This course will focus on airborne contaminants and begin by discussing the definition, history, and rationale for the containment of compounds and processes. An exploration of different containment philosophies, methods of source containment, and a hierarchy of containment approaches will also be covered.
After establishing the need for containment and presenting alternative methods, the course will focus on the importance of fully understanding a manufacturing process in all its dimensions (physical hardware, remedial containment provisions, facility considerations, operator interface, cleaning and decontamination, and other aspects) before optimal containment solutions may be developed and incorporated into the manufacturing processes.This course will also address plant operations ranging from pilot scale to commercial manufacturing.
Immediately apply the course learning objectives with pre and post assessments, a complementary downloadable Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition), learning reviews highlighting important points, hot-links to regulatory and industry information, and an online resource handout as a quick reference for all web links discussed.
This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.
ISPE CEUs are provided once you achieve an 80% passing grade and complete the evaluation as required.
Approximate Course Duration: 1 Day (this is a self-paced course)
*NOTE* You will have 7 calendar days to access and complete this course from time of purchase.
ISPE CEUs: .60 ISPE CEUs will be awarded upon successful completion of grading requirements