Commercial Building Pressurization – Air Pressure
Why Building Pressurization Matters
In commercial construction, one often overlooked aspect of planning and design is keeping a building in a homeostatic state in terms to air pressurization. The reason for this is simply that, there are a lot of variables that can affect a building’s air pressure that can not be accounted for.
There exists many unaccounted for variables that affect a buildings air pressure which can cause it to function much differently than the way it was originally designed or engineered. Abnormal foot traffic patterns, causing doors to be opened more than anticipated is one of the more obvious ways. Natural degradation of building materials and/or poorly functioning HVAC systems is another; albeit this may take years to be noticible. Even something as simple as not changing air filters in the HVAC blowers can affect the pressurization of a building. In any case, the inability to create or maintain a homeostatic building pressurization can cause a multitude of issues.
Poor Building Air Pressurization = Poor Air Quality
Most buildings attempt to maintain an environment of positive air pressure. In short, this means there is greater or “higher” pressure inside the building than that of the outside atmospheric resting pressure. This serves a few basic functions. It ensures that dust, dirt and debris introduced into a building is “pushed” back out once a door or window is opened. You probably experience this when you enter a commercial building. In most commercial buildings, when the automatic door opens you typically feel a rush of air exiting the building. That air can be likened to deflating a balloon – the pressure in the balloon seeks to deflate to an area of lower pressure – so the balloon air rushes out.
This air moving into or out-of a building is due to the pressure differential. If the air pressure in the building is greater than the air pressure outdoors, it is called a “positive pressure room” or “positive air pressure building.” Conversely, if the pressure inside the building is less than the pressure outdoors, the room or building is said to have “negative pressure.” Generally it is not desirable to have negative pressure inside a building. The problem with negative pressure is that once a door or window is opened – any exterior air is permitted to enter the building. That unfiltered air brings with it pollen, dust, dirt, biological and chemical particulates, etc. These particles entering the building and affect the people working in the building and the general cleanliness of the building.
Filtration For Cleaner Air
Keeping the air fresh in a positive pressure building requires precise engineering. To keep a building pressurized requires air to be drawn into the building to create the positive pressure. Since it is not being pulled from undesirable sources like unfiltered air via doors and windows – it must be pulled from an outside source across a filtration system.
HVAC systems pull air from a fresh air duct and through various types of filters. The more fine the filter media the more force required to pull the air across it. So the more robust the HVAC system will need to be. This is like sucking a milkshake through a straw with a tiny diameter. Now, let’s imagine a person sucking the same milkshake through a very large straw. Same concept – more suction/blowing power is needed to pull more air through more filters or finer filters.
And how tight or leaky a building is will determine the amount of air per cubic foot per minute to inflate the building envelop (balloon). Some buildings require as little as 45 CFM per 1000 SqFt. Other, more drafty or leaky buildings may require up to 300 CFM. The amount of air needed to positively pressurize and maintain pressurization will initially affect the design of the building HVAC system, and after the building is completed, the energy costs. It is much better to seal up air leaks in a building than to use larger fans to ‘push’ more air into a leaky building to maintain a positive pressure.
Negative Pressure Areas
Even in the most strict of positive pressure room and building environments you will want areas of negative pressure. These include maintenance closets, bathrooms, food prep areas, areas where chemicals are used, etc. In these areas, it is important to create negative room or area pressure so the fumes exit these areas quickly. To create they localized areas of negative pressure exhaust fans can be used very effectively. Once installed they will function to relive the area of polluted air, and at the same time, allow an equal volume of clean air to constantly flow into the area.
It is important from an engineering perspective to refill the area of negative pressure with an equal volume of clean air. This air is called “make up air” – or “air that makes up for the deficit of air created by the exhaust.” The overall building HVAC system must be engineered and calibrated to account for these deliberate breeches in positive air pressurization.
Monitoring results
Because there are areas of positive and negative pressure inside a building it is not possible to measure “building pressure” at any one spot. Different rooms and areas have different pressures – some positive and some negative. It is much more important to think of local pressure. In a hospital, for example, it might be important to have negative pressure in patient’s rooms but positive pressure in lobby areas. It is critical, in fact even mandated by federal laws and local codes, to have negative pressure in areas of nuclear medicine. The system of maintaining positive and negative air pressure is a very complex process, more art than science in many cases. However, it is an important concept to understand. Just because a building “feels” like it has positive air pressure in no way means it is acting the way it should. This is where it is critical to ensure absolute certainty that a each area of a building’s air pressurization system is functioning properly. in fact, if it is not working properly – it can cost hundreds or even hundreds of thousands of dollars in operating costs, depending on the size of the building.
Simple yet effective systems exist that can either be integrated with existing building management and control systems and/or act as standalone monitoring systems for room air pressure. Some of these systems are capable of monitoring both negative and positive air pressure and in multiple rooms simultaneously. Even further, some systems allow for monitoring of temperature and humidity – both of which are complimentary variables in overall environmentally controlled rooms and especially in positive and negative air pressure rooms.
Installing many of these systems requires little or no technical experience and can be set up and running out of the box in a few minutes. The advantage of using some of the more reliable systems on the market is the ability to alerting one or more building maintenance personnel of issues before they are in a “no turning back” scenario. In such systems, authorized building personnel can receive alerts via test/SMS messaging, email alerts, and even phone calls. In essence, if there is too little pressure in a controlled environment, it means the company is spending more money in wasted energy to maintain positive pressure. If a system were put into place to monitor positive pressure, there would be no more doubt and even better – no more wasted money.
