ISO 5 cleanroom with a maximum of 3,520 particles per cubic meter has become the gold standard for ampoule and vial production in Iran. In this article, you will learn about the latest requirements from the Food and Drug Organization and the best necessary equipment.
- In 2025, the Iranian Food and Drug Organization officially announced that all sterile injectable drug production lines (ampoules, vials, serums) must be at least in ISO 5 class (former Class 100). This means a maximum of 3,520 particles ≥0.5 micrometers per cubic meter!
Why Did ISO 5 Become Mandatory?
- Increase in reported microbial contamination cases in 2022–2024
- New PIC/S and EU-GMP requirements that Iran has joined
- 99.97% reduction in bacterial endotoxin contamination risk
Real Differences Between ISO 5, ISO 7, and ISO 8 (2025 Comparison Table)
| Parameter | ISO 5 (Class 100) | ISO 7 (Class 10,000) | ISO 8 (Class 100,000) |
|---|---|---|---|
| Maximum particles ≥0.5μm | 3,520 | 352,000 | 3,520,000 |
| Minimum air changes per hour | 480–600 times/hour | 60–100 times/hour | 20–40 times/hour |
| Required positive pressure | 15–25 Pascal | 10–15 Pascal | 5–10 Pascal |
Essential Equipment for ISO 5 Cleanroom in 2025:
- Class A laminar flow with air velocity 0.45 m/s ±20%
- Dynamic pass box with UV-C and internal HEPA
- Full-body sterile garment with covered zipper and integrated boots
- Online particle monitoring system for 0.3 and 0.5 micrometer particles (audible and SMS alerts)
Cost of Setting Up a 30 m² ISO 5 Cleanroom in 2025
≈ 2.8 to 4.2 billion Tomans (depending on imported or Iranian equipment)
Conclusion
If your injectable line is still in ISO 7 class, you have until the end of 2026 to upgrade, otherwise the production license will not be renewed!
