pilot plant scale up study.

1. PILOT PLANT SCALE
UP
Guided By-
Dr.Tamboli F.A
Department-Pharmacognosy
Bharati Vidyapeeth College Of Pharmacy
Kolhapur.
Presented By-
Mr Madane Vikram Appa
Department-pharmaceutical Quality
Assurance
Bharati Vidyapeeth College Of Pharmacy
Kolhapur.
Roll No-8
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2. INDEX
Introduction
Definitions
Significance
Scale And Scale Up
Pilot Plant Design
Pilot Plant Operations
• Validation
• Training
• Engineering Support
• Maintainance And Calibration
• Computerized System
• Process And Manufacturing Activity
• Quality Assurance
• Quality Control
Reference
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INTRODUCTION –
What is Pilot plant : “Defined as a part of the pharmaceutical
industry where a lab scale formula is transformed into a viable
product by the development of liable practical procedure for
manufacture.”
Why conduct Pilot Plant Studies?
• 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
• It is usually not possible to predict the effects of a many-fold
increase in scale
• It is not possible to design a large complex food processing plant
from laboratory data alone with any degree of success

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A pilot plant can be used for
• Evaluating the results of laboratory studies and making
product and process corrections and improvements
• 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 • Determining possible salable by-
products or waste stream requiring treatment before
discharge
• Providing data that can be used in making a decision on
whether or not to proceed to a fullscale production process;
and in the case of a positive decision, designing and
constructing a full-size plant or modifying an existing plant

5. • Plant:- It is a place where the 3 M’s that are Man,
Material and Money are brought together for the
manufacturing of products.
• Pilot Plant:- It is the part of the pharmaceutical industry
where a lab scale formula is transformed into a viable
product by development of liable practical procedure of
manufacturing.
• Scale-up:- The art for designing of prototype using the
data obtained from the pilot plant model.
DEFINITIONS-
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6. SIGNIFICANCE
• Permits close examination of formulae to determine its
ability to withstand batch scale and process
modification.
• Review of Equipment - most compatible with the
formulation & most economical, simple and reliable in
producing product.
• Raw materials - consistently meet the specifications
required to produce the product can be determined.
• Production rate adjustment after considering marketing
requirements.
• Give rough idea about physical space required and of
related functions.
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7. SCALE AND SCALE-UP
• R&D
• Pilot Scale
• Scale-Up
• Large Scale Production
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8. PILOT PLANT DESIGN-
• Formulation and Process Development
• Technology evaluation, Scale-Up and
Transfer
• Clinical supply manufacture
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9. PILOT PLANT
OPERATIONS
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11. VALIDATION-
• Design specifications
• Installation Qualification
• Operational Qualification
• Performance Qualification
• Compliance with cGMPand FDA
standards
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12. TRAINING-:
• Compliance with GMP
• Safety and environmental
responsibilities
• Compliance with SOPs
• Technical skills and
knowledge
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13. ENGINEERING SUPPORT-:
• Design of facility
• Construction of facility
• Co-ordination, scheduling,
direction of ongoing operations
• Validation of facility
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14. MAINTENANCE & CALIBRATION-
• To ensure data integrity and equipment
• To meet cGMP norms Maintenance & Calibration
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15. COMPUTERIZED SYSTEM-
• Material control
• Inventory
• Orders (FIFO)
• Labeling (GMP-GLP)
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16. PROCESS & MANUFACTURING
ACTIVITIES-:
• Formulation & Process
Development studies
• Technology evaluation,
Scale Up & Transfer
• Clinical supply
manufacture
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17. QUALITY ASSURANCE
• Auditing pilot plant
• Auditing and approval of component
suppliers
• Reviewing, approval and maintaining
batch records for clinical supplies
• Sampling and release of raw materials and
components required for clinical supplies
• Release of clinical supplies Maintaining
and distributing facility and operating
procedures (SOPs)
• Review and approval of validation and
engineering documentation
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18. QUALITY CONTROL-:
• Release Testing of finished product
• Physical, Chemical and Microbiological
testing of finished clinical products,
components required for clinical supplies
• Testing for validation and revalidation
programs
• QC in-process testing during development,
Scale-Up and Technology transfer activities
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19. REFERENCE
1. The theory & practice of industrial pharmacy
by Leon Lachman, Herbert A. Lieberman, Joseph L. Kenig,
3rd edition, published by Varghese Publishing house.
2. www.google.co.in01/25/13 DEPT OF PHARMACEUTICS
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