Supplementary Training Modules on Good Manufacturing Practice

Heating, Ventilation and AirConditioning (HVAC)

Part 1 (b): Introduction and overview
WHO Technical Report Series, No. 937, 2006. Annex 2
HVAC | Slide 1 of 31 May 2006

HVAC
Objectives
To continue from Part 1(a), now focus on:
 Air filtration

 The role of HVAC in dust control
 HVAC system design and its components (part 2)  Commissioning, qualification and maintenance (part 3)

HVAC

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Slide 2 of 31

May 2006

HVAC
Air Filtration
 Degree of filtration is important to prevent contamination
 Type of filters to be used dependent on the quality of ambient air, return air and air change rates  Manufacturer to determine, select and prove appropriate filters for use considering level of ambient air contamination, national requirements, product specific requirements

4.2.1, 4.2.3

HVAC

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Slide 3 of 31

May 2006

HVAC Levels of protection and recommended filtration Level of protection Level 1 Level 2 and 3 Recommended filtration Primary filters. e.2.1 Level 2 and 3 *Filter class should be referenced to the standard test method HVAC | Slide 4 of 31 May 2006 .g.g. EN779 G4 plus F8 filters) Production area with recirculated plus ambient air with a risk of cross-contamination: Primary plus secondary plus tertiary filter (e.g. EN779 G4* Production area with 100% outside air: Primary plus secondary filter (e. EN779 G4 plus F8 plus EN1822 H13 filters) 4.

4 – 4.HVAC Contamination should be prevented through appropriate:  Materials for components and construction  Design and appropriate access to dampers.2.10 HVAC | Slide 5 of 31 May 2006 .2. filters and other components  Personnel operations  Airflow direction  Air distribution component design and installation and location  Type of diffusers (non-induction type recommended)  Air exhaust (normally from a low level) 4.

HVAC HVAC | Slide 6 of 31 May 2006 .

HVAC Airflow patterns Filtered air entering a production room or covering a process can be   turbulent. or unidirectional (laminar)  GMP aspect  economical aspect Other technologies: barrier technology/isolator technology. HVAC | Slide 7 of 31 May 2006 .

HVAC Airflow patterns Turbulent dilution of dirty air Unidirectional/laminar displacement of dirty air HVAC | Slide 8 of 31 May 2006 .

HVAC Airflow patterns Prefilter AHU Main filter 1 2 3 Turbulent HVAC | Slide 9 of 31 May 2006 Unidirectional Turbulent .

HVAC Airflow patterns (4) Workbench (vertical) Cabin/booth Ceiling HVAC | Slide 10 of 31 May 2006 .

10 HVAC | Slide 11 of 31 May 2006 . or to protect operator UDAF in weighing areas  The aim is to provide dust containment  Airflow velocity should not affect balance  Position of material. balance.1 – 4.3.3.HVAC Unidirectional airflow (UDAF): Provided where needed over product or material to prevent contamination. operator determined and validated – no obstruction of airflow or risk 4.

7. HVAC | Slide 12 of 31 May 2006 .HVAC Annex 5.

HVAC Annex 5. HVAC | Slide 13 of 31 May 2006 . 7.

HVAC Infiltration  Facilities normally under positive pressure to the outside  Prevent infiltration of unfiltered. penicillin manufacture). Special precautions to be taken 4.4.4 HVAC | Slide 14 of 31 May 2006 . contaminated air from outside  Some cases .4.negative pressure (e.1 – 4.g.

HVAC Cross-contamination  General aspects and concepts  Displacement concept – low pressure differential.5 HVAC | Slide 15 of 31 May 2006 . low airflow  Physical barrier concept 4. high airflow  Pressure differential concept – high pressure differential.

cubicles at higher pressure than atmosphere 4. prevent movement of dust between areas where different products are processed  Directional air movement and pressure cascade can be helpful – dust containment  Normally. corridor at higher pressure than cubicles.5.1 – 4.5.HVAC General aspects  Multiproduct OSD manufacturing.3 HVAC | Slide 16 of 31 May 2006 .

highly potent products (in some cases. pressure cascade regime negative to atmosphere) – Processing methods  Building structure should be considered including airtight ceilings and walls. e.5.4 – 4. sealed light fittings 4.9 HVAC | Slide 17 of 31 May 2006 . close fitting doors.HVAC Containment concepts  Pressure cascade regime influenced by: – Product and product group.5.g.

HVAC Displacement concept  Air supplied to the corridor.10 – 4. through the doors (grilles) to the cubicles  Air extracted at the back of the cubicle  Velocity high enough to prevent turbulence in doorway  Requires large air quantities (Not preferred method) 4.5.5.12 HVAC | Slide 18 of 31 May 2006 .

sink and bubble type  Sufficient pressure differential required to ensure containment and prevent flow reversal – but not so high as to create turbulence  Consider effect of other items such as equipment and extraction systems in cubicles  Operating limits and tolerances HVAC | Slide 19 of 31 May 2006 4.5.5. low airflow.13 – 4. 4. and airlocks in the design  Airlock types include: Cascade.HVAC Pressure differential concept  Concept can include high pressure differential.22 .5.18.

