Unit Operation

Definition

A unit operation is a discrete, defined step within the overall manufacturing process, such as mixing, granulation, drying, or compression, that transforms materials in a specific way. Unit operations are the building blocks of the Master Batch Record, each with its own defined parameters, controls, and documentation requirements.

Benefits

Structuring the EBR around discrete unit operations, each with clearly defined parameters and required documentation, makes it easier to isolate exactly where in the process a deviation occurred, rather than treating the entire batch record as an undifferentiated sequence of steps.

Use Case

A deviation investigation needs to determine whether an issue originated during the granulation or compression unit operation. Because the EBR organizes the batch record by discrete unit operations, the investigation team can quickly isolate the data, equipment, and parameters specific to each step rather than reviewing the entire batch record undifferentiated.

Frequently Asked Questions (FAQ)

Related Terms

• Master Batch Record (MBR)
• Critical Process Parameter (CPP)