Overview

By creating and managing input, intermediate, and output materials, you can maintain a high level of control and visibility over the entire manufacturing process. This not only helps ensure product quality and consistency but also streamlines compliance with regulatory requirements.

Steps

1. Log in to your company’s Sandbox and navigate to an existing Project (this can be the project you created in a previous exercise or an existing practice project in your Sandbox).

2. Open the “Cell Culture (or Fermentation)” Unit Operation you created in an earlier exercise.

   1. See Creating Process Records if none exist

3. Go to the Sterilization and Media Preparation Step

   • Click the "+" sign to add a new Project Material

   • Name: Cell Culture Media

   • Other Fields to complete:

     1. Category: Media

     2. Use: DS

   • Scroll down to "Relationship to Process"

   • Check that Input Material is selected and then select "Cell Culture (or Fermentation)" as the Unit Operation and "Sterilization and Media Preparation" as the Step.

   • Click "Save Draft"

4. Go to the Inoculation and Culture Growth Step

   • Click the "+" sign to add a new Project Material

   • Name: Inoculum

   • Other Fields to complete:

     1. Category: Other Material

     2. Use: DS

   • Scroll down to "Relationship to Process"

   • Check that Input Material is selected and then select "Cell Culture (or Fermentation)” as the Unit Operation and "Inoculation and Culture Growth" as the Step.

   • Click "Save Draft"

5. Go to the Inoculation and Culture Growth Step

   • Click the "+" sign to add a new Project Material

   • Name: Cell Culture Broth

   • Other Fields to complete:

     1. Category: Other Material

     2. Use: DS

   • Scroll down to "Relationship to Process"

   • Select Output Material and then select "Cell Culture (or Fermentation)" as the Unit Operation and "Inoculation and Culture Growth" as the Step.

   • Click "Save Draft"