CALL US: 919.635.8438 | ISO 9001:2015 CERTIFIED PRODUCTS SERVICES RESOURCES ABOUT US CAREERS CONTACT CLEANROOM CLASSIFICATIONS WHAT IS CLEANROOM CLASSIFICATION? Cleanrooms are classified according to the cleanliness level of the air inside them. The cleanroom class is the level of cleanliness the room complies with, according to the quantity and size of particles per volume of air. The primary authority in the US and Canada is the ISO classification system ISO 14644-1. This standard includes the cleanroom classes ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9, with ISO 1 being the “cleanest” and ISO 9 the “dirtiest” class (but still cleaner than a regular room). The most common classes are ISO 7 and ISO 8. In addition, cleanrooms must also comply with industry-specific and regional standards. For example, EU GGMP (A-B-C-D) applies to pharmaceutical products and USP (795, 797 and 800) to compounding pharmacies. CLEANROOM CLASSIFICATION PARTICLE COUNT The basis of cleanroom standards is the micrometer, or micron for short (µm), which is the size of the particles to be filtered. As stated before, cleanrooms are classified by how clean the air is, according to the quantity and size of particles per volume of air. The cleanroom classification table below shows the maximum concentration limits (particles/m3 of air) for particles equal to and larger than the considered sizes shown. Some classifications do not require certain particle sizes to be tested because the respective concentrations are too low or too high to be tested, but they should not be zero. HOW TO READ THE CLEANROOM CLASSIFICATION PARTICLE COUNT GRAPH For ISO 7, particles smaller than 0.5 microns (≥0.1 µm, ≥0.2 µm, ≥0.3 µm) are not taken into consideration. The concentration of particles of ≥0.5 µm and above should be below 352,000, for particles of 1 micron and above 83,200 or lower and for particles of 5 microns and above 2,930 or lower. CLEANROOM CLASSIFICATION AND AIR CHANGES PER HOUR Air cleanliness is achieved by passing the air through HEPA filters. The more often the air passes through the HEPA filters, the fewer particles are left in the room air. The volume of air filtered in one hour divided by the volume of the room gives the number of air changes per hour. CLEANROOM CLASS AND CLEANROOM LAYOUT Depending on the class of cleanroom you would like to reach, it is important to allow for enough square footage. This is critical not just for the clean zone, but also for the airlocks/gowning room which prevent the migration of particles from outside into the clean space. The rule of thumb is that you should not skip over more than one class when you move towards a cleaner room (for example, from ISO 7 to ISO 6, not from ISO 8 to ISO 6), as illustrated below. In reality, however, you can reach a cleaner class with fewer airlocks than described below with the appropriate air changes per hour. This depends on the process taking place inside the cleanroom, the size of the cleanroom, the number of people working inside, the equipment inside, etc. Seek the help of a cleanroom expert who can create the optimal layout for your particular needs. ISO 8 Cleanroom (Class 100 000) Let’s assume that an unclassified space (office or lab) is ISO 9. In this case, you can directly enter an ISO 8 cleanroom, without an airlock. Depending on the production process inside the cleanroom, however, you may have to add a gowning room. ISO 8 zone | 15–25 air changes per hour Non-unidirectional airflow ISO 7 Cleanroom (Class 10 000) This is one of the most common classes of cleanrooms. If you need an ISO 7 cleanroom, you should consider having an ISO 8 airlock/gowning room prior to entering the ISO 7 room. The air changes per hour will vary in both rooms as described below. ISO 7 zone | 30–60 air changes per hour ISO 8 zone | 15–25 air changes per hour (ante-room) Non-unidirectional airflow ISO 6 Cleanroom (Class 1 000) In theory, for an entire room to reach ISO 6 air cleanliness, you need to enter the cleanroom via an ISO 8 (ante-room), then go through an ISO 7, to finally get into the ISO 6, as shown in the image. In reality however, you can reach an ISO 6 clean room with 1 (recommendation is 2) airlock. Again, it depends of the size of the room, the process taking place inside the cleanroom, the number of people working inside, the equipment inside, etc. Unidirectional airflow is sometimes recommended to reach ISO 6 classification. For a room of less than 4–6 meters in width (depending on the activities taking place inside the cleanroom), air returns can be positioned on the side of the walls instead of in the floor. Installing air returns in the floor is more expensive. ISO 6 zone | 90–180 air changes per hour ISO 7 zone | 30–60 air changes per hour ISO 8 zone | 15–25 air changes per hour (ante-room) ISO 5 Cleanroom (Class 100) In theory, for a classified room (not just below a LAFW hood) to reach ISO 5 air cleanliness, you need to enter the cleanroom via an ISO 8 (ante-room), then go through an ISO 7, followed by an ISO 6 to finally get into the ISO 5. In reality, however, you can reach an ISO 5 cleanroom with 2 or 3 airlocks. The optimal layout depends on the process taking place inside the cleanroom, the size of the room, the number of people working inside, the equipment inside, etc. In addition, an ISO 5 cleanroom needs to use unidirectional airflow. Unidirectional airflow cleanrooms use much more air than non-directional airflow cleanrooms. High efficiency filters are installed across the entire ceiling. The air sweeps down the room in a unidirectional way, at a velocity generally between 0.3 m/s and 0.5 m/s, and exits through the floor, removing the airborne contamination from the room. Cleanrooms using unidirectional airflow are more expensive than non-unidirectional ones, but can comply with more stringent classifications, such as ISO 5 or lower. ISO 5 zone | 240–360 air changes per hour ISO 6 zone | 90–180 air changes per hour ISO 7 zone | 30–60 air changes per hour ISO 8 zone | 15–25 air changes per hour (ante-room) Very special thanks to MECART Cleanrooms for their information and graphics. 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