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by Abraham Marinelarena
The need for a clean environment is rooted in the control of infections in hospitals. Microbiologist and surgeons for the past hundred years have established that bacteria cause wound infections. It therefore followed that the elimination of bacteria from the hospital and, in particular, the operating room would prevent infection. This was the scientific basis for the first cleanrooms. The control of infection was approached using antiseptic techniques to clean instruments, wounds and surgeon’s hands. To prevent airborne infection the same antiseptic solution was sprayed into the air. Latter aseptic techniques such as sterilization of wound dressings and instruments and the use of surgical gloves, masks and gowns were adopted together with antiseptic techniques to further reduce infection. Although antiseptic and aseptic techniques helped to control infection, the principal omission was positive ventilation by filtered air. It was found that proper ventilation substantially reduced airborne infection of people. But, it is only towards the end of second world war that ventilation in hospitals was adopted for contamination control. The development of the first cleanrooms for industrial manufacturing started during the second world war in the United States and England in an attempt to improve the quality and reliability of instrumentation used in guns, tanks and aircraft. It was realized that the cleanliness of the production environment had to be improved or such items would malfunction. It therefore followed that airborne dispersion of large quantities of particles by machines and people had to be removed by large quantities of filtered air.
What is a Cleanroom ?
Airborne particles occur in nature as pollen, bacteria, miscellaneous living and dead organisms, windblown dust, and sea spray. Industry generates particles from combustion processes, chemical vapors, and friction in manufacturing equipment. People in the work space generate particles in the form of skin flakes, lint, cosmetics, and respiratory emissions. Today, many manufacturing processes require that spaces be designed to control particulate and microbial contamination while maintaining reasonable installation and operating costs. Federal Standard 209E defines a cleanroom as a room in which the concentration of airborne particles is controlled to specified limits. British Standard 5295 defines a cleanroom as a room with control of particulate contamination, constructed and used in such a way as to minimize the introduction, generation and retention of particles inside the room and in which the temperature, humidity, air flow patterns, air motion and pressure are controlled. The industry differentiates between the cleanliness of rooms by referring to Class Numbers. The methods most easily understood and universally applied is the one suggested by the Federal Standard
000 part/m3 350 1240 3500 12400 35000 part/ft3 9.000 100. Cardiac by-pass Systems Brewery Production.5µµ part/m3 10. Gyroscopes Lenses.5 70.5 M2 M2.1 350 991 0.14 7.209E in which the number of particles equal to or greater than 0. Miniature Bearings. The more susceptible the product is to contamination the stricter the standard.2µµ part/m3 75. Unsterilized Food and Drinks Immunodeficiency Therapy. The required standard of cleanliness of a room is dependent on the task performed in it. Isolation of Contagious Patients. Class Name S1 M1 M1.000 cleanroom limits the concentration of airborne particles equal to or greater than 0. The table below shows the relationship between Class Numbers and the volume of particles of a various sizes in a cubic foot of air.0 28. Operating Rooms Types of Cleanrooms Page 2 .0 99.9 106 309 1060 3090 10600 30900 part/ft3 0.0 175 700 1750 Table 1.000 10.5 M4 M4.75 30.5 300 875 0.00 2.5 M5 M5.283 1. Cleanroom Classifications Cleanroom Users The application of cleanrooms has increased and diversified as technology advances.00 17. Magnetic Tapes Integrated Circuits Compact Disc Players. Photographic Film. a class 100. Sterile Disposable Heart Valves.00 8.0 214 750 1240 0.5 M6 M6.5 microns to 100.0 35.3 100 353 1000 3530 10000 35300 100000 353000 1000000 3530000 1000000 part/ft3 0.1µµ inch-lb 1 10 100 1. Laser Equipment Antibiotics.0 87.000 particles in a cubic foot of air.3µµ part/m3 30.3 100 283 1000 2830 10000 28300 100000 283000 5µµ part/m3 part/ft3 247 618 2470 6180 24700 61800 7.5 microns measured in a cubic foot of air designates the class number. TV-tubes.0 265 757 2650 7570 26500 75700 part/ft3 2. The table below shows a selection of products that are now being made in cleanrooms or require contamination control facilities.4 75.83 10.9 35. For example.5 M7 0.5 M3 M3.50 21. Generic Engineering Sterile Pharmaceuticals. ELECTRONICS SEMICONDUCTORS MICROMECHANICS OPTICS BIOTECHNOLOGY PHARMACY MEDICAL DEVICES FOOD AND DRINK HOSPITALS Computers.875 3.
