Particle limits (ISO 14644-1)
These are the maximum particles of 0.5 micron and larger per cubic metre of air.
| ISO class | Particles at 0.5 micron and larger per m3 | Roughly equal to | GMP grade (at rest) |
|---|---|---|---|
| ISO 5 | 3,520 | Fed Std 209E class 100 | Grade A and B |
| ISO 6 | 35,200 | Class 1,000 | - |
| ISO 7 | 352,000 | Class 10,000 | Grade C |
| ISO 8 | 3,520,000 | Class 100,000 | Grade D |
What changes in the consumables
| Item | ISO 7 and 8 | ISO 5 and cleaner |
|---|---|---|
| Wipers | Polyester or nonwoven, laundered or cleaned | Continuous filament polyester with sealed edges, double bagged, often sterile |
| Garments | Coverall, hood or cap, shoe covers | Full coverall with hood, boots, face mask and goggles |
| Gloves | Powder-free nitrile | Powder-free nitrile, often sterile and sleeve-length |
| Mats | Tacky mats at the entrance | Tacky mats at every transition and change room |
| Paper | Cleanroom paper | Cleanroom paper or tablet-based record systems |
Rules that apply at every class
- Do not bring in ordinary paper, cardboard or cotton.
- Wipe items down before they enter.
- Move slowly, and keep doors closed.
- Change garments on a set schedule.
Typical practice, not a standard. Your quality team, your customer and the standard that applies to you decide what each class needs. Pharma sites should follow EU GMP Annex 1 or their local rules.
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 [email protected].