Selecting the Right Container System

The current global market of prefilled syringes is comprised of over two billion units per year and growing. Many chronic diseases, such as multiple sclerosis and rheumatoid arthritis, require home-based administration of injectable therapies. Auto-injectors that include a glass syringe have been a safe and convenient delivery system, but they have notable limitations, including:

  • Breakage
  • Performance Issues
  • Protein Aggregation

Any glass product runs the risk of breakage, which can lead to particulate contamination. Particulate contamination is the unintended presence of extraneous, mobile and/or undissolved particles in a therapy or parenteral solution. These particles can be of various sizes, usually only detectable by visual inspection in general greater than or equal to 50 Um or sub-visible with a range of 2-50 um, demanding specific analytical tests for their detection. Particulate contamination may cause inflammation, which can affect a patient’s brain, eyes, lungs, liver, heart, intestines, kidneys and spleen.

In addition, traditional syringe systems may include the use of silicone oil. Drug products that are contaminated with silicone oil particles can lead to certain types of lung disease (Bowen et al. 1981). While little is known about the effect of silicone oil in humans over a long period of time, it is believed that serious adverse events can occur when silicone oil comes into contact with drug proteins.

Cyclic olefin polymers, such as Daikyo Crystal Zenith® (CZ), may provide a better patient risk profile and drug delivery system. This highly break resistant material can help to avoid the issues of particulate contamination, glass breakage and silicone oil. The material also forms an excellent moisture barrier, which helps to ensure extremely low particulate levels.

The Daikyo Crystal Zenith syringe with the FluroTec® barrier film-coated piston may eliminate the risk of delays and patient safety issues that are the unintended consequences of traditional combination delivery products in use today.

For more information about the CZ syringe or other injectable solutions from West, visit our website.


Cancelliere Kevin

Kevin Cancelliere
Director, Marketing


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

Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.

Daikyo Crystal Zenith® and FluroTec® technologies are licensed from Daikyo Seiko, Ltd.

Convenient Sourcing in Small Quantities

Small things sometimes come in large packages. When it comes to pharmaceutical components, small items like stoppers and plungers are often sold in quantities large enough to supply drug products to the world. But sometimes, and in particular during the early stages of drug development, large quantities are just too much of a good thing.

In addition, different drug products require different formulations and configurations to help ensure safe and effective delivery to patients. A stopper designed to work with a vial with an American blow-back ring simply won’t work on a European ISO straight wall glass vial. As more companies make the switch to ISO-standard glass vials, obtaining compatible ready-to-sterilize components from a convenient source has been difficult.

Convenient sourcing

To provide easy sourcing and convenient access for its customers, West is pleased to announce that we now offer small quantities of bromobutyl, ready-to-sterilize NovaPure® components from a local distribution center in North America. NovaPure 4023/50 RS stoppers are compatible with ISO-standard glass vials and coated with FluroTec® film to further safeguard drug products from issues such as extractables and leachables.

West NovaPure components offer an unrivaled level of quality for elastomeric closures. Offered in clean, modern formulations, NovaPure components are protected with FluroTec barrier film and are fully visually-inspected. NovaPure component’s tight particle specification is made possible by an advanced level of process understanding and control. NovaPure stoppers in rubber formulation 4023/50 gray are available in ready for sterilization (RS)formats. When customers are ready to transition products into prefilled syringes, NovaPure plungers using identical elastomer and film materials are available to help ensure that the drug products are packaged in a safe and effective system.

Contact your West Account Manager or the West Technical Customer Service team for more details about NovaPure components.


Whitney Winters
Senior Manager, Sales

NovaPure and FluroTec are registered trademarks of West Pharmaceutical Serivces, Inc., in the U.S. and other jurisdictions.

FluroTec technology is licensed from Daikyo Seiko, Ltd.

West Germany Employees Help Refugees in the Local Community


The number of people fleeing from war to seek refuge in Europe is increasing every day. Many people arrive with harrowing tales of overcoming long distances carrying small children in their arms, having nothing but the clothes on their backs.

About 800,000 refugees are expected to arrive in Germany this year. Cities and local authorities are doing their best to provide food, shelter and medical treatment, but are struggling to cope with the huge number of people. Recently, 150 refugees arrived in Stolberg and 151 in Eschweiler.

Citizens of Stolberg and Eschweiler are demonstrating solidarity and offering their support to help refugees assimilate by raising money, donating goods, and providing housing. One volunteer said, “It is very important that we all let the refugees know that they have our support to help them get settled.”

