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

3. 2 GMP Manufacturing Environments Air Handling Systems HVAC Systems Heating Heating Ventilation Ventilation Air Conditioning Air Conditioning Module 2: AC Components

4. 3 Topics for this Module: 1. The need & reason for pharmaceutical Air Handling Systems 2. The technical requirements for Air Handling Systems 3. Different types of Air Handling Systems 4. Component problems and misuse  GMP Manufacturing Environments

5. 4 Purpose of an Air Handling System Air Handling System Production Room With Defined Requirements Supply Air Outlet Air

6. 5 Air Handling Systems In the following slides, we will study the components of Air Handling Systems in order to: 1. become familiar with the components 2. know their functions 3. become aware of possible problems 

7. 6 Main Sub-systems

8. 7 Sub-system Components Primary Filter Cooling Coil Humidifier Supply Air Fan Secondary Filter HEPA Filter Primary Filter Secondary Filter HEPA Filter Exhaust Air Fan

9. 8 Components: Filters… Primary Panel Filter Secondary Filter HEPA or Tertiaary Filter

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

11. 10 Filter Classes Dust filters Standard Aerosol FineCoarseULPAHEPA 10 µ m > Dp > 1 µ m Dp > 10 µ m Dp < 1 µ m F5 - F9G1 - G4U 15- 17H 11 - 14 EN 1822 StandardEN 779 Standard Filter Classifications… PIC/S PH 1/97 # 5.19

12. 11 Components: Cooling coil Cooling coil inside air handling unit. Cooling coil inside air handling unit. Beware of bacteria in the drain pan!

13. 12 Other Components… Humidifier Silencer Heating & Cooling Units

14. 13 Control Damper for Air Flow De-humidification Filter Pressure Gauges AHU with fan Variable Speed Controller Humid room air Air Heater Regeneration Air Humid room air Adsorber wheel Dry Air Air Handling Unit Volume regulator…

15. 14 Chemical Drier & AHU

16. 15 Air Ducts… Internal duct insulation Internal duct insulation Loose fibre-glass insulation Fibre glass liberation into the air stream is hazardous!

17. 16 Diffusers… Low Induction Swirl Diffusor (preferred) High Induction Office Type Diffusor (avoid)

18. 17 Diffuser Types Perforated Plate Diffuser Office Induction Diffuser

19. 18 Swirl Type Air Diffusors With Terminal Filters 1 Filter 2 Diffuser plate 1 2

20. 19 Incorrect Use of Filters Filters must not be used on door grilles. Filters must not be used on door grilles. Can cause cross- contamination. Can cause cross- contamination. Retention is inadequate. Retention is inadequate. Filter behind door grille

21. 20 Problems caused by misuse or malfunction Filters Filters Fan Fan Flow rate controller Flow rate controller Control damper Control damper Humidifier Humidifier Cooling coil Cooling coil Ducts Ducts 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 Problems with Components

22. 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