Cleanrooms have been an evolution of necessity, originating out of the medical field around the 1860s with the observation of bacteria, and resulting understanding that bacterial exclusion in operations, greatly improve recovery rates. This was one of the starting points of aseptic methods around the world and subsequent cleanroom development. During World War Two there [...]
Over time I have been in numerous conversations with people who have shown some confusion over the terms commissioning, validation and qualification. These terms are used in the pharmaceutical industry on a daily basis (usually by a quality manager). While pharmaceutical companies have a good grasp of these terms and the associated requirements, in many [...]
There is a lot that can go wrong entering a cleanroom environment. Your cleanroom personnel’s behaving accordingly to the established standards is absolutely necessary in order to sustain the classification of your cleanroom. It is a widely known fact that people and the machinery used in the cleanroom are the biggest source of contamination. There [...]