Keep this in mind next time you receive your heating and cooling bill. It may well be that lowering energy cost is a simple fix – but one you’ll be able to realize unless you are certain what your current environmental conditions are.
Preventing Mold In Hospitals
Mold in Hospitals?
Mold is a collective term which refers to fungi that grows in the form of multi-cellular thread-like structures called hyphae as opposed to fungi that exist as single cells are called yeasts. Some molds as well as yeasts cause disease or food spoilage while others are beneficial and play an important role in biodegradation or in the production of various foods, beverages, antibiotics and enzymes. Ironically, while most mold types are potentially harmful to patients, penicillin is a mold used in hospitals that is used to actually treat patients!
In a healthcare setting, it is important to prevent mold growth of any kind where possible; even the most harmless types can cause health issues for patients with serious illnesses and compromised immune systems. A patient with a compromised immune system can be especially at risk.
Although hospitals are generally considered to be clean and sterile environments, a closer look tells us there is actually a greater potential for problematic viral, fungal and bacterial threats due to the very nature of hospitals. Think of it this way, hospitals typically house patients with severe illnesses. These illnesses can be transferred to the garments, linens, walls and floors of the hospital. This is in addition to the obvious blood and other bodily fluids transferred from patient to hospital assets. Basically, there is a lot of fluids in one form or another being transferred from patients to the hospital itself. Where there are fluids, there is the potential for mold growth.
Keeping the hospital clean for patients and preventing cross-contamination is a full-time job, usually for several personnel – and can be a real challenge.
In all hospitals, heavy cleaning agents along with water as a dilutant are used to launder linens, clean surfaces and for general-purpose sanitizing. As you probably know, where there is water, there is a potential for mold growth. Additionally, some hospitals may be older structures with leaky roofs, and foundations; allowing for even greater potential for mold growth.
In any case, prevention is key. Once mold starts to grow, it can become a devastating and never-ending cycle of growth and remediation. Keeping mold growth to a minimum requires monitoring temperature and relative humidity effectively. It may also be beneficial to monitor and correct for undesirable differential air pressures in patient rooms and entire floors. A patient room with a positive air pressure will expel air along with any pollutants in the air every time the door is opened. So any mold spores quickly move in the hall ever time someone enters or leaves the room.
Sources of Mold
Mold growth can originate in places where standing water is present or in use such as bathrooms, showers, laundry areas and kitchens. Moisture, temperature and humidity are usually monitored in these locations. However, it is usually places that are not monitored effectively where mold can start growing and thrive.
Mold in ceilings
Most hospitals have drop-tile ceilings in rooms and hallways. These are usually made of mold-resistant materials and a general inspection of these tiles usually indicates a water or moisture problem because the ceiling tiles will have visible brown or discolored areas. These may appear as circular, and start from one corner or from the middle of the tile. Sources for the water leak may be the roof (if on higher floors) or from fresh water pipes, sprinkler systems or other plumbing. The problem is, by the time you can see evidence of water leaks it is too late to prevent mold growth. You are unfortunately just seeing the “tip” of the iceberg.
There are other instances where pipes may sweat because of temperature changes and relative humidity. This creates a humid environment which facilitates mold growth, even though there may be no visible sign of water leakage. HVAC and AC systems can be an especially common source for mold growth and increased relative humidity – heated air mixed with condensation; creating an environment that is relatively tropical. As a note, tropical climates are know to exponentially increase mold, bacteria and viruses.
It is advantageous and advisable for all hospitals to install temperature and relative humidity sensors in ceilings to constantly monitor humidity and temperature. Any temperature fluctuations can lead to greater condensation and relative humidity.
For many hospitals, installing a complete system would be a challenge because of having to install wire throughout a facility to a centralized location or trying to integrate it with an existing BACnet or other building management system. Fortunately, there are wireless systems that allow hospital administrators to monitor relative humidity, differential air pressure and temperature in ceilings throughout the entire hospital without construction costs. In fact, some systems even allow for automated email alerts, text/SMS alerts with automated phone calls to management personnel or maintenance staff long before a environment becomes too humid.
Can you prevent mold growth?
Mold can grow in obvious areas like hospital kitchens, bathrooms, showers, laundry, etc. Keeping these areas dry and properly ventilated is key. It requires more than just drying up the water; the room temperature may naturally increase the relative humidity – creating an environment for mold growth. An often overlooked way to combat this higher relative humidity is by using proper ventilation via exhaust systems and monitoring differential air pressure between common “wet” areas and dryer areas. Keeping a wet area under constant positive air pressure will allow the room to “push” the damper air to areas of dryer air. As the air mixes, it will become more homogeneous and stable.
If wet areas have negative air pressure, and inadequate exhaust, the air can become overly humidified and stale. The key takeaway is “Do you actually know for sure if you have adequate pressurization and ventilation between rooms?” If not, finding out the hard way can cost millions and even result in the potential loss of life.
While mold is less common in modern/new construction hospitals, it can still happen. Simple engineering and construction inconsistencies can allow for water to slowly trickle in from outdoors or allow for unwanted condensation in plumbing and HVAC systems. The problem is, no one really knows there is a problem – until there is a problem.
