Common classes
| ISO class | Max particles of 0.5 micron and larger, per m3 | Often used for |
|---|---|---|
| ISO 5 | 3,520 | Aseptic filling, critical semiconductor steps |
| ISO 6 | 35,200 | Clean assembly, some medical device work |
| ISO 7 | 352,000 | Pharma support areas, electronics assembly |
| ISO 8 | 3,520,000 | Gowning areas, general controlled spaces |
Lower numbers are cleaner. These limits are for 0.5 micron particles in the at-rest or operational state you define. Check the current edition of ISO 14644-1 for the full table and test method.
What class means for your supplies
- Wipers. Tighter classes need low-shedding knitted polyester with sealed borders.
- Gloves. Cleanroom gloves are made and packed for low particles and low residues.
- Garments. Higher classes need more complete gowning and low-shed fabric.
- Tacky mats. Used at the entry to take particles off shoes and wheels.
- Paper and notebooks. Use cleanroom paper in controlled areas.
Pharma grades
Pharmaceutical sites also use the EU GMP Annex 1 grades A to D. Grade A, for example, is for the most critical zones. Your quality team maps grades to ISO classes for your site.
Class limits, test conditions and grades are set by the standards and your regulator. Use this as a guide only.
Keep reading
Talk to Sucatec
Questions about your area?
Ask a specialist about products, standards or supply. We reply within one business day.
- Reply within one business day
- We supply worldwide, from Singapore
- No obligation, no spam
Prefer to chat? WhatsApp +65 8839 1637 or email sales@sucatec.com.