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Beside recent advances and developments, some aspects of cleanroom technology are still in their infancy. Advent of modular cleanroom concept is reducing the cleanroom building cost.
Cleanrooms are controlled environments, and are especially designed and constructed in a way which is designed to minimise contamination. This is through the control of air, the disinfection of surfaces and the gowning of personnel, together with appropriate training and use of procedures. The key word in this definition is ‘controlled’. Cleanrooms, through Heating, Ventilation and Air Conditioning (HVAC) systems control air quality, pressure, temperature and humidity. These functions have controlled parameters which must be met in order for the cleanroom to function correctly.
Cleanrooms have been in use for manufacturing, in a recognisable form, since the 1950s. Cleanrooms were developed during World War II for items ranging from the manufacture of gyroscopes to the atomic bomb project. From then on, cleanrooms were used for the production of electronic components and cleanrooms had become established as essential part of the manufacturer of pharmaceutical compounds by the 1970s. Cleanrooms are used for the manufacture of non-sterile products (like tablets), terminally sterilized products and aseptic filled products. For terminally sterilized products and aseptically filled products, the filling of a product vial takes place within a 'cleanzone'. Of these different types of manufacturing, aseptic filling takes place under conditions of greatest risk because the product is subject to no further treatment once the product vial has been filled. The main focus of this whitepaper is upon innovations which relate to aseptic filling.
Although cleanroom technology, in terms of cleanroom design, is a long established technology, advances in cleanroom technologies emerged relatively slowly with cleanrooms not changing significantly from the 1950s through to the mid-1980s, with he advent of isolator technology. During the 1960s and 1970s the main focus was upon improvements to air-filtration. This paper surveys some of the most recent technological developments which have taken place to cleanroom design and to cleanroom operations.
The key advance in cleanroom technology is barrier technology for the key design for improved contamination control is use of barrier systems, like isolators, which is gradually being adopted to replace conventional cleanrooms. In addition to the use of barrier technology, the second biggest advance has been with the use of single-use disposable systems, which avoid the costs and risks associated with sterilizing equipment. Other innovations include advances in cleaning and disinfection and to personnel gowning. The driving forces for such technological changes centre on saving time, lowering costs and reducing contamination risks. Learn more about these developments by reading the whitepaper.
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Published: 06/28/2011 | Redaktion PROCESS