Cleanroom Planning / Pharma
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.
Manufacturers of pharmaceutical products are directly linked to the demographic reality: The life expectancy of people in highly civilized countries is increasing year by year, so new drugs are also constantly being developed for side effects of old age. However, these drugs must be produced at efficient prices, as the overburdened healthcare systems have to calculate very precisely. New production technologies are helping in the development and manufacture of medicines. In addition to high quality, it is essential to always keep an eye on costs.
Despite these immense demands, the regulatory framework of the pharmaceutical industry – pharmaceutical research, production and logistics – remains unchanged. Continuous logging and documentation of environmental conditions (especially temperature) from the first production step until administration to patients pose major challenges to pharmaceutical companies. This traceability is also referred to as “track and trace” or “GxP”, i.e. either GMP (Good Manufacturing Process) or GDP (Good Distribution Process).
Cleanroom planning in the pharmaceutical sector is focused on product protection. High demands on the purity of the ambient air and compliance with the required temperature and humidity are at the forefront of technical implementation.
Your added value
Our clients have one contact for construction planning and implementation in the field of cleanrooms, namely us. We have years of experience and knowledge of how to plan and construct a building so that it optimally fulfills the required function. We speak the language of process technologists and understand their requirements.
As general planners, we work closely with the client and the process technology planners from the initial idea to commissioning. The structuring of the building and the internal layout are developed on the basis of GxP storage and manufacturing-related processes. In doing so, we ensure that all building code requirements, in particular fire safety and employee protection, as well as energy efficiency are met or implemented in such a way that the building’s purpose can be optimally fulfilled.
Precise structuring and technical knowledge ensure that we guarantee cost stability and adherence to deadlines.
We put the construction services out to tender, support our clients in the awarding of these services and, as the local construction supervisor, handle the implementation. In doing so, the scheduling and technical interface with the process technology supplier is important.