West Pharmaceutical Services Inc.’s Waterford, Ireland facility is a global center of excellence for the company’s advanced manufacturing network. The facility, situated on a 44-acre campus, will produce West’s elastomeric laminate sheeting, which is used to package insulin for use in pen injectors. Additionally, it will offer high-value finishing for components, including stoppers and plungers, produced at other West facilities around the world. These services, designed to mitigate the risk of potential contamination and compatibility issues with packaging components, include pharmaceutical washing (Westar RS components), Envision verification, steam sterilization (Westar RU components) and flexible packaging offerings.

Pharmaceutical Processing spoke with David Montecalvo, Sr. Vice President, Global Operations and Supply Chain at West, about these recent facility upgrades.

Q: Why was the decision made to open a new facility in Waterford?
A: In 2014, West announced plans to expand its global manufacturing operations to include a new site in Ireland. A 44-acre site in Co. Waterford, Ireland was chosen for the following reasons: its location within Southeast Ireland’s business-friendly environment and growing health science industry; the strong presence of Pharma customers; attractive overall economic conditions; and the availability of a highly skilled workforce experienced in Pharma and GMP (good manufacturing processes).

The Waterford site is an integral part of West’s Global Operations Strategy and serves as a center of excellence for West’s advanced manufacturing network supporting growing demand from our pharmaceutical and biotech customers. This site is considered to be a strategic growth site with high capability and competencies to serve our customers now and into the future with industry-leading, quality solutions for packaging and delivery. The facility will produce West’s proprietary elastomeric laminate sheeting used to package insulin for use in pen injectors for those who suffer from diabetes. We will also offer high-value finishing for components, including stoppers and plungers at other West facilities around the world, with first-in-class quality levels for our Pharmaceutical customers.

Q: How will the upgraded facility accommodate new trends in pharmaceutical research?
A: West’s Waterford facility includes a state-of-the-art laboratory, designed to streamline a variety of testing workflows for West’s products, helping to ensure the highest level of product quality. The laboratory is well equipped with the most modern and sensitive instrumentation to meet the needs of testing requirements for West’s high value products. It includes an ISO Class 5 cleanroom for particle analysis preparation and testing to minimize contamination, as well as a microbiological laboratory to perform appropriate testing for biological testing on West products. Testing in the laboratory ranges from raw material testing to multiple chemical and microbiological release tests—all designed to ensure the highest level of quality in West’s products.

Q: What kinds of up-to-date equipment are housed in the new facility?
A: West’s Waterford state-of-the-art site incorporates a variety of automated technology that helps drive operational excellence and efficiencies throughout the manufacturing process.

Automated feeding systems integrated into the production lines increase efficiencies by ensuring a constant flow of product, reducing reliance on human interaction during the running process. Not only does this automation improve efficiencies, it also lessens human interaction with product, therefore improving quality by reducing the risk of contamination.

Additional automation technology includes:

• Automated cleaning of transporting vessels built into the design
• Automated feeding into an automated, program-controlled vision inspection system for Envision vision inspection products
• Automated distribution of garments
• Automated Guided Vehicle (AGV) transportation capabilities built in, planning ahead for expansion

While the automation and technology used in Waterford drives efficiencies into the processes, it also gives access to meaningful data, creating the opportunity to leverage real-time data and analytics into the decision-making process, allowing for greater responsiveness and helping to further drive continuous improvement and operational excellence.

To help customers meet increasing quality standards, West has developed next generation quality for ready-to-use components. West’s Westar Select brand builds on West’s industry-proven Westar component pharmaceutical washing and sterilization processes that help to reduce the risk of variability and its potential effects on drug quality, safety and efficacy. The integration of an autoclave for steam sterilization into the Waterford site bolsters West’s global product portfolio, adding additional capability into the global network, now enabling West to supply a ready-to-use product manufactured in the EU region.

West is committed to supporting a healthy planet by using resources responsibly. Integrating the principles of Energy Efficient Design (EED), West’s Waterford site uses state-of-the-art equipment and design efficiencies to ensure the utmost in energy efficient operations and care for the environment. Taking advantage of outside air temperatures to assist in heating and cooling, capturing and reusing heat to heat water, HVAC heat recovery and dry cooler water systems are just some progressive ways West has built sustainability into its Waterford facility.

Q: What kinds of flexibility options are offered in this new facility, should the need for changes arrive?
A: The West Waterford site was designed and built with both the present and the future in mind, using an innovative and unique “Spoke and Hub” design. This design enables more efficient product flow, as well as office space which houses teams together under one roof, creating an environment which enables valuable synergies and collaboration.

The main buildings (the hub) are connected by other buildings in a spoke-like shape, hosting separate levels for offices, production and material transportation. The current levels are built in a scalable and expandable layout.

The plot of land and unique building design was developed in a way that will enable the infrastructure to be expanded in all directions, providing maximum flexibility for future capacity expansions without impacting production in the original buildings. Importantly, this will mitigate future supply risk by enabling new construction to take place without the need to stop production, helping to ensure an uninterrupted supply of product to customers.

Waterford’s current modular system provides maximum flexibility. As the site develops, the warehouse storage areas will be able to change their functions if necessary.  Currently, the warehouse houses raw material as well as finished goods, in separated areas. In future phases, these areas can be easily reconfigured, enabling expanded room for separate raw materials and finished goods warehouses, both being interconnected on the same level utilizing AGV material transport corridors.

Q: Does West plan to upgrade or open any additional facilities, in Ireland or elsewhere?
A: Currently West has manufacturing operations in 28 global locations. With respect to Ireland, in addition to the facility in Waterford, West also has a Contract Manufacturing site in Dublin, which has been in operation since 1998 and has seen multiple expansions over the years. Most recently, West invested in its Dublin site with a new 60,000 sq. ft. building, making it possible to service the Company’s growing healthcare and medical device contract manufacturing business, which supplies high-quality injection molding and assembly solutions for the production of medical devices such as auto injectors and continuous glucose monitoring systems. West has also upgraded and expanded its center of excellence site in Kinston, NC, most recently in 2016, performing 62,000 sq. ft. of expansions since 2008.

One of the primary objectives of West’s Global Operations strategy is to drive a strong partnership with our global customers by ensuring the highest quality products with a goal of zero defects, produced by advanced and automated manufacturing processes, industry leading lead times and flexibility to meet our customers changing demand. West is positioned to achieve this objective by continuing to invest in high capability manufacturing across our global facilities and strategic sites.