Area Classification as per cGMP, WHO, US FDA, and UK MHRA

Area Classification as per cGMP, WHO, US FDA, and UK MHRA

At SUN CleanAir Systems, we specialize in designing and engineering cleanroom environments tailored to meet the stringent regulatory requirements of global pharmaceutical and biotechnology industries. Our area classification solutions are compliant with current Good Manufacturing Practices (cGMP) and conform to international guidelines including those set by WHO, US FDA, and UK MHRA.

What is Area Classification?

Area classification refers to the systematic segmentation of cleanroom and controlled environments based on the permissible limits of airborne particulate matter. This classification ensures the necessary air quality for various manufacturing stages—from sampling and dispensing to formulation, filling, and packaging.

Standards We Adhere To :

1. cGMP (Current Good Manufacturing Practices) :
   
   • Emphasis on controlled environmental conditions to prevent contamination.
   • Classified zones from Grade A (critical) to Grade D (less critical) based on activity and exposure risk.
2. WHO (World Health Organization) :
   
   • Aligns closely with EU-GMP, focusing on healthcare and pharmaceutical product safety.
   • Classifies areas by cleanliness in both "at rest" and "in operation" states.
3. US FDA :
   
   • Refers to Federal Standard 209E and ISO 14644 for cleanroom classification.
   • Requires robust monitoring and validation of air handling units, HEPA filters, and pressurization schemes.
4. UK MHRA (Medicines and Healthcare products Regulatory Agency) :
   
   • Complies with EU GMP Annex 1.
   • Emphasizes risk-based approaches for sterile manufacturing environments.

Our Expertise Includes :

• Cleanroom Layout & Air Flow Design
• HVAC System Design & Validation
• HEPA Filter Selection and Installation
• Pressure Cascade & Air Change Rate Planning
• Monitoring & Documentation as per Global Standards

Industries We Serve:

• Pharmaceutical
• Biotechnology
• Medical Devices
• Food & Beverage
• Electronics

Why Choose SUN CleanAir Systems?

• Deep expertise in global regulatory compliance
• End-to-end solutions from concept to commissioning
• Customized modular cleanroom setups
• Seamless integration of air handling and filtration systems
• Proven project track record across India