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Selection of Efficient Cleaning Validation Strategies
Monday, November 12
8:00 am – 10:00 am
Roundtable
ACPE #073-999-07-512-L04
One of the most time consuming efforts in validation is for cleaning validation. It is never done fast enough, requires too much risk, and never supports what manufacturing really wants. This effort must consider some or all of the following, very low acceptable change over residue levels, the number of batches in a campaign, the time for the campaign, the "dirty hold time", and the "clean hold time". You also have to factor into analysis time for API residue, cleaning agent residue and microbial levels after cleaning. These take time and often are balanced with the need to start using the equipment again. During this session new strategies will be proposed and discussed for approaches to support manufacturing requirements and innovative ways to establish residue level and more rapid analysis techniques.
ModeratorS
Saji Thomas, Ph.D.
Par Pharmaceuticals
Chris Ames, Ph.D.
Hoffmann-LaRoche, Inc.
Speech title to be Announced
Andy Walsh, Ph.D.
Hoffmann-LaRoche, Inc.
Cleaning Validation
Richard Forsyth, Ph.D.
Merck and Company, Inc.
Cleaning Validation
Yanxi Tan Cain, Ph.D.
Wyeth Pharmaceuticals