The high efficiency filters used in cleanrooms are installed at the point of air discharge into the room. usually horizontal or vertical at a uniform speed of between 60 to Page 3 . This additional air supply is mainly provided to dilute to an acceptable concentration the contamination produced in the room. A typical turbulent air flow cleanroom would have at least 10 air changes per hour and likely to have between 20 and 60. This is done by extracting less air from the room than is supplied to it. High efficiency filters are used to filter the supply air into a cleanroom to ensure the removal of small particles. schools. These are turbulent air flow and laminar air flow cleanrooms. The cleanroom is positively pressurized with respect to these dirtier areas. Room pressurization is mainly provided to ensure that untreated air does not pass from dirtier adjacent areas into the cleanroom. Turbulent Air Flow The general method of ventilation used in turbulent air flow cleanrooms is similar to that found in buildings such as offices. Laminar Air Flow Laminar air flow is used when low airborne concentrations of particles or bacteria are required. a cleanroom differs from an ordinary ventilated room in three ways. These are increased air supply. the use of high efficiency filters and room pressurization. malls. shops. The increased air supply is an important aspect of particle control. auditoriums. The air is supplied by an air conditioning system through diffusers in the ceiling. Figure 1 shows the typical air flow patterns in a turbulent air flow cleanroom. manufacturing plants.Cleanrooms have evolved into two major types which are differentiated by their method of ventilation. This air flow pattern is in one direction. etc. However.
Table 2 shows the relationship between cleanroom airflow requirements versus cleanroom class as specified under Federal Standard 209E. whereas the turbulent air flow ventilated system relies on mixing and dilution to remove contamination. Higher contamination concentrations will be established in the turbulent areas. and throughout the entire space. Any contaminant released into the air can therefore be immediately removed by this laminar flow of air. In an empty room with no obstructions to the airflow. contamination is removed faster by air velocities much lower than those mentioned above. it has been found that the cleanliness of a laminar air flow cleanroom is directly proportional to the air velocity. Figure 2 shows the typical air flow patterns in a laminar air flow cleanroom.90 ft/min. Particle Control Because air flow is such an important aspect of particle control. However in practical situations there are obstructions and people moving in the space. it is common for air systems to deliver considerably more air than would be needed solely to meet temperature and humidity design points. The curves show the range between idea. Page 4 . Depending on the degree of cleanliness required. The air velocity is sufficient to remove relatively large particles before they settle onto surfaces. Therefore. the design of a clean room requires careful consideration to air motion and airflow patterns. Obstructions will cause the laminar air flow to be turned into turbulent air flow around the obstructions. standard and compromised conditions. Air changes per unit of time are related to the volume of the room and are many times greater than those supplied to a turbulent air flow cleanroom.
For example. The source of the contamination is divided into external sources and internal sources. windows and cracks. . lint. cosmetics.Standard .09 1 1 10 100 1000 ROOM CLASS 10000 100000 Ideal ------------. External Sources For any given space. a decision must be made as to how critical this particulate matter is to the process or product. External contamination is brought in primarily through the air conditioning system. Room Class Airborne particles can be organic or inorganic. there exists the external influence of gross atmospheric contamination.. Internal Sources People and the production process are some of the greatest sources of internal contamination. The external contamination is controlled primarily by the type of filtration used and space pressurization. while a 1 micron particle might take 15 hours to settle. The quantity of the particles of a given size that might be present within the area must be considered. Particles of different sizes behave differently as air moves through a room.1000 AIR CHANGES PER HOUR 100 20 16.5 10 6. Most contamination control problems concern the total gross contamination within the air. a particle in the 50 micron range might take 60 seconds to settle.. . Also. People in the work space generate particles in the form of skin flakes. Before any methods of contamination control of airborne particles can be applied. and respiratory Page 5 .. in an eight foot high room. Compromised Table 2: Air Changes v. external contamination can infiltrate through building doors. These sources include air pollution in general and dust storms.
