Conceptual designs for ATMP facilities
Progress has been involved with several confidential clients who required new cleanroom facilities, specifically aimed at the production of Advanced Therapeutic Medicinal Products (ATMPs). Our consultants use a structured approach that allows us to create a conceptual design in a short time, while we work closely with the client as one multidisciplinary team.
Tailor-made
We start by gaining a thorough understanding of the client’s specific needs, such as the type(s) of ATMPs they plan to produce, production volumes, typical modes of operation and location constraints. This ensures that the design is tailored to their unique requirements. This information is used to draw up an adjacency diagram for the necessary rooms to visualize their interdependence. During this stage, we already start to consider trivial aspects such as the use of isolators versus the use of Biological Safety Cabinets (BSCs) and the advantages and feasibility of unidirectional flows.
Preventing issues
Using the adjacent diagram, an initial layout can be made, taking into account the limitations of the building or available space. With our extensive experience in Good Manufacturing Practice (GMP), we are able to implement solutions to potential future problems in the conceptual design of facilities. Examples of such problems include inefficiencies in both personnel and material flow, as well as in HVAC systems, and specific issues with contamination control.
Result
The result of our involvement in the conceptual design phase is a sleek conceptual design that can be used for the detailed design of the facility. In this approach, the client is closely involved to ensure that the result meets the wishes of the organization. Our aim is to deliver a tailor-made design that is efficient in use, future-proof and makes optimal use of the available space.
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