scope:

Microbial contaminants on surfaces and in the air (including cleanroom air), as addressed by this guideline, include all microorganisms capable of proliferation (bacteria and their spores, fungi and their spores) and capable of having harmful effects on products by their settling and proliferating on them. Organic cell fragments and metabolic products of biotic origin are not included.

This guideline describes origins and possible consequences of microbial contamination in air and on surfaces of cleanrooms and their equipment, and its detection, quantitative analysis, avoidance, reduction and control (biocontamination control). It gives consideration to the effects of microbial contamination on humans in cleanrooms, on raw materials and products produced or stored in cleanrooms and on auxiliary materials. The guideline specifies general principles for treating, handling, avoiding and reducing microbial contamination in cleanrooms. These principles are based on the performance characteristics of known and available technical solutions as well as on the economic features of these solutions.

The guideline aims to aid the operator of clean production processes where hygiene is critical in decisions for establishing optimized concepts for microbial contamination control in accordance with the state of the art.

Microbial contaminants may be transferred by air as well as by other media; these include, in particular, water, aqueous solutions, further process liquids and process gases. The effects of microbial contaminations by these process media affect all producing industries listed above, especially the food and luxury goods, pharmaceutical, genetic- and medical-engineering industries.

Process media are not covered by this guideline and require separate consideration.

The scope of this guideline covers all types of controlled environments, i.e., in addition to production areas, it also includes storage areas where products and processes may come into contact with microbial contamination.

Under certain conditions, the competent supervisory authorities can impose additional stipulations or limitations.

Cleanrooms as defined by this guideline are, e.g.:

• buildings or parts of buildings with active or passive technical installations suitable to establish controlled conditions in terms of the characteristics of thermodynamic air conditions, the content of airborne substances and the contamination of media, surfaces and products
• small-volume environments and spaces within a cleanliness cascade as, e.g., in production cells (mini-environments/isolators/RABS and other barrier systems, see also VDI 2083 Part 16.1) and storage vessels