🎯 What is a GMP Cleanroom?
A GMP Cleanroom (Good Manufacturing Practice) is a controlled environment designed to maintain strict conditions for:
- Airborne particle concentration
- Microbial contamination
- Temperature and humidity
- Pressure differentials
👉 Purpose:
To ensure product quality, prevent contamination, and comply with regulatory requirements in industries such as pharmaceuticals, food, electronics, and healthcare.
📏 GMP Cleanroom Standards
To meet GMP requirements, a cleanroom must comply with several critical standards:
✔️ 1. Particle Control (ISO 14644)
- Classified from ISO Class 5 to Class 8
- Controls particle count per cubic meter of air
✔️ 2. Microbial Control
- Limits bacteria and mold levels
- Requires periodic monitoring and calibration
✔️ 3. Pressure Differential
- Maintains positive pressure between zones
- Prevents cross-contamination
✔️ 4. Temperature & Humidity
- Temperature: 18–25°C
- Humidity: 40–65%
🏭 Cleanroom Classification
Cleanrooms are categorized based on cleanliness levels:
- ISO Class 5
Highest standard – used in sterile pharmaceutical production - ISO Class 6–7
Used in medical devices and electronics manufacturing - ISO Class 8
Common for food processing and packaging
💰 GMP Cleanroom Cost
The cost of building a cleanroom depends on multiple factors:
📌 Key Factors:
- Room size
- Cleanliness class (ISO level)
- Equipment systems (HVAC, HEPA filters, AHU)
- Monitoring & calibration systems
💡 Estimated Cost:
- ISO Class 8: ~ $80 – $160/m²
- ISO Class 6–7: ~ $160 – $320/m²
- ISO Class 5: > $320/m²
(Costs are indicative and vary by project requirements)
⚙️ Cleanroom Construction Process
A standard GMP cleanroom project includes:
- Site survey & consultation
- System design
- Installation & construction
- Testing & calibration
- Handover & operation
🚀 Why Invest in a GMP Cleanroom?
✔️ Ensure regulatory compliance (GMP, ISO)
✔️ Maintain product quality and safety
✔️ Enhance brand credibility
✔️ Facilitate export and global market access
🏢 GERA VIETNAM – YOUR CLEANROOM EXPERT
Gera Hi-Tech Vietnam provides comprehensive cleanroom solutions:
- Cleanroom design & consulting
- Turnkey construction
- HEPA/ULPA leak testing & calibration
- Cleanroom equipment supply
👉 With extensive experience across industries, Gera delivers:
✔️ Cost-optimised solutions
✔️ Full compliance with GMP & ISO standards
✔️ Long-term technical support
📞 Contact Us
Hotline: 0867.730.168
👉 Get expert consultation for:
- New GMP cleanroom construction
- System upgrades
- Testing & calibration services
👉 Contact Gera today to optimise your cleanroom performance and ensure compliance with global standards.
