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Planner

Section Goals

After completing this section, you will:

  • Understand the role of the Planner

  • Know how to create Batches

  • Know how to print Sample labels

Term

Definition

Batch

Manufacturing run to produce a Product.

Product

The therapeutic being manufactured.

Recipe

Manufacturing process to produce a Product.

Specification Plan

Numeric fields with upper and/or lower limits in the Batch process (Recipe).

Sample Plan

Number and type of Samples collected in the Batch process (Recipe).

MES Tab

Activity

Permission(s)

Landing Page

Create Batch

MES → Batch Creation

LIMS → Workflow Chain Instance → Create

Sample Plan

Print labels

MES → Batch Creation

Analysis → Pipeline → Execute

The Planner is responsible for creating Batches and printing Sample labels. To complete these tasks, they use the L7 MES landing page and Sample Plan tab within the Batch Record.

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The L7 MES landing page displays all Batches that have been created in L7 MES. To review or work with a Batch, select the relevant Batch Number.

Batches are listed in descending order of their creation date, and organized into three tabs:

  • In Process – Batches that are currently active (default view)

  • Completed – Batches that have been completed or failed

  • All – in-process and completed Batches

All three tabs display the same Batch details:

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  • Batch Number – name of the Batch

  • MBR Process – Recipe used for the Batch

  • MBR Process Version – Recipe version used for the Batch

  • Current Batch Sections:

    • If the Batch is in process, this column lists all active Batch Sections

    • If the Batch is completed, this column lists the last Batch Section

    • If the Batch is failed, this column lists the last Batch Section that was active at the time of failure

  • Status:

    • In process – data is actively being collected

    • In review – all Sections and Steps have been completed, but at least one Step requires review

    • Reviewed – all Sections and Steps have been reviewed, and the Batch is ready for quality review signatures

    • Sign-off – quality review signatures are complete, and the Batch is ready for final sign-off

    • Complete – all work for the Batch is complete

    • Failed – the Batch has been failed

  • Started – date time the Batch was created

  • Last Update – last date time any activity was recorded for the Batch

Follow the steps below to create a new Batch.

  • From the L7 MES landing page, select + New Batch Record

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  1. Enter a Batch Name (free-form text)

  2. Select which Product is being manufactured

    1. The Process (Recipe) is auto-populated due to its linkage with the Product

  3. Select which Version of the Process to use

Note

Production environments should only use pinned versions

  1. Select a Specification Plan (optional)

  2. Select a Sample Plan (optional)

  3. Enter any additional Batch-specific information that may be required

    1. Depending on how the manufacturing process has been configured, the Planner may need to enter additional information about the Batch, including Kit assignments.

  4. Click Create

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During Batch creation, L7 MES reserves Sample IDs so that labels can be printed for use in the Batch. These labels are typically attached to the Sample and scanned during production to complete registration.

Labels can be printed at any time during processing, but the Planner typically prints them before Batch processing begins.

Follow the steps below to print Sample labels.

  1. Go to the Sample Plan tab

  2. Click Print Labels at the top of the tab

  3. Select a Printer

  4. Select the labels to print:

    1. All samples in the entire Batch – print one (1) label for every Sample ID reserved for the entire Batch

    2. All samples within a Batch Section – print one (1) label for every Sample ID reserved in the selected Batch Section

    3. Specific Sample Point – print one (1) label for every Sample ID reserved in the selected Sample Point

  5. Click Print

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If printing is successful, the Print Count for each label is incremented.

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