Jim Agalloco, Russ Madsen and Jim Akers developed a comprehensive set of comments to the draft revision of Annex 1. The authors believe it is essential that the EMA receive comments that outline the difficulties that the draft presents. Their more than 170 comments cover the entire document and detail its many shortcomings. Feel free […]
The transient overheat in empty autoclave chambers is a phenomenon that frequently occurs during validation studies. This article by Italian sterilization practitioner Vittorio Mascherpa investigates the main causes of it and suggests some methods to prevent it or to cope with it. The article also includes a useful table of superheating effects due to adiabatic […]
This paper summarizes the concept of F0 and its related parameters (D, z). Essential notions on sterilization kinetics are explained. The idea of physical and biological “equivalent time” is presented and its application in moist-heat sterilization processes is discussed.
Presentation Importance of Sterilization Processes Current Best Practices Sterilization processes and approaches that everyone, including regulators can agree on. Expected Future Developments Current processes with a modest twist. These may create some angst. Thinking outside the current box that might be a part of our future.
Sterilization is a critical process in the pharmaceutical industry for the control of microbial populations. While most prevalent in the manufacture of sterile products it can be used in a variety of settings where microbes have potential impact on patients or products. Sterilization really isn’t that difficult, but inattention to science through excess criteria and […]
Book chapter – Steam Sterilization: A Practitioner’s Guide (Ch.23) Chapter summary BACKGROUND STABILITY TESTING REQUIREMENTS – Maximum Fo – Methods to Reduce Thermal Degradation of Product – Change in Sterilization Process – Presterilization of Some Components or Difficult-to-Sterilize Areas of the Product – Changes in the Sterilization Model Utilized – Aseptically Filling the Product […]
Book chapter – Steam Sterilization: A Practitioner’s Guide (Ch.11) Summary – How Does One Determine Whether the Product Withstands a Thermal Process That Is Encountered in Moist Heat Sterilization? – Expectations of Regulatory Agencies Concerning Sterilization of the Solution and Cycle Selection on the Basis of Solution Selection—Development Studies That Need to Be Conducted – […]
This short article is an introduction to the basic selection of sterilization autoclaves. It defines this type of equipment, summarizes the varieties available and discuss the preliminary problems to cope with in specification and design of sterilization autoclaves.