1. Adding Vaping Businesses to the List of FDA Regulated

    The Food and Drug Administration proposed last year to add electronic cigarettes, or e-cigs, under its jurisdiction in order to regulate the production of the e-liquid that produces the vapor and the flavor, and the addition of the e-liquid to the e-cigarette device. Many vaping companies that produce and sell e-cigs in communities are looking ahead to upcoming regulations for the mixing of the e-liquid. One such regulation suspected to be included in with the new regulations is that the ingredients for the e-cigs will have to be mixed within a cleanroom. Cleanrooms regulate the amount of contaminants and bioburden in the room, keeping the ingredients being mixed for the e-liquid to be of the highest purity. Arguments can be made for the e-…Read More

  2. The FDA’s Move to Regulate Electronic Cigarettes

    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 poss…Read More

  3. Be One Step Ahead of the Standards with a USP 800 Certified Clean Room

    Upcoming changes for USP 795 and 797 clean rooms will be made through USP 800. They will be incorporating the information currently in place and adding to it to insure proper handling of hazardous drugs in healthcare facilities and settings. This will help protect both the handler and the end product from contamination. OSHA standards for the clean room are a large priority in the new. Keeping hazardous drugs secure and separate from others is crucial in the creation of the compounds. The new standards will address this. Part of avoiding contamination is having a clean room that’s compliant with USP 800. The other part is to follow the standard guidelines, wearing personal protective equipment, having proper training for compounding perso…Read More

  4. Our USP 797 Clean Rooms Will Lock-In…

    In the development of our USP 797 Clean Rooms, we spare no expense in any regards. We know that they have to be not only sealed tight when put together, but they have to be federally compliant to the measures set forth by their strict guidelines. We are building rooms that can not let the slightest of molecules in, as just one small piece of hair can be completely destructive. There are several classes of air cleanliness, especially when airborne particulates are analyzed at different levels. The meticulously strict protocols we abide by during construction are some of the toughest protocols to follow in any manufacturing industry. Our USP 797 rooms need to be clean for many reasons: They need to be ready for advanced chemical testing They …Read More