Scale Up Technology

A client may choose to develop a toller who is qualified, but will need additional or improved equipment and technology to meet the eventual production levels required later in the life of the toll contract. The client may require the toller to make changes or modifications at their plant in order to effectively manufacture a particular product in increasing quantity. Some areas of concern applicable to scale up were listed in Various Points to Consider, Section 3.1. Additional considerations to address in the contract may include  

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Scale-up. Technology transfer lack of clear boundaries dividing research, process development, and manufacturing for protein products. 

The use of appropriate DOE can be an invaluable tool to optimize use of resources at all stages of product development, and to shorten the development time from for-mulation/process screening to optimization. When the formulation and manufacturing processes of a pharmaceutical product are designed and optimized by a scientific and systematic approach, the scale-up, technology transfer between manufacturing sites, and process validation can be more efficient because of the robustness of the formulation and manufacturing process. 

C. H. Dubin, Scale-up technology transfer, from the laboratory to commercial production, P/zarm. Formulation Quality Oct/Nov (2003), 19-21. 

Further research is underway to reconfirm the hydrogen productivity of the 50 NL-H2/h SI test facilities for an extended operation time. On the other hand, the domestic research partners, KIER and KIST, are also investigating the scale-up technologies of SI process components to obtain the equipment design information. The goal is to establish an engineering database to design a pilot scale SI process coupled to the secondary helium loop of the VHTR. 

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