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HVAC Design Criteria and Guidelines

CLEANROOMS

Overview

A cleanroom is an environment, typically used in manufacturing, scientific research, pharmaceuticals production, pharmacy sterile compounding, etc. with a low level of particulate pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. More accurately, a cleanroom has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size.

To give perspective to the word “clean,” the ambient outdoor air in typical urban environments contains an average of 35,000,000 particles per cubic meter in the size range 0.5 μm and larger in diameter, corresponding to an ISO-9 cleanroom. But, an ISO-1 cleanroom allows no particles in that size range and only 13.39 particles per cubic meter of 0.3 μm and smaller.

The primary authority for cleanroom classifications is the International Organization for Standardization (ISO) Standard 14644-1, as follows:

Class Maximum Particles / m3

≥0.1 µm ≥0.2 µm ≥0.3 µm ≥0.5 µm ≥1 µm ≥5 µmISO 1 10 2.37 1.02 0.35 0.083 0.0029ISO 2 100 23.7 10.2 3.5 0.83 0.029ISO 3 1,000 237 102 35 8.3 0.29ISO 4 10,000 2,370 1,020 352 83 2.9ISO 5 100,000 23,700 10,200 3,520 832 29ISO 6 1.0×106 237,000 102,000 35,200 8,320 293ISO 7 1.0×107 2.37×106 1,020,000 352,000 83,200 2,930ISO 8 1.0×108 2.37×107 1.02×107 3,520,000 832,000 29,300ISO 9 1.0×109 2.37×108 1.02×108 35,200,000 8,320,000 293,000

(µm = micron particle size)

Note that an ISO-9 cleanroom is not really considered as clean since it represents typical outdoor environments.

The ISO classes are based on the formula

Cn = 10N (0.1 / D)2.08

where

Cn = maximum permitted number of particles per cubic meter equal to or greater than the specified particle size, rounded to whole number.

N = is the ISO class number, which must be a multiple of 0.1 and be 9 or less.

D = is the particle size in microns.

Engineering Design Guidelines

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For the HVAC designer, cleanroom design encompasses much more than conventional temperature and humidity control in the following ways:

1. Increased Air Supply: Whereas comfort air conditioning would require about 0.5-10 air changes/hr, a typical cleanroom would typically require 20 - 60 air changes and could be as high as 600 for absolute cleanliness. This large air supply is provided to eliminate the settling of the particulate and dilute contamination produced in the room to an acceptable concentration level.

2. The use of high efficiency filters: The use of high efficiency particulate air (HEPA) filters, having filtration efficiency of MERV 17 or greater, is another distinguishing feature of cleanrooms.

3. Room pressurization: Typically, cleanrooms are positively pressurized with respect to the adjacent areas in order to eliminate incoming particulate contaminants. However, there are some applications (such as sterile compounding pharmacies using hazardous drugs) in which the cleanroom must be maintained at a negative pressure.

Airflow and Distribution

The general guidelines provided by ASHRAE and others for cleanroom design include the following:

Cleanliness Classification Airflow Pattern Average Room Air

Velocity (fpm)Air Change Rate

(AC/Hr)

ISO-1 or -2 Unidirectional 60 – 100 360 - 600

ISO-3 Unidirectional 60 – 90 360 – 540

ISO-4 Unidirectional 50 – 90 300 – 540

ISO-5 Unidirectional 40 – 80 200 - 480

ISO-6 Unidirectional 25 – 40 125 - 240

ISO-7 Unidirectional/Non-Unidirectional 10 – 15 30 – 60

ISO-8 Non-Unidirectional 1 – 8 5 – 30

ISO-9 Non-Unidirectional N/A 0.5-4

Despite these published guidelines, studies in recent years have concluded that there is "no consistent design strategy for air change rate (ACR), even for cleanrooms of the same cleanliness classification." And, several studies indicate that a lower ACR often resulted in cleaner air since lower ACR tends to minimize turbulence, improving cleanliness. For designers, studies conclude that the "[b]est practice for ACRs is to design new facilities at the lower end of the recommended ACR range."

