Part I of this article discusses examples for cycle types used in moist heat sterilization, parameter requirements for a standard cycle as defined by pharmacopeias, methods used to design sterilization cycles, and various approaches used to measure the efficiency of the sterilization process.
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.