5.HVAC Pressure differential concept (2)  Calibrated monitoring devices.26 May 2006 HVAC | Slide 20 of 31 .19 – 4. set to alarm system  Monitoring and recording of results  Doors open to higher pressure  Dust extraction system design – – – Interlocked with air-handling system No airflow between rooms linked to same system Room pressure imbalance 4.5.

HVAC Pressure cascade solids Protection from cross-contamination Room 1 15 Pa Room 2 15 Pa Room 3 15 Pa Room 1 15 Pa Room 2 15 Pa Room 3 15 Pa Air Lock Air Lock Air 30 Pa Lock E 0 Pa Passage 15 Pa Note : Direction of door opening relative to room pressure Air Lock Air Lock Air 30 Pa Lock E Passage 15 Pa 0 Pa Note : Direction of door opening relative to room pressure HVAC | Slide 21 of 31 May 2006 .

HVAC Physical barrier concept  In some cases.28 HVAC | Slide 22 of 31 May 2006 .5. impervious barriers are used to prevent cross-contamination  Spot ventilation  Capture hoods 4.27 – 4.5.

– 4. well sealed and airlocks where necessary  HVAC design – also prevent moisture migration 4.6. operator comfort  Minimum and maximum limits  Premises design appropriate.6. e.g. monitored and recorded where relevant  Materials and product requirements. low humidity areas.HVAC Temperature and relative humidity (RH)  Controlled.6 HVAC | Slide 23 of 31 May 2006 .1.

some corrosion inhibitors/chelating agents) 4.7.g.HVAC Temperature and relative humidity (RH) (2)  Remove moisture.6.6. or add moisture as necessary  Dehumidification – Refrigerated dehumidifiers with cooling media – Chemical dehumidifiers  Humidifiers should not be sources of contamination – Use of pure steam or clean steam – No chemicals added to boiler system if these can have a detrimental effect on product (e. – 4.11 HVAC | Slide 24 of 31 May 2006 .

atomizers. insulation of cold surfaces  Air filters not immediately downstream of humidifiers  Chemical driers – used if not sources of contamination 4.6. – 4. water-mist sprays  Suitable duct material.HVAC Temperature and relative humidity (RH) (3) Humidification systems: Design should be such that the system does not become the source of contamination:  No accumulation of condensate  Avoid evaporative systems.12.18 HVAC | Slide 25 of 31 May 2006 .6.

hazards.HVAC Dust Control  Dust and vapour removed at source  Point of use extraction – fixed points or movable hood – plus general directional airflow in room  Ensure sufficient transfer velocity to prevent dust settling in ducting  Risk analysis – airflow direction.7 HVAC | Slide 26 of 31 May 2006 . – 5. operator 5.1.

HVAC Dust Control (2)  Normally air supplied through ceiling diffusers. glove boxes – totally enclosed garments with air-breathing systems  Fresh air rate supply – comfort. leakage. barrier technology. – 5. 5.g. etc. odour and fume removal. pressure control.8.14 HVAC | Slide 27 of 31 May 2006 . and air extracted from low level – aids flushing effect  Extraction of vapours – consider density of vapour  Handling harmful products – additional steps needed – e.

1. coating. FBD.HVAC Protection of the environment (Exhaust air dust)  Exhaust air from equipment and some areas of production carry heavy loads of dust (e. hormones) – EN1822 H12 (HEPA) filter recommended – In some cases two banks of HEPA filters – Safe change filter housings ("bag-in bag-out" filters) 6.5 HVAC | Slide 28 of 31 May 2006 .g.1.g.1 – 6. weighing)  Filtration needed to prevent ambient contamination  Not highly potent material – EN779 F9 filter recommended  Harmful substances (e.

1.10 HVAC | Slide 29 of 31 May 2006 .HVAC Protection of the environment (Exhaust air dust) (2)  Filter banks provided with pressure differential indication gauges  Limits indicated. Building Automated Systems.1. System Control and Data Acquisition systems  Automated systems provided with alarm or similar system to indicate OOS 6. Building Management Systems.6 – 6. results monitored at regular intervals – Manual.

1.1.15  Determine exhaust air quality to verify filtration efficiency HVAC | Slide 30 of 31 May 2006 . and disruption of pressure cascade  Wet scrubbers – Use suitable drainage system for dust slurry 6. – Continuous operation – no interruption of airflow  Dust collectors with mechanical shakers – Used in a manner not to become source of contamination – Switched off at times resulting in loss of airflow.11 – 6.HVAC Protection of the environment (Exhaust air dust) (3)  Reverse pulse dust collectors – Should be equipped with cartridge filters with compressed air lance.

1 – 6. effluent control  Wet scrubbers – Added chemicals for increased adsorption efficiency  Deep bed scrubbers – Activated carbon or chemical adsorption granular media – Specific to type of effluent – Type and volume prepared 6.2. dust.2.HVAC Protection of the environment (Fume removal)  Appropriate design. installation.5 HVAC | Slide 31 of 31 May 2006 . and operation of fume.