This course will identify microbiological and particulate control concepts and principles as they relate to the manufacture of pharmaceutical products, and other designated controlled environments.
The course will discuss, in detail, controlled environmental test methods, with a focus on microbiological control. The most stringent concepts of environmental monitoring as it relates to facility control and compliance are presented for sterile product manufacturing, but these concepts can also be used as an aid to design a program for non-sterile product manufacture.
This laboratory course will give you the opportunity to work hands-on with environmental monitoring equipment and media. You’ll have the opportunity to work with the instructors to develop a surface and air environmental monitoring program for PDA’s clean room. You will utilize the information presented in the lectures to determine appropriate sampling sites and methods based on area classification, activities performed and surface type.
Environmental surveillance is a tool utilized to evaluate the effect of controls on the manufacturing environment. A process to assess the clean room and other controlled environments of a pharmaceutical facility can serve as an adjunct to the sterility assurance program for the microbial quality of drugs. The items addressed in this course include definitions, standards, surveillance support systems, system surveillance, validation systems, definitions and typical frequencies and levels.