Room construction is important to provide an enclosure that will house a process to exclude outside contaminants and that the material finishes will not contribute to particle generation in the space. People must wear garments to minimize the release of particles into the space.emissions. coveralls. Filter Effectiveness The ability of a filter to remove particles from the air is reflected by its efficiency rating. and head and shoe covers are clothing accessories commonly used in clean spaces.3 to 0. usually represented as a percentage. it alone does not guarantee that cleanroom conditions will be met. gloves. Arrestance is the amount of dust removed by the filter. filters with an arrestance of 90% have little application in cleanrooms. Since large particles make up most of the weight in an air sample. doors. Construction finishes. HEPA and ULPA Filters A HEPA filter. The type of garments depend on the level of cleanliness required by a process. chemical vapors. Materials and equipment must be cleaned before entering the cleanroom. personnel and garments. but hardly any of the 0. Other sources of internal contamination is generated through the activity of manufacturing equipment.5 micron particles. Smocks. floors. a filter could remove a fairly high percentage of those particles while having no effect on the numerous small particles in the sample. Room construction and material finishes are an important part of cleanroom design. and Air Conditioning Engineers (ASHRAE) has developed a standard for measuring filter effectiveness. Refrigerating. ASHRAE efficiencies of 80% to 95% can remove 50% to 70% of the 0. materials and equipment. and windows are construction materials that must be carefully selected to meet cleanroom standards. i. Also. lighting fixtures. Room entrances such as air locks and pass-throughs are used to maintain pressure differentials and reduced contaminants. and building entrances and exits are other sources of particulate contamination that must also be controlled. A HEPA filter is rated by its efficiency in removing small particles from air and Page 6 . Efficiency measures the ability of the filter to remove the fine particles. ASHRAE efficiencies of between 10% and 40% should remove 20% to 40% of the 1 micron particles in the air. and cleaning agents. Room Construction and Operation Although airflow design is critical. The standard describes test procedures to classified filters in terms of arrestance and efficiency.3 micron particles.e. high efficiency particulate air filters is defined by its particle removal efficiency and its air flow rate. soldering fumes. The American Society of Heating. ceiling tiles. air showers are used to remove contaminants from personnel before entering the clean space. Industry generates particles from combustion processes. Thus. Walls.
that formaldehyde and other vapors given off by building materials and furniture are diluted. people. ultra low penetration air is a filter that has efficiencies higher than those of a standard HEPA filter. High efficiency filters used in cleanrooms are subjected to a DOP penetration test to determine the percentage of particles passing through the filter. and that air changes occur with sufficient frequency to minimize the chance for high concentration of airborne pollutants within the building. An agent often used to test high efficiency filters is composed of atomized droplets of hot di-octylphthalate (DOP). and lighting within the facility. Human comfort requirements typically call for temperatures in the range of 72F to 75 F.e. A ULPA filter. i.2 microns. Positive differential pressures should be maintained between the rooms to ensure air flows from the cleanest space to the least clean space. and provide personnel comfort. eliminate static electricity. This provides assurance that carbon dioxide and oxygen remain in balance.99%. Rooms in a clean facility should be maintained at static pressures higher than atmospheric to prevent infiltration by wind. These filters are constructed and will function the same way as a HEPA filters.3 microns and larger. The human comfort zone is generally in the range of 30% to 70% relative humidity. DOP has a fairly consistent average particle size of about 0. The only exception to using a positive differential pressure is when dealing with specific hazardous materials where governmental agencies require the room to be at a negative pressure. Page 7 . condensation on work surfaces. These high efficiency filters are usually designed to remove particles of 0. Pressurization A cleanroom facility may consist of multiple rooms with different requirements for contamination control. They differ in that the filter medium that is used has a higher proportion of smaller fibers and is hence more efficient.has a minimum efficiency of 99. Humidity control is necessary to prevent corrosion. Temperature control is required to provide stable conditions for materials. replace process exhaust and for building pressurization. Ventilation and Make Up Air Ventilation and makeup air volumes are dictated by the amount required to maintain indoor air quality.97%. HVAC Design Considerations Temperature and Humidity Most cleanroom require year-round cooling as a result of the fan energy associated with high cleanroom airflow as well as the heat generated by the process. instruments. An ULPA filter will have an efficiency greater than 99. since workers frequently wear cleanroom garments over street clothes. and personnel comfort.
contacted at 915/534-9110. Abraham Marinelarena is a mechanical engineer with Bath Engineering Group. provided the Owner is willing to justify the associated cost. location. The technology is readily available to design as clean a room as desired. He can be Page 8 . The design and specification of a cleanroom requires close coordination between the many departments impacted by it and the design team.Recommendations A cleanroom design requires careful consideration of its intended use. manufacturing process and of course cost. Close coordination between the Owner and its design team will guarantee the best and most cost effective results. permissible particle concentration.
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