ii. To review the processing equipment used in the manufacturing of a product

iii. To check compliance with guidelines for production and process control

iv. To conduct evaluation and validation of process

v. To identify the critical characteristics of the process

vi. To provide master manufacturing formula

1.3.4 Relation between Pilot-Plant and Scale-up (Figs 1.2 and 1.3)

Fig. 1.2: Relations between pilot-plant and scale-up

Introduction to Pilot-Plant and Scale-up 7

PRACTICE QUESTIONS

Long Answer Type Questions

1. Define pilot-plant. Explain pilot-plant operations and need for conducting pilotplant studies.

2. Explain scale-up process. What are the steps in conducting scale-up studies?

Short Answer Type Questions

1. What is pilot-plant? Explain the reasons for conducting pilot -plant studies.

2. Define scale-up and elaborate the need for scale-up.

3. Describe the relation between pilot-plant and scale-up.

4. What are the objectives of establishing pilot-plant?

Objective Type Questions

1. Which of the following is/are reason for conducting pilot-plant studies?

a. Evaluation of results b. Determination of waste products

c. Decision making d. All of the above

2. The manufacture of either drug or drug product by a procedure fully representative

of and stimulating that used for full manufacturing scale is known as

a. Pilot-plant b. Validation

c. Scale-up d. Commercial production

3. Which of the following is one of three key objectives of designing pilot-plant?

a. Clinical supply manufacture b. Profit making

c. Marketing d. None of the above

4. The plant size of set up is bigger than pilot-plant but smaller than commercial

manufacturing is known as

a. Scale-up b. Clinical trial batch

c. Trial batch d. None of the above

5. Which of the following provides base for commercial-scale production?

a. Pilot-plant b. Scale-up

c. Trial batch d. All of the above

Fig. 1.3: Different steps followed in the development process of the product from laboratory-scale to

commercial-scale

8 Industrial Pharmacy II

6. Arrange the following in accordance with the development process

1. Pilot-plant

2. Laboratory-scale

3. Scale-up

4. Commercial-scale

a. 1, 2, 3, 4 b. 3, 1, 2, 4

c. 2, 1, 3, 4 d. 4, 3, 2, 1

7. Match the following

Content Terminology

1. Batch size is larger than pilot-plant but smaller a. Quality assurance

than commercial-scale.

2. Releasing and testing of finished products. b. Pilot-plant

3. Testing of products in-between processes. c. Quality control

4. When a lab-scale formula is transferred before d. Scale-up

commercial batch production

8. Fill in the blanks

a. A plant can be defined as a place where Ms like ____________, _____________,

method, man and ___________ are brought together for manufacturing process.

b. Scale-up is defined as art of designing of ___________ using the data obtained

from _____________ process/model.

c. Pilot-plant is larger than ____________ scale.

d. Pilot-plant provides base for ____________.

e. Validation, training, engineering, maintenance, ____________, material control,

___________, orders, ____________ are operations of pilot-plant studies.

ANSWERS