CLEANROOM GUIDELINES

by Abraham Marinelarena

Brief History
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

Class Name S1 M1 M1.5 M4 M4. Isolation of Contagious Patients.000 100. TV-tubes. Laser Equipment Antibiotics.5 M7 0.83 10.3µµ part/m3 30. ELECTRONICS SEMICONDUCTORS MICROMECHANICS OPTICS BIOTECHNOLOGY PHARMACY MEDICAL DEVICES FOOD AND DRINK HOSPITALS Computers.0 214 750 1240 0.00 2.00 8.5 microns measured in a cubic foot of air designates the class number.5 M2 M2.5 M5 M5.9 35.0 28. The more susceptible the product is to contamination the stricter the standard.5µµ part/m3 10.000 cleanroom limits the concentration of airborne particles equal to or greater than 0.0 35. Photographic Film. Generic Engineering Sterile Pharmaceuticals.875 3. The table below shows a selection of products that are now being made in cleanrooms or require contamination control facilities. Unsterilized Food and Drinks Immunodeficiency Therapy.5 M6 M6. Magnetic Tapes Integrated Circuits Compact Disc Players. For example.4 75. Gyroscopes Lenses. a class 100. Miniature Bearings.14 7.1 350 991 0.50 21. Cleanroom Classifications Cleanroom Users The application of cleanrooms has increased and diversified as technology advances.283 1.3 100 283 1000 2830 10000 28300 100000 283000 5µµ part/m3 part/ft3 247 618 2470 6180 24700 61800 7.209E in which the number of 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.75 30.0 87.1µµ inch-lb 1 10 100 1.3 100 353 1000 3530 10000 35300 100000 353000 1000000 3530000 1000000 part/ft3 0.0 175 700 1750 Table 1. The required standard of cleanliness of a room is dependent on the task performed in it.000 particles in a cubic foot of air.9 106 309 1060 3090 10600 30900 part/ft3 0.0 99.000 part/m3 350 1240 3500 12400 35000 part/ft3 9.0 265 757 2650 7570 26500 75700 part/ft3 2.5 70.00 17. Operating Rooms Types of Cleanrooms Page 2 .000 10.5 300 875 0.2µµ part/m3 75.5 microns to 100. Sterile Disposable Heart Valves.5 M3 M3. Cardiac by-pass Systems Brewery Production.

The high efficiency filters used in cleanrooms are installed at the point of air discharge into the room. etc. shops. However. These are increased air supply. malls. This is done by extracting less air from the room than is supplied to it. This additional air supply is mainly provided to dilute to an acceptable concentration the contamination produced in the room. These are turbulent air flow and laminar air flow cleanrooms. Room pressurization is mainly provided to ensure that untreated air does not pass from dirtier adjacent areas into the cleanroom. Laminar Air Flow Laminar air flow is used when low airborne concentrations of particles or bacteria are required. This air flow pattern is in one direction. usually horizontal or vertical at a uniform speed of between 60 to Page 3 . a cleanroom differs from an ordinary ventilated room in three ways. Figure 1 shows the typical air flow patterns in a turbulent air flow cleanroom. manufacturing plants. The air is supplied by an air conditioning system through diffusers in the ceiling. auditoriums. High efficiency filters are used to filter the supply air into a cleanroom to ensure the removal of small particles. schools. The cleanroom is positively pressurized with respect to these dirtier areas.Cleanrooms have evolved into two major types which are differentiated by their method of ventilation. Turbulent Air Flow The general method of ventilation used in turbulent air flow cleanrooms is similar to that found in buildings such as offices. A typical turbulent air flow cleanroom would have at least 10 air changes per hour and likely to have between 20 and 60. The increased air supply is an important aspect of particle control. the use of high efficiency filters and room pressurization.

the design of a clean room requires careful consideration to air motion and airflow patterns. Therefore. and throughout the entire space. In an empty room with no obstructions to the airflow. The curves show the range between idea. 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. Depending on the degree of cleanliness required. Particle Control Because air flow is such an important aspect of particle control. it has been found that the cleanliness of a laminar air flow cleanroom is directly proportional to the air velocity. Page 4 . Higher contamination concentrations will be established in the turbulent areas. Obstructions will cause the laminar air flow to be turned into turbulent air flow around the obstructions. Any contaminant released into the air can therefore be immediately removed by this laminar flow of air. Figure 2 shows the typical air flow patterns in a laminar air flow cleanroom. standard and compromised conditions. Table 2 shows the relationship between cleanroom airflow requirements versus cleanroom class as specified under Federal Standard 209E.90 ft/min. The air velocity is sufficient to remove relatively large particles before they settle onto surfaces. it is common for air systems to deliver considerably more air than would be needed solely to meet temperature and humidity design points. However in practical situations there are obstructions and people moving in the space. whereas the turbulent air flow ventilated system relies on mixing and dilution to remove contamination. contamination is removed faster by air velocities much lower than those mentioned above.

