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H eating V entilation and A ir C onditioning (HVAC) – Part 2 Workshop on GMP and Quality Assurance of TB products Ku

H eating V entilation and A ir C onditioning (HVAC) – Part 2 Workshop on GMP and Quality Assurance of TB products Kuala Lumpur Malaysia, 21 – 25 February 2005 Maija Hietava M.Sci.Pharm

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H eating V entilation and A ir C onditioning (HVAC) – Part 2 Workshop on GMP and Quality Assurance of TB products Ku

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  1. HeatingVentilation andAir Conditioning (HVAC) – Part 2 Workshop on GMP and Quality Assurance of TB products Kuala Lumpur Malaysia, 21 – 25 February 2005 Maija Hietava M.Sci.Pharm Quality Assurance and Safety: Medicines, Medicines Policy and Standards, Health Technology and Pharmaceuticals Cluster Tel: +41.22.791.3598 Fax: +41.22.791.4730 World Health Organization E-mail: hietavam@who.int

  2. Air Handling System Production Room With Defined Requirements Supply Air Outlet Air • Purpose of an air handling system

  3. 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

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

  5. 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 Exhaust Air Grille Heater Secondary Filter Re-circulated air

  6. 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 Components (1)

  7. Heating unit Cooling unit /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 pre-determined dimensions and/or micro-organisms To transport the air Components (2)

  8. Flow rate controller 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 Problems with components

  9. Air types Exhaust air + Fresh air (make-up air) Supply air Production Room Return air (re-circulated)

  10. Comparing International Cleanroom Classifications

  11. Filter classes Dust filters Standard Aerosol Coarse Fine HEPA ULPA Dp > 10 µ m 10 µ m > Dp > 1 µ m Dp < 1 µ m G1 - G4 F5 - F9 H 11 - 13 U 14- 17 EN 779 Standard EN 1822 Standard

  12. HEPA or tertiaary filter Primary panel filter Secondary filter

  13. Humidifier SilencerHeating and cooling units

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

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

  16. High induction office type diffusor (avoid) Low induction swirl diffusor (preferred)

  17. Regulation of room pressure – pressure differentials concept Room pressure gauges Room pressure indication panel

  18. Pressure cascade injectablesProtection from micro-organisms and particles

  19. Pressure cascade solids Protection from cross-contamination

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