MOST OF THE TECHNIQUES DEVELOPED FOR THE FREEZE DRYING OF PHARMACEUTICALS HAVE EVOLVED SLOWLY OVER TIME.

MOST OF THE TECHNIQUES DEVELOPED FOR THE FREEZE DRYING OF PHARMACEUTICALS HAVE EVOLVED SLOWLY OVER TIME. A DEPARTURE FROM THE STANDARD PRACTICES OFTEN UNCOVERS A VARIETY OF PROBLEMS, SOME MAY BE ANTICIPATED, OTHERS MAY APPEAR UNEXPECTED. THE PROPOSED RESEARCH PROGRAM WILL INVOLVE A SERIES OF EXPERIMENTS DESIGNED TO EVALUATE THE BEHAVIOROF FLEXIBLE POUCHES IN THE FREEZE DRYING CYCLE. THESE INCLUDES, THE SELECTION OF A SUITABLE TEST SOLUTION, IN BAG FREEZING STUDIES, AND A STUDY OF THE PARAMETERS EFFECTING THE CONFINED LYOPHILIZATION PROCESS. THE EXPERIMENTAL DATA WILL BE INCORPORATED INTO A MODIFIED NUMERICAL SIMULATION OF THE LYOPHILIZATION WITHIN A FLEXIBLE BAG TO PROJECT THE EFFECTS OF PACKAGE CONFIGURATION AS WELL AS TO TEST PROSPECTIVE CONTROL STRATEGIES. KNOWLEDGE OF THE COMPROMISES INHERENT IN DEFINING OPERATING CONDITIONS, CONTROL METHODS, AND SELECTING A BAG DESIGN WILL ESTABLISH THE NECESSARY FOUNDATION FOR THE OVERALL DEVELOPMENT PROGRAM.