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Exercise 9: Specifications

Reference Material

Specifications

Exercise Objectives

  • Part 1: Create two (2) new Spec Types

  • Part 2: Add Specifications to CAR T Processing

  • Part 3: Create a new Batch Record in MES to test these changes

Scenario

In manufacturing, a number of critical and key process parameters and quality attributes are recorded in the Batch Record. In CAR T Processing, some of these specifications still need to be defined.

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Your Task

Part 1: As a Super User, you have been asked to add the following Spec Types:

  • KPP (Key Process Parameter)

  • KPI (Key Process Indicator)

Tip

Spec Types are managed in the Configuration app.

Part 2: Add the following Specifications to CAR T Processing:

Cleanroom Line Clearance Sub-Step

  • Field: Line Clean Duration

  • Critical Quality Attribute

  • Measured in min

  • Must be at least 15

Cell Counting Sub-Step

  • Field: VCD

  • Critical Process Parameter

  • Measured in x10^5 cells/mL

  • Must be between 1 and 2.5

  • Field: Viability

  • Critical Process Parameter

  • Measured in %

  • Must be at least 80

Part 3: Create a new Batch Record for CAR T Processing to confirm that these requirements were modeled correctly.

Tip

Questions to consider:

  • Where is the defined range displayed in the Batch Record?

  • How do you know if the recorded value is in-range?

  • Where is the spec type displayed in MES?

In this section: