How do the operating and design engineers approach this different and unique design?
We are past the time when bio-pharma engineers used to say: “I’m glad I will retire soon, before the isolation technology will be the system of choice for my clients.” We have today a wealth of knowledge both from the engineering and from the equipment manufacturing sides. Gradually, the regulatory field got to know the system and — when presented with well-documented data, statistical results, and perhaps computer graphics with simulations — the reaction from most is surprisingly positive. The main concern we hear is about the cleaning validation of isolators and it is no surprise that so many good articles have addressed this issue in recent years. How do the clients operate the facility once it is certified for the intended use? Many find it challenging to accept the change in mind-set from working in an “open system” with process equipment in dedicated cleanrooms to a “closed system” where the isolator is the cleanroom holding the equipment inside. Others are excited by the challen
