Cleanroom
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.
In April 2022 we had our cleanroom and procedures audited for GFSI Standard BRC Packaging ISSUE 6. 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.
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 allowed | 102.000 | 35.200 | 293 |
| Iso 7 – maximum quantity allowed | – | 352.000 | 2.930 |
| Iso 8 – maximum quantity allowed | – | 3.520.000 | 29.300 |
| Cleanroom main working space | 4.993 | 1.639 | 0 |
| Cleanroom goods in & out | 7.567 | 2.724 | 0 |
Below the results of the migration test of microorganisms, yeasts and fungi. Again, all far within the allowed limits.
| Microorganisms | Yeasts | Fungi | Enterobacteriaceae | |
|---|---|---|---|---|
| ISO 4833-1 | ISO 7954:1987 | ISO 7954:1987 | ISO 4833-1 | |
| AIR sampling main room |
10 (max allowed 300) |
0 (max allowed 300) |
10 (max allowed 300) |
– |
| AIR sampling goods |
80 (max allowed 300) |
0 (max allowed 300) |
0 (max allowed 300) |
– |
| RODAC Plate count |
18 (max allowed 50) |
– | – | 0 (max allowed 5) |
Qbig is ISO Certified
Development and supply of customer tailored industrial packaging liners and fitments.
