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 to be Covered:
Clean Room Classification Design and Operation
Engineering and Budget Considerations
Air Filtration and Maintaining Positive Pressure
Interlocks and Pass Throughs
Controlling Human Factors
Who will Benefit:
This discussion will benefit any organization that wants to improve the control of their current clean room faclity or those considering building or upgradeing their clean rooms. It should be of interest to:
QA and Manufacturing Managers
Auditors responsible for designing or qualifying controlled environments or operating within them