After all, how many hospital staff have the job description requiring them to physically inspect all plumbing, wet walls, and wet areas, ceilings, roof, etc.? Fortunately, there are automated systems that can monitor just about any area within fractions of a degree in temperature and relative humidity and provide advanced warning in the instance of environmental instability.
Note: If you are a hospital administrator and would like additional information on ways to keep mold and bacteria growth to a minimum with automated instrumentation, call (877) 241-0042 and ask for Rick Kaestner.
Air Filtration and Filtering In Cleanrooms – Part 2
Filter Media Rating
Air filters are commonly described and rated based upon their collection efficiency, pressure drop (or airflow resistance), and particulate-holding capacity. The American Society of Heating, Refrigerating, and Air Conditioning Engineers (ASHRAE) have developed standards 52.1-1992 and 52.2-1999 that classify filters in terms of “Arrestance” and “Efficiency”.
Standard 52.1-1992 measures arrestance, dust spot efficiency, and dust holding capacity. Arrestance means a filter’s ability to capture dust and describes how well an air filter removes larger particles such as dirt, lint, hair, and dust. The dust holding capacity of a filter is the amount by weight of standard dust that the filter will hold without exceeding the resistance 0.18 inch-w.c. for low-resistance filters, 0.50 inch-w.c. for medium-resistance filters and 1.0 inch-w.c. for high-resistance filters. Be aware that, arrestance values may be high; even for low-efficiency filters, and do not adequately indicate the effectiveness of certain filters for chemical or biological protection. Dust spot efficiency measures a filter’s ability to remove large particles, those that tend to soil building interiors. Dust holding capacity is a measure of the total amount of dust a filter is able to hold during a dust loading test. Dust arrestance can be expressed as
µa = 1 – Ca / Cb
Where
µa = dust arrestance
Ca = dust concentration after filter
Cb = dust concentration before filter
Since large particles make up most of the weight in an air sample, a filter could remove a fairly high percentage of those particles while having no effect on the numerous small particles in the sample. Thus, filters with an arrestance of 90 percent have little application in cleanrooms.
ASHRAE Standard 52.2-1999 measures the particle size efficiency (PSE). Efficiency measures the ability of the filter to remove the fine particles from an airstream by measuring the concentration of the material upstream and downstream of the device. If a supplier of filter only indicates efficiency as 95% or 99%, it does not really mean
anything unless it specifies the particle size range.
The ASHRAE Standard 52.2-1999 quantifies filtration efficiency in different particle size ranges and rates results as MERV (Minimum Efficiency Reporting Value) between 1 and 16. This numbering system makes it easier to evaluate and compare mechanical air filters and eliminates some of the confusion regarding the overall effectiveness of any type of a mechanical air filter on removing airborne particulates, especially those that are less than 2 microns in size. A higher MERV indicates a more efficient filter.
HEPA filters
HEPA stands for High Efficiency Particulate Air. The HEPA filters work on diffusion principle to remove particulate matter and are extremely important for maintaining contamination control. These filter particles as small as 0.3 µm (microns) with a 99.97% minimum particle-collective efficiency. This is remarkable considering that the outside air we breathe may contain up to 5 million suspended particles of dust, smog, and pollen in one cubic foot.
These filters typically use glass fiber media and are available in thicknesses of 6” and 12”. These have pressure drop of 1 inch- w.c. when clean and generally need to be replaced when the pressure drop exceeds 2 inch- w.c.
HEPA air filters are not MERV rated as they exceed the ASHRAE test protocol 52.2 used in determining the MERV ratings. In fact, HEPA air filters are the ONLY mechanical air filters that are tested and certified to meet a specific efficiency at a specific particle size. All HEPA air filters must meet a minimum efficiency of 99.97% at 0.3 microns.
ULPA filters
ULPA stands for Ultra Low Particulate Air. Growing market demand from advanced science and technology led to development of ULPA filters which provide a minimum of 99.999% efficiency (0.001% maximum penetration) on 0.3 micron particles for achieving better cleanliness classes and cleaner working environments. These are used for ultra- cleanrooms, where contamination levels have to be controlled at levels better than that which can be achieved with conventional HEPA filters.
Boron free ULPA filters of 99.9997% efficiency for particles down to 0.12 micron size for Class 10 and Class1 cleanrooms are specially used in electronic/semiconductors/ wafer manufacturing industries, where tolerance to contamination level above 0.12 micron is also very critical and not permitted.
Note that the text information for instance on the efficiency @ 99.97% and 99.997% of HEPA filters look similar but in reality the difference is not insignificant. A 99.97% efficient filter has a fractional penetration of 0.0003; while a 99.99% filter’s fractional penetration is 0.0001. This means that a 99.99% filter is three times more efficient in removing 0.3-micron particles.
Filter Testing
The efficiency of filter is of paramount importance and must be measured in an appropriate way. Typically the filters are shop tested and only provide the quality certification for required efficiency to the end user. But following installation, a check of the filter seals is recommended on a ninety-day basis, with a complete scan of the filters two times a year. There are five fundamentally different methods used to evaluate efficiency: (1) The Particle Count Method; (2) The Weight Method; (3) The Atmospheric Dust Spot Efficiency Method; (4) The Cold DOP Method and (5) The Hot DOP Method.
1) The Particle Count Method: In this method, actual particle count per unit volume of air is determined through microscopic analysis of the air sample. This procedure is extremely tedious and is susceptible to human error. The dust concentration must be quite low (or the sampling time must be unreasonably short) because the sample cannot be allowed to become too dense to count.
