What are the classification of a clean room?
Cleanrooms are industrial rooms that are cleaner than conventional rooms containing less dust, less microorganisms and fewer particles in general than a common room. Pharmaceutical companies, medical companies and other types of companies use pure rooms to produce sterile products. Classification of clean rooms varies according to the control standard, but some standards overlap. Each class of a particular standard may contain a maximum number of particles of a certain size for a specified air volume. The specified air volume is usually a cubic meter or cubic stop. ISO 1 rooms must not contain no more than 10 particles 0.1 micrometers per cubic air meter and no more than two particles 0.2 micrometers per cubic air meter.
There are several standards in some countries, there are several applications for clean rooms, depending on which regulatory standards must satisfy the factory. For example, the United States uses Federal Standard 209 and ISO STANDARD and European factories use ISO Standard and Farmaceutical Cleanroom classification, although the UK can also use the British standard.
The reason why clean rooms are classified is that many items such as medicinal products to be injected into a vein must be sterile. Contamination of microorganisms or particles may be dangerous to consumers. Non -sterile products such as ointments should be prevented as much as possible, but it is not necessary to wrap them in a completely sterile way.
clean rooms are generally tested for particles under certain conditions. The standard determines whether the area should be at rest, which means that the room works as usual, but has no staffing for some time, because people can create the beliefs that dig up the particles from the floor to the air. The analyst uses the particle meter to stretch the specifiedM air and meter will calculate particles.
Classification of clean rooms also help divide areas of production. For example, European classification of pharmaceutical clean rooms distributes areas into class D, degree C, grade B and grade A, with the purest grade A. degree D is a staging area where the materials are ready to enter degree C. Degree B is an area around grade A that filling workers walk to transfer the product from grade C to grade A.
US standards range from M1 to M7, with the purest class M1. Limits M1 for 0.1-mikrometer particles are 350 per cubic meter and 75.7 0.2-mikrometer particles per cubic meter. The Briticlassification System uses the letter C per M, with C the cleanest room. It does not test on particles less than 0.1 micrometer and allows up to 100 0.3 micrometers.