Clean Room HVAC Performance Testing

Cleanroom systems are specialty areas in healthcare, biomedical, pharmaceutical, veterinary, food, chemical, biotech, aerospace and defense industries. General characteristics of clean rooms;

- The concentration of suspended particles in the air is measured under constant control
- It is arranged in such a way as to minimize intrusion, dispersion and 'accommodation of limited particles
- Maintain constant temperature, humidity, pressure and variables such as air flow

HVAC performance tests, performed as part of chamber validation white, are part of the overall testing and inspection processes. Except for the HVAC performance test; DQ (Design Qualification), IQ (Installation Qualification), OQ (Operation Qualification) and PQ (Performance Qualification) assessments are also important stages.

• TS EN ISO/IEC 17020: Conformity assessment - Requirements for the operation of various types of bodies performing inspections
• TS EN ISO 14644-1: Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
• TS EN ISO 14644-2: Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration</ li>
• TS EN ISO 14644-3: Cleanrooms and associated controlled environments - Part 3: Test methods
• IEST-RP-CC006.3: Cleanroom Test 2004
• IEST-RP-CC034.3: 2009 Leakage test of Hepa and Ulpa filters
• VDI 2083-Part 3: Cleanroom technology - Metrology
• Eudralex Volume 4: 2008 Medicinal product for human and veterinary use Annex 1
• FDA c GMP: 2004 sterile drugs produced by aseptic processing
• DIN 1946-4: Ventilation and air conditioning - Part 4: Ventilation in buildings and rooms of health care