. Internal Sources People and the production process are some of the greatest sources of internal contamination. Before any methods of contamination control of airborne particles can be applied. external contamination can infiltrate through building doors. External contamination is brought in primarily through the air conditioning system. The source of the contamination is divided into external sources and internal sources. External Sources For any given space. Particles of different sizes behave differently as air moves through a room.. For example.1000 AIR CHANGES PER HOUR 100 20 16.Standard . lint. The external contamination is controlled primarily by the type of filtration used and space pressurization.5 10 6. windows and cracks. and respiratory Page 5 .. Room Class Airborne particles can be organic or inorganic. Most contamination control problems concern the total gross contamination within the air. Compromised Table 2: Air Changes v. . a particle in the 50 micron range might take 60 seconds to settle. a decision must be made as to how critical this particulate matter is to the process or product.09 1 1 10 100 1000 ROOM CLASS 10000 100000 Ideal ------------. cosmetics. there exists the external influence of gross atmospheric contamination. The quantity of the particles of a given size that might be present within the area must be considered. People in the work space generate particles in the form of skin flakes. These sources include air pollution in general and dust storms. while a 1 micron particle might take 15 hours to settle. Also.. in an eight foot high room.

People must wear garments to minimize the release of particles into the space. The American Society of Heating. high efficiency particulate air filters is defined by its particle removal efficiency and its air flow rate. Efficiency measures the ability of the filter to remove the fine particles. Smocks. a filter could remove a fairly high percentage of those particles while having no effect on the numerous small particles in the sample. materials and equipment. coveralls.3 micron particles. Room Construction and Operation Although airflow design is critical. floors. i.3 to 0. 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. ASHRAE efficiencies of between 10% and 40% should remove 20% to 40% of the 1 micron particles in the air. Other sources of internal contamination is generated through the activity of manufacturing equipment. and windows are construction materials that must be carefully selected to meet cleanroom standards. Room entrances such as air locks and pass-throughs are used to maintain pressure differentials and reduced contaminants.5 micron particles. Arrestance is the amount of dust removed by the filter. Walls. Refrigerating. The standard describes test procedures to classified filters in terms of arrestance and efficiency. The type of garments depend on the level of cleanliness required by a process. Industry generates particles from combustion processes. chemical vapors. ASHRAE efficiencies of 80% to 95% can remove 50% to 70% of the 0. Since large particles make up most of the weight in an air sample.e. lighting fixtures. Construction finishes. HEPA and ULPA Filters A HEPA filter. usually represented as a percentage. and building entrances and exits are other sources of particulate contamination that must also be controlled. ceiling tiles.emissions. personnel and garments. Room construction and material finishes are an important part of cleanroom design. Filter Effectiveness The ability of a filter to remove particles from the air is reflected by its efficiency rating. A HEPA filter is rated by its efficiency in removing small particles from air and Page 6 . Also. but hardly any of the 0. and Air Conditioning Engineers (ASHRAE) has developed a standard for measuring filter effectiveness. doors. Thus. and cleaning agents. air showers are used to remove contaminants from personnel before entering the clean space. it alone does not guarantee that cleanroom conditions will be met. and head and shoe covers are clothing accessories commonly used in clean spaces. Materials and equipment must be cleaned before entering the cleanroom. filters with an arrestance of 90% have little application in cleanrooms. gloves. soldering fumes.

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. i.97%. Human comfort requirements typically call for temperatures in the range of 72F to 75 F. Page 7 . Temperature control is required to provide stable conditions for materials. Rooms in a clean facility should be maintained at static pressures higher than atmospheric to prevent infiltration by wind. instruments. An ULPA filter will have an efficiency greater than 99. A ULPA filter. The human comfort zone is generally in the range of 30% to 70% relative humidity. Ventilation and Make Up Air Ventilation and makeup air volumes are dictated by the amount required to maintain indoor air quality. Positive differential pressures should be maintained between the rooms to ensure air flows from the cleanest space to the least clean space.has a minimum efficiency of 99. people. ultra low penetration air is a filter that has efficiencies higher than those of a standard HEPA filter. These filters are constructed and will function the same way as a HEPA filters. Pressurization A cleanroom facility may consist of multiple rooms with different requirements for contamination control. replace process exhaust and for building pressurization. These high efficiency filters are usually designed to remove particles of 0. and provide personnel comfort.3 microns and larger.e. This provides assurance that carbon dioxide and oxygen remain in balance. Humidity control is necessary to prevent corrosion. An agent often used to test high efficiency filters is composed of atomized droplets of hot di-octylphthalate (DOP). condensation on work surfaces. and that air changes occur with sufficient frequency to minimize the chance for high concentration of airborne pollutants within the building. and lighting within the facility.99%. They differ in that the filter medium that is used has a higher proportion of smaller fibers and is hence more efficient.2 microns. 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. eliminate static electricity. since workers frequently wear cleanroom garments over street clothes. and personnel comfort. DOP has a fairly consistent average particle size of about 0. that formaldehyde and other vapors given off by building materials and furniture are diluted. High efficiency filters used in cleanrooms are subjected to a DOP penetration test to determine the percentage of particles passing through the filter.

Close coordination between the Owner and its design team will guarantee the best and most cost effective results. Abraham Marinelarena is a mechanical engineer with Bath Engineering Group. contacted at 915/534-9110. permissible particle concentration. The technology is readily available to design as clean a room as desired. manufacturing process and of course cost.Recommendations A cleanroom design requires careful consideration of its intended use. He can be Page 8 . provided the Owner is willing to justify the associated cost. The design and specification of a cleanroom requires close coordination between the many departments impacted by it and the design team. location.

Sign up to vote on this title
UsefulNot useful