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 […]
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.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.
Book chapter – Steam Sterilization: A Practitioner’s Guide (Ch.01) Chapter summary WHAT DO WE MEAN BY MOIST HEAT STERILIZATION? COMPARISON OF MICROBIAL SENSITIVITY MECHANISMS OF INACTIVATION – Vegetative Cells – Bacterial Spores -Bacterial Spores Defined -Spore Characteristics – Spore Formation – Mineralization – The Transition from Spore to Vegetative Cell – Thermal Injury to Spores […]
Steam sterilization kinetics is the base for a correct understanding of industrial practice of moist heat sterilization, but is a too often neglected topic. This article by the well known Italian sterilization practitioner Dario Pistolesi and his former assistant Vittorio Mascherpa provides a simple but rigorous introduction to it.
Material transfer to sterile suite issue and available technologies; Surface bio-decontamination drivers; QbD and risk assessment and mitigation overview; Surface chemical bio-decontamination cycle; Cycle validation approach;