chapter  10
12 Pages

CYCLE OPTIMISATION AND PROCESS TRANSFER

It is usual for most freeze drying processes to be developed as part of the protocol for the manufacture of a new product. In the past, many products have been generated up to the final dosage presentation be­ fore a decision was made as to how the product will be marketed. As freeze drying must rank as one of the most expensive ways to prepare a product for sale, all other presentations may well have been tried and discounted for a variety of reasons. There will always be pressure on any R&D unit to transfer products to production so that returns on in­ vestment may be obtained as soon as possible. This pressure, added to any delay in turning to freeze drying for final product presentation, may result in little time being allowed for either the development or the optimisation of the process. This may then result in the freeze dry­ ing cycle not being the best possible.