Experience in the design and use of isolator systems for sterility testing.
The use of isolator systems for sterility testing is on the increase. Prior to installation 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.
Akers
J E
JE
Akers, Kennedy and Associates, Kansas City, Missouri, USA.
Agalloco
J P
JP
Kennedy
C M
CM
D004867:Equipment Design; D013242:Sterilization / Q000295:instrumentation* / Q000592:standards; D013696:Temperature