Other studies indicate that the cleanliness improvement at ACRs exceeding 200-250 are minimal and these values may be considered the “upper limit” for design of cleanrooms.

Numerous airflow-management concepts have been devised over the years to supply and circulate air in cleanrooms. The two most common design strategies for air handling system are (1) the “single pass” 100% outdoor (or “once through”) configuration and (2) the recirculation configuration.


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With a single pass system, filtered outdoor air enters the room and is not recirculated…all the air is exhausted to the outdoors. This configuration is used for cleanroom processes demanding 100% makeup air due to process demands, such as when the potential for releasing dust or aerosolized materials within the cleanroom exists. Recirculation air systems are far more popular since they are less complex and significantly more energy efficient. In this configuration, filtered air enters the cleanroom, exits through return intakes (typically located low on the room’s perimeter walls), and is recirculated through a sealed plenum equipped with HEPA filters. There are two fundamental recirculation system configurations: circulation by central air-handling units (AHUs) or circulation via ceiling-mounted fan-filter units (FFUs).

Where a centralized air-handling system is applied, the AHU supplies pre-filtered air for pressurization and to offset both sensible and latent cooling loads. Where FFUs are applied, air is supplied to each room via these units, recirculating their air from a common ceiling plenum. Filters may be incorporated as part of the an air diffuser when ducted air distribution to each space is provided by a central AHU or as part of FFUs they are used for air distribution.

The FFU system design has the following characteristics:

1. Small fans force air through filters. The units often have adjustable speed control and typically have full speed energy consumption of 190–250 watts. The newer installations use more efficient DC motors.

2. The main advantage of FFU system is simplicity and these systems are very popular. However, the FFU puts out a fixed airflow rate in a 2'x4' or 2’x2’ ceiling space. Since airflow rate and air velocity are not independent variables, these units may not lend itself to efficient design for proper airflow distribution.

3. FFUs are quite expensive. Even though the unit cost of a fan-filter unit is relatively low, a typical cleanroom module will require many such units; and the total cost may exceed that of centralized AHU system.

4. FFUs require larger air passageways in order to reduce static pressure losses. This increases both the overall building width and height.

5. FFUs can be set in a gasketed ceiling since the ceiling plenum operates at a negative pressure.

6. The electrical installation cost is highest for FFUs. Even though the motors are much smaller, there are many more of them. Also, the automation costs are higher for fan-filter units, again due to the large quantity of fans.

7. The noise level from a typical FFU is low at 53 dba @ 90 FPM face velocity. However, the use of multiple fans (in some cases hundreds of them) can result in significant noise level being radiated into the cleanroom.

Aluminum or Type 304 stainless steel ductwork is generally provided to supply air to the cleanroom and to bring back air from the return air grilles to the return air fan. Galvanized ductwork should be avoided to eliminate zinc particles “shedding” into the supply airstream.

The following precautions should be taken while designing the duct system:


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1. Ducts should be sealed in accordance with Class A requirements defined by SMACNA’s Duct Contruction Standards Metal and Flexible. Stainless steel duct with welded joints is preferred for ISO-1 through ISO-4 cleanrooms. 2. Rubber gaskets should be used at transverse joints.

3. Flanged joints must be avoided and instead pocket slips or angle iron flanged joints should be used.

4. No acoustic insulation should be provided inside the ducts.

5. Dampers provided in the system should be of aluminum and should have extended handle to accommodate insulation thickness.

6. Return air risers should be designed for velocities not exceeding 1800 fpm, with a minimum velocity of 1200 fpm at the highest point in order to carry particulate matter along with return air. However, the inlet velocity at the return grille should be in the range of 300 to 400 fpm.

7. Return air grilles should be aluminum, stainless steel, or enamel/epoxy painted construction in order to withstand routine cleaning.

8. Provisions should be provided in each return air riser for periodic cleaning.

9. Whenever terminal filters are mounted in the ceiling, properly sealed access doors should be provided for access to dampers and filters for balancing and maintenance. Sealed ceiling tiles are the norm for cleanrooms and removing a tile for access to ceiling equipment introduces a potential point for contamination.

