World Health Organization

World Health Organization
15 April, 2017 Good Manufacturing Practices: HVAC Heating, Ventilation and Air- Conditioning (HVAC) Part 2: Air flows, Pressure concepts Heating, Ventilation and Air Conditioning (HVAC) Part 2 Air flows, pressure concepts WHO Technical Report Series, No. 961, Annex 5

15 April, 2017 HVAC Objectives To continue from previous section of Part 1, now focus on: Air filtration and air flow patterns The role of HVAC in dust control HVAC system design and its components (part 3) Commissioning, qualification and maintenance (part 4) 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 15 April, 2017 Air Filtration Degree of filtration of air is important to prevent contamination Type of filters to be used is dependent on: Quality of ambient air, Return air / re-circulation Air change rates National requirements Products and required class of clean room etc. Manufacturer to determine, select and install appropriate filters for use 4.2 Air filtration Note: The degree to which air is filtered plays an important role in the prevention of contamination and the control of cross-contamination. 4.2.1 The type of filters required for different applications depends on the quality of the ambient air and the return air (where applicable) and also on the air change rates. Table 2 gives the recommended filtration levels for different levels of protection in a pharmaceutical facility. Manufacturers should determine and prove the appropriate use of filters. 4.2.1, 4.3.3

HVAC World Health Organization 15 April, 2017 Levels of protection and recommended filtration Recommended filtration Level of protection Primary filters, e.g. EN779 G4 Level 1 Production area with 100% outside air: Primary plus secondary filter (e.g. EN779 G4 plus F8 or F9 filters) Level 2 Production facility operating on re-circulated plus ambient air, where potential for cross-contamination exists: Primary plus secondary plus tertiary filters (e.g. EN779 G4 plus F8 plus EN1822 H13 filters) (For full fresh air system, without recirculation, G4 and F8 or F9 filters are acceptable) Level 3 Levels of protection and recommended filtration Level of protection Recommended filtration Level 1 Primary filters only (e.g. EN779 G4 filters) Level 2 Production facility operating on 100% outside air: primary plus secondary filters (e.g. EN779 G4 plus F8 filters) Level 3 Production facility operating on recirculated plus ambient air, where potential for cross-contamination exists: Primary plus secondary plus tertiary filters (e.g. EN779 G4 plus F8 plus EN1822 H13 filters) (For full fresh air system, without recirculation, G4 and F8 or F9 filters are acceptable)Note: The filter classifications referred to above relate to the EN1822 and EN779 test standards (EN 779 relates to filter classes G1 to F9 and EN 1822 relates to filter classes H10 to U16). Note: The filter classifications referred to above relate to the EN1822 and EN779 test standards (EN 779 relates to filter classes G1 to F9 and EN 1822 relates to filter classes E10 to U17). Refer to Figure 8 for comparative classifications of other filter standards. 4.2.2 Filter classes should always be linked to the standard test method because referring to actual filter efficiencies can be very misleading (as different test methods each result in a different value for the same filter). (Referring to filter classifications such as an 85% filter or a 5µm filter are not valid classifications and should not be used, as this can lead to the incorrect filter being installed. Only the EN 779 and EN 1822 classifications