2) The Weight Method: The weight method indicates the weight of the dust removed by the filter as a percentage of the weight of dust in the air before filtering. The Weight Arrestance Test is a simple test which involves feeding a synthetic dust to a filter and rationing the weight of dust exiting the filter to the weight of dust originally fed into the filter. This method is very popular and easy to use. However, it has some shortcomings because weight measurements give predominantly the weight of the largest particles in the sample. Since small particles have little mass, this method offers almost no way of factoring small particle collection efficiency. Implications of the weight method are very important. Most, perhaps all, impingement-type filter manufacturers claim more than 80% efficiency for their products. They may be right, but only from one point of view. If the weight of the particulate matter collected by their filters is compared with the total weight of the particle samples from unfiltered air, they honestly obtain 80% efficiency or more by weight. Perhaps the filter traps only the 300 largest of the 300,000 particles actually in the air, but these 300 captured particles weigh enough to account for 80% of the total weight.
3) The Atmospheric Dust Spot Efficiency Method: Where small-particle efficiency is critical, the Dust Spot Test is often used. Here standard ambient air is passed through the test filter and the airstream has special test filters in front of and behind the test filter to monitor the presence of airborne particulate. Over time, both filters become soiled and are measured optically for relative soiling. These results are then translated into a filter efficiency rating. The justification for using such a test is that it is based on one of the observable effects of air pollution-the soiling effect. One drawback to the Dust Spot Test is that it uses atmospheric air. Because this air changes constantly, it is difficult to obtain repeatability for verification. As a result, many tests have to be run and the data averaged.
4) The Cold DOP Test: To overcome the drawback of the Dust Spot Test, the Cold DOP (Di-octyl Phthalate) test can be used. Cold DOP generators produce aerosol at room temperature, with particles ranging in size from 0.2 to 1.2 microns and with a mean diameter of 0.7 micron. The aerosol is introduced to the unit being tested and light scattering, due to particle concentration, is measured at the inlet and outlet of the unit. Because light scattering varies in direct proportion to particle concentration, the collecting efficiency of the unit can be expressed as a function of the difference in light scattering measured at the inlet and outlet at any given time.
5) The Hot DOP Test: In this test, DOP is evaporated by heat and condensed to form 0.3 micron particles with very little variation in size. This particle size is the most difficult for all kinds of air cleaners to collect and will normally produce a slightly lower efficiency on all kinds of air cleaning devices than the Cold DOP Method.
HEPA filters are tested using Hot DOP method. Here DOP is boiled and the vapor injected into the airstream in front of the test filter. As the vapor condenses back to ambient temperature, it forms very uniform droplets about 0.3 micron in diameter. By the use of light scattering instrumentation, upstream and downstream particle concentrations can be measured. In essence, if 10,000 .3 micron sized particles are blown into a HEPA air
filter, only 3 particles are allowed to pass through. Thus, you get the 99.97% at .3 micron rating. If you were to use the HEPA test on a 95% ASHRAE air filter they would be about 50% efficient on .3 micron sized particles once they loaded up with dust. So, HEPA air filters are at least 50% more effective at removing respirable sized airborne particles than any of the ASHRAE air filters on the market.
Installing HEPA/ULPA filters directly in the ceiling of the cleanroom is driven by the desire to minimize, if not eliminate, dust-collecting surfaces, such as the inside of ductwork, between the downstream face of the filter and the cleanroom. Remote mounting of HEPA filters is common in Less Stringent applications since the number of particles that can be contributed by ductwork downstream of the HEPA filters is small as a proportion of the amount that can be tolerated. An exception would be where a standard air– conditioning system with no cleanliness classification is being upgraded to support a cleanroom intended to carry a cleanliness rating per Federal Standard 209 or ISO Standard 14644. In that case, all ductwork downstream of the filter should be thoroughly cleaned.
The average HEPA filter, properly installed, and with frequent changes of the prefilter, should last from five to eight years. There are always unusual cases: filter used to capture hazardous particles or pathogenic organisms should, of course, be changed when they become unsafe for use. Otherwise, the resistance of the filter as indicated on a monometer or the air flow measured with a velometer is indications of need for a change.
Air Filtration and Filtering In Cleanrooms – Part 1
HVAC SYSTEM DESIGN FOR CLEAN FACILITY
HVAC systems in cleanrooms are dramatically different from their counterparts in commercial buildings in terms of equipment design, system requirements, reliability, size and scale.
What differentiates cleanroom HVAC from conventional systems?
Cleanroom design encompasses much more than conventional temperature and humidity control. Typical office building air contains from 500,000 to 1,000,000 particles (0.5 microns or larger) per cubic foot of air. A Class 100 cleanroom is designed to never allow more than 100 particles (0.5 microns or larger) per cubic foot of air. Class 1000 and Class 10,000 cleanrooms are designed to limit particles to 1000 and 10,000 respectively. Reducing the number of particles present in a cleanroom to meet one of these classes can be very complicated. Conditioning air for a cleanroom differs from a normal comfort air conditioned space , in the following ways.
1. Increased Air Supply: Whereas comfort air conditioning would require about 2-10 air changes/hr, a typical cleanroom would typically require 20 – 60 air changes and could be as high as 600 for absolute cleanliness. The large air supply is mainly 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 99.97% down to 0.3 microns is another distinguishing feature of cleanrooms. The HEPA filters for stringent cleanrooms are normally located at the terminal end and in most cases provide 100% ceiling coverage.
