In the Recipe designer, you must create one or more Unit Operations to be able to execute your Recipe. You can also optionally configure Definitions and Steps for each Unit Operation to provide operators with the information they need.
In this article, we will learn how to configure a Unit Operation, Definitions, and Steps in the Recipe designer.
Step 1: Rename the Default Unit Operation
When you enter the Recipe designer, one untitled Unit Operation will automatically be generated.
Use the textbox to enter the name of your Unit Operation then click the the ✔️ icon to save the name.
If you click away from the Unit Operation and the textbox disappears, or if you need to rename the Unit Operation, double click on the existing name to access the textbox.
Step 2: Create a New Unit Operation
Click the + icon to the left or right of your first Unit Operation to add a new Unit Operation. Use the textbox to name it, then click the ✔️ icon to save the name.
Create additional Unit Operations as needed for your process by repeating this step until all the Unit Operations that you need are represented in your Recipe.
Step 3: Configure Definitions
Next, enter Definitions for each Unit Operation (e.g., Parameters, Material Inputs, Material Outputs, Equipment) by clicking the gear icon on the Unit Operation. Select the Edit details option.
In the modal that comes up, click the Edit button in the upper right corner. Fill out the relevant Definition table(s) that you would like to capture for the Unit Operation. You are required to fill out the name and type columns for each Definition that you add.
- Note: Each material, parameter, and equipment defined within a Unit Operation must have a unique name.
Once you’ve completed the relevant table(s), click the Submit button in the upper right corner. Navigate to the next Unit Operation you’d like to add a definition for using the Flowchart > Edit dropdown. Or, you can navigate back to the overall Recipe by selecting “Flowchart” in the top left corner of the screen.
Step 4: Configure Steps
If you are already in the Edit details modal of a Unit Operation, click on the Step Configuration tab at the top of the modal to configure Steps for a Unit Operation. If you are not, click the gear icon of the Unit Operation and select the Edit details option before clicking on the Step Configuration tab of the modal.
In the Step Configuration tab, click the + Add step option in the Step Group (e.g., Pre-run, Run, Post-run) that you want to create a Step for. Click into the title area of the entry that appears on the right side and replace the default title (Untitled step) with the name of your Step.
Add any check-lists, structured tables, or unstructured tables to the body of the Step. Click the + Add step option to add more steps within the Step Group or to another Step group.
Navigate to the next Unit Operation you’d like to configure Steps for using the Flowchart > Edit dropdown.
Note: you must add a title to your Step in order to execute your Recipe.
Once you’ve configured your Unit Operations, you are able to create a Study to execute your Recipe.
Pro-tip
- In the Recipe designer, you can drag and drop Unit Operations to re-order them
- When configuring Steps, you don’t need to manually add Steps to confirm and record parameters, material inputs, material outputs, or equipment. These Steps will be automatically generated in the Unit Operation Worksheet when you create your Study based on the Definitions tables you set up for each Unit Operation.
Unit Operations Best Practices
Here are some guidelines to help you determine when a single process should use one or multiple unit operations:
Indicators of Multiple Unit Operations:
- Equipment Transfers: If materials are entirely moved from one piece of equipment to another (e.g., from a bioreactor to a centrifuge), this typically indicates separate unit operations.
- Distinct Parameter Sets: When a process involves two or more sets of distinct parameters and values, it likely consists of multiple unit operations.
- Intermediate Production: The creation of a process intermediate that can be stored or frozen for use in subsequent steps may suggest separate unit operations.
- Independent Optimization: If two parts of the process can be optimized or experimented with independently, they should be considered separate unit operations.
- Documentation Separation: In documentation, such as batch records, if an activity is delineated with a major header, a page break, or requires a different document, it usually marks a new unit operation.
- Sub-Cultivations: In processes like cell culture, where there are multiple distinct sub-cultivations (e.g., N-2, N-1, N stages), each stage should typically be treated as a separate unit operation.
When Not to Split Unit Operations:
- Minor Parameter Changes: A small change in parameters, such as a temperature shift during a culture, does not necessarily require a division into multiple unit operations. Instead, model these as individual parameters within a single unit operation.
- Extended Processes: Processes that extend over several days, such as a 10-day cell culture, should generally be considered a single unit operation unless there are significant changes in the process conditions or equipment used.
Additionally, as you configure your Steps and Worksheets within a Unit Operation, we recommend creating sub-templates for common actions or instructions. This allows you to easily insert them into Worksheets during configuration or execution. For example, if you perform multiple cell counts across different Unit Operations, you can create a sub-template with instructions and schemas for cell counts, and quickly insert the sub-template into all the appropriate Steps and Unit Operations of the Recipe that require a cell count.