West employees in Germany have responded with a targeted call for donations. First, a collection of waterproof clothing for refugee children in Eschweiler was organized overnight and delivered the next day. “Because families arrive wearing their summer clothes, they are not prepared for the local weather,” explained a social worker.

A second call for donations was initiated the following day. About 50 suitcases and travel bags, several boxes of toiletries, and childcare products were donated by West employees. In addition to the West donations, the Stolberg location of Dalli/Mäurer & Wirtz (Europe’s second-largest consumer goods manufacturer of personal care and home care products) decided to donate another two pallets of hygiene articles.

“We were so thrilled when we heard the news that the general manager of Dalli/Mäurer & Wirtz, Mr. Wirtz, decided to join our initiative by donating two more pallets of articles,” said Patricia Poschen, Executive Assistant. “It is nice to see what you can achieve in your local community when people are working together to support those in need.”

Anne Faust, whose husband Jim works for West as Vice President, Global Process Engineering and is temporarily based in Germany, offered her help to support the refugees who arrived in Aachen. Anne will be serving lunch to the families and children who are suffering from their long and difficult journey to Germany.

It has been very moving to see this effort come together so quickly and to have the ability to support refugees in a way that engages West, our employees, and the surrounding communities.

West Stolberg Celebrates 25 Years


West Pharmaceutical Services, Inc. celebrated its 25th anniversary in Stolberg, Germany on September 12, 2015. It was a special occasion for all in attendance and a good opportunity for employees to get together away from day-to-day business operations.

Guests were welcomed by Plant Manager, Erik Classen who acknowledged the outstanding performance that all employees have made to the growth and success of the plant. Heino Lennartz, President, Pharmaceutical Packaging Systems, EU, stressed the team spirit that is unique to Stolberg and still prevails today. “We are celebrating not only a building but its people,” said Heino. “Shared values and collective responsibility has helped to grow the seeds that the founder of Pharma-Gummi, Hans Wimmer, planted many years ago.”

Fred McCleery, Vice President, Seals Operations travelled from Tampa, FL to address the crowd in German. In his speech he highlighted his long history and connection with the Stolberg plant, having managed the facility from 1997 through 2006. “It is like coming home to family,” said Fred when recalling his frequent visits.

Special guest, Mayor Tim Gruettemeier, underlined the importance of West as an innovative market leader in the business hub of Stolberg and remarked that he was impressed by the modern plant technology he saw when visiting the facility in March. Hans Wimmer, the founder of Pharma-Gummi, looked back on the historic milestones of the plant and is now pleased to see his “baby” thrive and prosper.

West traces its roots in Europe to 1960 when Hans Wimmer formed Pharma-Gummi in Vicht, Germany, with a vision to serve Europe’s pharmaceutical manufacturers with safe and reliable elastomer components. Pharma-Metall was founded in 1982 and moved into the new facility in Stolberg in 1990.

West and HealthPrize are moving along at a rapid pace in delivering on our joint connected health vision

KatrinaHeadShot2014 cropped

West is pleased to welcome guest blogger Katrina Firlik, MD, Chief Medical Officer and Co-Founder of HealthPrize Technologies. This is the first installment in a four-part series on the West/HealthPrize collaboration.

In October 2014, we announced a strategic collaboration to integrate HealthPrize’s digital medication adherence and patient engagement platform with West’s injectable drug delivery systems. This will offer patients a true end-to-end connected health solution to help improve the patient experience, medication adherence, and clinical outcomes.

Today we are pleased to announce completion of the first two phases of our four-stage development process: (1) self-reporting and (2) barcode scanning. Read the full press release here.

Both allow for tracking of individual self-injected medication doses, which then trigger the rewarding of points redeemable for various forms of merchandise, gift cards, coupons or charitable donations. Scanning of the barcode on the injector provides quick and easy self-reporting, accurate injection system traceability information, along with the ability to track other details such as expiration date and dosage.

Equally important, this tracking of self-injection events is the gateway through which patients can engage with other elements of the digital platform, including educational offerings which are critical to strengthening the intrinsic motivation required for long-term medication persistence.

The two final phases still in progress are legacy connected health in which existing auto-injectors are used in combination with an external attachment, and integrated connected health which will not require any attachment, as all monitoring will be intrinsic to the injection system itself, via Bluetooth low energy.

What is most exciting about our collaboration is the potential it holds to truly enhance the patient experience by making adherence to medication more enjoyable. No one wishes to be a patient with a “condition,” and for many, there is a significant negative psychology surrounding the need to maintain a chronic medication regimen, particularly one requiring injections. The pain is not only physical, but also psychological.

