PILOT PLANT SCALE UP TECHNIQUES introduction , scale up, objective, significance, general consideration, and basic knowledge about scale up tech.

1. PILOT PLANT SCALE UP
TECHNIQUES
Mohammad Ataulla Khan
B.PHARM 7th SEM
Regd. No. : 1803268048
Subject : Industrial Pharmacy II
Concern Teacher: Mr. Aswini Sethy
Jeypore College Pharmacy

2.  Introduction
 Scale up
 Objectives
 Significance
 General consideration
CONTENTS :

3. What is pilot plant :
It is the part of the pharmaceutical industry where a lab
scale formula is transformed into a viable product by
developement of liable practical procedure of manufacturing.
R & D Production
Pilot Plant
 Scale Up :
The art of designing of prototype using the data
obtained from the pilot plant model.
Introduction:

4.  To find mistakes on small scale and make profit on large
scale.
 To produce physically and chemically stable therapeutic
dosage form.
 Review of the processing equipment.
 Guidelines for production and process control.
 evaluation and validation.
 To identify the critical features of the process.
 To provide master manufacturing formula.
OBJECTIVES :

5.  Close examination of formula.
 Review of equipment - most compatible with the
formulation & economical, simple & reliable in producing
product.
 The specification of the raw material.
 Give rough idea about physical space required and of
related functions.
 Appropriate records & reports to support GMP.
IMPORTANCE :

6. 1. Reporting responsibility :
R &D group with The formulator who developed the
separate staffing . product can take into the production and
can provide support even after transition
into production has been completed.
GENERAL CONSIDERATION :

7. 2. Space requirements :
Administration Physical testing Standard equipment storage area
and information area floor space
processing
• Administration and information process:
Adequate office and desk space should be provided for
both scientist and technicians.
The space should be adjacent to the working area.

8. • Physical testing area:
This area should provide permanent bench top space
for routinely used physical- testing equipment.
• Standard pilot-plant equipment floor space:
Discreet pilot plant space, where the equipment needed for
manufacturing all types of dosage form is located. Intermediate – sized
and full scale production equipment is essential in evaluating the effects
of scale-up of research formulations and processes. Equipments used
should be made portable so that, after use it can be stored in the small
store room. Space for cleaning of the equipment should be also
provided.
• Storage Area :
Different areas should provided for the storage of the
in-process materials, finished bulk products from the pilot-
plant & materials from the experimental scale-up batches
made in the production. Storage area for the packing
material should also be provided.

9. • A thorough review of the each aspect of
formulation is important.
• The purpose of each ingredient and it’s contribution
to the final product manufactured on the small-scale
laboratory equipment should be understood.
• Then the effect of scale-up using equipment that
may subject the product of different types and
degrees can more readily recognized.
3. Review of the formula :

10. 4. Raw Materials :-
• One purpose/responsibility of the pilot-plant is the
approval & validation of the active ingredient & excipients
raw materials.
• Raw materials used in the small scale production
cannot necessarily be the representative for the large
scale production.
5. Equipments:
• The most economical and the simplest & efficient
equipments are used.
• The size of the equipment should be such that the
experimental trials run should be relevant to the
production sized batches.
• If equipment is too big then the wastage of the expensive
active ingredients.

11. 6. Production Rates:-
The immediate as well as the future market
trends/requirements are considered while determining
the production rates.
7. Process Evaluation:
PARAMETERS
Heating &
cooling rates
Rate of addition of
granulating
agents, solvents
etc.
Mixing time &
speed
Order of
mixing of
components
Drying temp.
& drying time
Screen size
Filters size