scope:

This guideline applies to the ongoing, system-specific monitoring of individual parameters of cleanroom systems. Monitoring may be continuous (e. g. for pressure, temperature, humidity) or sequential (as in microbiology).

Measurements in cleanrooms for qualification purposes are described in DIN EN ISO 14644-3, and are explained and supplemented in view of the respective application in VDI 2083 Part 3. These measurements serve for classification of air cleanliness as per DIN EN ISO 14644-1. A distinction must be made between one-time measurements for classification or qualification of rooms on the one hand, and the metrological monitoring of certain parameters, be it periodic or continuous. Only the latter variant, i. e. classical "monitoring", is the subject of this guideline.

In the case of specific applications, as in pharmaceutics, biotechnology, genetic engineering, medical engineering, the techniques described in this guideline are associated with the proof of sterility and other microbiological tests (see, e. g., EU GMP Guide). This guideline does not contain a detailed description of microbiological tests; such details are provided in the standards DIN EN ISO 14698-1 and -2 and in VDI 2083 Part 18.

The present guideline specifies techniques for measurements in cleanroom systems and describes the instrumentation required so as to define a standard for monitoring.

Stipulations regarding the monitoring measurements aim to aid the user in selecting methods that will allow him to detect system- and process-related deviations from operational specifications (such as pressure cascading, particle concentrations).

This guideline does not apply to the monitoring of cleanrooms using data loggers designed for mere data storage and periodic readout. If, however, data loggers immediately transmit the data recorded to a master system, which means, strictly speaking, that they are only used as sensors, their use is not ruled out.

Note: Using data loggers for monitoring in the former sense (i. e. data recording and storage, no immediate transmission to master systems) is deemed reasonable but as a supplementary measure