluroTec® and B2-coating technology are licensed from Daikyo Seiko, Ltd.

USP Chapter 1207 Package Integrity Evaluation – Sterile Products

The challenge of assuring integrity of a sterile package is more complicated than many realize. As such, drug formulators in pharmaceutical and biotechnology companies often times underestimate the potential impact of the primary packages they select. A critical aspect to understand is container closure integrity (CCI) and leakage (i.e., failure of CCI or package integrity), is a major quality issue for sterile injectable products, as shown below.

UPS Chapter 1207

Ref: Brian Hasselbalch, CDER, FDA Drug Quality Regulation, June 2014

Recently, a new USP chapter was released that provides guidance on the integrity of packaging intended for sterile products. This comprehensive chapter provides an overview on various considerations. It consists of several sections:

<1207>
This includes an overview, general introduction, and glossary.

<1207.1> Package Integrity Testing in the Product Life Cycle
This section discusses test methods selection and validation.  It also states that in order to choose appropriate test methods, there is a need to understand the package design, materials of construction and mechanics.

Also discussed is the critical importance of understanding the Maximum Allowable Leakage Limit.  Determining this Limit, which is specific to the sterile product, is typically the responsibility of the package engineer.

Further, there is discussion of deterministic versus probabilistic methods. Deterministic methods (i.e., methods that follow a predictable chain of events and can be controlled) are recommended for objective quantitative data.

<1207.2>
This section discusses leak test methods and their proper use. Deterministic and probabilistic methods are considered. Probabilistic methods, such as blue dye testing, and microbial challenge, were very common to the industry in the past.

<1207.3>
Finally, there is discussion of package seal quality test methods. Package seal quality tests are used to characterize and monitor the quality and consistency of parameters related to the package seal. These provide some assurance of the package’s ability to maintain integrity.  Seal quality tests and CCI tests work together to ensure package integrity.

It is recommended that anyone involved with choosing, or supporting, sterile packaging become familiar with this USP chapter—as it becomes effective August 1, 2016. Please contact West’s Technical Support or Analytical Lab Services if you are interested in further consultation or support on this subject.
PEOP WEMP DeGrazio Fran 122 LREZ

 

Fran DeGrazio
VP, Scientific Affairs & Technical Services
Fran.DeGrazio@westpharma.com

 

 

To All Those Who Protect and Serve: We Salute You

shutterstock_88165867.jpg

As we celebrate our 240th Independence Day, we would like to take a moment to express our appreciation to veterans and their families who serve to help keep America safe and to those who came before them in this noble cause.

In July 1776, fifty-six representatives from the thirteen colonies gathered in Philadelphia, PA to consider the case for independence. Upon signing the Declaration of Independence, these representatives pledged their lives to defend the right to “life, liberty and the pursuit of happiness.” Their legacy lives on through the many generations of Americans who have made that same pledge of service to oppose tyranny and to preserve freedom.

West is committed to recognizing veterans for the leadership, resilience, critical thinking and drive that they possess.

To show our appreciation for veterans and recognize their incredible experience and invaluable skills, West has developed a recruitment program called Ties to Stripes. The program ensures that veterans make a smooth transition from the military to the workplace. West encourages veterans to build a meaningful career, aligned with their capabilities and interests.

As we celebrate America’s 240th birthday, let us reflect on the service and tremendous sacrifice made by those who defend liberty and independence. Happy Fourth of July!

“This nation will remain the land of the free only so long as it is the home of the brave.” 

-Elmer Davis

To learn more about the Ties to Stripes program click here.

West on the Road: Tempe, AZ – Part 1

Supporting customers by staying ahead of the curve

Pharmaceutical and healthcare companies around the world rely on the expertise of West’s Tech Group to create innovative, safe and effective drug delivery systems that bring important therapies to patients. For those companies – like ours – quality and innovation are of the utmost importance.

