scope:

This standard specifies requirements regarding periodic checking of a cleanroom or controlled environment for demonstrating continued compliance.

These requirements refer to the functional tests regarding operation of the systems as described in VDI 2083 Part 1, VDI 2083 Part 3, DIN EN ISO 14644-1 and DIN EN ISO 14644-3. The functional tests include:

• visual inspection
• determination of air velocity or air volume flow and air change rate in the rooms
• filter leak test
• determination of pressure differential across the filter and between rooms
• air cleanliness classification
• determination of recovery time
• measurement of temperature, relative humidity, sound pressure level and illuminance

In the case of specific applications, as in pharmaceutics, biotechnology, genetic engineering, medical engineering, the methods described here are associated with the demonstration of sterility and other microbiological tests, cf., e. g., EU GMP Guide.

This standard does not contain a description of microbiological tests.

This standard specifies intervals between measurements in cleanroom systems with the aim of introducing these intervals as standard practice for performance qualification.

Routine qualification or requalification consists in checking the systems and their specified normal operation for continued compliance with the specifications. The stipulations regarding monitoring measurements aim to aid the user in selecting methods that will allow him to detect system- and process-related deviations from the specifications.