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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)
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May 2006
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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
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Levels of protection and recommended filtration
Level of protection
Level 1 Level 2 and 3
Recommended filtration
Primary filters, e.g. EN779 G4* Production area with 100% outside air: Primary plus secondary filter (e.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 plus F8 plus EN1822 H13 filters)
4.2.1
Level 2 and 3
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Contamination should be prevented through appropriate:
Materials for components and construction Design and appropriate access to dampers, 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)
4.2.4 4.2.10
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Airflow patterns
Filtered air entering a production room or covering a process can be
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Airflow patterns
Turbulent
dilution of dirty air
Unidirectional/laminar
displacement of dirty air
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Airflow patterns
Prefilter
AHU
Main filter
Turbulent
HVAC | Slide 9 of 31 May 2006
Unidirectional
Turbulent
HVAC
Airflow patterns (4)
Workbench (vertical) Cabin/booth Ceiling
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Unidirectional airflow (UDAF):
Provided where needed over product or material to prevent contamination, or to protect operator
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Annex 5, 7.
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Annex 5, 7.
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Infiltration
Facilities normally under positive pressure to the outside Prevent infiltration of unfiltered, contaminated air from outside Some cases - negative pressure (e.g. penicillin manufacture). Special precautions to be taken
4.4.1 4.4.4
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Cross-contamination
General aspects and concepts Displacement concept low pressure differential, high airflow Pressure differential concept high pressure differential, low airflow Physical barrier concept
4.5
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General aspects
Multiproduct OSD manufacturing, 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, cubicles at higher pressure than atmosphere
4.5.1 4.5.3
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Containment concepts
Pressure cascade regime influenced by:
Product and product group, e.g. highly potent products (in some cases, pressure cascade regime negative to atmosphere) Processing methods
Building structure should be considered including airtight ceilings and walls, close fitting doors, sealed light fittings
4.5.4 4.5.9
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Displacement concept
Air supplied to the corridor, 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)
4.5.10 4.5.12
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Pressure differential concept
Concept can include high pressure differential, low airflow, and airlocks in the design Airlock types include: Cascade, 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
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Pressure differential concept (2)
Calibrated monitoring devices, 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 4.5.19 4.5.26
May 2006
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Pressure cascade solids Protection from cross-contamination
R oom 1
15P a
R oom 2
15P a
R oom 3
15P a
Air Lock
30P a
0P a
Pa ssa ge
15P a
HVAC
Physical barrier concept
In some cases, impervious barriers are used to prevent cross-contamination Spot ventilation Capture hoods
4.5.27 4.5.28
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Temperature and relative humidity (RH)
Controlled, monitored and recorded where relevant Materials and product requirements, operator comfort Minimum and maximum limits Premises design appropriate, e.g. low humidity areas, well sealed and airlocks where necessary HVAC design also prevent moisture migration
4.6.1. 4.6.6
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Temperature and relative humidity (RH) (2)
Remove moisture, or add moisture as necessary Dehumidification
Refrigerated dehumidifiers with cooling media Chemical dehumidifiers
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, atomizers, water-mist sprays Suitable duct material, insulation of cold surfaces Air filters not immediately downstream of humidifiers Chemical driers used if not sources of contamination
4.6.12. 4.6.18
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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, hazards, operator
5.1. 5.7
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Dust Control (2)
Normally air supplied through ceiling diffusers, and air extracted from low level aids flushing effect Extraction of vapours consider density of vapour Handling harmful products additional steps needed
e.g. barrier technology, glove boxes totally enclosed garments with air-breathing systems
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Protection of the environment (Exhaust air dust)
Exhaust air from equipment and some areas of production carry heavy loads of dust (e.g. FBD, coating, weighing) Filtration needed to prevent ambient contamination Not highly potent material
EN779 F9 filter recommended
HVAC
Protection of the environment (Exhaust air dust) (2)
Filter banks provided with pressure differential indication gauges Limits indicated, results monitored at regular intervals
Manual, Building Management Systems, Building Automated Systems, System Control and Data Acquisition systems
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Protection of the environment (Exhaust air dust) (3)
Reverse pulse dust collectors
Should be equipped with cartridge filters with compressed air lance, Continuous operation no interruption of airflow
Wet scrubbers
Use suitable drainage system for dust slurry
6.1.11 6.1.15
HVAC
Protection of the environment (Fume removal)
Appropriate design, installation, and operation of fume, dust, effluent control Wet scrubbers
Added chemicals for increased adsorption efficiency
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May 2006