HVAC 15 April, 2017 Contamination can be prevented by considering: Appropriate materials of construction of HVAC components Placement of components (e.g. upstream of final filters) Design and appropriate access (from outside) to dampers, filters and other components Personnel operations and protection Airflow direction Air distribution component design, installation and location Diffusers (type, design, location) Air supply and air exhaust location Materials for components of an HVAC system should be selected with care so that they do not become a source of contamination. Any component with the potential for liberating particulate or microbial contamination into the air stream should be located upstream of the final filters. Where possible ventilation dampers, filters and other services should be designed and positioned so that they are accessible from outside the manufacturing areas (service voids or service corridors) for maintenance purposes. Directional airflow within production or primary packing areas should assist in preventing contamination. Airflows should be planned in conjunction with operator locations, so as to minimize contamination of the product by the operator and also to protect the operator from dust inhalation. HVAC air distribution components should be designed, installed and located to prevent contaminants generated within the room from being spread. Supply air diffusers should be selected with care taking consideration of, e.g. room requirements and positions of equipment and operators in the room. Supply air diffusers of the high induction type (e.g. those typically used for office-type air-conditioning) should where possible not be used in clean areas where dust is liberated. Air diffusers should be of the non-induction type, introducing air with the least amount of induction so as to maximize the flushing effect. In rooms where the process results in high dust liberation; perforated plates or low induction swirl diffusers with low level extract or return should be used (to contain the dust at the lower level of the room). (see Figures 9–11 for illustrations of the three types of diffuser.). In cases where dust liberation is low, ceiling return air grilles may be acceptable. Induction and certain swirl diffusers induce room air vertically up to the diffuser to mix with the supply air. These diffusers create good dilution of contaminants in the room and may be used in rooms where there is low dust liberation. However, if used in rooms where excessive dust is generated, the distribution of dust in the room could be hazardous for the operators in the room. 4.2.4 –

HVAC World Health Organization 15 April, 2017 Induction and certain swirl diffusers induce room air vertically up to the diffuser to mix with the supply air. These diffusers create good dilution of contaminants in the room and may be used in rooms where there is low dust liberation. However, if used in rooms where excessive dust is generated, the distribution of dust in the room could be hazardous for the operators in the room. Induction diffuser

HVAC 15 April, 2017 Perforated plate

HVAC 15 April, 2017 Swirl type diffuser

15 April, 2017 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. As seen in the previous slide, filtered air entering a production room or covering a process can be Turbulent Uni-directional (laminar) Two aspects have to be considered: GMP aspect: uni-directional air (laminar) installations give a better protection, because of the displacement effect rather than the dilution effect. Economical aspect: turbulent air installations are cheaper, as less air has to be treated. For certain operations, namely in class A, a “laminar flow” must be used. It should be said here that such installations can give a false impression of security, and that the purpose of such installations is that there should be, whenever possible, no human interventions under them during the process. If interventions have to occur, they should be performed in a well-documented way, and recorded and evaluated for possible damage to the products. The use of barrier technology systems (isolator technology) is highly recommended in cases of operations in class A, or for sterility testing operations.

15 April, 2017 HVAC Airflow patterns Turbulent dilution of dirty air Unidirectional/laminar displacement of dirty air There are 2 ways to supply air to a room or a piece of equipment: • Turbulent air flow Uni-directional flow, often called laminar flow The air speed in the uni-directional flow is defined by the WHO at: 0,45 m/s for horizontal units 0,30 m/s for vertical units (most commonly used) It is important to know that the WHO definition(*) for the air speed differs from those of other guidelines. For the air exhaust, in case of a vertical unit, a low return is more favourable, as the air is better distributed in the room. Objects in the room can significantly disturb the flow of air, and even block it, so that there might be pockets without air circulation. During the qualification phase, the air flow is visualized if possible, and air samples are taken in different points, to make sure that there are no such pockets, in which case adjustments to the layout or to the air handling systems must be made. (*) WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second Report. Geneva, World Health Organization, 1992: (Technical Report Series, No. 823). Annex 1, 17.3.

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15 April, 2017 HVAC Prefilter Airflow patterns AHU Main filter Unidirectional Turbulent 1 2 3 This slide shows an HVAC installation feeding 3 rooms, each one with terminal filters, all terminal filters protected by a remote pre-filter. Room 1 has a turbulent air flow, with low level exhaust. Room 2 has a uni-directional air flow, over the largest part of the surface, hence the large number of filters, with low level air returns. Due to the high cost of the ventilation in class A areas, the tendency is to keep these areas as small as possible. Room 3 has a turbulent air flow, with ceiling exhaust. Good design practices recommend that cleanrooms A, B and C (ISO Class 5, 6 & 7) should have low level air returns.

