West on the Road—Jersey Shore, PA


Put on your mask and suit up as Production Manager, Adam Wrench takes us inside West’s Jersey Shore plant. Despite the familiar name, there’s no beach or boardwalk here. Rather, Jersey Shore is a town nestled Pennsylvania’s Allegheny foothills. At this plant, employees create numerous West components, including FluroTec® and Teflon® laminated 13- and 20mm stoppers. It’s the only West facility that includes two steam sterilizers for Westar® RU sterile ready-to-use components.

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. These segments show 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.

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

The Challenge of Cryogenic Storage for Cell Therapy

Nova set

Cell-based therapies are a unique solution to a variety of health issues, and can make an undeniable impact on a person’s life. But with this unique solution comes several challenges, including packaging issues associated with cryogenic storage, inspection, and extraction of the drug product. Selecting the right packaging for the cell line can mitigate risks of breakage and cell death, enhance your ability to conduct crucial stability and integrity testing, and enable ease of transition during each phase of development.

Cell lines require low temperature storage. Many packaging systems are made of glass, which can’t handle the challenges of cryogenic storage, nor can glass systems maintain seal integrity at such low temperatures. Issues like breaking and cracking when the vials are dropped or brought to room temperature can lead to cell death. In addition, many cryovials are not transparent, making visual inspection of the vials difficult. Finally, extracting the cell line with a needle can damage or shear the cells.

By tackling packaging challenges early in development with a market-ready system designed to withstand the rigors of cryogenic freezing and thawing, pharmaceutical manufacturers can save time and effort, and help smooth the path from research and development to commercialization.

Use of a cyclic olefin polymer vial, like the Daikyo Crystal Zenith® vial, can help mitigate the risks associated with cryogenic storage.  Daikyo Crystal Zenith vials are made from a break-resistant cyclic olefin polymer that has excellent thermal characteristics and can withstand cryogenic temperatures as well as sterilization by autoclave.  These vials have been shown to successfully maintain container closure integrity at -165 °C after eight days of storage. In addition, needle-free vented vial adapters can help reduce the impact of shear and cell rupturing when extracting from vials.

The West Ready Pack® System featuring Daikyo Crystal Zenith vials, FluroTec® stoppers, seals and vial adapters can help you get through the next phase of your development. Ready Pack can be ordered in small quantities during research and development, and when you’re ready to go to market, scale-up is simple and there’s no need to change packaging.

For more information about Crystal Zenith or the Ready Pack system, visit our website or contact Technical Customer Support today.


Jess Bohn
Specialist, Sales – Pharmaceutical Packaging Systems



Ready Pack and FluroTec are trademarks or registered trademarks 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.

Global Regulatory Submission Support Packages for West Customers


West’s customers are very familiar with our Drug Master Files (DMFs) and Letters of Authorization. West maintains some of the most active DMFs held by the FDA and Health Canada, and we’ve provided customers with over 9,000 LOAs since 2008.

However, many customers also require support for drug applications in other regulatory markets around the world, where DMFs aren’t an option. West meets that need by making Global Submission Support Packages available to our customers.

Global Submission Support Packages provide customers with the technical information they need to file West products and processes. Each package contains information regarding West components and any other processes applied (e.g., wash, sterilization). The content is specifically designed to meet agency expectations for drug applications. If a reviewing Health Authority requires more information, West Regulatory Affairs (RA) can provide the necessary response.

West currently has packages for the following products and processes:

Standard elastomers Westar RS Lined Seals
Westar® RS NovaPure® RS/RU
WestarRU Steam Daikyo Crystal Zenith® (CZ) Vials
Westar RU Gamma CZ Cartridge System

Special Features of Global Submission Support Packages:

They’re in Common Technical Document (CTD) Format

The CTD format is widely-used around the world and is typically accepted in most major regulatory markets. West’s submission support packages can be easily integrated into customers’ applications in this format.

They’re provided as Word Documents

Having the documents in Word gives customers the flexibility to use the information in their regulatory submissions as needed, for both CTD and non-CTD submissions.

They’re backed by West Global RA Support

West’s Regulatory Affairs department will assist customers in providing responses to any Health Authority questions relating to our products or processes. If confidential information is required as part of the response, West will respond directly to the Health Authority.

For more information, contact West today or visit our website.


Steve LoCastro
Director, Regulatory Affairs




Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
NovaPure® and Westar® are registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.



West’s Four Facilities in Germany Wrap-up a Successful West Without Borders Campaign


We would like to thank all West employees in Germany for their commitment and hard work during this year’s West without Borders charitable campaign. More than 16,000 Euro was raised and presented to the three selected organizations—Kids auf Trab, Zwischen Uns e.V. and FortSchritt Städteregion Aachen e.V.—during a closing ceremony on September 24.

What is even more rewarding is the long-term relationships that were established with the organizations we support. FortSchritt sent a special thank you letter to Heino Lennartz, President, Pharmaceutical Packaging Systems, EU, praising the extraordinary commitment and continued support of the West team in Germany. West has been a supporter of the organization since its inception, enabling it to grow and offer its unique conductive therapy to kids and young adults in the community and neighboring countries.

FortSchritt hosted its intensive two-week conductive education session and was happy to report that the newly purchased therapy furniture was delivered on time and already put to good use. In addition to the monetary donation, West provided volunteer hours and transportation to assist FortSchritt in delivering the therapy furniture and equipment to their facility.

