Pilot Plant Scale- Up Technique

1. BANARAS HINDU
UNIVERSITY
Pilot Plant Scale - Up Technique.
Presented By
Mr. Abhijeet Kumar
B.Pharma (Ay.) IMS, RGSC, BHU

2. Plant
• It is a place where the 5M’s like money,
material man, method and machine are
brought together manufacturing of the
products .
Pilot Plant
• It is the part of the pharmaceutical
industry where a lab scale formula
transformed into a viable products by
development of liable product and
practical procedure of manufacture .
Scale- Up
• The art for the designing of the
prototype using the data obtained from
the pilot plant model.
Definitions

3. R&D
Pilot
Scale
Scale
Up
Large
Scale

4. 
To Produce physically and chemically
stable of therapeutic dosage forms
Review of the processing equipment
Guideline for the production and
process control
Evaluation and Validation for process
and Equipment
To identify critical features of the process
and avoid scale up problem
To provide master manufacturing formula
(MMF)
Objective
s

5. Pilot Plant Can be Used
For
Evaluating
results for
laboratory
studies
Product
and
process
corrections
Sensory
Chemical
Microbiologic
al Evaluation
Shelf life
and stability
studies
Designing
and
constructio
n of a full
size plant
or
modifying
existing
plant

6. Define
product
economics
base .
Conduct
laboratory
studies and
scale- up
planning
Define Key
rate -
controlling
steps
Conduct
preliminary
larger than
laboratory
studies
with
equipment
Design
and
construct a
pilot plant
and
evaluate
pilot plant
results
Steps in scale
Up

7. General
Consideration
Reporting Responsibility
Personnel Requirement
Space Requirements
Review of the Formula
Raw materials
Processing Equipment
Production Rate
Process Evaluation
Master Manufacturing Procedure
Product Stability & Uniformity

8. GMP Consideration
Equipment qualification
Process validation
Preventative maintenance
Review and revalidation
Relevant written SOP
Technically qualified personnel
Well defined technology
Validated cleaning procedures
Orderly arrangement of equipment

9. Scale- Up of Solid Dosage
Forms
Material handling system
Mixing (Dry Blending )
Granulation
Drying
Reduction of particle size
Blending
Dry Compaction/ Slugging
Compression
Coating

10. Scale-Up of Liquid
Orals
• Emulsion
s
• Suspension
• Solution
s
• Physical
Plant

11. Scale-up of Semi- Solid dosage
forms
Working
temperature
range etc.
Heating and
cooling process
Motors
Mixing
equipment
Mixing
Speed
Parameters

12. SUPAC Guidelines – Define
Level of
Change
s
• Minor changes
• Moderate changes
• Major changes
Filing
• Annual Report
• Changes being affected supplement
• Prior approval supplement
Test
• Application / Compendial test
• In vitro- dissolution /release
• In Vivo
 SUPAC ; Scale-up and post approval
changes

13. Reference
s
1. The theory and practice of Industrial pharmacy by Leon
Lachman ,Herbert A. Lieberman , joseph L. Keing,3rd
edition , published by Varghese Publishing house .
2. www.google.com