Manufacturing of Pharmaceutical Proteins || Planning, Construction and Commissioning of a Manufacturing Plant

✍ Scribed by Behme, Stefan

• Publisher: Wiley-VCH Verlag GmbH & Co. KGaA
• Year: 2009
• Tongue: German
• Weight: 161 KB
• Edition: 1
• Category: Article
• ISBN: 3527324445
• DOI: 10.1002/9783527627691.ch9

✦ Synopsis

Planning, construction and commissioning of a manufacturing plant constitute one of the most demanding and interesting areas of biotechnological production.

Each manufacturing plant is custom-made and designed individually to accommodate the projected demands of the company. The challenge is to find the compromise between functionality and flexibility, on the one side, and the financial constraints as to capital investment and operating costs, on the other. The planning process has to anticipate future trends in GMP requirements, process technology and capacity demand, and create the basis for a long operating time and optimized usage of the asset.

The present chapter introduces the principles of an investment project. It starts in Section 9.1 with an explanation of the phases of the planning, construction and commissioning process. Section 9.2 discusses typical time schedules of engineering projects, Section 9.3 elaborates on cost estimates and Section 9.4 is dedicated to the organization of such a project. Since engineering projects are usually executed with specialized external engineering companies, one focus of this chapter lies on how to build and maintain contractual relationships.

Section 9.5 discusses success factors for the execution of an engineering project. Section 9.6 deals with the legal framework for the construction of an industrial plant.

9.1 Steps of the Engineering Project

The pathway to plant construction is paved with technical and organizational challenges. The principal steps are:

. Identification of user requirements. This includes the collection of data as to the desired capacity up to qualification requirements.