10. Return air grilles should be located low near the floor and made as long as possible to increase the collection of dust particles over a larger area.

11. When locating return grilles, care should be taken to avoid placing grilles near door openings into an adjoining lower pressure cleanroom to prevent creation of a low pressure zone near the door, thus preventing air leakage from the low pressure to high pressure room when the door opens.

ISO-1 through ISO-7 cleanrooms typically rely on unidirectional, or “laminar,” airflow. Laminar airflow means that filtered air is (more or less) uniformly supplied in one direction at a fixed velocity in parallel streams. ISO-8 and ISO-9 cleanrooms, which have much lower cleanliness criteria, generally utilize non-unidirectional, or “turbulent,” airflow. This means the air is not regulated for direction and speed. The advantage of laminar over turbulent airflow is that laminar provides a uniform environment and prevents air pockets where contaminants might congregate.

The term “unidirectional” can be applied to describe either horizontal or vertical air movement in the space. Vertical air movement is much more commonly applied since particles 0.5 microns and larger are susceptible to gravity (they do not “float” in convective air currents) and a downward air pattern augments gravity to direct particles to the low returns in each cleanroom. Careful consideration should be made to ensure that the supply airflow is never contaminated before it comes into contact with the product.

In critical applications (electronics, medical device manufacturing, etc.), cleanrooms are typically rated for ISO-1, -2, -3, or -4 classification and are designed for 100% filtered ceiling supply air delivery, with return


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through a raised floor plenum. For ISO-5 rooms, the typical configuration is again 100% filtered ceiling supply air delivery, but return is via low returns located along the long axis of the room. For ISO-6, -7, and -8 cleanrooms, the supply air is delivered from the ceiling, with the coverage is reduced to match the ACR requirements of the room, with low wall returns. (Optionally, for ISO-8 cleanrooms, a side-access HEPA filter bank in an air-handling unit may be used for air cleaning in lieu of ceiling filters.)

Laminar Airflow: Typically, laminar flow is achieved by supplying air through HEPA filters, ensuring 100% ceiling coverage by diffusers or FFUs. The air moves vertically downward and then laterally from the ceiling to returns at or near the floor. This approach allows the contamination generated by the process or surroundings to drift to the floor. The particles are finally captured by a vacuum pump in the floor void or sucked back for recirculation through the HEPA filters in the ceiling.

The key characteristics of unidirectional air flow system are as follows:

1. Unidirectional airflow system is designed for an air velocity across the cleanroom of 60 to 90 FPM. This air velocity is sufficient to keep the contaminants directed downwards and remove particles before they settle onto surfaces.

2. For wider rooms (>16ft), it is best to provide raised floor return so that the airflow tends to remain parallel (or within 180 degrees of parallel). Where the clean space is fairly narrow, of the order of 14 to 16 ft from wall to wall, the raised floor can be eliminated in favor of low sidewall return grilles. The air will move vertically downward to within 2 to 3 ft of the floor before splitting and moving toward the sidewall returns.

3. Unidirectional (laminar) airflow tends to become turbulent if it encounters obstacles such as people, process equipment and workbenches. Placing these obstructions in a manner that prevents dead air spaces from developing will minimize turbulence. Use of workstations with perforated tabletops will allow the air to pass through them uninterrupted. Equipment shall also be raised on a platform (plinth) where possible to allow free air flows beneath it. 4. HEPA filter banks must be "pinhole" tight and checked for any pinhole leaks in the media, sealants, frame gaskets, and supporting frames.

5. In some designs, the supply air can be projected upwards from floor void and is drawn into a ceiling void. This arrangement is preferred in applications where the localized hardware or equipment has high heat dissipation. The conventional supply airflow from ceiling may not be directional enough to cool the equipment that results in hot spots.

Unidirectional Airflow: The unidirectional design is typically provided in one of the three major configurations: (1) clean work stations, (2) tunnel design, or (3) open bay design.

