GMP and EU GMP Requirements for Cleanroom Air Filtration Systems
In the pharmaceutical industry, air quality control is not merely a technical requirement — it is a mandatory legal condition. GMP (Good Manufacturing Practice) and EU GMP Annex 1 (2022 revision) set strict standards for cleanroom classification, air change rates, filter efficiency, and periodic testing protocols for each production area.
1. Cleanroom Classification under Pharmaceutical GMP
GMP divides manufacturing environments into four grades:
- Grade A: Direct product contact zones (filling, open vials, aseptic compounding) — equivalent to ISO Class 5. Requires unidirectional airflow ≥0.45 m/s and HEPA H14 filters.
- Grade B: Background environment for Grade A — ISO Class 5 (in operation), ≥20 ACH, HEPA H13/H14.
- Grade C: Less critical preparation steps — ISO Class 7 (in operation), ≥15 ACH, HEPA filtration.
- Grade D: Support areas and primary packaging — ISO Class 8, F9/H10 filtration.
2. Specific Requirements under EU GMP Annex 1 (2022)
The 2022 revision emphasises the Contamination Control Strategy (CCS) — a comprehensive contamination management framework in which the HVAC system and filters play a central role. Key requirements include:
- HEPA filter integrity testing: DOP/PAO testing at least every 12 months.
- Air distribution system: Must not create dead zones or turbulence within Grade A areas.
- Positive pressure cascade: Grade A > B > C > D, with ≥10–15 Pa differential pressure per grade.
- Continuous particle monitoring: Required in Grade A and B areas during production.
3. Air Filtech Solutions for Pharmaceuticals
Air Filtech supplies a complete filtration chain compliant with GMP and EU GMP Annex 1 requirements:
- G4/M5 pre-filters: Protect HEPA filters and extend system lifetime.
- F7/F9 intermediate filters: Capture PM2.5 particles and support Grade C/D requirements.
- Camfil HEPA H13/H14: Globally trusted filtration solutions with efficiency of ≥99.95–99.995% at MPPS.
- Terminal Housing Green: Air Filtech product featuring a 304 stainless steel frame, easy filter replacement, and suitability for Grade A/B ceiling installation.
- FFU (Fan Filter Unit): Suitable for mobile Grade A zones or laminar flow workstations.
All HEPA/ULPA products carry EN 1822 certification with per-batch test certificates.
Air Filtech has deployed GMP-compliant air filtration systems at numerous pharmaceutical plants in Vietnam, including:
- DHG Pharmaceutical Company (Can Tho) — Upgraded HVAC systems for Grade A/B cleanrooms to support EU GMP Annex 1 requirements.
- Imexpharm Pharmaceutical Plant (Dong Thap) — Installed HEPA H14 filters and Terminal Housing throughout aseptic compounding areas.
- Central Pharmaceutical Company No. 1 (Hanoi) — Implemented a comprehensive filtration solution across three manufacturing plants.
Each project includes complete IQ/OQ documentation to support GMP inspection and qualification requirements.
Free Consultation: 08 999 44 666 | info@airfiltech.vn
