Facilities

Pharmaceutical, Device and Biotech facilities are the vehicles that allow products, which have successfully transited drug discovery, development and approval to be manufactured and delivered to consumers. These facilities are often unique in their own right and also contain many specialized technologies necessary for product manufacture to assure purity, efficacy and safety. Cleanliness is of paramount concern and virtually every aspect of these specialized sites has been designed and constructed to assure quality. Whether the product is a traditional drug, such as a tablet, capsule, liquid, a device such as contact lenses, implant, syringe, or a biologic such as vaccine, antitoxin, toxoid, the facilities that are responsible for manufacture must meet rigorous standards and are subject to inspection and in some cases registration and certification. This presentation will review many of the key aspects of facility design as well as a number of the core technologies considered critical to successful operation.