Air Handling Systems Heating Ventilation and Air Conditioning

Air Handling Systems Heating Ventilation and Air Conditioning (HVAC) – Part 3 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 WHO - PSM

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

Air Handling Systems Air flow patterns (1) Turbulent Uni-directional / laminar dilution of dirty air displacement of dirty air 0, 30 m/s WHO - PSM

Air Handling Systems Air flow patterns (2) Filtered air entering a production room or covering a process can be l l turbulent uni-directional (laminar) ä GMP aspect ä economical aspect New technologies: barrier technology/isolator technology. WHO - PSM

Air Handling Systems Question no 19 Turbulent and unidirectional air are called what? ? WHO - PSM

Air Handling Systems Prefilter Air flow patterns (3) AHU Annex 1, 17. 3 Main filter 1 2 Turbulent Uni-directional 3 Turbulent WHO - PSM

Air Handling Systems Air flow patterns (4) Workbench (vertical) Cabin/ booth Ceiling WHO - PSM

Air Handling Systems Positioning of filters (1) AHU mounted final filter Filter in terminal position HEPA Filter + Production Room HEPA Filter WHO - PSM

Air Handling Systems Positioning of filters (2) Prefilter AHU Main filter Ceiling exhausts 2 1 3 Low level exhausts WHO - PSM

Air Handling Systems Positioning of filters (3) Final filter AHU Prefilter 1 2 WHO - PSM

Air Handling Systems Air re-circulation The filtered air entering a production room can be l l 100% exhausted or a proportion re-circulated ä GMP aspect ä economical reasons WHO - PSM

Air Handling Systems Ventilation with 100% fresh air (no air re-circulation) Washer (optional) Exhaust Unit W Central Air Handling Unit Production Rooms WHO - PSM

Air Handling Systems Ventilation with re-circulated air + make-up air Exhaust Unit Central Air Handling Unit Return air WHO - PSM

Air Handling Systems Definition of Conditions as built at rest in operation air air WHO - PSM

Air Handling Systems Question no 20 • Air is often recirculated in production area because of _____ reasons. WHO - PSM

Air Handling Systems Qualification / Validation issues A good design is essential, but it has to be complemented by: l Qualification of air handling systems l Process validation l Maintenance and periodic re-qualification l Adequate documentation WHO - PSM

Air Handling Systems Qualification (OQ, PQ) (1) Uni-directional airflow / LAF Test Turbulent / mixed airflow Differential pressure on filters 2 2 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 Description 1 : = As built (ideally used to perform IQ) 2 = At rest (ideally used to perform OQ) 3 = Operational (ideally used to perform PQ) IQ tests are not mentioned on this slide WHO - PSM

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

Air Handling Systems Microbiological validation Definition of alert / action limits as a function of cleanliness zone 1. Identification and marking of sampling points 1. 2. 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? ” WHO - PSM

Air Handling Systems Question no 21 • For microbiolgical environmental monitoring there have to be _______ and action limits in place. WHO - PSM

Air Handling Systems Cleanroom monitoring program (1) Cleanrooms should be monitored for micro-organisms and particles air Sampling point WHO - PSM

Air Handling Systems Cleanroom monitoring program (2) Routine monitoring program as part of quality assurance Additional monitoring and triggers 1. 2. 3. 4. Shutdown Replacement of filter elements Maintenance of air handling systems Exceeding of established limits WHO - PSM

Air Handling Systems Cleanroom maintenance program (1) WHO - PSM

Air Handling Systems Cleanroom maintenance program (2) WHO - PSM

Air Handling Systems Question no 22 • When going over the limits in microbiological monitoring ______ sampling has to be carried out. WHO - PSM

Air Handling Systems Documentation requirements 1. 2. 3. 4. 5. 6. 7. 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) WHO - PSM

Air Handling Systems Inspecting the air handling plant 1. Verification of design documentation, including ä description of installation and functions ä specification of the requirements 2. 3. 4. 5. 6. 7. 8. Operating procedures Maintenance instructions Maintenance records Training logs Environmental records Discussion on actions if OOS values Walking around the plant WHO - PSM

Air Handling Systems Question no 23 What is the basic requirement for all the equipment in pharma industry? It is very critical especially for air conditioning unit. WHO - PSM

Air Handling Systems Conclusion Air handling systems: l l l Play a major role in the quality of pharmaceuticals Must be designed properly, by professionals Must be treated as a critical system WHO - PSM