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Oracle Manufacturing Execution System for Process Manufacturing User's Guide
Release 12.1
Part Number E13690-04
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Dispensing

Dispensing the right materials to the right batches prior to the manufacturing process is a key activity in life sciences and other process industries. The process is critical when working with potent active pharmaceutical ingredients (APIs) in drug manufacturing. Decimal errors in API calculation can be life threatening. Companies preweigh materials to avoid these errors and to assure rapid delivery at the critical stages of the drug formulation process.

OPM MES Dispensing lets you deliver material in several modes of operation with full label printing capabilities. Functionality supported includes:

This chapter covers the following topics:

Requirement

Following is a requirement that customers have for supporting dispensing room operations:

Does the application support dispensing room operations?

Yes. Dispensing functionality is a key requirement in the life sciences industry. Dispensing appropriate materials to the right batches prior to the manufacturing process is a key activity in the pharmaceutical and life sciences Industries.

Full Dispensing Room Support

Oracle Manufacturing Execution System (MES) for Process Manufacturing assists the dispensing operator with the in the formulation process by tracking quantities of critical materials used in the manufacturing process. For example, drugs require critical quantities of materials to be added in the manufacturing process. Each material has specific quality parameters and ingredient addition quantities. Oracle Manufacturing Execution System (MES) for Process Manufacturing provides full dispensing room support that is integrated with weigh scale operations to avoid costly manufacturing errors. Drug formulation requires sterile cleanroom environments that must which must be maintained and cleaned according to documented standard operating procedures (SOPs). Weighing equipment must be calibrated and verified. Therefore full dispensing room support for both the environmental conditions and equipment used is essential to accurate drug manufacture.

Understanding Dispensing

Oracle Manufacturing Execution System (MES) for Process Manufacturing manages dispensing and pre-weigh processes to control the labeling, containerization, and delivery of precise quantities of specific materials to their appropriate batch steps. All delivery stages are tracked, including material identification from the point of issue in inventory to point of delivery in the batch manufacturing process. Tracking is critical when working with active pharmaceutical ingredients in drug formulation. Dispensing must meet the guidelines set forth by the U.S. Food and Drug Administration (FDA) regulations (Title 21 Part 211.101). Dispensing is also critical when using ingredients that have hazardous properties such as the volatile organic compounds (VOCs) used in paint and plastics manufacturing. Control over the precise delivery of material is essential to ensure a safe manufacturing process and consistent quality product. Standard weighing scale integration into the dispensing process provides a precise, safe, effective delivery of material. Oracle Manufacturing Execution System (MES) for Process Manufacturing minimizes the risk of data entry errors by removing error prone manual steps from the batch manufacturing process. Dispense material automatically or manually to labeled pallets in the holding cage. The application generates labels for full traceability throughout the manufacturing process. Oracle Manufacturing Execution System (MES) for Process Manufacturing provides online access to standard operating procedures (SOPs), detailed acknowledgeable work instructions, and simplified e-signature processing. This seamless integration streamlines signoff processes for even the most complex batch operations. Operator and supervisor approvals are orchestrated with a complete audit trail that follows current guidelines for good manufacturing practices.

The dispensing functionality:

The functionality supports partial dispenses. Partial dispense is when the full quantity required is not achieved in one dispense, possibly because of the size of the containers into which you are dispensing. For example, the amount required is 112.5 kg, but the minimum number of dispenses to achieve is three: two of 50 kg and one of 12.5 kg. When there is an partial dispense, another dispense is required to complete the allocation for the raw material used in the partial dispense. A check is performed on the reserved material before selecting the raw material so that the actual quantity required displays on the window.

The dispensing functionality is comprised of the following components:

Redispense the dispensed material after a reverse dispense.

Approve dispense operations individually using e-records and e-signatures.

Dispensing Process Flow

Following summarizes the process to dispense material:

  1. Create a batch.

  2. Create detailed reservation for material that must be dispensed.

  3. Acknowledge the defined instructions.

  4. Weigh materials.

  5. Perform dispensing.

  6. Obtain electronic signatures.

  7. Print labels.

Dispensing Features

Following presents the dispensing features provided:

Material Identification

You can identify the material or lots to dispense to the target batch and requisitioned from the warehouse or dispensing store. You can also identify the material or lots required to support dispensing for a specified batch by determining the material or lots reserved for dispensing.

Multiple Dispensing Modes

Following are dispensing modes offered:

Tare Weights

Tare weight is the weight of the actual container when it is empty. The tare weight function lets you:

The tare weight of the target container defaults from the entry made in the Oracle Inventory Item Master. You can enter this value manually.

