Sterility testing isolation technology

Many isolator applications at the clinical trial scale of manufacturing are based on the same scale of technology used for sterility testing. The aseptic dispensing of pharmaceutical products in hospital pharmacies is also carried out on this scale. Such manufacturing is not carried out on a continuous basis, but in relatively small batches that can be transferred from the isolator with the help of one of the more secure transfer systems. In this type of application, one isolator is being used to dispense a variety of products or several isolators are used for separate tasks. 

There have been major technological advances in two areas that mitigate some of the limitations of the sterility test. They are the use of isolation chambers for performing the test and the development of new technologies to provide rapid—approaching real time—sterility tests. 

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