3. Room pressurization: The cleanroom is positively pressurized (to 0.05 in-wc) with respect to the adjacent areas. This is done by supplying more air and extracting less air from the room than is supplied to it.
There is much more into the design of cleanrooms in terms of details of technology of equipment, the type of filtration, efficiency, airflow distribution, amount of pressurization, redundancy, noise issues, energy conservation etc…etc…
FILTRATION SYSTEM
Any air introduced in the controlled zone needs to be filtered. Air filtration involves the separation of “particles” from airstreams. Their removal method is almost as diverse as the size ranges of the particulates generated. Understanding separation techniques requires an exact definition of what particles are. As particles become very small, they cease to behave so much like particles as they do gas phase molecules. It is difficult to tell whether such small particles are actually suspended in air (particles) or diffused throughout it (gas or vapor). The bottom boundary where particles act as true particles is about 0.01 micron. The normal theory of separation does not apply to particles below this size and removing them from air requires techniques reserved for gaseous materials. Particles above 0.01 micron are usually considered to be filterable.
All air entering a cleanroom must be treated by one or more filters. High-efficiency particulate air (HEPA) and ultra-low penetration air (ULPA) filters are the most common filters used in cleanroom applications.
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.
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.
Air enters the filter through the upstream side. It flows through the filter, contaminants are taken out of the air, and the ‘clean’ air exits through the downstream side. How
‘clean’ the air is on the downstream side depends on the efficiency of the filter.
Filtration Principles
Filtration of particles relies on four main principles: (1) inertial impaction, (2) interception, (3) diffusion, and (4) electrostatic attraction. The first three of these mechanisms apply mainly to mechanical filters and are influenced by particle size.
1) Impaction occurs when a particle traveling in the air stream deviates from the air stream (due to particle inertia) and collides with a fiber. Generally impaction filters can only satisfactorily collect particles above 10 microns in size and therefore are used only as pre-filters in multi-stage filtration systems. The higher the velocity of air stream, the greater is the energy imparted to the particles and greater is the effectiveness of the principle of impaction.
2) Interception occurs when a large particle, because of its size, collides with a fiber in the filter that the air stream is passing through. In this method, particles are small enough to follow the air stream. The particles come in contact with the fibers and remain “stuck” to the fibers because of a weak molecular connection known as ‘Van- der-Waals’ Forces.
3) Diffusion occurs when the random (Brownian) motion of a particle causes that particle to contact a fiber. Diffusion works with very small particles and works in HEPA and ULPA filters. The particles are so small that they move in a random motion causing the particle to acquire a vibration mode. Because of this vibration mode, the particles have a good chance of coming in contact with the fibers. The smaller the particle, the stronger this effect is. For large particles, over one micron in diameter, this filtration mechanism has virtually no effect.
In the order list above, the most critical areas lie between interception and diffusion. Impaction and interception are the dominant collection mechanisms for particles larger than 1 µm, and diffusion is dominant for particles smaller than 1 µm.
4) Electrostatic attraction, the fourth mechanism, plays a very minor role in mechanical filtration. If a charged particle passes through an electrostatic field, it is attracted to an oppositely charged body. Such charges can be generated and imparted to particles in an airstream in much the same way as static charges develop during the combing of one’s hair or just walking across a rug.
The typical electrostatic air filter is made from polyester or polypropylene strands that are supposedly charged as the air passes through them. Whether particle charges are induced by applying energy to a dirty airstream or occur naturally, they can be valuable tools in increasing air cleaning effectiveness.
Air Filtration and Filtering In Cleanrooms – Part 3
Terminal Filters
These filters are available in two types of constructions: (1) Box type and (2) Flanged type.
1) Box type filters are more suitable for housing within the ceiling slab cutout where removal of filter is from above. Whenever filter removal is not from above e.g. in case of filter being mounted in false ceiling, flanged type of filters is used.
2) With flanged type of filters, additional housing is required to facilitate the mounting of filters and transfer the load to false ceiling members. These housings can also be provided with an alternate arrangement to transfer the filter load to ceiling slab.
Aluminum / stainless steel slotted type protective grilles can be provided under the terminal filters. The housing and grilles should be epoxy/stove enamel painted.
Pre-filters to HEPA Filters
In order to prolong the service life of HEPA filters, pre-filters are recommended to filter out majority of particles above 1 micron. Pre-filters are normally mounted in a separate plenum with an access door after supply air fan discharge at an appropriate location. Normally flanged filters are used for mounting in such plenums.
It should be convenient to clean and replace these filters without disturbing the rest of the filtration system.
Pre-filters are available in various sizes with 6” and 12” thickness and with pressure drop in the range of 0.2” to 0.25” w.c. However, dust holding capacity of these filters is poor. For applications which require a filtration system with good dust holding capacity, bag type filters with fiberglass scrim cloth media are recommended. These can have efficiencies from 85% (down to 20 microns) to 99.97% (down to 5 microns).
For years, a value of 90 fpm (0.46 m/s) ±20% has been used to specify the airflow in the cleanest of cleanrooms. The primary objective is to maintain airflow in parallel flow streams that has two purposes: first, it needs to dilute particle concentrations that may have formed in the room due to personnel or process activity and second, to carry away particles or contaminants generated within the room. Although, higher air velocity is advantageous in particle removal/settlement, this will also result in over sizing of equipment that may be very energy inefficient, leading to higher energy costs.
