James E Akers

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Variations in biological indicator (BI) lethality have been reported for several types of commercial BIs. This phenomenon has been observed among different lots of the same species and strain BIs from a single vendor. It has also been reported among BIs from different vendors but of the same species and strain that are intended to challenge the same general(More)
healthcare products are manufactured in one of two ways. The first is by the physical sterilization of the product in its final container, typically by moist heat or radiation. The other is by filtration whereby contamination is excluded from the process stream, followed by the now-sterile effluent being contained in an aseptic environment. The practice of(More)
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(More)