Aspects to Consider for Clean Room Qualification and Operation

Overview: Controlled environmental conditions are often used when making medical devices and pharmaceuticals. However, to make sure these clean rooms are continuously operating in a state of control can be a difficult task unless the appropriate controls are incorporated into the design. This talk will focus on the controls that need to be considered during the design and construction and the methods to demonstrate these controls are effective. Areas Covered in the Session: Clean Room Classification Design and Operation Engineering and Budget Considerations Air Filtration and Maintaining Positive Pressure Interlocks and Pass Throughs Controlling Human Factors Acceptance Criteria