1. Clean work stations are used for localized areas and involve the use of hoods with HEPA filters. These find quite a use in laboratories and research centers. These offers energy efficient operation as only small volume is provided with desired class cleanliness level rather than the whole area.

2. Tunnel design incorporates HEPA filters in ceilings instead of hoods. Similar to clean work stations, this arrangement too, provide localized cleanliness with a difference that the cleanroom space is partitioned from rest of the area and HEPA filters are mounted on


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ceiling. This arrangement is suitable for modular spaces typically between 11 and 14 feet wide. Wider tunnels experience too much or turbulent flow. The advantage of a tunnel is reduced HEPA filter coverage and ease of expanding additional tunnel modules into unaffiliated areas. The disadvantage is they restrict new equipment layouts as processes change, and products change.

3. Total cleanroom (“open bay” design) strategy involves open bay designs that typically use HEPA filters in the entire ceiling and returns in the floor. The design is suitable for large areas up to 50,000 sq ft with interior walls placed wherever production processes dictate. These rooms are more costly to build and maintain but do provide flexibility for change as new products are introduced and production equipment or processes are improved.

Non-Unidirectional Airflow: Airflow is typically supplied through terminal HEPA diffusers installed in the ceiling in a pattern that provides fairly uniform coverage. The HEPA filters are sometimes installed straight in the ductwork or the air handler itself. The return is usually through the sidewall grilles uniformly distributed around the periphery of the room.

It is good practice to limit the horizontal distance air must travel to a return outlet to 14 to 16 ft. Therefore, a room 28 to 32 ft wide only needs return grilles located in the peripheral walls. For wider rooms, it is common practice to box in support columns and incorporate return grilles and return air ductwork within the box.

A shortcoming of non-unidirectional cleanrooms is pockets of air with high particle counts. These pockets can persist for a period of time, and then disappear. This is due to currents that are set up within the room due to process related activity combined with the random nature of the downward airflow. Sidewall return arrangement can pose a challenge when process equipment is intended to occupy wall space. When possible, the equipment should be moved off the wall to permit air to flow behind it.

Air Filtration

Any air introduced into a cleanroom needs to be filtered. Particles above 0.01 micron are usually considered to be “filterable” and all air entering a cleanroom must be treated by final filters with following efficiencies:

Cleanroom Classification Required Filter EfficiencyISO-1 and -2 99.99999%@0.12 µm

ISO-3 99.9995%@0.12 µmISO-4 99.999%@0.12 µm

ISO-5 thru ISO-8 99.99%@0.30 µm

Cleanroom design criteria requires that HEPA filters be selected for a face velocity of 90 fpm, ±20 fpm.

HEPA air filters are constructed of filter media, sealants, a frame, and sometimes a faceguard and/or gasket.

1. Media is the filtering material. Common types of media include glass fiber, synthetic fiber, non-woven fiber, and PTFE. High efficiency filters use sub-micron glass fiber media housed in an aluminum framework.


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2. Sealant is the adhesive material that creates a leak-proof seal between the filter media and the frame.

3. Frame is where the filter media is inserted. It can be made from a variety of materials including aluminum, stainless steel, plastic or wood.

4. Faceguard is a screen attached to the filter to protect the filter media during handling and installation.

5. Gasket is a rubber or sponge like material used to prevent air leaks between the filter and its housing by compressing the two together.

Cleanroom Pressurization: As a rule of thumb, the quantity of outdoor makeup air can be determined by summing all the exhaust airflows from each space, then adding two additional air changes per hour. This semi-empirically derived value has proven to be a safe quantity to use to size the makeup air handler. Actual makeup air introduced at any one time will vary depending on door openings, leakage, and actual exhaust in operation. This quantity of outdoor air used for make-up provides assurance that code-required ventilation requirements for the occupants will be provided and that sufficient excess airflow to maintain cleanroom pressures will be maintained.

However, the key to establishing and maintaining pressure relationships between different spaces is that the HVAC design incorporates adequate air balancing devices so that the supply airflow, exhaust airflow, and return airflow from each space can be adjusted to meet design requirements.


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