Abstract
A multidimensional space that encompasses combinations of machine design and processing variables that provides assurance of suitable product performance. This review article mainly focuses on design space in the concern of developing and scaling up all the process variables with reference of one particular material for the development of individual product protocol. The design space should be developed as an envelope for every product specifying its sublimation rate, shelf temperature, and chamber pressure, one boundary of the design space is established by failure of the formulation under aggressive cycle conditions. Other boundaries of the design space are determined by equipment performance including refrigeration capacity, condenser capability, heating capacity or limitations of the dynamics of water vapor flow within the system. The characterization of this design space assures a thorough understanding of both the product and the process. It minimizes the probability of unpleasant surprises in the technology transfer process. Hence we can develop a collection of protocols regarding the individual product lyophilization in a very similar manner like I.P., B.P., U.S.P. etc. This will result in restriction from process variation and thus different troubles can be resolved.
Highlights
Wide range of the products such as foodstuffs, pharmaceuticals, biotechnology products, vaccines, diagnostics and biological materials can be dehydrated by the technique of sublimation and the process is known as Lyophilization (Freeze-drying) and this can be carried out on various scale i.e. from bench top through pilotscale to a full-scale and the process supports various advantages over the conventional drying and many other traditional methods of drying[1]
In second stage the product is sublimed at the temperature below the glass transition or collapse temperature and the crystallized water is sublimed. This overall phenomenon is an endothermic process which is controlled by chamber pressure and shelf temperature and various other factors such as heat transfer in container, container design, stopper design, shelf space design, freezing behavior and freezed structure of the compound etc are all important factor for the sublimation rate of the freezed crystals
A paper published by Pikal et.al[4], in 1983 describes about the thickness of the vial and viscosity of the different compound with their own partial pressure will require different self temperatures and work of Marco et al5, 1995 explains the 12% variation in the results when the parameters are not optimized
Summary
Wide range of the products such as foodstuffs, pharmaceuticals, biotechnology products, vaccines, diagnostics and biological materials can be dehydrated by the technique of sublimation and the process is known as Lyophilization (Freeze-drying) and this can be carried out on various scale i.e. from bench top through pilotscale to a full-scale and the process supports various advantages over the conventional drying and many other traditional methods of drying[1]. The quality of the product dehydrated by sublimation is much more superior the product dehydrated by traditional methods
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