Air-Tightness of Cleanrooms & Containment Solutions: VDI 2083 Part 19 Updated
Recommendation
29/30 October 2024
Organisation of a GMP-compliant Site Change
The question of how tight the cleanrooms must be needs to be answered as early as the planning phase of a facility. Assistance is provided by the DIN EN 15727 standard and the new version of the VDI guideline VDI 2083 Part 19, which specifies a procedure for testing and classifying the tightness of isolators, cleanrooms and air ducts and contains instructions for creating tight cleanrooms. It applies to all rooms that are operated in positive or negative pressure compared to the environment, both for personal and product protection.
The version published in February 2024 replaces the previous version 08/2018 and contains the following changes:
- In Table 6, the note has been added that the sealing frame (when using blower door devices) must be suitably tight in order to comply with the measurement accuracy requirements set out in Table 5.
- In equation 3, the pressure and temperature specifications for standard conditions (101325 Pa and 293.25 K) have been corrected.
- In section 6.3.5 it was pointed out that for very tight systems with room tightness class >= 3 special test requirements apply. In particular, atmospheric pressure and air temperature in the containment to be tested should be recorded during the test and the influence on the measurement results evaluated.
- The literature references have also been updated.
You can view the table of contents of VDI Guideline 2083 Part 19 on the VDI website. The guideline can be purchased from Beuth Verlag.
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