Set velocity of 90 FPM! Is it Mandatory Requirement?
There is nothing called set velocity; the 90 fpm velocity is just a widely accepted practice. There is no scientific or statutory basis for this guideline. The figure 90 fpm velocity is purely derived from past practices over two decades and has become a common industry practice. In recent years, companies have experimented with lower velocities and have found that airflow velocity specifications ranging from 70 to 100 fpm (0.35 to 0.51 m/s) ± 20% could be successful, depending on the activities and equipment within the room. For example, in an empty room with no obstructions to the airflow, even the air velocities @70 FPM should remove contamination effectively. There is no single value of average velocity or air change rate accepted by the industry for a given clean-room classification. In general, the higher values are used in rooms with a greater level of personnel activity or particle-generating process equipment. The lower value is used in rooms with fewer, more sedentary, personnel and/or equipment with less particle-generating potential.
Airflow based on Air change rate (ACR)
Air change rate is a measure of how quickly the air in an interior space is replaced by outside (or conditioned) air. For example, if the amount of air that enters and exits in one hour equals the total volume of the cleanroom, the space is said to undergo one air change per hour. In addition to air change rate, air flow rate is measured in appropriate units such as cubic feet per minute (CFM) and can be calculated with this formula;
Air flow rate = Air changes x Volume of space/ 60
Air change rate is an indication of the air-tightness of a room, but it is difficult to pin down because it depends significantly on how the room is used, as well as the wind and temperature differentials experienced during the year. Even if the rate were determined with great precision with a blower-door test, there is no assurance the resultant value would apply under different conditions. The air change per hour criterion is most commonly used in cleanrooms of less stringent cleanliness. Intermediate cleanrooms are usually designed with hourly air change rates between 20 and 100, while less stringent cleanrooms have hourly air change rates up to 15. The designer selects a value based on his experience and understanding of the particle-generating potential of the process. This is a highly subjective process, which better than nothing, is not very scientific.
Higher ACR equate to higher airflows and more energy use. In most cleanrooms, human occupants are the primary source of contamination. Once a cleanroom is vacated, lower air changes per hour to maintain cleanliness are possible allowing for setback of the air handling systems. Variable speed drives (VSD) should be used on all recirculation air systems allowing for air flow adjustments to optimize airflow and/or account for filter loading. Where VSD are not already present, they can be added and provide excellent payback if coupled with modest turndowns. The benefits of optimized airflow rates are
1) Reduced Capital Costs – Lower air change rates result in smaller fans, which reduce both the initial investment from construction cost. A 20 percent decrease in ACR will result in close to a 50 percent reduction in fan size.
2) Reduced Energy Consumption – The energy savings opportunities are comparable to the potential fan size reductions. According to the fan affinity laws, the fan power is proportional to the cube of air changes rates or airflow. A reduction in the air change rate by 30% results in a power reduction of approximately 66%. A 50 percent reduction in flow will result in a reduction of power by approximately a factor of eight or 87.5 percent.
Designing a flexible system with variable air flow can achieve the objectives of optimized airflow rates. Existing systems should be adjusted to run at the lower end of the recommend ACR range through careful monitoring of impact on the cleanroom process (es).
Criteria for Selecting Citations and Studies for This Review:
Articles dealing with outbreaks of infection due to environmental opportunistic microorganisms and epidemiological- or laboratory experimental studies were reviewed. Current editions of guidelines and standards from organizations (i.e., American Institute of Architects [AIA], Association for the Advancement of Medical Instrumentation [AAMI], and American Society of Heating, Refrigeration, and Air-Conditioning Engineers [ASHRAE]) were consulted. Relevant regulations from federal agencies (i.e., U.S. Food and Drug Administration [FDA]; U.S. Department of Labor, Occupational Safety and Health Administration [OSHA]; U.S. Environmental Protection Agency [EPA]; and U.S. Department of Justice) were reviewed. Some topics did not have well-designed, prospective studies nor reports of outbreak investigations. Expert opinions and experience were consulted in these instances.
Negative Pressure Rooms
Negative Pressure Rooms: Protecting People
Negative Pressure Rooms are used primarily in hospitals and bio-tech facilities to ensure staff and patients are safe from cross contamination from airborne disease and other potentially dangerous contaminants. Negative Pressure Rooms are very different from standard cleanrooms whereas standard cleanrooms are designed to push air out when an air lock is opened, or have “positive pressure” at all times.
In a hospital setting, certain populations are more vulnerable to airborne infections including immune-compromised patients, newborns and elderly people. Of course, hospital personnel and visitors can also be exposed to airborne infections as well.
A negative pressure room in a hospital is used to contain airborne contaminants within the room. Harmful airborne pathogens include bacteria, viruses, fungi, yeasts, molds, pollens, gases, VOC’s (volatile organic compounds), small particles and chemicals. This is just part of a much larger list of airborne pathogens present in a hospital or laboratory environment.