HealthPrize’s rewarding, gamified, and educational solution adds that dose of positivity—and even the “fun factor”—so often lacking in healthcare. After all, patients are only human (and we’re all patients, now or in the future). It’s intuitive that we’re all more likely to stick with something that we can find reason to enjoy.

To learn more about what the West/HealthPrize collaboration can mean for patients, attend a live webinar taking place on October 20, 2015.

West on the Road, Clearwater–Episode 3: Thinking Outside-the-Box to Deliver on Quality


In the third and final installment of the West On The Road visit with our Clearwater, Florida facility, we dive a little bit deeper into the day-to-day processes and outside-the-box thinking that allows us to deliver packaging components and drug delivery systems of the highest quality.

As Andy Phillips, Director of Operations in Clearwater, says, “We specifically look for engineers who have a strong desire to come in and do things differently—look at the process, determine where the waste is, find the problems in the process and eliminate them.”

This approach, also known as Lean manufacturing, is a cornerstone in our ability to continually evolve with the healthcare environment and address the current and future needs of our customers. It’s this dedication to continuous improvement that allows us to support our pharmaceutical partners in providing safe, effective drug products to even the youngest of patients.

“We had a customer come in and tell us that over the past 20 years, we’ve helped save a million babies’ lives…our seal goes on a product that is used when newborn babies can’t breathe,” shares Andy. “That kind of information really makes you want to come here and do the best things that you can.”

“We affect peoples’ lives every day,” adds Glenn York, Engineering Manager. “That drug would not be getting to the patient unless we were there to package it—it’s important.”

Trends in Drug Delivery- The Growth of Cartridge Based Technology

Drug delivery via cartridge-based systems has been around for many years, with traditional applications being for the dental and insulin markets. These traditional markets will continue to maintain much of the volume for cartridge-based systems in the future; however, there is an increasing trend toward other therapeutic classes of drugs, such as those that treat auto-immune diseases, that never used cartridges before. This trend, along with the projected growth in the insulin market, indicates substantial overall growth in the cartridge space over the next several years. This Blog discusses the issues driving these trends and the West product portfolio in the cartridge market.

As pharmaceutical companies evaluate the appropriate delivery system for their drug product, there are several reasons why they may select a cartridge-based system compared to a pre-filled syringe or vial. There are patient benefits around safe and accurate dosing, as well as an advantage in the flexibility of dosing and the ability to administer multiple doses in one container. Integrating a device and cartridge system can support the pharmaceutical industry’s long-term strategies and help differentiate products in the market.

For pharmaceutical manufacturers, new fill-finish technology allows for a flexible design to fit multiple container systems (vial, PFS, cartridge). However, component processing is a source of risk for cartridge components just as it is for syringe or vial components. Many in-house component processing lines use legacy procedures, inadequate validation support, and older equipment. The investments required to meet today’s quality expectations can be costly and create a source of regulatory scrutiny in manufacturing operations. Older processes and equipment cost money to maintain or upgrade and may cause variability in component quality. The risks associated with in-house washing, siliconization, and sterilization can be reduced by outsourcing component processing to a proven partner.

To help simplify drug development, shorten development time and streamline manufacturing, pharmaceutical manufacturers are trending toward ready-to-use (RU) containers and components. This flexible fill-finish technology is driving West and other suppliers such as glass cartridge manufacturers to offer solutions in ready-to-use formats.

West’s industry proven Westar® component processing reduces the risk of variability in component quality and the potential effects on drug product safety and efficacy. Westar RU cartridge components include 1.5mL and 3mL cartridge plungers and 8mm monolayer lined seals (for puncture applications of less than five punctures) and 8mm laminate lined seals (for greater than five punctures).

Westar cartridge plungers have been developed to meet the need for ready to use sterile components for various applications typically administered using a device such as a pen injector. West’s cartridge plungers have been designed to meet the requirements specified in ISO standards for both pen systems and glass cartridges. Westar RU steam plungers have been shown to demonstrate optimal performance characteristics when tested in standard glass cartridges.

Westar lined seals have been designed in accordance with industry standards for single dose or multi-dose applications. Our laminate technology is best-in-class and leverages a bi-layer seal for industry leading resealability specifications, while minimizing both fragmentation and minimizing particles.

Westar RU cartridge components support the safe self-administration of cartridge based drug products and are backed by more than 90 years of West’s technical knowledge and expertise. To learn more about West cartridge technology, visit our website.


Royce Brockett
Senior Product Manager


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



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