Pfizer plans to develop a clinical manufacturing facility at its Ringaskiddy site. Credit: IDA Ireland.
The company’s Ringaskiddy site produces the active pharmaceutical ingredient (API) of Viagra. Credit: i viewfinder / Shutterstock.
The new facility will house multiple clinical products, which will be manufactured through either batch or continuous (FAST) processing or a hybrid mechanism. Credit: Pfizer.

Pfizer’s Ringaskiddy complex in Cork, Ireland, was the first of six sites developed by Pfizer in the country. It is the firm’s largest production facility outside the US.

The first synthesis facility at the site was developed in 1969 and previously housed a citric acid plant. Pfizer built the OSP1 synthesis plant in 1972 and commissioned the OSP2 plant in 1984.

The third synthesis plant, OSP3, required a $130m investment and was completed in 1995, doubling its production capacity. A later expansion involved an investment of $302m, while the OSP4 synthesis facility began production in mid-2001.

Pfizer is developing the Ringaskiddy Clinical Manufacturing Facility (RCMF) at the Ringaskiddy site. The company filed an environmental plan for this facility in April 2021.

The new facility is expected to produce its first clinical lot by the first quarter of 2024. It is intended to expedite Pfizer’s global research and development efforts.

Details of Pfizer’s Ringaskiddy facility development

RCMF will be developed on approximately 1.3ha at the Pfizer Ringaskiddy site, which covers around 33ha.

The facility will include a building built on an 11,468m2 (1,23,440ft2) area, which will have a maximum height of 29.425m and five storeys. The building will be built in two phases, with Phase I covering an area of 9,465m2 (1,01,880ft2) and the remaining 2,003m2 (21,560ft2) to be built under Phase II.

The RCMF will include production areas, laboratories, office space, a Just in Time warehouse, and a warehouse drum store. The single-storey warehouse drum store building will cover an area of 420m2 (4,521ft2) and measure 13m in height.

An external utility yard consisting of an electrical building, an emergency generator with a flue stack, one liquid nitrogen tank, two evaporators, three bunded chillers, two bunded receiver tanks, two bunded glycol tanks, a steel frame structure for accommodation, dry coolers heat exchangers, and other utilities will also be developed.

An elevated structural steel pipe rack will be required to provide piped utility services to the new facility.

Utility of the new facility

The RCMF will accommodate multiple clinical products, which will be developed through either batch or continuous (FAST) processing or a hybrid of both, having different overall process flows through the equipment trains.

The batch system will have the capability to produce batches of up to 100kg and consist of various components. It will feature two crystallisers, which will be shared with the FAST system where products are manufactured.

The FAST system will be capable of producing in batches of up to 20kg a day continuously. A fume-hood suite will initially contain six walk-in fume hoods, fully serviced to house continuous processing modules to run a continuous manufacturing process.

Pfizer’s existing Ringaskiddy facility details

OSP 1 is served by two hydrogenation plants and features equipment such as reactor vessels, holding tanks, centrifuges, filtering equipment, dryers, mills, and crystallisers.

In 2007, a Kilo Technology Laboratory (KTL) for process development was opened by the Pfizer Global Process Development Centre at the Ringaskiddy site.

Manufacturing activity at OSP2 had stopped by the end of 2007. Part of its infrastructure was retained, while the rest was reformed as the New Products Technology Laboratory (NPTL), which was commissioned in May 2014. NPTL was developed with an investment of $30m and comprised two equipment trains; one train had a capacity of up to 5kg, while the other train’s capacity ranged from 5kg to 25kg.

OSP 3 is served by three hydrogenation plants and solvent recovery and equipment similar to OSP 1.

Pfizer’s OSP4 synthesis facility is a multi-purpose manufacturing plant whose construction began in 1998 in response to anticipated global demand for Sildenafil citrate, the active pharmaceutical ingredient (API) of Viagra. The OSP4 plant is used to manufacture bulk active ingredients for a range of Pfizer-produced drugs such as Viagra, Norvasc, Zoloft, and Zithromax.

As with OSP 1, OSP 4 is served by four hydrogenation plants and solvent recovery and equipment. The OSP4 facility is capable of producing primary bulk, batch pharmaceutical products at a nominal reactor capacity of 150,000l and six lines of these products at full production scale.

The production services at the site facilitate all the activities involved in the large distribution of utilities, solvents, bulk gases, and chemicals.

The production buildings OSP1, NPTL, OSP3, and OPS4 are all supported by the API Milling facility in milling and packaging finished products for shipment. In 2003, Pfizer sought planning permission to build a third liquid waste incinerator at Ringaskiddy to service OSP4.

The products manufactured at the plant are bulk active ingredients or drug substances. The bulk materials are shipped to other Pfizer sites where they are incorporated into their finished formulations and packaged.

Contractors and subcontractors involved in the project

Multinational automation company ABB reviewed the possibility of reducing electricity costs of chiller applications at the Ringaskiddy site in association with Caltech, California Institute of Technology, and EMSA Consultants. In September 2010, ABB supplied its EEx deIE2 motors and new variable speed drives for the Ringaskiddy site.

Engineering contracting company Jones Engineering provided mechanical, electrical, instrumentation, and fire protection services for the Ringaskiddy site.

The contract for the architectural and engineering design for NPTL was provided to DPS, a global consulting, engineering and construction management company.

SIAC Construction, a construction company based in Ireland, installed external cladding for OSF3, OSF4, and SDD buildings in 2016.

A construction contract was awarded to Foster Wheeler UK and Project Management of Cork. Foster Wheeler UK and Project Management were responsible for the construction of the OSP4 plant and a finished goods building (FGB), alongside all supporting services.

A building contract for OSP4 was given to construction company Sisk Building Contractors, which worked on the foundations, superstructure and cladding. Sisk Building Contractors also provided external and underground services for the building.

Architectural glass for the curtain-walling of stairwells and thermally broken windows was provided by building products supplier Classic Building Solutions. Industrial automation company Douglas Control and Automation supplied control, automation and data management systems for the OSP4 plant, as well as being involved in validation.

Solartron Mobrey installed Squing, a short fork-level switch, as an intrinsically safe sensor system to detect chemical levels as part of the solids containment system. Built from hastelloy for corrosion resistance, the Squing was installed in head tanks, filters and crystallisation vessels. It was chosen for its reliability and absence of secondary electronics.

In 2000, Heinzer Eco-management, an environmental management consulting and auditing company, carried out a pre-assessment of the OSP4 environmental management systems as part of a pre-validation check.

Environmental consultant Sustech acted as an effluent operator and provided environmental management training for the project.

Viagra manufacturing

Pfizer manufactures APIs for Viagra at its Ringaskiddy site, which accounts for 15% of its total output. The company also produces around 17 other products, including Norvasc, which is used in the treatment of hypertension and angina and is one of Ireland’s largest sources of investment.