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1.3 SCALE-UP

It is defined as an art for designing of prototype using the data obtained from the

pilot-plant process/model. The size of set up is bigger than pilot-plant but smaller

than commercial manufacturing.

1.3.1 Need of Scale-up

1. A well-defined process is needed for manufacturing of product at commercial-scale.

Scale-up is the most trustworthy process to create that.

2. A product may give perfect results at laboratory scale and pilot-plant but may fail

in quality assurance at a commercial scale. It will cause huge loss to the manufacturer.

So, to avoid that loss scale-up is the method where behaviour of product at largescale can be determined and improvements can be done accordingly.

3. Processes are scale-dependent. Processes behave differently on a small-scale and

large-scale. So, scale-up is necessary to determine the scale effect on process and to

generate a well-defined process design for commercial scale.

1.3.2 Steps in Scale-up

The various steps involve in scale-up are shown in Fig 1.1.

Fig. 1.1: Steps of scale-up

6 Industrial Pharmacy II

1. Define product economics: All the financial prospects related to product should be

defined at the first step. The product economics is defined based on market size,

competitors in the market. It will provide guidance for permissible manufacturing

costs.

2. Conduct of laboratory studies and scale-up techniques: The conduct of laboratory

studies and scale-up techniques should be done at the same time. It will help in

identifying the need for change at the laboratory-scale itself.

3. Identification of key-controlling steps: During the laboratory studies a proposed

process will be created. In this step, the main rate-controlling steps of the proposed

process will be identified.

4. Conduct large-scale studies: In this step, the preliminary larger than laboratory

studies will be done. These studies should be done with the same equipment which

is to be used in the rate-controlling step. It will help as an aid in plant design.

5. Design, construction and evaluation of pilot-plant results: In this step a pilotplant which has provisions for process and environment controls, packaging and

waste handling systems, cleaning and sanitizing systems, regulatory compliance,

etc will be designed and constructed. After designing and construction evaluation

of the pilot-plant results for both product as well as process will be done. The product

economics will also be considered in the evaluation process because it helps in

making corrections as per permissible limit of money. This step is the final step and

needs for making a decision on whether or not to proceed with a full-scale plant

development.

1.3.3 Objectives of Scale-up

i. To produce physically and chemically stable quality therapeutic and diagnostic

drugs