Conceptual design of a pharmaceutical plant

This thesis was carried out during an industrial internship at Kedrion, one of the leading biopharmaceutical companies in the production of plasma-derived product. The project consists of the development of the conceptual design for the construction of a new pharmaceutical facility in Bolognana, Italy. In the existing facility present in Bolognana, the concentration of human normal immunoglobulin obtained is equal to 5% and the company aims to double this concentration up to 10% to align the downstream and purification sector. In the first part of the proposal, the attention is focused on the articulation of the technological roadmap of the industry by testing the feasibility of the project and on taking key decisions on the manufacturing strategy and design concept. This paper describes the analysis of the practices of the modern plasma fractionation industry: from the collection of the raw plasma material to the industrial production of fractionated products. In addition, aspects of the good manufacturing practices and the regulatory environment governing the entire manufacturing chain are highlighted. A detailed strategy on how to ensure the compliance with the quality requirements of plasma for fractionation is reported, together with an illustration of the methods chosen to ensure tolerable levels of airborne infectious agents. To enable the separation of process flows, Kedrion decided to integrate transfer panels to connect two production areas located on different floors. Multi-port transfer panels are used to organize the installation and the support of product and piping, and to facilitate connections for the required additions or operations such as Cleaning in Place. Finally, a preliminary economic assessment of the brownfield project is presented by defining the capital expenditure based on the offers from the suppliers of equipment and automation systems.