Modular cleanrooms are currently required by USP 797 for the manufacture of parts and products for industries like aviation, food processing, compounding pharmacies, nanotechnology and much more. There has been a move to add electronic cigarettes (also called e-cigarettes and e-cigs) to the list of items manufactured within the confines of a cleanroom environment over the last couple of years with health scares that stem from a lack of regulation. There is now a move to ID purchasers of the e-cigarettes since they contain nicotine, but the ingredients are still largely unregulated.
As e-cigs gain popularity among all ages, there is talk of the move toward regulation, some are choosing to be proactive and keep their customers as safe as possible in the production and filling of the e-cigs. Just like with any ingredients ingested in food or pharmaceuticals or inhaled as medicine or tobacco, there is a need to regulate what goes into the substance, as well as the environment in which it is produced.
The need for filling and manufacturing the inhalants that create the vapor from e-cigs within a controlled environment like a cleanroom is critical to the purity of the substance inhaled. Just like in the instance in the pharmaceutical manufacturing company that was improperly handling medicines, e-cigs have that potential for introducing dangerous contaminants into a human body and leaving the potential for causing illness or death, thus raising the need for manufacturing them in a cleanroom environment. The FDA is currently working to deem e-cigs the same as existing tobacco products and with that will come regulation.