ABSTRACT
Barrier isolators are being used over parenteral filling lines to improve the environment surrounding the process and to isolate operating personnel from the product being filled. Both batch and continuous ultraviolet (UV) transfer chambers have been developed to facilitate transport in a sterile manner of presterilized components from the exterior of the barrier isolator to the interior environment. The germicidal mechanism of UV light is based on its ability to alter deoxyribonucleic acid code replication, which, in turn, disrupts an organism’s reproductive ability. A number of different alternatives have been reported as means of introducing components into a pharmaceutical barrier isolator. The chamber consists of UV germicidal lamps mounted in a cylindrical configuration around the center of the chamber. The basic validation strategy involved setting up laboratory conditions that would demonstrate the effectiveness of the UV pass-through to decontaminate a higher level of microorganisms under conditions more stringent than those found in the environment.
