Multiple examples of problems arising during the use of commercial and in-house containment installations will be presented. The content will expose the audience to minor and major pitfalls that they may encounter when implementing a containment solution. Examples are drawn from every stage of manufacturing of the Active Pharmacological Ingredient (API) ranging from Bench-scale discovery work through Kilo-scale, Pilot Plant, Clinical Trial and Launch material preparation, and final Full Scale manufacturing in 4,000 gallon tank and 10 ton solids blending equipment. A range of containment solutions including the common barrier technologies – rigid, flexible, hybrid, airflow, and protective clothing will be highlighted. The importance of the proximity, availability, and support of the vendor to assist in solving your process issues as distinct from protecting their product will be illustrated for a number of manufacturing sites in N and S America, and Europe. The applications will illustrate manufacturing processes for API's as diverse as lachrymators and other irritants, allergens, and the broad range of potent compounds including hormone disruptors and cytotoxins. Such practical manufacturing experiences are a critical dimension in the scoring process used for the rapidly advancing adoption of Risk-MaPP. Even more important is the value of these learning experiences as an integral part of the selection of remedial solutions needed once a Risk-MaPP conclusion is formalized. Click Here For Complete Article Text
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