In selecting the construction components, important factors to consider are
National and international guidelines also require risk assessments when designing plants and when determining the scope of qualification/validation.
This gives rise to special hygienic and cleanroom requirements for components. Different requirements also result from the intended type of usage. Administration, research and laboratory buildings have different requirements than production rooms. The requirements for production areas and clean rooms used for pharmaceutical purposes have a higher standard than other buildings, even if these components are not in direct contact with pharmaceutical products. An example of a risk-based assessment of surfaces in connection with their proximity to the product and cleanability is discussed in chapter 1.9 Example of a risk assessment for surfaces.
Special operational requirements can also include measures for ergonomic workstation design that is well accepted by the operating personnel (e.g. colour schemes for surfaces, etc.)
The need to provide greater heights and thus increased space for the room-air installations above the cleanroom ceiling and their accessibility for maintenance is also an essential factor in the shell construction.
In the following chapters, the design options for pharmaceutical cleanroom construction of GMP classes A–D are described. The requirements for non-sterile production are not as high. Solutions for non-sterile production and also temperature-controlled areas (cooling rooms, incubation rooms, etc.) are not explicitly dealt with here, but can be applied analogously.
 From Report No. 6, Particle transport through leaking façades (Partikeltransport durch undichte Fassaden), Dohm Pharmaceutical Engineering, Dr.-Ing. Wolf Ziemer, DI(FH) Mike Urack, May 2009, www.dphe.de
An excerpt from the e-book A Pharma Guide to Planning and Constructing Cleanrooms
Planning and constructing cleanrooms is a complex task. Get to know how to successfully get through all steps of planning and construction.
The e-book offers expert knowledge on:
Order now your copy of Pharma Guide to Planning and Constructing Cleanrooms!