HVAC 15 April, 2017 Unidirectional airflow (UDAF) Often used in weighing and sampling areas (Airflow Protection Booths) and provides: Dust containment and product and operator protection Note: For Airflow Protection Booths (APB): Airflow velocity should not affect balance (may be lower than for Class A areas) Position of material, balance, operator determined and validated – no obstruction of airflow or risk 4.3 Unidirectional airflow 4.3.1 Unidirectional airflow (UDAF) should be used for weighing booths or sampling booths to provide operator and product protection and should also have a slight air in-flow from the room to enhance containment. Dust containment at the weigh booth should be demonstrated by smoke airflow pattern tests, or other appropriate tests. UDAF can also be used to provide protection of other dusty processes. 4.3.7 The unidirectional flow velocity should be such that it does not disrupt the sensitivity of balances in weighing areas. Where necessary the velocity may be reduced to prevent inaccuracies during weighing, provided that sufficient airflow is maintained to provide containment. Conventional unidirectional airflow systems, where a Grade A condition is required, have a guidance airflow velocity of 0.36 to 0.54 m/s. However, in a weigh booth or sampling booth a lower velocity can be used as a Grade A condition is not required. It is often necessary to reduce velocities to a lower level in order not to influence balance readings. The airflow velocity and directional flow should still ensure product containment. For this type of application it is sometimes better to refer to the unit as an airflow protection booth (APB) rather than a UDAF, in order to avoid confusion, with a Grade A requirement. 4.3.8 The position in which the operator stands relative to the source of dust liberation and airflow should be determined to ensure that the operator is not in the path of an airflow that could lead to contamination of the product 4.3

15 April, 2017 HVAC Airflow patterns Workbench (vertical) Cabin/booth Ceiling Uni-directional flow units exist mostly as vertical, but also as horizontal, units. These booths are often placed in a clean room. In some cases, the units can be integrated into the ceiling of a room and also connected to the central air conditioning system. Due to the high air velocity, it is important to have objects with good aerodynamical properties under the Uni-directional flow. If not, turbulences and, therefore, particles are unavoidable. Uni-directionalflow units are comparatively expensive. Surfaces covered by them should be reduced to a minimum. The placement of the AFB in the room, the finishing of the room and environmental conditions in the room must be appropriate to ensure that there is dust containment, no risks of contamination and cross contamination, and that there are no obstructions to air flows in a way that can be considered to have a negative impact on the activitiy. Return or exhaust air grilles in rooms or at weigh or sampling booths should preferably be of the perforated grille types, which are easy to clean. Return/exhaust air filters can either be installed at the room terminal or in the air-handling unit. Maintenance and cleaning of filters and ducts should be addressed to ensure constant airflow.

HVAC 15 April, 2017 Unidirectional airflow (UDAF): Sampling and weighing area classification – same as other processing areas following sampling and dispensing Dust containment shown through smoke tests as part of validation / qualification Location and type of return and exhaust grilles Cleaning and maintenance Will discuss examples in the following figures 4.3.3 Sampling of materials such as starting materials, primary packaging materials and products, should be carried out in the same environmental conditions that are required for the further processing of the product. 4.3.4 In a weighing booth situation, the aim of the UDAF is to provide dust containment and operator protection. 4.3.

15 April, 2017 HVAC The dust generated at the weighing station is immediately extracted through the perforated worktop, thus protecting the operator from dust inhalation, but at the same time protecting the product from contamination by the operator by means of the vertical unidirectional airflow stream.

15 April, 2017 HVAC The position in which the operator stands relative to the source of dust liberation and airflow should be determined to ensure that the operator is not in the path of an airflow that could lead to contamination of the product

15 April, 2017 HVAC .3.9 Once the system has been designed and qualified with a specific layout for operators and processes, this should be maintained in accordance with an SOP. There should be no obstructions in the path of a unidirectional flow air stream that may cause the operator to be exposed to dust. Figure14 illustrates the incorrect use of a weighing scale which has a solid back. The back of the weighing scale should not block the return air path as this causes air to rise vertically, resulting in a hazardous situation for the operator.

