Aseptic/Sterile Processing

Oct 01, 2002
Pharmaceutical Technology Europe
A limit test using ion mobility spectrometry (IMS) has the potential to dramatically reduce the time required for cleaning verification and cleaning method development. The traditional approach to cleaning verification, often using HPLC, is relatively resource intensive and can lead to significant delays in reporting results. The main advantage of IMS is that results are seen virtually instantaneously, so any necessary re-measurement can be done very quickly. If the results demonstrate cleanliness, production can resume in a matter of hours not days.
Mar 01, 2002
Pharmaceutical Technology
When FDA reviewed PDA's Technical Report No. 34 about isolator systems, significant differences of opinion between the organizations came to light.
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