Facility management/operations to strict GMP standards for Sanofi

Industry: Health care; Sanofi, Frankfurt

How do you build a 25,000-m²-GEA production plant to GMP standards?

Sanofi, one of the world's leading pharmaceutical companies, planned to build a new production facility for insulin pens. Four new buildings were needed to house the assembly and packing operations for the medical products. The company also required testing labs for quality assurance, administrative offices, an incoming goods center, a high-bay warehouse and a temperature-controlled storage aisle. All the production facilities had to meet a strict clean-room classification. Plans were drawn up for 20 service areas to be ventilated separately. In addition, building automation and an energy-management system had to allow Sanofi to directly allocate the cost of energy procured from different networks to the various products.

The bottom line

The project was completed without Sanofi experiencing any operational disruptions in a record-breaking 15 months. The customer-centric completion strategy implemented the user's requirements from the interim operational phase all the way to standard operations; it kept operations running smoothly during all four construction stages. Infraserv Höchst made a strong showing with its planning, construction and operational expertise – even when it came to licensing management. After successfully completing the implementation phase, Infraserv Höchst took over the technical and infrastructural facility management for the production plant.

Infraserv Höchst´s services

	Planning, architecture and realization of the implementation phase • Planning, financing and erection as the general contractor • Providing support during FM-compliant planning in strict conformity with clean-room classifications • Supplying guidance during inspection, acceptance and initial start-up • Interface management • Consulting and preparing an operating plan for comprehensive facility management • Setting up GMP-compliant building operations Operational services • Assembling and integrating a service team • Assuming operator responsibility • Providing technical and other services in production, management, warehousing and workshops • Ensuring system and building availability with individual service level agreements on service strategies, cleaning, machine availability, and employee training using blended learning (ZEUS) • Quality and incident management Timeframe The project was completed in four stages (15 months in total): Stage 1: building 1, 1/2007 (20%) Stage 2: building 2, 5/2007 (40%) Stage 3: building 3, 7/2007 (70%) Stage 4: building 4, 4/2008 (100%)