Scale Up of Industrial Process Dr Bhavesh Patel

Scale Up of Industrial Process Dr Bhavesh Patel Principal V P & R P T P Science College, Vallabh Vidyanagar

What is SCALE-UP • All the fermentation processes begins in the research lab and if successful finish in the production plant. • Definition – “Scale up is an act of using results obtained from laboratory studies for designing a prototype and a pilot plant process; construction a pilot plant and using pilot plant data for designing and constructing a full scale plant or modifying an existing plant”

Why SCALE-UP • As there is a vast difference in the process followed at laboratory scale and that adopted at industrial scale, which must be accommodated in any scale up exercise. The major differences are – Ø Media : Quantity and Quality, method of its sterilization Ø Inoculum : Volume Ø Aeration and Agitation : Devices and method Ø p. H & Temperature : Monitoring and maintaining Ø Foaming, Vortex etc.

SCALE-UP • Media volume at different stages – Ø Shaken flask scale – 100 to 500 ml Ø Laboratory fermenter – 1 to 5 lit. Ø Pilot scale fermenter – 5 to 500 lit. Ø Production fermenter – 1000 to 50000 lit.

SCALE-UP v Enormous increase in media volume from lab to production must be accommodated in most of the scale up exercises v It is not practical or economic to transfer the results from lab to production scale in a single step. v Scale up is therefore a multistep, multidisciplinary process v Scientist from disciplines like microbiology, biochemistry, biochemical engineering, chemistry are involved in any successful scale up process. v For a successful scale up a close collaboration among the team of scientists is required.

Steps in Scale-Up v Define product economics based on projected market size and competitive selling and provide guidance for allowable manufacturing costs v Conduct laboratory studies and scale-up planning at the same time v Define key rate-controlling steps in the proposed process v Conduct preliminary larger-than-laboratory studies with equipment to be used in rate-controlling step to aid in plant design v Design and construct a pilot plant including provisions for process and environmental controls, cleaning and sanitizing systems, packaging and waste handling systems, and meeting regulatory agency requirements v Evaluate pilot plant results (product and process) including process economics to make any corrections and a decision on whether or not to proceed with a full scale plant development

Why conduct Pilot Plant Studies? v A pilot plant allows investigation of a product and process on an intermediate scale before large amounts of money are committed to full-scale production v It is usually not possible to predict the effects of a many-fold increase in scale v It is not possible to design a large scale plant from laboratory data alone with any degree of success

A pilot plant can be used for v Evaluating the results of laboratory studies and making product and process corrections and improvements v Producing small quantities of product for sensory, chemical, microbiological evaluations, limited market testing or furnishing samples to potential customers, shelf-live and storage stability studies v Determining possible salable by-products or waste stream requiring treatment before discharge v Providing data that can be used in making a decision on whether or not to proceed to a full-scale production process; and in the case of a positive decision, designing and constructing a full-size plant or modifying an existing plant

Considerations in pilot plant development v Kind and size – depends on goals; evaluating product and process; producing samples of product for evaluation; market testing or furnishing to potential customers v Location: near R&D facility? At an existing plant? Close liaison between R&D and pilot plant staff is essential v Labor requirements and costs: engineering staff, skilled operations and maintenance staff- pilot plant costs may exceed those of usual plant production costs. The pilot plant may be used for training personnel for a full- scale plant