12/29/2023 0 Comments Cip sip definitionHowever, ISO 14644.7 is not application-specific, so additional application-specific definitions and terminology are taken from other standards and guidelines, such as the EC GMP. Standard information relating to such definitions will be found in EN/ISO 14644 – Part 7: Separative devices (clean air hoods, glove boxes, isolators and mini-environments). Some understanding of the definitions and terminology used in the design of isolators will be helpful. For those wishing to understand this area in greater depth, a guidance book on the topic will be published in 2003.(1) Future articles will focus on access devices and isolator leaks. In this article we consider the selection of an appropriate isolator design for your particular application. This series of articles will attempt to clarify the appropriate selection and use of isolators. In the absence of defined regulatory control there is considerable advice available, but its use and interpretation is a factor that causes confusion. With the large number of different features available, it is important that the optimum configuration is wisely selected. All of these processes, except the nuclear industry, were previously undertaken without barrier isolation. Isolators have a role in the specialist handling of food and drink, laboratory processes, pharmaceutical dispensing, animal containment, surgical implant manufacture, nuclear medicine, secondary pharmaceutical manufacture, primary pharmaceutical manufacture, sterility testing, nuclear fuel processes, secure transfer and manipulation of toxic waste. This versatility is reflected by the number of different applications that exist. Isolators are available in a wide range of sizes and configurations, making them extremely versatile.
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