From July 2025, all production lines for ampoules, vials, serums, and sterile injectable drugs must be in ISO 5 class (former Class 100). In this comprehensive 2025 article, you will learn all the new requirements from the Food and Drug Organization, real costs, precise equipment, and complete setup checklist.
From July 2025, the Iranian Food and Drug Organization officially announced: "Any filling, lyophilization, or final packaging of sterile injectable drugs (human or veterinary) performed in an environment lower than ISO 5 class (former Class 100) is illegal, and the GMP license for that production line will be revoked."
This decision was not overnight; after 42 recalls of injectable drugs from 2022 to 2024 due to unacceptable particle contamination and bacterial endotoxin, Iran officially joined PIC/S and was required to fully implement EU-GMP Annex 1 2022 edition standards.
In this highly comprehensive article, we aim to show you exactly why ISO 5 class is no longer a "luxury option" but the only way to survive in Iran's injectable pharmaceutical industry in 2025 and beyond.
Section 1 – Real Differences Between Classes in Practice (Not Just on Paper)
| Parameter | ISO 5 | ISO 6 | ISO 7 | ISO 8 |
|---|---|---|---|---|
| Max particles ≥0.5μm per m³ | 3,520 | 35,200 | 352,000 | 3,520,000 |
| Max particles ≥5μm per m³ | 29 | 293 | 2,930 | 29,300 |
| Minimum air changes per hour | 480–720 | 150–480 | 60–150 | 20–60 |
| Laminar flow air velocity | 0.45 ±20% m/s | 0.3–0.45 m/s | Not required | Not required |
| Positive pressure relative to surroundings | 15–30 Pa | 12–20 Pa | 10–15 Pa | 5–10 Pa |
| Direct sterile filling possible | Yes (Grade A) | Only with isolator | No | No |
Practical Conclusion: Only ISO 5 (or isolator/RABS in ISO 7) allows direct filling without additional cover.
Section 2 – New Requirements from Iranian Food and Drug Organization (June 2025 Regulation)
- All filling points must be under Grade A laminar flow with continuous monitoring of 0.5 and 5 μm particles
- Vial washer and sterilization tunnel must be directly connected to ISO 5 room (without ordinary pass box)
- Personnel garments must be full-body, gamma sterile, with integrated mask and goggles
- HEPA filter leak test every 6 months with DIOCTYL PHTHALATE or PAO and 100% filter surface scan
- Environmental microbial monitoring at least twice weekly (Settle plate + Active air sampling)
- Maximum allowed CFU in Grade A: Less than 1
Section 3 – Essential and Up-to-Date Equipment for ISO 5 Cleanroom in 2025 (With Brands Available in Iran)
- Class A Ceiling or Horizontal Laminar Flow
- Available brands: Telstar Spain, Sara Tajhiz, Pak Tehran, Behdad Pharma
- Air velocity: Exactly 0.45 m/s ±20%
- H14 filter with EN 1822 certification and factory leak scan
- Dynamic Double-Door Pass Box with UV-C 254 nm + Internal HEPA
- UV cycle time: 10–15 minutes automatic
- Magnetic interlock + Digital display
- Dedicated Hygienic AHU
- Minimum capacity 600 air changes per hour for 30 m² room
- Three-stage filtration F7 + H13 + H14
- Separate chiller and heater (not central hospital system)
- Online Particle, Temperature/Humidity/Pressure Monitoring System
- Available brands: Beckman MET ONE (USA), Particle Measuring Systems, or Iranian Behdad Electronic
- SMS and email alerts when out of range
- Gamma Sterile Garments, Gloves, Boots, and Masks
- Reliable brands: Kimberly Clark, DuPont Tyvek, or Iranian Pak Tan Poosh
- Double vacuum packaging + Gamma indicator
Section 4 – Real Cost of Setting Up ISO 5 Cleanroom in 2025 (Prices December 2025)
| Item | Approximate Price (Tomans) | Description |
|---|---|---|
| Clean sandwich panel + Fast door | 110–140 million for 30 m² | 60 mm thickness with polyurethane foam |
| Hygienic AHU + Ducting | 650–950 million | With separate chiller and heater |
| Class A Laminar Flow (4×2 m) | 380–550 million | Imported Telstar or high-quality Iranian |
| Dynamic + Static Pass Box | 120–210 million | With UV and HEPA |
| Monitoring System + Software | 180–320 million | 8 particle + pressure + temp sensors |
| Antibacterial Epoxy Flooring | 3.2–4.1 million/m² | With nanosilver |
| Initial Testing & Validation (IQ/OQ/PQ) | 140–220 million | By FDA-approved company |
| Total (30–40 m²) | 2.8 to 4.6 billion | Depending on Iranian/imported ratio |
Section 5 – 45-Item Checklist for ISO 5 Cleanroom Setup (Approved by General Directorate of Medical Equipment 2025)
(You can print this checklist and give it to the contractor)
- Initial design based on GMP Annex 1 2022
- Approved URS and DQ drawings
- Selection of contractor with ISO 14644 certification
...
- Smoke Pattern test under laminar flow (video recorded)
- Recovery Time test (less than 15 minutes)
- Final certification from reference laboratory
Conclusion
In 2025, you can no longer produce injectable drugs with "almost clean." If you start today, it takes at least 8–10 months to have a fully operational ISO 5 cleanroom with GMP license.
The minute you're reading this article, your competitors are signing contracts for AHUs and laminar flows. What about you?
Contact our experts for free end-to-end consultation on ISO 5 cleanroom setup in 2025.