15 April, 2017 HVAC Here an open bin is placed below a vertical unidirectional flow distributor. The downward airflow should be prevented from entering the bin, and then being forced to rise again, as this would carry dust up towards the operator’s face. In such an occurrence it may be necessary to add a partial cover over the bin to limit the entry of air. Point extraction could also be used but this can result in the excessive loss of product.

15 April, 2017 HVAC A solid worktop can sometimes cause deflection of the vertical unidirectional airflow resulting in a flow reversal. A possible solution would be to have a 100 mm gap between the back of the table and the wall, with the air being extracted here.

15 April, 2017 HVAC The manufacturer should select either vertical or horizontal unidirectional flow and an appropriate airflow pattern to provide the best protection for the particular application.

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HVAC 15 April, 2017 Infiltration Prevent infiltration of unfiltered, contaminated air from outside Facilities normally under positive pressure to the outside Building structure well sealed Some cases - negative pressure (e.g. penicillin manufacture). Special precautions to be taken. See separate guidelines 4.4.1 – 4.4.4 4.4.1 Air infiltration of unfiltered air into a pharmaceutical plant should not be a source of contamination. 4.4.2 Manufacturing facilities should normally be maintained at a positive pressure relative to the outside, to limit the ingress of contaminants. Where facilities are to be maintained at negative pressures relative to the ambient pressure, special precautions should be taken. Refer to the WHO guideline for hazardous products, for further guidance on negative pressure facilities. 4.4.3 The location of the negative pressure facility should be carefully considered with reference to the areas surrounding it, particular attention being given to ensuring that the building structure is well sealed. 4.4.4 Negative pressure zones should, as far as possible, be encapsulated by surrounding areas with clean air supplies, so that only clean air can infiltrate into the controlled zone. Explain with the help of drawing / layout what is meant by the facility being under positive pressure; and how a corridor around a production area can protect the facility further from ingress of air in different cases (positive or negative to the environment)

HVAC 15 April, 2017 Cross-contamination Multiproduct facility – even if in different areas - risk for cross contamination (dust from area to area) Correct direction of air movement and pressure cascade Normally, corridors positive to cubicles and cubicles positive to atmosphere Consider building structure, ceilings, walls, doors etc Different concepts discussed in following slides 4.5 Cross-contamination 4.5.1 Where different products are manufactured at the same time, in different areas or cubicles, in a multiproduct OSD manufacturing site, measures should be taken to ensure that dust cannot move from one cubicle to another. 4.5.2 Correct directional air movement and a pressure cascade system can assist in preventing cross-contamination. The pressure cascade should be such that the direction of airflow is from the clean corridor into the cubicles, resulting in dust containment. 4.5.3 The corridor should be maintained at a higher pressure than the cubicles, and the cubicles at a higher pressure than atmospheric pressure. 4.5.4 Containment can normally be achieved by application of the displacement concept (low pressure differential, high airflow), or the pressure differential concept (high pressure differential, low airflow), or the physical barrier concept. 4.5

HVAC 15 April, 2017 Displacement concept Not a preferred method (Found in older facilities) Based on low pressure differentials and high airflows Air supplied to the corridor – then through the doors (grilles) to the cubicles Air extracted at the back of the cubicle Velocity high enough to prevent turbulence in doorway Note: This method of containment is not the preferred method, as the measurement and monitoring of airflow velocities in doorways is difficult. This concept is commonly found in production processes where large amounts of dust are generated. 4.6.1 Under this concept the air should be supplied to the corridor, flow through the doorway, and be extracted from the back of the cubicle. Normally the cubicle door should be closed and the air should enter the cubicle through a door grille, although the concept can be applied to an opening without a door. 4.6.2 The velocity should be high enough to prevent turbulence within the doorway resulting in dust escaping. 4.6.3 This displacement airflow should be calculated as the product of the door area and the velocity, which generally results in fairly large air quantities. 4.6

