Steam Sterilization Processes in the Pharmaceutical Industry
Book Details
Description
This session will help you:
Comprehend the important concepts, such as aseptic processing and sterility assurance level
Know all about equipment that is used and what items are subjected to steam sterilization
With the theoretical aspects including the properties of saturated steam, kinetics of thermal death and the definitions of D-value, Z-value, and Fo
Understand steam sterilization operations, starting with the key steps in a typical process and how cycles can be effectively developed
Identify essential elements of how such processes are validated, based upon regulatory guidance, including the use of biological indicators, temperature mapping tests, and loading pattern studies
Know the requirements for on-going process control, such as periodic requalification and routine testing
You will get to know about the technical and compliance aspects of steam sterilization operations in the pharmaceutical and biotechnology industries.
