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Contributor
facility , it must undergo rigorous testing to verify performance and compliance :
• Leakage testing – Ensures casing integrity and filter efficiency
• Airflow and pressure testing – Confirms design parameters
• Noise and vibration testing – Evaluates operational stability
• HEPA filter integrity testing – Validates filter performance
• Installation best practices
1 . Site preparation and handling Pharmaceutical AHUs are large and delicate systems that require careful handling during installation . Best practices include :
• Ensuring site readiness with proper access , supports and vibration isolation
• Using dedicated lifting and transport equipment to prevent structural damage
• Installing units in compliance with cGMP guidelines to avoid contamination risks
2 . Ductwork and piping connections Ductwork and piping must be installed with precision to maintain system performance :
• Sealed , insulated ducts – Prevent leakage and condensation
• Stainless steel ducting for high-cleanliness areas – Reduces
particulate contamination
• Flexible connections for vibration isolation – Protects against structural stress
3 . Commissioning and validation Once installed , the AHU must undergo thorough commissioning and validation :
• IQ / OQ / PQ protocols – Installation Qualification , Operational Qualification , and Performance Qualification ensure compliance with GMP standards
• Airflow and balancing tests – Adjust and verify pressure differentials
• Microbial and particulate testing – Confirms cleanliness levels meet cleanroom classifications
Designing , manufacturing , and installing pharma-grade AHUs requires a meticulous approach to meet stringent regulatory requirements . By implementing best practices in material selection , filtration strategies , energy efficiency , and quality control , HVAC professionals can ensure reliable , compliant and cost-effective AHU solutions for pharmaceutical manufacturing facilities . The ongoing evolution of smart monitoring and AIdriven BMS integration will further enhance the performance and compliance of pharma HVAC systems in the coming years . RACA
AIR CONDITIONING
Airstream Components Africa ( Pty ) Ltd
Unit 17 , 178 Barbara Road , Elandsfontein Tel : 011 8221486 | Fax : 011 8221493 Email : cliff @ airstreamafrica . co . za
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AIR CONDITIONING
AIR CONDITIONING
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RACA Journal I April 2025 www . refrigerationandaircon . co . za