Cleanrooms are used to manufacture sterile products and have different classifications based on regulatory standards. The ISO has classifications from 1 to 9, with 1 being the cleanest. Cleanrooms are tested for particles and divided into manufacturing areas. Different countries have different standards, but all aim to prevent contamination of products.
Cleanrooms are industrial rooms that are cleaner than regular rooms, containing less dust, fewer microorganisms, and fewer particles overall than a regular room. Pharmaceutical companies, medical device companies, and other types of businesses use cleanrooms to manufacture sterile products. Cleanroom classifications vary according to regulatory standards, but some standards overlap. Each class of a particular standard can contain a maximum number of particles of a certain size for a specified volume of air. Typically, the specified volume of air is one cubic meter or one cubic foot.
The International Standards Organization (ISO) has cleanroom classifications from ISO 1 to ISO 9, with ISO 1 being the cleanest of all and ISO 9 being the least clean. ISO 1 rooms may contain no more than 10 0.1 micrometre particles per cubic meter of air and no more than two 0.2 micrometre particles per cubic meter of air.
In some countries, there are different standards applied to cleanrooms, depending on which regulatory standards a factory must meet. For example, the United States uses Federal Standard 209 and the ISO standard, and European factories use the ISO standard and European Union pharmaceutical cleanroom classifications, although Great Britain may also use the British standard.
The reason cleanrooms are classified is that many items, such as pharmaceuticals to be injected into a vein, must be sterile. Contamination with microorganisms or particulates can be dangerous for the consumer. Non-sterile products, such as ointments, should be kept as free of contamination as possible, but it is not necessary to package them completely sterile.
Cleanrooms generally are tested for particles under certain conditions. The standard specifies whether the area must be at rest, meaning that the room is functioning normally but there has been no movement of personnel for a specified time, because people can create eddies which lift particles deposited from the floor into the air. An analyst will use a particle meter to draw in the specified volume of air and the meter will count the particles.
Cleanroom classifications also help divide manufacturing areas. For example, European pharmaceutical cleanroom classifications divide areas into Grade D, Grade C, Grade B and Grade A, with Grade A being the cleanest. Grade D is a staging area, where materials are prepared for entry into Grade C. Grade C is where solution is prepared, and Grade A is where sterile product is filled . Grade B is the area around grade A that fillers move to to transfer product from grade C to grade A.
US standards range from M1 to M7, with M1 being the cleanest class. The M1 limits for 0.1 micrometre particles are 350 per cubic meter and 75.7 0.2 micrometre particles per cubic metre. The British rating system uses the letters C to M, with C being the cleanest room. Does not test for particles smaller than 0.1 micrometer and allows up to 100 0.3 micrometer particles.
Protect your devices with Threat Protection by NordVPN
