ISO 146441-1 Class 7 Cleanroom

Cleanroom assembly

We installed a custom designed and purpose-built cleanroom for our Qbig valves and filters for the high-end packaging industry. The cleanroom consists of a main working space, a goods receivable and a goods deliverable area. Having our own cleanroom is completely in line with our company vision, quality and traceability first.

ISO 146441-1 Class
7 Cleanroom

Our cleanroom is fitted with two fan units provided with ULPA U15 (99,9995% @ 0,12 micron) filters, that ensure a particle measurement to the specifications of an ISO 14644-1 Class 7 cleanroom. These filters provide 16 air changes every hour. On regular basis, we have air quality and migration tests performed throughout the cleanroom to ensure our procedures are effective and meet the official ISO 14644-1 Class 7 standards and requirements.

Below the maximum quantity allowance

Class 7 certification

As you can see in the results below, the particle measurements have stayed below the maximum quantity allowance, needed for the -Class 7 certification.

≥ 0.3 mm≥ 0.5 mm≥ 1.0 mm
Iso 6 – maximum quantity allowed102.00035.200293
Iso 7 – maximum quantity allowed352.0002.930
Iso 8 – maximum quantity allowed3.520.00029.300
Cleanroom main working space4.9931.6390
Cleanroom goods in & out7.5672.7240

Below the results of the migration test of microorganisms, yeasts and fungi. Again, all far within the allowed limits.

ISO 4833-1ISO 7954:1987ISO 7954:1987ISO 4833-1
AIR sampling main room kve/m310
(max allowed 300)
(max allowed 300)
(max allowed 300)
AIR sampling goods in & out kve/m380
(max allowed 300)
(max allowed 300)
(max allowed 300)
RODAC Plate count ( ISO 18593 ) kve/16cm218
(max allowed 50)
(max allowed 5)