Reduce Cost, Improve Adherence for Self Administration of New Biologics

Body SmartDOse

Many of the newer biologic products being developed are for long-term administration in chronic disease conditions, including oncology, autoimmune disorders and high cholesterol. Historically, these biologics have been administered by costly intravenous (IV) injection in a hospital, clinic or doctor’s office. IV administration has been used due to the higher dosing requirements – upwards of 100 mg. To help improve patient compliance and lower the cost of therapy, some of these products have been reformulated down to 1 mL or below. At this volume they can be self-administered using an auto-injector for the 1 mL long pre-filled syringe.

The challenge arises when a drug cannot be concentrated to fit into a 1 mL long syringe. Patient use would then require multiple injections to achieve a therapeutic dose, potentially reducing patient compliance and adherence. In addition, the concentration increases the viscosity which is problematic for many auto-injectors.

There is a trend toward wearable injectors for bolus delivery to help improve adherence and lower total cost of therapy. In one clinical study at a major multinational pharmaceutical company, a 5 minute subcutaneous injection was equivalent in efficacy to a 2.5 hour IV infusion1. This greatly improves the patient experience and can lead to improved adherence. Bolus injectors, such as the West SmartDose® electronic wearable injector, can help to address these challenges.

In addition, West has collaborated with HealthPrize Technologies, LLC to integrate HealthPrize’s Software-as-a-Service (SaaS) medication adherence and patient-engagement platform with West’s injectable drug delivery systems to provide an end-to-end connected health solution for pharmaceutical companies and the patients they serve. The combined offering will provide voluntary, electronically connected drug delivery systems that track when patients take their medication. The HealthPrize system engages and educates patients to help increase adherence and medical literacy, rewarding interaction and compliance with prescribed treatment plans, and contributing to better health outcomes.

To learn more about the SmartDose electronic wearable injector or any of West’s injectable systems, visit our website today.


1Dias C et al, Tolerability of High-Volume Subcutaneous Injections of a Viscous Placebo Buffer, AAPS, 2015



Zach Marks
Director, Delivery Systems Marketing



SmartDose® is a registered trademark of Medimop Medical Projects Ltd., a subsidiary of West Pharmaceutical Services, Inc.

West seeks partners for its SmartDose® injector technology platform. This platform is intended to be used as an integrated system with drug filling and final assembly completed by the pharmaceutical/biotechnology company.

West at CPhI/Innopack 2015–Madrid

Cphi booth Oct 2015

Last week, West once again exhibited at CPhI/Innopack—Europe’s premier trade show that brings together approximately 36,000 senior pharmaceutical professionals from more than 150 countries. West was among the show exhibitors that included providers of packaging, finished doses, machinery, ingredients, contract services, and other related services.

West sales, marketing and technical customer service teams welcomed visitors from all over the world at the West booth and shared the company’s recent innovations, while also discussing important trends in the pharmaceutical and biopharmaceutical industry.

West showcased a range of the company’s products and launched Daikyo RUV® (ready-to-use, validated) components. Daikyo RUV components are manufactured using clean, high-quality elastomer formulations and then washed, camera-inspected and sterilized to help reduce the customer’s manufacturing footprint, streamline processes, minimize risks around component preparation and eliminate bioburden.

Visitors at CPhI/InnoPack also got deeper insight into two additional high-quality drug components during the show: Flip-Off® PlusRU seals and NovaPure® components. Flip-Off Plus are sterile, high-quality seals that consistently achieve reproducible container integrity for drug products while ensuring low levels of bioburden, which may help make drugs safer for patients. NovaPure components are developed with a process that incorporates Quality by Design principles and support customers to protect the efficacy and purity of sensitive and demanding drug products. The NovaPure product offering includes serum and lyophilization stoppers and syringe plungers.

CPhI offered a unique opportunity to exchange ideas with technology leaders and experts from across multiple markets within the pharmaceutical industry. West is already looking ahead to CPhI 2016 in Barcelona.


Looking for Ways to Reduce End of Line Rejects Significantly?

In today’s manufacturing processes, defects such as loose and embedded foreign matter may cause end of line rejects of drug products—potentially leading to a loss of product or even market recalls. At the same time, regulatory authorities are becoming increasingly more stringent and continually lowering acceptable levels of particulate matter.

The West Envision™ verification system can help with both of these challenges, as it enhances the quality of Westar® ready-to-sterilize pharmaceutical com­ponents by significantly reducing adhered and embedded partic­ulate found in primary pharmaceutical packaging components. Envision verification is also a tool to effectively reduce cosmetic defects that are of special concern in some markets like Japan. Furthermore, if a customer has special concerns, West can complete a standard defect library to catalogue findings.

The West Envision verification system uses automatic, program-controlled vision inspection technology to inspect all surfaces of elastomeric com­ponents. Envision inspected products assist in reducing the total cost of goods by minimizing the risk of drug product rejection because of visible particulates and closure defects.

Compared to other inspection methods, Envision verification allows for 100% inspection of all articles from solid to complex deep cavities passing through the machine. Therefore, you can be assured that every Envision inspected item packed for delivery to your facil­ity meets enhanced quality specifications by statistical means.

Envision graphic_3
Fig. 1 –Example of a possible decrease in defect rate on finished product before and after implementation of the West Envision verification system


West Envision components help reduce lot-to-lot variability in stoppers and syringe plungers. This leads to increased product yield, because the number of drug product rejects is minimized. Ultimately, the customer’s operational efficiency increases because of optimized throughput.

The West Envision verification system is an optional tool that can be used with Westar RS and Westar RU quality, and is an inherent part of West’s NovaPure® components.


Bjoern Henze, Ph.D.
Manager, Technical Customer Support Europe


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



Get every new post delivered to your Inbox.

Join 1,454 other followers