Client
Pfizer/Warner-Lambert
Location
Little Island, Cork, Ireland

Pfizer/Warner-Lambert Pharmaceutical Operations Expansion EPCMV

Pfizer is one of Ireland's largest pharmaceutical multinationals and leading pharmaceutical sector investor. Ireland is a primary manufacturing base for Pfizer for export to global markets.

To meet the increasing consumer demand for its products, Pfizer needed to expand its Irish production of several best-selling medicines. A $365 million expansion program of the existing Warner-Lambert pharmaceutical operations complex was approved. The program spanned four years and included five major projects.

Fluor provided a full range of project services for the comprehensive program, including Health, Safety, and Environmental (HSE), complete engineering, procurement, construction management, start-up and validation (EPCMV) services.

The five major projects were a bulk-finishing facility, a multiproduct batch organic synthesis facility, two related organic synthesis facilities, and a central utility building (CUB).

The bulk pharmaceutical manufacturing complex produces Lipitor® (atorvastatin), the cholesterol-lowering compound that has become one of the most successful pharmaceutical products ever launched.


Client's Challenge

In 1997, Warner Lambert acquired the site as part of its Lipitor manufacturing capacity expansion. Warner-Lambert pharmaceutical complex is located on a peninsula in Cork, Ireland. In 2000, Warner Lambert merged with Pfizer and all intermediates. The $365 million pharmaceutical expansion was well underway with plans to manufacture final API for Lipitor.

The Little Island API facilities are situated on 19 acres and contain several manufacturing areas:

  • OP1 is a large volume organic synthesis facility, which has specialised low temperature and hydrogenation capabilities.
  • OP2 is a dedicated API drying and milling facility.
  • OP3 is a small volume high containment facility and has the only OEB5 API capability in Pfizer.
  • The support infrastructure includes laboratories (e.g., high containment), a utilities building housing two steam boilers, each capable of generating 13 tonnes of steam per hour, a waste water treatment plant capable of treating 500 tonnes of processed water each day, an administration building, and warehousing.

Fluor's Solution

Fluor provided EPCMV services for a $365 million pharmaceutical operations expansion program that included five major projects. Conceptual work, basic engineering, and detailed design were performed by Fluor with field support from our Cork, Ireland office.

The projects were a bulk-finishing facility, a multiproduct batch organic synthesis facility, two related organic synthesis facilities, and a CUB.

The largest facility completed by Fluor was a $132 million schedule-driven, bulk-finishing facility with multiple lines to produce 5.5 billion tablets per year, with future capacity for expansion. The 262,000-square-foot facility is among the largest tablet facilities in the world.

Fluor also completed the new $85 million, multiproduct batch organic synthesis facility that included a hydrogenation suite and multiple, glass-lined reactor systems.

The fast-track project was successfully completed in 27 months, and the first batch met specification. Final APIs for Lipitor are now supplied from this site.

Fluor also provided full project services for renovation of two related organic synthesis facilities at Cork and Little Island, Ireland. The fifth project was a $40 million central utilities building.

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Conclusion

Fluor provided EPCM and validation services for a $365 million pharmaceutical operations expansion program that included 5 major projects. The projects were a bulk-finishing facility, a multiproduct batch organic synthesis facility, two related organic synthesis facilities, and a CUB. The expansion program spanned four years, completing in 2000.

The bulk pharmaceutical manufacturing complex produces Lipitor (atorvastatin), the cholesterol-lowering compound that has become one of the most successful pharmaceutical products ever launched.