This online 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 an electronic download of Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition).
Course Modules/Learning Objectives
- Module 1: Fundamental Concepts and Risk
- Scope and goal of the course
- Definition, background and fundamental concepts
- Module 2: Principles for managing and controlling a containment system
- Applying the Containment Hierarchy of Responses
- Containment applications
- Putting it all together
- Ongoing operations
- Resources: Standards, Articles, Texts, Vendors
- Wrap Up
- Professionals who need knowledge of fundamental containment principles, such as facilities and process development engineers, regulatory compliance and quality assurance specialists, safety and industrial hygiene personnel, and operations and manufacturing managers.
- Engineering professionals and other consultants who work with the pharmaceutical industry.
Community of Practice (COP): This training course is of particular interest to existing and future members of the ISPE Containment Community of Practice (COP).
Jonathan Lind is a Distinguished Project Engineer with Corden Pharma Colorado (formerly Roche Colorado Corporation) in Boulder, Colorado. An experienced engineer, he has worked on a range of significant and complex projects for the pharmaceutical and medical diagnostics industry for 30 years. He has significant experience working with various sized manufacturing units (large, small, lab and pilot plant scale) in support of chemical and peptide synthesis for intermediate and active pharmaceutical ingredient (API) manufacturing facilities. He is very knowledgeable in the field of containment, which is the management of high hazard materials (frequently referred to as “potent compounds”) in a development and manufacturing environment. In addition to his engineering experience, Jonathan has 5 years of experience in the regulatory field having worked in environmental compliance for a pharmaceutical API facility. Jonathan brings a diverse background to a variety of projects and systems required in the pharmaceutical development and manufacturing field. He is an active member of the ISPE Containment COP.