HVAC 15 April, 2017 Pressure differential concept Used where there is low dust in areas. Alone or in combination with other control techniques High pressure differential, low airflow, and airlocks Airlock types include: Cascade, sink and bubble type (See next slides) 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 Note: The pressure differential concept may normally be used in zones where little or no dust is being generated. It may be used alone or in combination with other containment control techniques and concepts, such as a double door airlock. The high pressure differential between the clean and less clean zones should be generated by leakage through the gaps of the closed doors to the cubicle. The pressure differential should be of sufficient magnitude to ensure containment and prevention of flow reversal, but should not be so high as to create turbulence problems. 4.7.3 In considering room pressure differentials, transient variations, such as machine extract systems, should be taken into consideration. A pressure differential of 15 Pa is often used for achieving containment between two adjacent zones, but pressure differentials of between 5 Pa and 20 Pa may be acceptable. Where the design pressure differential is too low and tolerances are at opposite extremities, a flow reversal can take place. For example, where a control tolerance of ± 3 Pa is specified, the implications of rooms being operated at the upper and lower tolerances should be evaluated. It is important to select pressures and tolerances such that a flow reversal is unlikely to occur. The pressure differential between adjacent rooms could be considered a critical parameter, depending on the outcome of risk analysis. The limits for the pressure differential between adjacent areas should be such that there is no risk of overlap in the acceptable operating range, e.g. 5 Pa to 15 Pa in one room and 15 Pa to 30 Pa in an adjacent room, resulting in the failure of the pressure cascade, where the first room is at the maximum pressure limit and the second room is at its minimum pressure limit. . 4.7.6 Low pressure differentials may be acceptable when airlocks (pressure sinks or pressure bubbles) are used to segregate areas. 4.7.8 The pressure control and monitoring devices used should be calibrated and qualified. Compliance with specifications should be regularly verified and the results recorded. Pressure control devices should be linked to an alarm system set according to the levels determined by a risk analysis, 4.7.9 Manual control systems, where used, should be set up during commissioning, with set point marked, and should not change unless other system conditions change. Airlocks can be important components in setting up and maintaining pressure cascade systems and also to limit cross-contamination. Airlocks with different pressure cascade regimes include the cascade airlock, sink airlock and bubble airlock (Figures 19–21): • cascade airlock: higher pressure on one side of the airlock and lower pressure on the other; • sink airlock: lower pressure inside the airlock and higher pressure on both outer sides; • bubble airlock: higher pressure inside the airlock and lower pressure on both outer sides 4.7

HVAC 15 April, 2017 Essential / critical parameter here is pressure differentials Risk assessment may be done High enough to achieve containment; low permissible when airlocks are used No flow reversal should take place – therefore appropriate limits e.g. 5Pa to 20 Pa No turbulence No overlap (two adjacent rooms) A pressure differential of 15 Pa is often used for achieving containment between two adjacent zones, but pressure differentials of between 5 Pa and 20 Pa may be acceptable. Where the design pressure differential is too low and tolerances are at opposite extremities, a flow reversal can take place. For example, where a control tolerance of ± 3 Pa is specified, the implications of rooms being operated at the upper and lower tolerances should be evaluated. It is important to select pressures and tolerances such that a flow reversal is unlikely to occur. The pressure differential between adjacent rooms could be considered a critical parameter, depending on the outcome of risk analysis. The limits for the pressure differential between adjacent areas should be such that there is no risk of overlap in the acceptable operating range, e.g. 5 Pa to 15 Pa in one room and 15 Pa to 30 Pa in an adjacent room, resulting in the failure of the pressure cascade, where the first room is at the maximum pressure limit and the second room is at its minimum pressure limit. . 4.7.6 Low pressure differentials may be acceptable when airlocks (pressure sinks or pressure bubbles) are used to segregate areas. 4.7

