Pilot-Plant Scale-up Techniques

2 Industrial Pharmacy II

The pharmaceutical industry is growing with high speed in the last few years. New

drugs, as well as generic drugs, have been coming in the market. Research and development sector is also growing with good growth rate. Researchers are encouraged to

use the latest processes and technologies. In short, Cona, the pharmaceutical industry,

has witnessed significant innovations and inventions coming day by day. A huge sum

of money is invested in the pharmaceutical production to this much loss unit. According to a recent study, developing a new prescription medicine which gains market

approval is estimated to cost drug makers nearly $2 billion. One cannot afford loss

after setting up a commercial production unit.

So to avoid this loss, a replica of the main design has been set up but at a smallscale. This is known as pilot-plant and the data obtained from this pilot-plant is used

in establishing a commercial plant is known as scale-up. If we go with the dictionary

meaning then the pilot-plant is a “small factory that is built as a model to test systems

and processes before building other similar factories” and scale-up is “to increase the

size, amount, or importance of something, usually an organization or process.” In the

pharmaceutical industry pilot-plant scale-up techniques have different considerations

for different dosage forms.

1.1 PLANT

A plant can be defined as a place where 5Ms like money, material, method, man and

machines are brought together for the manufacturing of products. A plant contains all

assets of business like land, money, equipment, employees, etc. In the pharmaceutical

industry a plant is used as a synonym for manufacturing plant where drug/medical

devices/cosmetics manufacturing is going on. Various guidelines by regulatory authorities have to be followed by the manufacturer before setting up a manufacturing

plant in the pharmaceutical industry. There are several types of manufacturing plants

in the pharma industry like API manufacturing plant, formulation manufacturing plant,

contract manufacturing plant, etc.

1.2 PILOT-PLANT

There is a saying that “commits your blunders on a small-scale and make up your

profits on a large-scale.”

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Introduction to Pilot-Plant and

Scale-up

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