This presentation covers the problems and requirements of FDA compliance and validation. The lecture will explore oxygen uptake requirements, agitator power needs, heat transfer, and aeration. Use calculation methods provided to solve mixing, oxygen transfer, and heat transfer problems. Important design variables are determined and scale-up issues are considered. General factors considered include people, material and process flow.
Information is provided that relates to the design configuration and kill correlations.
The results of the Facility Design Workshop will be presented to Don Hill and the group of attendees. A discussion of the pros and cons of the developed design will be led by Don Hill. This will be a group critique. The impact on cells and this importance in equipment design is covered. Particular emphasis will be on designing for cleanability, operability and sterilization.