Francis Cauffman

Case Study:Quick Changeover of cGMP Manufacturing

McNeil Consumer HealthcareFort Washington, PA

Aerial View of Campus

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McNeil Consumer Healthcare retained the services of Francis Cauffman to assist in completing a comprehensive renovation and validation of five separate process areas totaling 35,000 SF. The project was completed during a five-week shutdown of its Fort Washington, PA, manufacturing facility. These areas were dispersed throughout an operating 350,000 SF oral solid and liquid dosage plant.

The keys to success for this challeng-ing project were:– Thorough preconstruction planning

and preparation by McNeil, Francis Cauffman, the engineers and the construction manager

– Qualification and validation requirements were an integral part of the project plan, allowing for all these activities to be completed on schedule

– Total team focus during construction.

TeamThe design/construction/validation requirements were specialized and highly interrelated.– The team included all stakeholders:

end users, facilities engineers, mechanical/electrical/plumbing engineers, the architect and the construction manager.

– The integrated solution and coordi-nated process resulted from a team that was competent, committed and juiced up with the right attitude.

– McNeil provided leadership that was clear about the scope of the project and willing to make decisions.

Preconstruction Effective planning and preconstruction were critical.– Accurate and timely information

from the facilities engineer meant that the design had a sound founda-tion; change orders were minimized.

– Francis Cauffman, the engineers and construction manager surveyed the facility in advance to build a comprehensive understanding of the area prior to construction.

– The construction schedule was aligned with the user group’s produc-tion shutdown schedule.

– A constructability review, which included the trade contractors, generated questions prior to con-struction so that potential problems could be considered and solutions documented.

– To maximize the minimal shutdown window, the design and construction sequence was reviewed with the trade contractors.

– The construction manager worked with the trades to identify all the tasks and the manpower required to complete the work on time. The trades were scheduled for two 10-hour shifts per day.

– To further assure the quantity and quality of manpower required to complete the work on time and to the specifications, different subcon-tracting companies were hired to perform different parts of the same bid package.

– Tasks that could be done prior to shutdown were identified, includ-ing early windows of opportunity when construction workers could have access to the cGMP areas to complete these tasks.

– Plans, specifications and the con-struction plan were reviewed with Quality Assurance to assure proper temporary protection and to confirm cleaning and testing protocols.

– Review and approval of submittals, prepurchasing, manufacturing and assembling of components were completed in advance to the great-est extent possible.

– On-site review of the project with local building code officials occurred prior to the start of work to address potential code issues.

Case Study:Quick Changeover of cGMP Manufacturing

Above: Tablet Compression SuiteAbove: Mezzanine

Left: Testing BenchBelow: Rooftop A/C Unit & Dunnage

McNeil Consumer Healthcare retained the services of Francis Cauffman to assist in completing a comprehensive renovation and validation of five separate process areas totaling 35,000 SF. The project was completed during a five-week shutdown of its Fort Washington, PA, manufacturing facility. These areas were dispersed throughout an operating 350,000 SF oral solid and liquid dosage plant.

The keys to success for this challeng-ing project were:– Thorough preconstruction planning

and preparation by McNeil, Francis Cauffman, the engineers and the construction manager

– Qualification and validation requirements were an integral part of the project plan, allowing for all these activities to be completed on schedule

– Total team focus during construction.

TeamThe design/construction/validation requirements were specialized and highly interrelated.– The team included all stakeholders:

end users, facilities engineers, mechanical/electrical/plumbing engineers, the architect and the construction manager.

– The integrated solution and coordi-nated process resulted from a team that was competent, committed and juiced up with the right attitude.

– McNeil provided leadership that was clear about the scope of the project and willing to make decisions.

Preconstruction Effective planning and preconstruction were critical.– Accurate and timely information

from the facilities engineer meant that the design had a sound founda-tion; change orders were minimized.

– Francis Cauffman, the engineers and construction manager surveyed the facility in advance to build a comprehensive understanding of the area prior to construction.

– The construction schedule was aligned with the user group’s produc-tion shutdown schedule.

– A constructability review, which included the trade contractors, generated questions prior to con-struction so that potential problems could be considered and solutions documented.

– To maximize the minimal shutdown window, the design and construction sequence was reviewed with the trade contractors.

– The construction manager worked with the trades to identify all the tasks and the manpower required to complete the work on time. The trades were scheduled for two 10-hour shifts per day.

– To further assure the quantity and quality of manpower required to complete the work on time and to the specifications, different subcon-tracting companies were hired to perform different parts of the same bid package.

– Tasks that could be done prior to shutdown were identified, includ-ing early windows of opportunity when construction workers could have access to the cGMP areas to complete these tasks.

– Plans, specifications and the con-struction plan were reviewed with Quality Assurance to assure proper temporary protection and to confirm cleaning and testing protocols.

– Review and approval of submittals, prepurchasing, manufacturing and assembling of components were completed in advance to the great-est extent possible.

– On-site review of the project with local building code officials occurred prior to the start of work to address potential code issues.

Case Study:Quick Changeover of cGMP Manufacturing

Above: Tablet Compression SuiteAbove: Mezzanine

Left: Testing BenchBelow: Rooftop A/C Unit & Dunnage

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LifeCell Corporation, Inc.Locus Pharmaceuticals, Inc.Lundbeck Research USA, Inc.McNeil Consumer HealthcareMcNeil NutritionalsMerck & Co., Inc.Monsanto CompanyNeose Technologies, Inc.Ortho-McNeil Pharmaceutical, Inc.Pfi zer, Inc.Regeneron Pharmaceuticals, Inc.Schering-Plough CorporationShaklee CorporationShire U.S. Manufacturing, Inc.Therakos, Inc.WyethValera Pharmaceuticals

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