The document discusses pilot plant scale-up techniques in pharmaceutical manufacturing, emphasizing its role in transforming lab-scale formulas into viable products through process validation and production control. It outlines the significance of pilot plants for investigating product and process viability, generating data for full-scale production decisions, and training personnel. Additionally, it highlights the need for optimizing processes, ensuring quality, and complying with regulations in the transition from research and development to commercial production.

1. PILOT PLANT SCALE UP
TECHNIQUES
Dr. Mahesh Kumar Kataria
Professor and Head, Department of Pharmaceutics,
Seth G. L. Bihani S. D. College of Technical
Education, Sri Ganganagar
Email: kataria.pharmacy@gmail.com
Dr. Mahesh Kumar Kataria 1

2. PILOT PLANT SCALE UP TECHNIQUES
Pilot plant:
“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.”
• Pre-commercial production system.
• knowledge obtained used for design of full-scale production.
• Non-technical purposes- public support for new technologies
and government regulations.
• Pilot plant studies include-
Close examination of formula to withstand batch scale,
Process modifications,
Availability of raw materials meeting the specification of
product.
Production and process control-evaluated, validated and
finalized.
Dr. Mahesh Kumar Kataria 2

3. Need of Pilot Plant Studies:
• Investigation of product and process on an intermediate
scale production.
• Not possible to design a large scale complex processing
plant.
Application of pilot plant:
• Evaluation of results from laboratory studies,
• Producing small quantities 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.
• Providing data to decide to proceed or not for full-scale
production.
• If proceeding - designing and constructing a full-size plant
or modifying an existing plant.Dr. Mahesh Kumar Kataria 3

4. Considerations in pilot plant development
• Kind and size –evaluating product and process by producing
samples
• Location: near R&D or existing plant? Close liaison between
R&D and pilot plant staff.
• Labor requirements and costs: engineering staff, skilled
operations and maintenance staff- pilot plant costs may
exceed.
• The pilot plant may be used for training personnel for a full-
scale plant.
Dr. Mahesh Kumar Kataria 4

5. Objective
• To try process on proposed model before investing large
money.
• Examination of the formula withstanding Batch-scale
• Evaluation and validation for process and equipments.
• To identify the critical features of the process
• Guidelines for production and process controls.
• To provide master manufacturing formula with instructions.
• To avoid the scale-up problems.
Dr. Mahesh Kumar Kataria 5

6. Significance/Importance of Pilot Plant
• Standardization of formulae.
• Review of range of relevant processing equipments.
• Optimization and control of production rate.
• Identification of critical features to maintain quality of a
product.
• Appropriate records and reports to support GMP
Dr. Mahesh Kumar Kataria 6

7. Pilot plant- Transferring the results of R&D to pilot plant and finally to
production scale
Also provides data- decision whether or not to proceed to a full-scale
production process.
Figure 1.1: Pilot Scale and Scale-Up
Figure 1.2: Meaning of Pilot Scale and Scale-Up
Dr. Mahesh Kumar Kataria 7
Pilot Scale Intermediate
batch scale
Manufactures drug product by a
procedure stimulatory to that of
manufacturing scale
Scale up Next to
Pilot scale
Process of increasing the batch size
(mixing) / procedure for applying the
same process to different output
volumes (tableting)

8. Scale Up Process
•Process of increasing the batch size.
•Batch size enlargement does not always translate into a size
increase of processing volume.
•Intermediate batch scale.
•Production of enough product for clinical testing and samples for
marketing.
Dr. Mahesh Kumar Kataria 8

9. The pilot plant scale up is performed because;
•Not possible to design a large scale processing plant from
laboratory data alone.
•Huge amounts of money invested to full-scale production.
•To evaluating results of laboratory studies, making product
and process corrections.
•To develop a master manufacturing formula (Critical steps,
raw materials handling and its specifications update the
processing equipment, to evaluate, validate and finalized the
production and process controls)
•To develop & formulate physically & chemically stable
therapeutic dosage forms.
Dr. Mahesh Kumar Kataria 9