1. Trial batches

2. Pre-exhibit batches

3. Exhibit batches

4. Validation batches

Trial Batches

These are the batches with small batch size. These batches are prepared after R&D

division work. In these batches, the stability and dissolution of product are checked.

These batches provide products for animal studies and clinical trials.

Table 2.10: Parameters of equipment used are to be considered during pilot-plant scale-up of

semisolids

Name of equipment Parameters to be considered

Mixing equipment Should efficiently move the semisolid mass from outside walls to the

centre and from bottom to top of the container

Motors Should handle the product at its most viscous stage

Transfer pumps Should be able to move any type of viscous material. It should not apply

excessive shear during the transfer process and also should not

incorporating air.

The following factors should be considered while choosing size and

type of pump

• Viscosity of product

• Required pumping rate

• Product compatibility with pump surface

• Required pumping pressure

22 Industrial Pharmacy II

Pre-Exhibit Batches

It has 70% of the size of the exhibit batch. In this batch, complete process documentation

is done. The fully validated analytical methodology is used at this stage. It helps in

detecting any problem that may arise during the manufacturing of exhibit batch.

Exhibit Batch

It is demonstration batch having main purpose of getting approval in the market from

a regulatory agency. It has 10% of the production scale batch. It contains all

manufacturing documentation, specifications, stability data reports, etc. It is

manufactured under GMP compliance. It is also called NDA or ANDA, bioequivalence,

regulatory reference or stability tested batch.

Validation Batch

The production of validation batches started after the regulatory agency of concerned

country approved the drug. The validation batches are divided into three parts:

i. Batch 1

ii. Batch 2

iii. Batch 3