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MCC PRESENTATION - GMP MANUFACTURING ENVIRONMENTS

MCC PRESENTATION - GMP MANUFACTURING ENVIRONMENTS. Module 2. Presented by : Deryck Smith Consulting Engineers. GMP Manufacturing Environments. Air Handling Systems HVAC Systems H eating V entilation A ir C onditioning Module 2: AC Components.

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MCC PRESENTATION - GMP MANUFACTURING ENVIRONMENTS

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  1. MCC PRESENTATION - GMP MANUFACTURING ENVIRONMENTS Module 2 Presented by : Deryck Smith Consulting Engineers

  2. GMP Manufacturing Environments Air Handling Systems HVAC Systems Heating Ventilation Air Conditioning Module 2: AC Components

  3. GMP Manufacturing Environments Topics for this Module: The need & reason for pharmaceutical Air Handling Systems The technical requirements for Air Handling Systems Different types of Air Handling Systems Component problems and misuse 

  4. Air Handling System Production Room With Defined Requirements Supply Air Outlet Air Purpose of an Air Handling System

  5. Air Handling Systems 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

  6. Main Sub-systems

  7. Sub-system Components Secondary Filter Cooling Coil HEPA Filter Primary Filter Supply Air Fan Humidifier HEPA Filter Exhaust Air Fan Secondary Filter Primary Filter

  8. Components: Filters… HEPA or Tertiaary Filter Primary Panel Filter Secondary Filter

  9. APPROXIMATION OF EQUIVALENT FILTER STANDARDS APPROXIMATION OF EQUIVALENT FILTER STANDARDS Eurovent Class – Eurovent 4/5 (2-9) Eurovent 4/9 (2-9) Eurovent 4/4 (10-14) Eurovent Class – Eurovent 4/5 (2-9) Eurovent 4/9 (2-9) Eurovent 4/4 (10-14) Dust Spot Efficiency ASHRAE 52/76 BS6540 Part 1 (1985) Dust Spot Efficiency ASHRAE 52/76 BS6540 Part 1 (1985) Sodium Flame efficiency Eurovent 4/4 BS3928 (1969) Sodium Flame efficiency Eurovent 4/4 BS3928 (1969) CEN/TC/195 WG1-G1-F9 WG2-H10-16 CEN/TC/195 WG1-G1-F9 WG2-H10-16 Arrestance % Arrestance % EN 1822 EN 1822 EN 1822 EU Class Eurovent class Arrest-ance % Dust spot efficiency ASHRAE 52/76 Sodium Flame Test % EN 779 & EN 1822 EU Class EU Class % % EN 779 & EN 1822 EN 779 & EN 1822 99,99995 U16 99,99995 99,99995 U16 U16 99,9995 U15 99,9995 99,9995 U15 U15 14 99,999 U14 14 14 99,999 99,999 U14 U14 13 99,99 H13 13 13 99,99 99,99 H13 H13 12 99,97 12 12 99,97 99,97 11 99,9 H12 11 11 99,9 99,9 H12 H12 10 % 95 H11 10 10 % % 95 95 H11 H11 9 95 85 F9/H10 9 9 95 95 85 85 F9/H10 F9/H10 8 90 75 F8 8 8 90 90 75 75 F8 F8 85 F7 85 85 F7 F7 7 80 7 7 80 80 75 75 75 6 70 F6 6 6 70 70 F6 F6 65 65 65 60 60 60 55 55 55 5 50 F5 5 5 50 50 F5 F5 45 45 45 40 40 40 % 35 % % 35 35 4 95 30 G4 4 4 95 95 30 30 G4 G4 90 25 90 90 25 25 3 85 20 G3 3 3 85 85 20 20 G3 G3 80 80 80 75 75 75 2 70 G2 2 2 70 70 G2 G2 65 65 65 G1 G1 G1 EN1822 Filter Classifications EN779 EN 779 EN 779 EN 779

  10. Filter Classes Filter Classifications… 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 - 14 U 15- 17 EN 779 Standard EN 1822 Standard PIC/S PH 1/97 # 5.19

  11. Components: Cooling coil • Cooling coil inside air handling unit. Beware of bacteria in the drain pan!

  12. Other Components… Humidifier Silencer Heating & Cooling Units

  13. Adsorber wheel Humid room air Regeneration Air Humid room air Air Heater Control Damper for Air Flow Volume regulator… Dry Air AHU with fan Variable Speed Controller Filter Pressure Gauges Air Handling Unit De-humidification

  14. Chemical Drier & AHU

  15. Air Ducts… Loose fibre-glass insulation • Internal duct insulation Fibre glass liberation into the air stream is hazardous!

  16. High Induction Office Type Diffusor (avoid) Low Induction Swirl Diffusor (preferred) Diffusers…

  17. Diffuser Types Office Induction Diffuser Perforated Plate Diffuser

  18. Swirl Type Air Diffusors With Terminal Filters 1 2 1 Filter 2 Diffuser plate

  19. Incorrect Use of Filters • Filters must not be used on door grilles. • Can cause cross-contamination. • Retention is inadequate. Filter behind door grille

  20. Filters Fan Flow rate controller Control damper Humidifier Cooling coil Ducts Problems caused by misuse or malfunction Problems with Components • Incorrect retention rate/leaking/badly installed • Low air flow ® loss of pressure cascade • Blocked ® poor pressure cascade ® cross-contamination • Poorly adjusted, bad pressure differential system • Bad water/steam quality/poor drainage/ • No elimination of condensed water/poor drainage/stagnating water • Inappropriate material/internal insulation • Leaking ducts

  21. Incorrectly Installed Components One of the major problems with components, is if they are incorrectly installed or installed in the wrong sequence. We will look at this in more detail in the next module. Questions & Answers

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