Before global cleanroom classifications and standards were adopted by the International Standards Organization (ISO), the U.S. General Service Administration’s standards (known as FS209E) were applied virtually worldwide. However, as the need for international standards grew, the ISO established a technical committee and several working groups to delineate its own set of standards.
A cleanroom or clean room is an environment, typically used in manufacturing or scientific research, with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. More accurately, a cleanroom has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size.
Achieving a specific cleanroom class requires not only clean physical design (non-particulating materials, etc.) but also a flow of clean, filtered air sufficient to both dilute existing particulates and to drive “dirty” air out of the controlled space.
Personnel in critical areas may be monitored for microbial contamination utilizing contact plates. The contact plates monitor areas of the body that may interact with the sterile field or product exposure areas. These may include gloved hands, forearms, or other areas. Personnel monitoring is a good indication of how well personnel are gowning when they enter the clean room. Many companies utilize this testing for proficiency based training programs for clean room personnel.
Air Flow Rates
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For a little over a century, emphasis on performing industrial and medical work in germ and contaminant free environments has risen dramatically following advances in our understanding of these contaminants’ effects. Additionally, as improvements in the sophistication and delicacy of components used in computers and other complex products progresses, the need to keep them contaminant free grows. As such, the development of cleanrooms has been as important to scientific research as it has been to the manufacturing of technology resulting from this research.
Imagine if the medication we ingest and the electronic components we use were produced in rooms populated with chemical vapors, dust, and airborne particulates. These impurities would settle on capsules and circuits and contaminate them. Instead, manufacturers create a controlled environment a cleanroom to limit exposure to contaminants.
While not always sterile, a cleanroom follows accepted standards for maximum particulates per cubic meter. Air is filtered in and recirculated through HEPA air filters. Equipment is designed to generate minimal air impurities. Employees wear gloves, face masks, and head covers. Often, donning jumpsuits or smocks is also necessary. The room is cleaned daily, sometimes every few hours, according to rigorous quality procedures.
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.
The old Federal Standard 209 (class 100,000; 10,000; 1,000; 100; 10; 1) was withdrawn in 2001 and officially replaced by ISO-14644-1 in 1999, but it is still widely used.
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.
Aerospace & Defense cleanroom classifications regulate a cleanroom’s degree of cleanliness and are defined by the allowed amount of contamination by particle count and size, as well as the necessary air change rates depending on the cleanroom’s classification level. Aerospace and defense cleanrooms are typically regulated by the classification standards of two major organizations: The International Standards Organization (ISO) and the American Society for Testing and Materials (ASTM).
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