In part one of our video series West on the Road – Tempe, we look at how The Tech Group’s Rockford campus in Tempe, Arizona is developing advanced automation systems and programs to ensure the quality and efficacy of drug delivery and monitoring systems. This begins by establishing manufacturing processes based on a deep understanding of the customer’s needs and the products themselves. Tech Group engineers at the 96,500-square-foot facility learn our customer’s products inside and out. They combine that insight with their deep knowledge of medical devices and materials, such as plastics, as well as the latest in insert and multi-shot molding techniques to ensure we’re meeting the needs of our pharmaceutical partners and the patients relying on them.

While the medical manufacturing industry today may be complex as ever, Director of Operations, Mike Moran, believes that manufacturing processes will only grow in complexity in the coming years as a changing healthcare environment—one that is ever more patient-centric—will continue to demand more of the pharmaceutical industry and their manufacturing partners.

Ultimately, people at the The Tech Group plant understand the critical role that they play in bringing drug delivery systems from concept to patient and delivering the high quality that our pharmaceutical customers – and patients – demand.

J Ragland

The “Why” Behind Medication Nonadherence

West is pleased to welcome guest blogger John Ragland, Jr., Chief Product Officer, HealthPrize Technologies. This is the third installment in a series on the West/HealthPrize collaboration.

When people hear about the medication nonadherence problem for the first time, they’re always surprised by the magnitude of the issue and immediately ask the why question: “Why don’t people take their medications?”

I had the pleasure of explaining the why behind nonadherence (and what to do about it) recently in a co-presentation with Chris Evans, Vice President, Global Innovation, at West when we spoke at Pharmapack 2016 in Paris, France.

Most people assume that cost and forgetfulness are the main causes. For that reason, many of the traditional adherence interventions have focused on cost reductions (co-pay cards, for example) and reminders (text messages, nurse phone calls, and blinking or beeping pill containers, to name a few).

Although cost and forgetfulness do certainly play a role, and such interventions can help to some degree, they don’t get to what we believe is the real root of the problem: human psychology. One central problem with taking medication for high cholesterol, hypertension or other asymptomatic conditions, for example, is that the payoffs are generally long-term. A patient may actually even feel slightly worse in the early days, either from transient and often minor side effects, or from the pain of self-injection, or the discomfort of shelling out a co-pay at the pharmacy.

It’s a hurdle we face with a host of other behaviors that are good for us, like saving for retirement (it’s more fun to spend now than to save for decades in the future) and maintaining a healthy diet (who doesn’t find it difficult to eat just one cookie coming out of the oven?). Most chronic therapies deliver mainly chronic rewards, and that barrier is not addressed by reminders or lower cost: we try and bridge that time gap with more short-term rewards.

HealthPrize programs provide immediate gratification for patients on chronic therapy by rewarding them with a positive experience including content and points for every dose and refill. Offering fun education in the form of “Daily Fortunes” as well as weekly quizzes and surveys (also for points) has a much greater proximate impact on the behavior we are trying to motivate or habit we are trying to form. Further game-derived elements include a monthly leaderboard competition and a weekly drawing. This is nothing like typical healthcare, and patients seem to enjoy the contrarian approach – not surprisingly, since it works quite well in most other industries.

What’s exciting about our collaboration with West is the ability to bring this adherence and engagement benefit to patients on self-injected therapies, in collaboration with the pharma companies that provide these therapies, and to tie a more positive experience to the generally loathsome injection event itself. In our existing ongoing programs, we’ve already demonstrated tremendous success. In a statin program of ours, for example, we recently announced a 99% reduction in “gap days” (days late to refill), an effect demonstrated immediately upon enrollment into the program. We look forward to achieving similar successes with West in collaboration with our pharma partners.

With West’s expertise in drug delivery, and HealthPrize’s in the application of novel engagement strategies, our pharma partners and the patients they serve can look forward to an enhanced experience around self-injection therapies and, ultimately, better outcomes.