Cleanroom planning in the pharmaceutical industry…
… is the planning of buildings for the production and storage of pharmaceutical products of all kinds.
The particular challenge here is that such buildings must be planned and constructed in compliance with GxP quality standards.
The basis for the planning of pharmaceutical buildings are the User Requirements (URS), which are defined by the client at the beginning of the planning process. They specify the structural requirements for the ambient conditions, including materiality, room air, room temperature and room humidity. The corresponding cleanroom class and pressure difference between the various cleanroom classes are also defined by the customer at this stage.
In accordance with the GxP regulations, the planning, awarding, construction and commissioning process passes through specific quality gates and acceptance tests. These must be documented and submitted to the accepting authorities. In the planning process of cleanrooms, the personnel and material flows play an essential role, as the transitions from one cleanroom class to another must be implemented by means of dedicated airlocks for materials and personnel. The design of cleanroom walls, ceilings and connections also require special know-how in planning and implementation in order to meet the legal requirements.
Intensive cooperation with the planners for the process equipment is also important. This must be correctly positioned in the floor plan according to the required manufacturing and processing sequences. Special attention must also be paid to the required generation and provision of media such as energy, processing water, compressed air and gases, as well as the handling of wastewater and its treatment.
When planning a building in the pharmaceutical sector, it is particularly important that the client and the process planner coordinate intensively right from the start. The requirements from the operational processes essentially determine the configuration of the building: Intelligent solutions for the flow of personnel and materials from the unclean area to the clean area and back out again are decisive.
Well planned is half built: Well thought-out plans are the basis for cost-effective construction and operation. Requirements from fire protection are important and must be integrated in any case, even if they often contradict the requirements from process flows and GxP.
Once the preliminary planning has been completed, the actual building design can begin: Preliminary design, draft design, and construction submittal are the stages to the finished building. Parallel to each planning step, cost evaluation and scheduling for the implementation phase take place.
After the building has been submitted, detailed planning and the preparation of the specifications for the awarding of the construction work begin. The aim is to have an executing company available as soon as the building permit is issued, so that construction can begin immediately.
We control the construction within the scope of the local construction supervision, so that the client can put the building into operation after completion of the construction work. During all planning and construction phases, the client, planners and process technology installers regularly and intensively coordinate with each other. The construction project is also handled in close coordination with the GxP qualifier so that all requirements and verifications can be met and are available during commissioning and official operating approval. Only through close cooperation can the plant succeed.