HVAC 15 April, 2017 Adequate room pressure differential indication provided Each critical room pressure must be traced back to ambient pressure (by summation of the room pressure differentials) – provides actual absolute pressure Gauges with appropriate range and graduation scale to enable accurate reading; analogue or digital; as pressure differentials or absolute pressures Normal operating range, alert and action limits defined and displayed OOS condition should be easily identifiable Adequate room pressure differential indication should be provided so that each critical room pressure can be traced back to ambient pressure (by summation of the room pressure differentials), in order to determine the room actual absolute pressure. Room pressure indication gauges should have a range and graduation scale which enables the reading to an accuracy, as appropriate; Normal operating range, alert and action limits should be defined and displayed at the point of indication. Colour coding gauge may be helpful. Room pressure indication may be either analogue or digital, and may be represented as either pressure differentials or absolute pressures. Whichever system is used any OOS condition should be easily identifiable. 4.7

15 April, 2017 HVAC Explain pressure cascades and pressure tolerances in the different examples in the slide, based on the previous slides. Explain pressure differential gauge readings, limits, zero checks

HVAC 15 April, 2017 Calibrated and qualified monitoring devices, verified at intervals Linked to alarm system Monitoring and recording of results Doors open to higher pressure, self closers Doors interlocked where possible Doors should open to the high pressure side, so that room pressure assists in holding the door closed and in addition be provided with self-closers. Should the doors open to the low pressure side, the door closer springs, should be sufficient to hold the door closed and prevent the pressure differential from pushing the door open. There should be a method to indicate if both doors to airlocks are open at the same time, or alternatively these should be interlocked. The determination of which doors should be interlocked should be the subject of a risk assessment study. 4.7

HVAC 15 April, 2017 Dust extraction system design is important as it may impact on pressure cascade Central systems interlocked with AHUs No airflow between rooms through common system What happens in the case of component failure? The pressure control and monitoring devices used should be calibrated and qualifi ed. Compliance with specifi cations should be regularly veri- fi ed and the results recorded. Pressure control devices should be linked to an alarm system set according to the levels determined by a risk analysis, Manual control systems, where used, should be set up during commissioning and should not change unless other system conditions change. Airlocks can be important components in setting up and maintaining pressure cascade systems. Airlocks with different pressure cascade regimes include the cascade airlock, sink airlock and bubble airlock (Figs 19–21). • Cascade airlock: high pressure on one side of the airlock and low pressure on the other. • Sink airlock: low pressure inside the airlock and high pressure on both outer sides. • Bubble airlock: high pressure inside the airlock and low pressure on both Figure 18 Examples of pressure cascades Tablets compr. Encapsulation Production corridor Design condition (15 Pa differential) Maximum differential (21 Pa differential) Minimum differential (9 Pa differential) Air lock 15 Pa ± 3 Pa 15 Pa ± 3 Pa 15 Pa ± 3 Pa 15 Pa 12 Pa 12 Pa 12 Pa 18 Pa 18 Pa 18 Pa 12 Pa 33 Pa 27 Pa 18 Pa 30 Pa ± 3 Pa 67 Doors should open to the high pressure side, and be provided with self-closers. Door closer springs, if used, should be designed to hold the door closed and prevent the pressure differential from pushing the door open. Sliding doors are not recommended. Central dust extraction systems should be interlocked with the appropriate air handling systems, to ensure that they operate simultaneously. Room pressure imbalance between adjacent cubicles which are linked by common dust extraction ducting should be prevented. Air should not fl ow from the room with the higher pressure to the room with the lower pressure, via the dust extract ducting (this would normally occur only if the dust extraction system was inoperative). 4.7

HVAC 15 April, 2017 Airlocks and Material Pass-though-hatches (PTH) Can be used to separate two zones Dynamic and passive PTH Also designed as bubble, sink or cascade See next slides for design principles Material pass-through-hatches (PTH) or pass boxes (PB) can also be used for separating two different zones. PTHs fall into two categories, namely a dynamic PTH or a passive PTH. Dynamic PTHs have an air supply to or extraction from them, and can then be used as bubble, sink or cascade PTHs. 4.7

HVAC World Health Organization 15 April, 2017 Airlocks with different pressure cascade regimes include the cascade airlock, sink airlock and bubble airlock • cascade airlock: higher pressure on one side of the airlock and lower pressure on the other; • bubble airlock: higher pressure inside the airlock and lower pressure on both outer sides.

