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Heating, Ventilation and Air- Conditioning (HVAC) Part 3: HVAC systems and components

Supplementary Training Modules on Good Manufacturing Practice. Heating, Ventilation and Air- Conditioning (HVAC) Part 3: HVAC systems and components. WHO Technical Report Series, No. 961, 2011. Annex 5. Section 7. HVAC. Objectives

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Heating, Ventilation and Air- Conditioning (HVAC) Part 3: HVAC systems and components

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  1. Supplementary Training Modules on Good Manufacturing Practice Heating, Ventilation and Air- Conditioning (HVAC) Part 3: HVAC systems and components WHO Technical Report Series, No. 961, 2011. Annex 5 Section 7

  2. HVAC Objectives In the following slides, we will study the components of air- handling systems in order to: Become familiar with the components Know their functions Become aware of possible problems

  3. Exhaust air treatment Fresh air treatment (make-up air) Terminal air treatment at production room level + Production Room Central air handling unit HVAC Main subsystems

  4. HVAC Components Components in HVAC may include, depending on need: • Filters • Fans • no fan failure; including supply air fans, return air fans, exhaust air fan, dust extract system fans • Driers • Drying of air with chemical driers, e.g. rotating desiccant wheel • Frost coils for preheating air 7.1.1 – 7.1.6

  5. HVAC General • Pharmaceutical products should be manufactured in areas of appropriate cleanliness • Prevent contamination and cross-contamination • Design of HVAC dependent on various factors e.g. • Outside air quality • Recirculation of air (or not) • Products and range of products • Risk assessment to determine clean room conditions. 7.1.1

  6. HVAC General • Two basic concepts of air delivery • a re-circulation system, and • a full fresh air system (100% outside air supply). • Recirculation – determine the amount of fresh air based on criteria: • to compensate for leakage and loss • to comply with national building regulations; and • for odour control. 7.1.2

  7. HVAC General • Validated automated monitoring systems (e.g. Building management systems (BMS), building automation system (BAS) or system control and data acquisition (SCADA) system) - capable of indicating any out-of-specification condition without delay e.g. by means of an alarm • Also helps with preventive maintenance and trend logging • Critical alarms easily identifiable, visible and/or audible • Fan interlock failure matrix • Fan failures can cause a system imbalance, resulting in a pressure cascade malfunction with a resultant airflow reversal. 7.1.3 – 7.1.6.

  8. HVAC Air distribution • Positioning of supply and extract grilles to provide effective room flushing. • Low-level return or exhaust air grilles preferred. • If not possible, a higher air change rate may be needed to achieve a specified clean area condition, e.g. where ceiling return air grilles are used. • There may be alternative locations for return air 7.2.1 – 7.2.2

  9. HVAC

  10. Air types Exhaust air + Fresh air (make-up air) Supply air Production Room Return air (recirculated) HVAC

  11. HVAC Recirculation systems • Increased risk of contamination and cross-contamination. • Need HEPA filters (EN1822 classification of H13) • HEPA filters may not be required: • a single product facility and there is evidence that cross-contamination would not be possible. • No dust generated e.g. secondary packing • HEPA filters installed in the air-handling unit or terminally placed • If terminally mounted - not with flexible ducting • If highly toxic processes – never recirculate 7.3.1 – 7.3.6

  12. HVAC Ventilation with recirculated air + make-up air Exhaust Unit Central Air-Handling Unit Return air

  13. HVAC Full fresh-air systems • 100% fresh air normally used in a facility dealing with toxic products or solvents, where recirculation of air with contaminants should be avoided  • Degree of filtration of the exhaust air depends on the exhaust air contaminants and local environmental regulations • HEPA filters in the exhaust system normally when handling hazardous materials 7.4

  14. HVAC

  15. HVAC Ventilation with 100% fresh air (no air recirculation) Washer (optional) Exhaust Unit W Central Air-Handling Unit Production Rooms

  16. HVAC Energy-recovery wheels • Risk assessment to determine cross-contamination risks • Should not become a source of possible contamination • Alternatives include crossover plate heat exchangers and water-coil heat exchangers • Prevent air leakage between the supply air and exhaust air • exhaust air system operates at a lower pressure than the supply system. 7.4.2 – 7.4.3.

  17. HVAC

  18. HVAC

  19. HVAC Components Components in HVAC may include, depending on need: • frost coils to preheat the air • reheaters for humidity control, moisture eliminators • automatic air volume control devices • sound attenuators • snow eliminators, dust eliminators, • fresh air precooling coils 7.5.3

  20. Overview components Flow rate controller Silencer Fan Filter Weather louvre Control damper + Humidifier Prefilter Terminal filter Production Room Cooling coil with droplet separator Heating coil HVAC Exhaust Air Grille Heater Secondary Filter Recirculated air

  21. Weather louvre Silencer Flow rate controller Control damper To prevent insects, leaves, dirt and rain from entering To reduce noise caused by air circulation Automated adjustment of volume of air (night and day, pressure control) Fixed adjustment of volume of air HVAC Components (1)

  22. Heating unit Coolingunit/ dehumidifier Humidifier Filters Ducts To heat the air to the proper temperature To cool the air to the required temperature or to remove moisture from the air To bring the air to the proper humidity, if too low To eliminate particles of predetermined dimensions and/or microorganisms To transport the air HVAC Components (2)

  23. Control damper for airflow Adsorber wheel Humid room air Regeneration air Humid room air Air heater HVAC Air-handling unit Dry air AHU with fan Variable Speed Controller Filter Pressure Gauges De-humidification

  24. HumidifierSilencerHeating and cooling units HVAC

  25. HVAC HEPA or tertiary filter Primary panel filter Secondary filter

  26. Swirl Type air diffusors with terminal filters HVAC 1 2 3 4 1 Filter 2 Tightening frame 3 Register outlet 4 Screw fixation for register

  27. Flow ratecontroller Control damper Humidifier Cooling battery Filters Ducts Blocked Poorly adjusted, bad pressure differential system Bad water/steam quality/ poor drainage No elimination of condensed water/ poor drainage Incorrect retention rate/damaged/badly installed Inappropriate material/internal insulator leaking HVAC Problems with components

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