The challenge staked out by the biotech Chemgineering’s client was certainly intriguing:

The idea is to conceive a multipurpose production plant with maximum flexibility for handling existing and even future products and coming, innovative processes. This was clearly a tall order for the design team, because in this case «multipurpose» stands for both a) multiproduct plant and b) highly flexible use. To meet this extremely demanding task, vast experience in handling comparably complex projects was a prerequisite.
To provide the capability of integrating even processes expected in future into the biotech plant at short notice, the following key criteria had to be observed:
n successive expansion, by product or process stage
n short installation time for new processes or products
n no or only short periods of production downtime
n lowest possible advance capital investment
Short installation time is crucial for the plant operator, because it directly affects the overall time-to-market lead time. In this case, fast installation can refer either to each individual process or to complex production interdependencies.
The design team’s first hurdle was to create the basis for the further conceptual design work and, in the programming session, to list and match the nature and complexity of possible processes and the specific customer requirements they could imply. Because, of course: designing starts with the process!
Following Chemgineering’s methodical procedure, the team tackled the process design, dimensioning, and selection of equipment. Space/function diagrams were produced based on the space required by the individual equipment modules and the available area. The processing steps and necessary production capacities determined the requirements of the supply and drainage piping and the logistics and storage facilities. The analysis of material and personnel flows enabled the team to optimize paths and avoid sources of contamination.
The specialists reviewed these complex planning relationships in their entirety and then drew up an optimized plant concept. Of course it also had to meet the special regulatory demands of the EU guidelines (such as Annex 1: Manufacturing of sterile medical products) and the FDA guidelines.
Besides protection of the product against contamination, explosionproofing requirements also had an impact on the plant layout. At the end of the day, the goal was to permit a GMP-compatible operation that would pass international audits and guarantee product and plant safety for humans and the environment.
Layout development was carried out in iterative steps, with further specific requirements such as classification of the production rooms (cleanroom classes), Ex zones and storage capacities being worked in successively. The applicable standard also includes engineering aspects such as functional relations between production and ancillary rooms, access to the different spaces (air lock arrangement), reduction of handling floor space, separation of cleanroom and equipment spaces, and even the achievement of nonintersecting personnel and material flows.
The layout takes into consideration all of the defined requirements and clearly shows the desired successive expansion possibilities of the plant as a whole.
One of the most apparent features of these layout goals is the demand-related conception of the supply system for ultrapure media, a common feature of this type of plant. Expansion stages and extension possibilities have to be estimated in the design of generators, storage facilities and distribution systems and then included in the layout.
Modern active ingredient production plants in the biopharmaceutical industry become efficient not least through a remarkable flexibility, such as that conceived by Chemgineering for this project. The new multiproduct plant will satisfy the high demands called for by today’s dynamically changing production strategies. ®