Rooms that should be negatively pressurized according to The 2014 FGI Guidelines/Standard 170-2013 include:
- ER waiting rooms
- Radiology waiting rooms
- Triage
- Restrooms
- Airborne infection isolation (AII) rooms
- Darkrooms
- Cytology, glass washing, histology, microbiology, nuclear medicine, pathology, and sterilizing laboratories
- Autopsy rooms
- Soiled workrooms or holding rooms
- Soiled or decontamination room for central medical and surgical supply
- Soiled linen and trash chute rooms
- Janitors’ closets
A negative pressure isolation room is commonly used for patients with airborne infections. For example, a patient with active/live tuberculosis, a disease caused by the bacteria Mycobacterium tuberculosis, will be placed in a negatively pressurized room because the tuberculosis bacterium is spread in the air from one person to another.
Using a negative pressure room can better contain the bacterium within the room.
Negative Pressure Room Basics
In a Negative Pressure Room, once an airlock is opened, air is only permitted to enter the room so any contaminants in the room can not escape. Constant vacuum pressurization inside a Negative Pressure Room allows it to maintain the suction at a specific pressure rating; thereby protecting anyone outside of the room from contaminants that could escape from inside the room.
Negative Pressure Rooms are nothing new. In fact a typical bathroom with a closed door and exhaust fan running is a type of Negative Pressure Room. In hospitals, however, the setup is much more complex and much, much cleaner. In hospitals, negative pressure is maintained by balancing the room’s ventilation system so more air is mechanically exhausted from a room than is supplied by the exterior/surrounding building HVAC system. When constructed correctly, this creates a ventilation imbalance, which the room ventilation compensates for by continually drawing air in from outside the room.
In a well-designed negative pressure room, this air is pulled in under the door through a gap. This gap is typically about half an inch high. Other than this single gap, the room is almost always air tight to prevent air from being pulled in through undesired cracks and gaps, i.e. around windows, light fixtures and electrical outlets. Leakage from these areas can compromise (or eliminate) room negative pressure, even if the system is balanced to achieve it. Think of these as small holes in the hull of a boat; eventually it will matter, even if the largest of them is plugged.
Overall, the minimum pressure difference necessary to achieve and maintain negative pressure that will result in air flow into the room is actually very small (0.001 inch of water gauge/ “w.c.). The actual level of negative pressure differential will depend on the difference in the ventilation exhaust and supply flows and the physical configuration of the room.
If a room is well sealed, negative pressures greater than the minimum of 0.001 inch of water are easily accomplished. However, if rooms are not well sealed, as typical with many facilities (especially older buildings with retro-fitted negative pressure rooms), achieving higher negative pressures may require exhaust/supply flow differentials beyond the standard ventilation system’s capacity. In these instances, contractors may have a custom Heating, Ventilation, Air Conditioning (HVAC)/air handler system designed to accomplish the desired result using multiple standard air handlers and filtration systems.
To establish negative pressure in a room that has a normally functioning ventilation system, the room supply and exhaust air flows are first balanced to achieve an exhaust flow of either 10% or 50 cubic feet per minute (cfm) greater than the supply (whichever is greatest). In 90% of cases, this specification should achieve a negative pressure of at least 0.001 inch of water. If the minimum 0.001 inch of water is not achieved and cannot be achieved by increasing the flow differential (within the limits of the ventilation system), the room most likely has some form of leakage (e.g. through doors, around windows, plumbing and equipment wall penetrations), and action should be taken to inspect and seal the leaks. Finding these leaks is accomplished using a simple smoke test (see below) in the room.
Negative pressure in a room can be altered by changing the ventilation system operation or by the opening and closing of the room’s doors, corridor doors or windows. Some rooms are outfitted with special plenums that can be electronically opened and closed based on digitally-acquired feedback systems that monitor the rooms environmental conditions.
What is a smoke test?
A smoke test is a simple procedure to determine whether a room is under negative pressure. The smoke tube is held near the bottom of the negative pressure room door and approximately 2 inches in front of the door. The tester generates a small amount of smoke by gently squeezing the bulb. The smoke tube is held parallel to the door, and the smoke is exhausted from the tube slowly to ensure the velocity of the smoke from the tube does not overpower the air velocity. If the room is under negative pressure, the smoke will travel under the door and into the room. If the room is not under negative pressure, the smoke will be blown outward or remain stationary.
Monitoring Negative Pressure Rooms
As important as maintaining negative rooms pressure, is continuously monitoring the systems which enable it. Without constant monitoring and validation, there is no immediate or physical way to verify proper room negative pressure levels. Even the slightest variations in air flow and variables that may affect it can severely disrupt proper pressurization, and potentially endanger staff, room personnel, and other innocent populations. A complete solution for monitoring negative room pressure would include functionality that would allow operators to quickly glance at a color display that reported both current room variables as well as historic room variables. These are sometimes referred to as “data loggers.” Additional features would include immediate reporting of room conditions such as temperature, relative humidity (RH) and room pressure.
If levels fall below or rise below specified values, becoming ‘unsafe’, a room alarm would notify personnel. Additional warnings would include a way to receive SMS/text alerts, email warnings and automated phone alerts to parties involved directly with the compliance and daily operation of the negative pressure room.
Clean Room Design: Pharmaceutical
Cleanrooms: Determining the scope
Most cleanrooms utilized for pharmaceutical use a class range to express cleanliness, Class 100 to Class 100,000. Cleanliness class is determined by particulate counts using a particle counter. Some areas without an official cleanliness classification are considered “controlled environments.”
