Clean room design standards pdf

This article is about the clean room design standards pdf or research environment. Cleanroom used for the production of microsystems.

To give perspective, the ambient air outside in a typical urban environment contains 35,000,000 particles per cubic meter in the size range 0. 9 cleanroom, while an ISO 1 cleanroom allows no particles in that size range and only 12 particles per cubic meter of 0. As employee of the Sandia National Laboratories, Whitfield created the initial plans for the cleanroom in 1960. Whitfield designed his cleanroom with a constant, highly filtered air flow to flush out impurities. Within a few years of its invention in the 1960s, Whitfield’s modern cleanroom had generated more than 50 billion USD in sales worldwide. Cleanrooms can be very large. Entire manufacturing facilities can be contained within a cleanroom with factory floors covering thousands of square meters.

There are also modular cleanrooms. Equipment inside the cleanroom is designed to generate minimal air contamination. Cleanroom furniture is designed to produce a minimum of particles and is easy to clean. Low-level cleanrooms may only require special shoes, with completely smooth soles that do not track in dust or dirt. However, for safety reasons, shoe soles must not create slipping hazards. In cleanrooms in which the standards of air contamination are less rigorous, the entrance to the cleanroom may not have an air shower.

Some manufacturing facilities do not use fully classified cleanrooms, but use some cleanroom practices to maintain their contamination requirements. Laminar, or unidirectional, air flow systems direct filtered air downward or in horizontal direction in a constant stream towards filters located on walls near the cleanroom floor or through raised perforated floor panels to be recirculated. Stainless steel or other non shedding materials are used to construct laminar air flow filters and hoods to prevent excess particles entering the air. Turbulent, or non unidirectional, air flow uses both laminar air flow hoods and nonspecific velocity filters to keep air in a cleanroom in constant motion, although not all in the same direction.

The rough air seeks to trap particles that may be in the air and drive them towards the floor, where they enter filters and leave the cleanroom environment. US FDA and EU have laid down guidelines and limit for microbial contamination which is very stringent to ensure freedom from microbial contamination in pharmaceutical products. In the healthcare and pharmaceutical sectors, control of microorganisms is important, especially microorganisms likely to be deposited into the air stream from skin shedding. Studying cleanroom microflora is of importance for microbiologists and quality control personnel to assess changes in trends. Cleanrooms are classified according to the number and size of particles permitted per volume of air.