This article describes a method for achieving the load equivalence model, described in
Parenteral Drug Association Technical Report 1, using a mass-based approach. The item …

The purpose of this article is to define one of the design approaches that can be used to
develop an autoclave cycle. The design approach discussed in this article is based on an …

Hospitals are under continual pressure to improve turnaround times for surgical procedures
and to find ways to release sterilized product without the need to wait for biological indicator …

For manufacturers of sterile drug products, steam sterilization is a common method used to
provide assurance of the sterility of manufacturing equipment and products. The validation of …

Sterilization is an integral component of an overall infection control program. The
sterilization process is unique in that it cannot be fully verified by inspection and testing after …

Steam sterilization Process Challenge Devices (PCDs) are devices which present a defined
challenge to a sterilization process. In part one of a two part series the authors review the …

Highlights•Sterility assurance requires continuous attention to the sterilizer performance, as
well as all aspects of the sterilization process.•Process failures can be troubling to …

Background: With the current methods specified in standards, not all the steam sterilisation
conditions as specified in standards can be guaranteed in every steam sterilisation process …

In practice it is claimed that load characteristics influence a surface steam sterilization
process. To the best of our knowledge, no information on this topic has been found in the …

Healthcare facilities must also demonstrate that the cycles they are running will sterilize the
contents of the loads being processed. ANSI/AAMI ST79: 2006, Comprehensive guide to …