In essence, a cleanroom is much like any other room; except that instead of containing typical levels of pollutants and contaminants, it is void of damaging particles, bacteria and molds. A few basic modifications could essentially convert any interior room in an office or commercial property into a cleanroom facility. The level of cleanliness determines the classification; which is determined by a international standards organization (ISO) level or United States Pharmacopeia (
Maintaining cleanliness
Maintaining cleanliness in cleanrooms or controlled environments is dependent on several factors. These include filtration, air exchange rate, pressurization, temperature control and humidity control. While controlling these variables is important, it is equally important to consistently monitor these conditions. Without continuous monitoring it is impossible to determine whether a cleanroom maintains its class level.
Filtration – See separate posts on filtration.
Air exchange rate – The air change rate, or rate by which the air in the room is completely recycled is controlled by the custom Heating ventilation air conditioning (HVAC) system. Specially designed air handlers move air, calculated in Cubic Feet per Minute (CFM), at a rate that completely “changes” the room air within a specified period of time – typically measured in minutes. This is quite different than ordinary rooms which may completely recycle the air in several hours.
Another point of consideration in both pharmaceutical cleanrooms and bio-tech cleanrooms is the air flow pattern. Non-unidirectional flow cleanrooms rely on air dilution as will as a general ceiling to floor airflow pattern to continuously remove contaminants generated within the room. Unidirectional flow is more effective in continuously sweeping particles from the air due to the piston effect created by the uniform air velocity.
The desired air change rate is determined based on the cleanliness class of the room and the type of operations to be performed in the room. An air change rate of 10-25 per hour is common for a large, low density Class 100,000 (M6.5) cleanroom whereas a class 10,000 (M5.5) cleanroom typically requires 40-60 air changes per hour.
In unidirectional flow cleanrooms, the air change rate is generally not used as the measure of airflow but rather the average cleanroom air velocity is the specified criterion. The average velocity in a typical Class 100 (M3.5) cleanroom will be 70-90 feet per minute, with a tolerance of ±20% of design airflow being acceptable.
Pressurization – A pressure differential should be maintained between adjacent areas, with the cleaner area having the higher pressure. This will prevent infiltration of external contamination through leaks and during the opening and closing of personnel doors. A minimum over-pressure between clean areas of 5 Pa (.02 inches of water column (in. W.C.”)) is recommended.
The pressure difference between a clean area and adjacent unclean area should be 12-14 Pa (.05 in. W. C.). Where several cleanrooms of different levels of cleanliness are joined as one complex, a positive pressure hierarchy of cleanliness levels should be maintained, including airlocks and gowning rooms, so that a greater pressure differential is maintained between rooms adjacent ambient air Note that for certain process it may be desirable to have a negative pressure relative to surrounding ambient in one or more rooms when containment of the area outside the cleanroom is a major concern. A “room-with-in-a-room” may have to be designed to achieve this negative pressure yet still meet the needs of clean operation.
Temperature – Where occupant comfort is the main concern a temperature of 68-70 F+- 2 F will usually provide a comfortable environment for people wearing a typical lab coat. Where a full “bunny suit” or protective attire is to be worn room temperature as low as 66 F may be required. If the temperature is to be controlled in response to process concerns the value and tolerance should be specified early in the design phase to insure that budgeting is accurate.
Humidity – Humidity requirements for comfort are in the range of 30-60%RH. If process concerns suggest another value it should be specified as soon as possible in the design process. Bio-pharmaceutical materials sensitive to humidity variations or excessively high or low values may require stringent controls.
Airlocks/AnteRoom – This is a room between the cleanroom and an un-rated or less clean area surrounding the cleanroom or between two rooms of differing cleanliness class. The purpose of the room is to maintain pressurization differentials between spaces of different cleanliness class. An airlock can serve as a gowning area. Certain airlocks may be designated as an equipment or material airlock and provide a space to remove packaging materials and/or clean equipment or materials before they are introduced into the cleanroom. Interlocks are recommended for airlock door sets to prevent opening of both doors simultaneously.
Other considerations
Designing a pharmaceutical cleanroom requires strategic planning and consideration. Keeping the controlled environment clean and free from contaminants and particles can be critical; equally important is ensuring a well-thought layout of the room, safety training for workers utilizing the room and monitoring equipment to ensure all room controls are working within industry specifications.
Typically, a cleanroom will have a separate HVAC monitoring system that is tied in to the building management/control system such as BACnet. To monitor humidity, temperature and room pressure, a independent room variable monitor is best practice. Independent instrumentation ensures a fail-safe measure to indicate room variables to workers outside of the equipment warning/monitoring system.
A complete monitoring solution would ideally include a large, well-lit color display that indicated current room condition variables such as room pressure, temperature and relative humidity. If these variables or environmental conditions were out of scope, a room alert/alarm would sound. More robust models would also have available functionality that would alert management staff and personnel via text/SMS, email and automated phone alerts.
Advanced models would also have options for cloud-based connectivity and controls. No matter which solution you choose, it is apparent designing a cleanroom for pharmaceutical use is complex, and involves precise instrumentation, expert contractors and lots of planning. Ultimately, the design and functionality will be based on what operations will take place; however, there are some standards that are common across the board; such as ensuring compliance with industry ISO and USP classifications. Always make sure you use a reputable contractor, and ensure you are using a monitoring solution in the room that is independent of the standard control devices; this will protect you, your company and employees and especially your end-consumers from any potential contamination.