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Heating, Ventilation and Air- Conditioning (HVAC) Part 1 (b): Introduction and overview PowerPoint PPT Presentation


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Supplementary Training Modules on Good Manufacturing Practice. Heating, Ventilation and Air- Conditioning (HVAC) Part 1 (b): Introduction and overview. WHO Technical Report Series, No. 937, 2006. Annex 2. HVAC. Objectives To continue from Part 1(a), now focus on: Air filtration

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Heating, Ventilation and Air- Conditioning (HVAC) Part 1 (b): Introduction and overview

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Gmp updated training modules

Supplementary Training Modules on Good Manufacturing Practice

Heating, Ventilation and Air- Conditioning (HVAC)

Part 1 (b): Introduction and overview

WHO Technical Report Series, No. 937, 2006. Annex 2


Gmp updated training modules

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)


Gmp updated training modules

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


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Levels of protection and recommended filtration

*Filter class should be referenced to the standard test method

4.2.1


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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


Gmp updated training modules

HVAC


Gmp updated training modules

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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/isolatortechnology.


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Unidirectional/laminar

displacement of dirty air

Turbulent

dilution of dirty air

HVAC

Airflow patterns


Gmp updated training modules

Airflow patterns

Prefilter

AHU

Main filter

2

3

1

Unidirectional

Turbulent

Turbulent

HVAC


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HVAC

Airflow patterns (4)

Workbench (vertical)

Cabin/booth

Ceiling


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HVAC

Unidirectional airflow (UDAF):

Provided where needed over product or material to prevent contamination, 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, operator determined and validated – no obstruction of airflow or risk

4.3.1 – 4.3.10


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Annex 5, 7.


Gmp updated training modules

HVAC

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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HVAC

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

4.5.13 – 4.5.18, 4.5.22


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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


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Pressure cascade solids

Protection from cross-contamination


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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

  • 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.g. some corrosion inhibitors/chelating agents)

4.6.7. – 4.6.11


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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

  • Fresh air rate supply

    • comfort, odour and fume removal, leakage, pressure control, etc.

5.8. – 5.14


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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

  • Harmful substances (e.g. hormones)

    • EN1822 H12 (HEPA) filter recommended

    • In some cases two banks of HEPA filters

    • Safe change filter housings ("bag-in bag-out" filters)

6.1.1 – 6.1.5


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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

  • Automated systems provided with alarm or similar system to indicate OOS

6.1.6 – 6.1.10


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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

  • Dust collectors with mechanical shakers

    • Used in a manner not to become source of contamination

    • Switched off at times resulting in loss of airflow, and disruption of pressure cascade

  • Wet scrubbers

    • Use suitable drainage system for dust slurry

  • Determine exhaust air quality to verify filtration efficiency

6.1.11 – 6.1.15


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Protection of the environment (Fume removal)

  • Appropriate design, installation, and operation of fume, dust, 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

6.2.1 – 6.2.5


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