+86 18186671616
Jason@cleanroomequips.com
MENU
Q: Why should I care about these classifications for my facility?
Jason Peng, Deiiang® Lead Designer: "Picture your smartphone assembly line - one dust particle can ruin a $1,000 chip. Our Deiiang™ iso 5 (Class 100) rooms maintain air 100x cleaner than a hospital OR. How? With GCC® certified vertical laminar flow and 300+ air changes/hour."
© Deiiang Project #CN2023-MEMS | GCC® Certification No.DEII-88765
Q: How does Deiiang® ensure compliance during verification?
Joebo Wang, Deiiang® Senior Validation Specialist: Last month at a vaccine lab, our Deii™ sensors caught 22% higher particles during operational state vs at-rest. We fixed it by recalibrating the:
- hepa filter sealant using Deiiang™ laser scanning
- Airflow velocity to 0.45m/s ±5% (ISO 14644-1 requirement)
- Pressure differentials between zones
Result: Passed FDA audit with zero observations - saving $350K in potential downtime.Project Report #DEII2024-BIO
| Classification | ISO Equivalent | Particles/m³ (≥0.5μm) | Typical Applications |
|---|---|---|---|
| Class 100 | ISO 5 | ≤ 3,520 | Microchip manufacturing, sterile fill lines |
| Class 1,000 | iso 6 | ≤ 35,200 | IV compounding, medical device assembly |
| Class 10,000 | iso 7 | ≤ 352,000 | Vaccine packaging, pharmaceutical warehousing |
Data source: iso 14644-1:2015 Annex A | Validation Protocol: GCC® Chapter 4