HVAC World Health Organization 15 April, 2017 What type of airlock is this? How does it work? Any examples of where It can be used? • sink airlock: lower pressure inside the airlock and higher pressure on both outer sides;

HVAC 15 April, 2017 Physical barrier concept In some cases, impervious barriers are used to prevent cross-contamination Closed systems Pump or vacuum transfer 4.8 Physical barrier concept 4.8.1 Where appropriate, an impervious barrier to prevent cross-contamination between two zones, such as closed systems, pumped or vacuum transfer of materials, should be used. This is dealt with in detail in the guideline where the production and control of products containing hazardous materials are discussed. 4.8

HVAC 15 April, 2017 Temperature and relative humidity (RH) Consider materials and product requirements as well as operator comfort in the design of the HVAC Where conditions are required, provide for control, monitoring and recording Alert and action limits; minimum and maximum limits Premises appropriately designed HVAC design to achieve and maintain conditions in different seasons 4.9 Temperature and relative humidity 4.9.1 Where appropriate, temperature and relative humidity should be controlled, monitored and recorded, where relevant, to ensure compliance with requirements pertinent to the materials and products and provide a comfortable environment for the operator where necessary. When specifying relative humidity, the associated temperature should also be specified. 4.9.2 Maximum and minimum room temperatures and relative humidity should be appropriate. Alert and action limits on temperatures and humidities should be set, as appropriate. 4.9.3 The operating band, or tolerance, between the acceptable minimum and maximum temperatures should not be made too close. Tight control tolerances may be difficult to achieve and can also add unnecessary installation and running costs. 4.9

HVAC 15 April, 2017 Relative humidity (RH) Low RH areas need well sealed walls and ceilings, and preferably air locks Remove or add moisture as necessary Dehumidification Refrigerated dehumidifiers - cooling media Chemical dehumidifiers Humidifiers should not be sources of contamination Use of pure steam or clean steam No chemicals that can have a detrimental effect 4.9.4 Cubicles, or suites, in which products requiring low relative humidity are processed, should have well-sealed walls and ceilings and should also be separated from adjacent areas with higher relative humidity by means of suitable airlocks. 4.9.5 Precautions should be taken to prevent moisture migration that increases the load on the HVAC system. 4.9.6 Humidity control should be achieved by removing moisture from the air, or adding moisture to the air, as relevant. 4.9.7 Dehumidification (moisture removal) may be achieved by means of either refrigerated dehumidifiers or chemical dehumidifiers. 4.9.8 Appropriate cooling media for dehumidification such as low temperature chilled water/glycol mixture or refrigerant should be used. 4.9.9 Humidifiers should be avoided if possible as they may become a source of contamination (e.g. microbiological growth). Where humidification is required, this should be achieved by appropriate means such as the injection of steam into the air stream. A product-contamination assessment should be done to determine whether pure or clean steam is required for the purposes of humidification. Where steam humidifiers are used, chemicals such as corrosion inhibitors or chelating agents, which could have a detrimental effect on the product, should not be added to the boiler system. Only appropriate additives should be added to the boiler system. 4.9

15 April, 2017 HVAC Relative humidity (RH) Humidifiers should be well drained - 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 Humidification systems should be well drained. No condensate should accumulate in air-handling systems. Other humidification appliances such as evaporative systems, atomizers and water mist sprays, should not be used because of the potential risk of microbial contamination. Duct material in the vicinity of the humidifier should not add contaminants to air that will not be removed by filtration further downstream. Air filters should not be installed immediately downstream of humidifiers, as moisture on the filters could lead to bacterial growth. Cold surfaces should be insulated to prevent condensation within the clean area or on air-handling components. When specifying relative humidity, the associated temperature should also be specified. Chemical driers using silica gel or lithium chloride are acceptable, provided that they do not become sources of contamination. 4.9

