TY - JOUR T1 - Experience in the Design and Use of Isolator Systems for Sterility Testing JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 140 LP - 144 VL - 49 IS - 3 AU - James E. Akers AU - James P. Agalloco AU - Colleen M. Kennedy Y1 - 1995/05/01 UR - http://journal.pda.org/content/49/3/140.abstract N2 - The use of isolator systems for sterility testing is on the increase. Prior to instalation and validation careful consideration must be given to the type of barrier to be used, and the design of the facility which will house the barrier system. The validation of these systems requires development and testing of the sterilization cycle. Vapor phase hydrogen peroxide has proven to be efficacious in this application, and examples of sterilization cycle development are presented in this paper. Also of concern is the penetration of sterilant into test articles, media and supplies. ER -