This document provides information about pharmaceutical pilot plants. It defines a pilot plant as the part of the pharmaceutical industry where a lab scale formula is transferred into a viable product. The objectives of a pilot plant are to produce stable dosage forms, review equipment, provide manufacturing guidelines, and identify critical process aspects. A pilot plant is used to scale up the manufacturing process from lab to production scale before committing funds to a full production plant. It allows examination of formulas, equipment, production rates, and identification of issues to resolve prior to full scale production.

1. PHARMACEUTICAL CHEMISTRY DEPARTMENT
B. PHARM VII SEM
Industrial Pharmacy
BP702T
Unit-1 (Part 1)
By: Mrs. Ritu Jaiswal

2. Contents-
1.Definition
2.Objectives
3.Steps in scale-up
4.General consideration

3. Definitions-
PLANT- It is a place were tha 5 “M“ like money,
material, man, method, machine are brought together
for the manufacturing of the products.
PILOT PLANT- It is the part of the pharmaceutical
industry where a lab scale formula is transferred into a
viable product.
By development of liable and practical procedure of
manufacture.

4. SCALE-UP:- The art for designing of protype
using the data obtained from the pilot plant
model.
R&D Production
Pilot Plant

5. Objectives of Pilot Plant:-
“Find mistakes on small scale and make profit on large scale”.
1. To produce physically and chemically stable therapeutic dosage forms.
2. Review of the processing equipment.
3. Guidelines for productions and process control.
4. Evaluation and validation for process and equipment.
5. To identify the critical features of the process.
6. To provide master manufacturing formula.
7. To try the process on a model of proposed plant before committing large
sum of money on a production unit.
8. Examination of the formulae to determine its ability to withstand batch
scale and process modification.
9. To avoid the scale-up problems.

6. Significance of Pilot Plant/ Importance of Pilot Plant:-
1. Examination of formulae.
2. Review of range of relevant processing equipment.
3. Production rate adjustment.
4. Idea about physical space required.
5. Appropriate records and reports to support GMP.
6. Identification of critical features to maintain quality.

7. Pilot Plant can be used for:-
1. Evaluating results for laboratory studies.
2. Product and process correction.
3. Sensory, Chemical, Microbiological evaluation.
4. Shelf life and stability studies.
5. Designing and construction of a full size plant.
6. Designing and construction of a full size plant or
modifying existing plant.

8. GENERAL CONSIDERATION
1. Reporting Responsibility
2. Personnel Requirement
3. Space Requirement
4. Review of the formula
5. Raw Materials
6. Equipments
7. Production Rate
8. Process evaluations
9. Master Manufacturing Procedures
10. Product Stability and Uniformity

9. 1. Reporting Responsibility:-
R&D group with The formulator who developed
Separate staffing the product can take into the
production and provide support
even after transition into
production has been completed.

10. 2. Personnel Requirement:-
Scientist with experience in
pilot plant operatons as in actual production area are the
most preferable.
The group should have some personnel with
engineering knowledge as well as scale up also involves
engineering principles.

11. 3. Space Requirement:-
Administration & Physical Standard Storage
Information testing area equipment floor area
Processing space
a. Administration & information processing:-
- Adequate office and desk space should be provided for both scientist and
technicians.
- The space should be adjacent to the working.

12. b. Physical testing area:-
This area should provide permanent bench
top space for routinely used physical testing equipment.
c. Standard equipment floor space:-
Discreat pilot space, where the
equipment needed for manufacturing all types of dosage form is
located.
- Equipment used should be made portable where ever possible. So
that after use it can be stored in the small store room.
- Space for cleaning of the equipment should be also provided.

13. d. Storage Area:-
It should have two areas divided as
approved and unapproved area for active ingredients as well as
excipients.
- Different areas (unapproved area) should provided for the
storage of the in process materials, finished bulk products from
the pilot plant and materials from the experimental scale-up
batches made in the production.
- Storage area for the packing material should also be provided.

14. 4. Review of the formula:-
A through review of the each aspect of
formulation is important. The purpose of each ingredients and its
contribution to the final product manufactured on the small scale laboratory
equipment should be understood.
5. Raw Materials:-
One purpose/ responsibility of the pilot plant is the
approval and validation of the active ingredients and excipients raw
materials.
Why
Raw materials used in the small scale production cannot necessarily be the
representative for the large scale production.

15. 6. Equipments:-
The most economical and the simplest and efficient
equipment which are capable of producing product within the proposed
specifications are used.
 If the equipment is too small the process developed will hot scale-up.
 If the equipment is too big then the wastage of the expensive active
ingredients.
7. Production Rate:-
The immediate as well as future market
trends/requirement are considered while determining the production
rates.

16. 8. Process Evaluations:-
PARAMETERS
Order of mixing of
components
Mixing space
Mixing time
Rate of addition of
granulating agents,
solvents solutions of
drugs etc.
Drying
temperature &
drying time
Screen Size
(solid)
Filters size
(liquid) Heating and
cooling rates

17. 9. Master Manufacturing Procedures:-
The Three IMP Aspects
Weight sheet Processing directions Manufacturing
Procedure
The weight sheet should clearly identify the chemicals required in a batch.
 To prevent confusion the names and identifying the ingredients should be
used on batch records.
A process directions should be precise and explict.
A manufacturing procedure should be written by the actual operator.
Various specifications like addition rates, mixing time, mixing speed,
heating and cooling rates, temperature, storing of the finished products
samples should be mentioned in the batch record directions.

18. 10. Product Stability and Uniformity:-
The primary objective of
the pilot plant is the physical as well as chemical stability of the products.
-Hence, each pilot plant batch representing the final formulation and
manufacturing procedure should be studied for stability.
- Stability studies should be carried out in finished package as well.