PILOT PLANT SCALE-UP TECHNIQUE

PILOT PLANT SCALE- UP TECHNIQUE Prepared by:- Guided by:- Mr. Jiten B. Patel Mr. Senthil kumar R. M.pharm(1 st sem) M.pharm,MBA,P.G.D.H.M B.M.C.P.

Contents ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object],[object Object],[object Object],Definitions

Objective ,[object Object],[object Object],[object Object],[object Object]

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08 June 2009 SRTM University, Nanded Define product economics based on projected market size and competitive selling and provide guidance for allowable manufacturing costs Conduct laboratory studies and scale-up planning at the same time Define key rate-controlling steps in the proposed process Conduct preliminary larger-than-laboratory studies with equipment to be used in rate-controlling step to aid in plant design

08 June 2009 SRTM University, Nanded 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 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? ,[object Object],[object Object]

A pilot plant can be used for ,[object Object],[object Object],[object Object]

General considerations ,[object Object],R & D group with separate staffing The formulator who developed the product can take into the production and can provide support even after transition into production has been completed

[object Object],[object Object],[object Object],2. Personnel Requirement:-

[object Object],Administration and information processing Physical testing area Standard equipment floor space Storage area

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[object Object],[object Object],[object Object],[object Object],[object Object],08 June 2009 SRTM University, Nanded

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[object Object],PARAMETERS Order of mixing of components Mixing speed Mixing time Rate of addition of granulating agents, solvents, solutions of drug etc. Heating and cooling Rates Filters size (liquids) Screen size (solids) Drying temp. And drying time

[object Object],[object Object],Weight sheet Processing directions Manufacturing procedure

GMP CONSIDERATION ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Advantages ,[object Object],[object Object],[object Object]

Disadvantages ,[object Object],[object Object]

Reference ,[object Object],[object Object]

PILOT PLANT SCALE-UP TECHNIQUE

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