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 […]
Presentation overview – A balance must be achieved between the need to maintain a safe, stable and efficacious product while providing sufficient lethality to attain a minimum level of sterility assurance •No sterilization method should be considered exempt •Sterilizing processes should be a compromise between the degradation effect on the materials and destruction of microorganisms […]
Presentation Overview – Terminal Sterilization Fundamentals ■ Steam ■ Radiation ■ Current Best Practices ■ TS processes and approaches that everyone, including regulators can agree on ■ Current processes with a modest twist. Those may that create will likely create some angst ■ Expected Future Developments ■ Thinking outside the current box that might be […]
This method is an effort to assess risk in aseptic processing. We believe because we have broadened the perspective of risk relative to aseptic processing that if nothing else we have increased awareness that risk can vary substantially in what are perceived by many to be equivalent (and thus equally acceptable) practices and technologies.
Aseptic processing is considered by many in this industry to be among the more difficult activities to execute properly. The number of variables that affect the safety of sterile products manufactured aseptically is substantial. In the design and operation of an aseptic production facility, it is essential that risk to the patient be minimized. This […]