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H eating V entilation and A ir C onditioning (HVAC)

Supplementary Training Modules on GMP. Air Handling Systems. H eating V entilation and A ir C onditioning (HVAC) Part 3: Design, qualification and maintenance. Module 3, Part 3: Qualification and maintenance Slide 1 of 27. WHO - EDM.

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H eating V entilation and A ir C onditioning (HVAC)

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  1. Supplementary Training Modules on GMP Air Handling Systems Heating Ventilation and Air Conditioning (HVAC) Part 3: Design, qualification and maintenance Module 3, Part 3: Qualification and maintenance Slide 1 of 27 WHO - EDM

  2. Characteristics of air handling systems • In the following slides, we will study alternatives in air handling systems • Turbulent or uni-directional airflows • Filter position • Air re-circulation vs fresh air • Return air systems (positions) • Overpressure requirements

  3. Uni-directional / laminar displacement of dirty air Turbulent dilution of dirty air Air flow patterns (1) 0,30 m/s Annex 1, 17.3

  4. Air flow patterns (2) • Filtered air entering a production room or covering a process can be • turbulent • uni-directional (laminar) • GMP aspect • economical aspect • New technologies: barrier technology/isolator technology. Annex 1, 17.3, 17.4

  5. Air flow patterns (3) Prefilter AHU Main filter 2 3 1 Uni-directional Turbulent Turbulent Annex 1, 17.3

  6. Air flow patterns (4) Workbench (vertical) Cabin/ booth Ceiling

  7. + Production Room Production Room Positioning of filters (1) AHU mounted final filter Filter in terminal position HEPA Filter HEPA Filter

  8. Positioning of filters (2) Prefilter AHU Main filter Ceiling exhausts 2 3 1 Low level exhausts

  9. Positioning of filters (3) Final filter AHU Prefilter 1 2

  10. Air re-circulation • The filtered air entering a production room can be • 100% exhausted or • a proportion re-circulated • GMP aspect • economical reasons Annex 1, 15.10, 17.24

  11. Ventilation with 100% fresh air (no air re-circulation) Washer (optional) Exhaust Unit W Central Air Handling Unit Production Rooms Annex 1, 17.24

  12. Ventilation with re-circulated air + make-up air Exhaust Unit Central Air Handling Unit Return air

  13. at rest in operation as built air air air Definition of Conditions

  14. Qualification / Validation issues A good design is essential, but it has to be complemented by: • Qualification of air handling systems • Process validation • Maintenance and periodic re-qualification • Adequate documentation

  15. Test Uni-directional airflow / LAF Turbulent / mixed airflow Description Differential pressure on filters 2 2 1 := As built (ideally used to perform IQ) 2 = At rest (ideally used to perform OQ) 3 = Operational (ideally used to perform PQ) Room differential pressure N/A 2, 3 Airflow velocity / uniformity 2, 3 Optional Airflow volume / rate 2 2 Parallelism 2 N/A Air flow pattern 2 3 Annex 1, 17. 4 IQ tests are not mentioned on this slide Qualification (OQ, PQ) (1)

  16. Test Uni-directional airflow / LAF Turbulent / mixed airflow Description Recovery time N/A 2 1 := As built (ideally used to perform IQ) 2 = At rest (ideally used to perform OQ) 3 = Operational (ideally used to perform PQ) Room classification (airborne particle) 2 2,3 Temperature, humidity N/A 2,3 Annex 1, 17. 4 Qualification (OQ, PQ) (2) IQ tests are not mentioned on this slide

  17. Microbiological validation • Definition of alert / action limits as a function of cleanliness zone • Identification and marking of sampling points • Definition of transport, storage, and incubation conditions Ask the question: “What are the alert and action Limits and what procedures are followed if these points are exceeded?”

  18. Cleanroom monitoring program (1) Cleanrooms should be monitored for micro-organisms and particles air Sampling point

  19. Cleanroom monitoring program (2) Routine monitoring program as part of quality assurance Additional monitoring and triggers • Shutdown • Replacement of filter elements • Maintenance of air handling systems • Exceeding of established limits Annex 1, 17.37

  20. Cleanroom maintenance program (1)

  21. Cleanroom maintenance program (2)

  22. Documentation requirements Description of installation and functions Specification of the requirements Operating procedures Instructions for performance control Maintenance instructions and records Maintenance records Training of personnel (program and records)

  23. Inspecting the air handling plant • Verification of design documentation, including • description of installation and functions • specification of the requirements • Operating procedures • Maintenance instructions • Maintenance records • Training logs • Environmental records • Discussion on actions if OOS values • Walking around the plant

  24. Conclusion Air handling systems: Play a major role in the quality of pharmaceuticals Must be designed properly, by professionals Must be treated as a critical system

  25. Further proceedings This series of explanations will now be followed by: • Group discussion, with a simple exercise • Short test

  26. Group Session

  27. Group Session – modified layout MAL = Material Air Lock PAL = Personnel Air Lock

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