1. Presented By Bs ID:20130107060 Course no: ACCE-402 Course title: chemical reaction engineering Dept. of ACCE BSMRSTU My topic: Importance of pilot plant model and scale up for chemical products

2. + Why Pilot plant needed………… 2 Needed to make supplies for bench studies, product characterization, purity animal studies toxicology pharmacokinetics, ADME efficacy clinical studies What is Pilot plant : “Defined as a part of the chemical industry where a lab scale formula is transformed into a viable product by the development of liable practical procedure for manufacture.”

3. + IMPORTANCE OF PILOT PLANT Examination of formulae. Review of range of relevant processing equipments. production rate adjustment. Idea about physical space required. Appropriate records and reports to support GMP. Identification of critical features to maintain quality.

4. + What is Scale-up : “The art of designing of prototype using the data obtained from the pilot plant model.” OBJECTIVES OF SCALE UP…. To provide master manufacturing forumla To identify the critical features of the process Evaluation and Validation Guidelines for production and process control Review of the processing equipment To produce physically and chemically stable therapeutic dosage

5. + Requirements of Scale-Up….. Personnel Requirements Space Requirements Administration and Information Process Physical Testing Area Standard Pilot-plant Equipment Floor Space Storage Area Review of Formula Process Evaluation Preparation of Master Manufacturing Procedures Product Stability and Uniformity

6. + Steps in Scale up for Chemical Products Define key rate-controlling steps in the proposed process Conduct laboratory studies and scale-up planning at the same time Define product economics based on projected market size and competitive selling and provide guidance for allowable manufacturing costs

7. + Steps in Scale up for Chemical Products 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 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 Conduct preliminary larger-than-laboratory studies with equipment to be used in rate-controlling step to aid in plant design

8. + Quality assurance Dissolution of drugs in solution Potency of drugs in suspension Temperature uniformity in emulsions Microbiological control Product uniformity Final volume Stability 8

9. + Yeast Scale-up Example Laboratory Scale Data: Fermenter, 15 L (12 L working volume). H/D 2:1, t = 30C., pH 4.5, heat output 3-4.4 kcal/ g yeast solids, dissolved O 2 7 ppm. Specific growth rate, 0.2/h, yield 0.55kg/kg fermentable sugars, cell conc. 0.65 g (dw)/L Pilot plant fermenter, 150 L

10. + Refference.. Baker, T.L. (1994), Doing Social Research (2nd Edn.), New York: McGraw- Hill Inc. Robert Edgeworth Johnstone(Hardcover – 1957): Pilot plants, models, and scale-up methods in chemical engineering Burns, N. and Grove, S.K. (1999), Understanding Nursing Research (2nd edn.), Philadelphia: W.B. Saunders Company. p 40. Chann, S.S. (1982), The epidemiology of unpublished randomised controlled trials. Clinical Research 30: 234A. https://www.slideshare.net/bharathpharmacist/scale-up-39686349