HVAC 15 April, 2017 Dust Control Where possible - 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 in extraction system to prevent dust settling in ducting Calculations and measurements Periodic checks for build up Risk analysis – airflow direction 5.1. – 5.6 Dust control Several operations can be generating dust. E.g. weighing, compressions, mixing of powders. 5.1 Wherever possible, dust or vapour contamination should be removed at source. Point-of-use extraction, i.e. as close as possible to the point where the dust is generated, should be employed. Spot ventilation or capture hoods may be used as appropriate. 5.2 Point-of-use extraction should be either in the form of a fixed high velocity extraction point or an articulated arm with movable hood or a fixed extraction hood. 5.3 Dust extraction ducting should be designed with sufficient transfer velocity to ensure that dust is carried away, and does not settle in the ducting. Periodic checks should be performed to ensure that there is no build up of the dust in the ducting. 5.4 The required transfer velocity should be determined: it is dependent on the density of the dust (the denser the dust, the higher the transfer velocity should be, e.g. 15–20 m/s). 5.5 Airflow direction should be carefully chosen, to ensure that the operator does not contaminate the product, and also so that the operator is not put at risk by the product. 5.6 Point extraction alone is usually not sufficient to capture all of the contaminants, and general directional airflow should be used to assist in removing dust and vapours from the room. Explain the principles, risks, procedures to be followed (e.g. cleaning, maintenance, operation) of the different types of dust collectors that can be used. These are at the point where dust is generated, common dust extraction systems, those that can be an integral part of a piece of equipment (e.g. some compression machines), moveable types.

HVAC 15 April, 2017 Dust Control (2) Normally air supplied through ceiling diffusers, near the door Air extracted from low level (rear) 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. 5.7 Typically, in a room operating with turbulent airflow, the air should be introduced from ceiling diffusers, located at the door entry side of the room and extracted from the rear of the room at low level to help give a flushing effect in the room. Correct flushing of the rooms may be verified by airflow visualisation smoke tests. 5.9 When dealing with particularly harmful products, additional steps, such as handling the products in glove boxes or using barrier isolator technology, should be used. 5.7. – 5.8.

HVAC World Health Organization 15 April, 2017 Explain the air flow pattern, with air being supplied from the top, and sweeping through the room, removing particles and exhaust air moving out at the lower level

HVAC 15 April, 2017 Mobile type dust collectors can become the source of contamination if not used, cleaned, and controlled in the correct manner.

HVAC 15 April, 2017 Explain some key components of a dust collector, how the contaminated air is sucked in, treated, how the dust is collected and the treated air is exhausted. Discuss components such as blowers (fans), air velocity, bags, filters, pressure gauges etc

HVAC 15 April, 2017 Common duct collecting systems can result in powder/dust from one cubicle being deposited in another cubicle. Discuss design principles, dampers, airflow velocity, interlocking systems, pickup hoods, ducting (and cleaning), bags, shakers, fans, gates.

HVAC World Health Organization 15 April, 2017 Exhaust air dust Exhaust air from equipment and some areas of production can carry heavy loads of dust, vapours and fumes (e.g. FBD, coating, weighing) Filtration may be needed to protect environment (see National legislation) Location of the inlet and exhaust points relative to one other important to prevent contaminants taken into inlet air Dust collection system 6.1.1 – 6.1.2 6.1. General 6.1.1 It should be noted that protection of the environment is not addressed in this guideline, and discharges into the atmosphere should be compliant with relevant local and national environmental legislation and standards. Dust, vapours and fumes could be possible sources of contamination; therefore, care should be taken when deciding on the location of the inlet and exhaust points relative to one other.

HVAC 15 April, 2017 Exhaust air dust Wet scrubbers can also be used Contaminated air is collected Dust is treated with a mist/spray / water Clean air is exhausted

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World Health Organization

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