ABSTRACT

Barrier isolator technology is the culmination of a long evolution in pharmaceutical manufacturing. Pharmaceutical manufacturing began with open-manual production and progressed to glove boxes. World War II saw developments of both drugs and blood products as well as clean rooms. Reduction in cost, using barrier isolators, is a significant factor given the atmosphere of medical cost containment in the industry. Merck has presented numbers indicating that capital cost savings of 50 percent to 70 percent can be achieved with barrier isolators over conventional clean room facilities of the same capacity. The filler design forms the foundation for the system and is the basis for the potential success of the system from an ergonomic standpoint. The product exit is the final consideration for interface with the barrier isolator. The product exit may be through a transfer star wheel system, or a small tunnel that feeds the finished product single file into the packaging section of the line.