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Exercise 1: Creating Steps and Sub-Steps

Reference Material

Modeling Steps (Protocols)

Objectives

  • Part 1: Update an existing Step in the Protocol builder

  • Part 2: Create a new Batch Record in MES to test these changes

Scenario

Before a product can be manufactured, the manufacturing suite must be cleared and cleaned with a sanitizing agent.

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Your Task

Part 1: As a Super User, you have been asked to add Line Clearance activities and instructions to an existing manufacturing process for CAR T-cells.

Manufacturing Operations has provided the following requirements:

Cleanroom Step

  • Step instructions that read:

    • Complete the Cleanroom Line Clearance per SOP-5256. Ensure the Line Clearance has been reviewed by QA, and that the room has been released for manufacturing.

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  • New Sub-Step named Cleanroom Line Clearance with a Sub-Step Table named Line Clearance

    • This new Sub-Step Table has the following fields:

      • Line Clearance instructions that read:

        • Enter the Cleanroom and verify that all previous production materials have been removed. Verify trash liners are empty and free of any residual material or packaging.

      • Line Clearance Location with the following options:

        • Cleanroom 1

        • Cleanroom 2

      • Line Clearance Date Time in the format YYYY-MM-DD HH:mm Z

Note

These fields should be the first three (3) fields in the Step.

Part 2: Create a new Batch Record for CAR T Processing to confirm that these requirements were modeled correctly.

In this section: