med 18

 

polymers

Maintaining the appearance Colorings, stabilizers, antimicrobial

of suspension preservatives, suspending agents,

flocculating agent

Increasing the connection Wetting agents

between API and vehicle

Masking of taste and smell Sweetners, flavouring agent

3. Emulsion Protecting the API Buffers, Antioxidants, Preservatives,

polymers

Particle size Solid particles, droplet particles

Maintaining the appearance Colorings, stabilizers, antimicrobial

of emulsion preservatives, emulsifying agents,

penetration enhancer, gelling agents

Masking of taste and smell Sweetners, flavouring agent

General Considerations and Pilot-Plant Considerations for Different Dosage Forms 21

2.5 DOCUMENTATION

The documentation is an essential part of pilot-plant scale-up process because of the

following “reasons”.

i. Act as a source of data for large-scale production

ii. Helps in the transfer of technology at pilot-plant scale-up stage only

iii. Helps in analysing the problems that can be there at the commercial stage

iv. Provides an efficient way of sharing knowledge

v. Supports the maintenance and enhancement of the system

vi. Facilitates internal communication between departments

vii. Helps in review procedure at any time and at any scale of production of the

concerned product

viii. Good documentation helps personnel by giving them sorted documents. They

only have to deal with the content relevant to them which saves time and increase

the efficiency level

ix. Provides a clear description of the responsibilities of different departments/

personnel

x. Provides data related to other activities like any updates, amendments, circulars,

notices, etc during scale-up or pilot-plant study

xi. Helps in identification of changes and reason for those changes during the process

xii. Helps in consulting previous historic versions where relevant

The documentation in scale-up is done stagewise. There are four stages in the scaleup process or we can call it as there are mainly four process scale-up batches (Fig. 2.5).