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Exercise 8: Sample Plans

Reference Material

Sample Plans

Exercise Objectives

  • Part 1: Add two (2) new Sample Points to an existing Step

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

Scenario

Throughout production, quality and retain samples are collected at defined points in the process. In CAR T Processing, a quality sample is collected before cell washing, and a retain sample is collected post-wash.

In this exercise, you will be adding these Sample Points to the process.

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Your Task

Part 1: As a Super User, you have been asked to add two (2) Sample Points to the Sepax Step.

Manufacturing Operations has provided the following requirements:

Cell Counting Samples (samples taken pre-wash)

  • Position: immediately downstream of the 2 mL Cryovial field

  • Name: Cell Counting Samples

  • Sub-Step: Cell Counting

  • Instructions: Before executing the cell wash, take samples for an initial cell count.

  • Sample Types: Whole Blood Sample

  • Min: 1 | Max: 2

Buffy Coat Samples (samples taken post-wash)

  • Position: immediately downstream of the Sepax Operation Errors field

  • Name: Buffy Coat Samples

  • Sub-Step: Post Sepax Sampling

  • Instructions: Under laminar flow, mix the final product and use the dedicated syringe port on the "Y" connector to take samples.

  • Sample Types: Buffy Coat Sample

  • Min: 1

Part 2: Create a new Batch Record for CAR T Processing to confirm that these requirements were modeled correctly. How do you know what ID to assign to each Sample?

In this section: