GxP-Blog

Security for the Concept: Building of New Plants, Reconstruction or Extension of a Manufacturing Plant

A new medicine, a changed manufacturing program or an extension of production – there are many good reasons to reconstruct or expand an existing manufacturing facility. For larger changes it can happen that entire new parts of buildings are constructed and/or extensions are built. Of course, the responsible persons face here the challenge to plan everything in such a way that a successful completion can be ensured at the end of the project and that the entire construction project does not end in chaos.

The steps of the design process are clear: Conceptual Design, Basic Design, Detail Design. From the conceptual design, the preliminary design for the investors, via the design submitted to obtain a construction permit until the detailed design for the beginning of construction works the design becomes more and more concrete in every step of the way. While the conceptual design is still flexible and can be changed, at the latest in the detailed design, all data must add up with millimeter precision.

A conceptual idea can quickly be put on paper and one can be convinced to have found the only possible and meaningful layout. However, if some requirements are still not clear, will the concept be later able to meet the real requirements? Can it be flexible and expandable without any problems, if the product portfolio changes in the middle run? Preparing a Project URS (User Requirement Specification) or specifications is not very popular. It requires work and forces the designer to make considerations that raise issues for which he, under the given circumstances, still does not have any answer. Above all issues regarding product development, market segments and capacities are difficult to evaluate in advance, so that we need flexible concepts. However, at the latest by the beginning of the construction works, the design may not be flexible anymore. Moreover, it should be literally etched in stone.

So, in the ideal case, everything has to be done correctly from the very beginning. The question of the essential aspects, which should be regarded as the basis for the design, is very important. This includes the required space for the necessary equipment, different utility connections, potential equipment for securing danger zones etc. A short and straightforward, not intersecting flow of material and personnel is the key to a smooth production process without mistakes. But where do bottlenecks occur if the production capacity is to be increased? Is there sufficient utility space, buffer and storage space even in case of increasing production volumes? Do the utilities suffice to increase the production or must new producers be added? There are still factors with no solution to them, which cannot be determined with certainty from the very beginning. In addition, there can be some uncertainties in the preliminary stage, for example, if a product has been only in research previously and should now move for the first time into commercial production. Laboratory conditions differ strongly from the conditions in large-scale plants. Then, apart from the requirements regarding space, there are also legal requirements for the project, as well as the wishes of investors (“as economical as possible”), the wishes of manufacturers (“as comfortable as possible and with the best equipment”) as well as the wishes of employees working in the plants (“best possible working conditions”). The biggest challenge is to accommodate all these interests.

Here it can be of great advantage to make use of the professional expertise of others. External professional consultants have the trained external view of the project and can, based on their experience in many projects in a similar or even totally different environment, find hidden potential again and again by asking specific questions, by thinking in other directions or by recommending already proven practices. In the same way, pitfalls can be identified that may not be noticed until regular operation has started (energy efficiency, process organization, capacities etc.). For who can assess a variant in a better way than those who have experienced it already in reality? Being able to imagine something is good, but it is better to have already implemented, suffered and optimized something. An independent product-neutral and solution-neutral consultant and designer can, together with the company’s own project manager, take this path and make the optimal solution out of the desired solution.

Getting the expert on board at the earliest possible stage is an undreamt-of added value. He knows on what to focus precisely in the laboratory, storage space, in the production (liquid, semi-solid, solid, sterile, etc.). For each trade or each process step it is decisive to ask questions to the right contact partner and not to the (self-proclaimed) allrounder. The company’s internal project manager knows his company, its history, the products, possibilities and framework conditions exactly. External qualified experts assess objectively e.g. the number of air exchanges, sizes of rooms, lock situations, paths and areas, the technique and the processes. Specialists should have plenty of experience in planning for diverse clients, having discussed concepts and defended them before authorities as well as qualified and validated such concepts. In the ideal case, experts have, in case of tricky questions, direct access to (former) authority representatives, so that uncomplicated and fast decisions can be made for potential variants.

Experience shows that experts that are presumed to be expensive are unwillingly hired in the process of finding ideas, because they cost money. The costs of correcting bad planning at later stages are many times higher. The large part of the later spent entire budget depends on the chosen solution. Therefore, this should also be the best possible solution for the planned project. As the project progresses, making changes to the planning becomes more and more expensive and above all more difficult. For this reason, it is recommended to involve the independent qualified review partner as soon as possible in the planning. It is worth it in any case!