Note: To set up the container item, navigate to the Item Master Physical Attributes tab. Select Container Item. The UOM must be the dispense UOM for items dispensed into a container. The weight = TARE Wt.

Tolerance

Tolerance is the permitted variation between requested or planned dispense quantity and the actual dispensed quantity.

Label Printing

The label printer automatically prints bar code labels at a specified dispensing location. You can reprint labels. If a label is reprinted, then the print count indicator clearly marks it as a reprint by showing the number of times the label was printed. Printable label types are:

You can specify the label to print in the manual mode of operation. Labels are preselected for printing in the automatic mode of operation.

Reverse Dispensing

A dispensed container can be reverse dispensed in the event of batch cancellation, or when you need to adjust the dispensed material quantity. Reverse dispense either the individual raw material or all the materials for a production batch.

Integration to Instructions

Dispensing and reverse dispensing windows are integrated with instructions. You can acknowledge instructions associated with dispensed material through the Recipe Details window in the Oracle Process Manufacturing Product Development application.

Device or Scale Integration

Dispensing and reverse dispensing windows are integrated with external devices to read weights directly from scales.

E-Record and E-Signature

Dispensing and reverse dispensing windows are integrated with Oracle E-Records to capture e-signatures for dispensing, reverse dispensing, and label printing operations.

Reporting

Generate XML Publisher-based reports to list all the pending dispense operations. These reports are:

Generate a new XML-Publisher based report to list all completed dispense operations. The reports are:

Reserving Material

You must detail reserve material before dispensing it. Refer to the Oracle Process Manufacturing Process Execution User's Guide for details on reserving the material.

Refer to "Dispensing Reserved Material" in this guide for detailed information on dispensing the reserved material.

Searching for Reserved Material to Dispense

Following is the procedure to search for reserved material to dispense.

To search for reserved material to dispense

  1. Navigate to the Dispensable Material window.

  2. Enter any of the following to narrow your search for reserved material.

  3. Deselect the Show Partially Dispensed indicator to display all dispenses where the total dispensed quantity is below the lower tolerance. This is the default. Select this indicator to display all dispenses less than target quantity.

  4. Click Go.

Executing Dispense Instructions

Following is the procedure to view dispense instructions for the material.

To view dispense instructions for the material

  1. Search for a reserved material from the Dispensable Material window. Refer to "Searching for Reserved Material" for detailed information.

  2. Select an item to dispense.

  3. Click Dispense.

  4. Perform tasks as defined in the instructions.

  5. Click Finish to navigate to the Dispense Material window.

Dispensing Reserved Material

Following is the procedure to dispense reserved material for each of the listed modes of operation.

To dispense reserved material using the Full Container mode

  1. Navigate to the Dispense Material window.

  2. Enter the Dispense Number. This is the dispense document number. It is valid only if you have configured manual document number entry. Required.

  3. Select dispensing Mode as Full Container.

  4. Search and select the Source Container by Container Name or Description.

    Note: Container information is set up in the Oracle Inventory Item Master.

  5. Click Read Measure to measure the container weight. The application calculates the full container quantity.

  6. Enter a Security Tag number.

  7. Select Dispense Label and Material Label to indicate label formats for printing.

  8. View the dispense instructions.

  9. View the Partial Dispense History report.

  10. Obtain e-signatures.

  11. Print the labels.

To dispense reserved material using the Source Container mode

  1. Navigate to the Dispense Material window.

  2. Enter the Dispense Number. This is the dispense document number. It is valid only if you have configured manual document number entry. Required.

  3. Select dispensing Mode as Source Container.

  4. Search and select the Source Container by Container Name or Description.

  5. Search and select the Target Container by Container Name or Description.

    Note: Click Read Measure to capture readings directly from an integrated device.

  6. The empty target container weight defaults. Modify this weight if required.

  7. Measure or enter the source container weight.

  8. Transfer the excess material into target container.

  9. Measure the target container weight with the material transferred. The dispensed quantity is calculated and displayed. This quantity is the tare adjusted source container weight minus the tare adjusted target container weight.

  10. Remeasure the source container weight to verify the dispensed quantity.

  11. Enter a Security Tag number.

  12. Select Dispense Label and Material Label to print labels.

  13. View the dispense instructions.

  14. View the Partial Dispense History report.

  15. Obtain e-signatures.

  16. Print the labels.

To dispense reserved material using the Target Container mode

  1. Navigate to the Dispense Material window.

  2. Enter the Dispense Number. This is the dispense document number. It is valid only if you have configured manual document number entry. Required.

  3. Select dispensing Mode as Target Container.

  4. Search and select the Source Container by Container Name or Description.

  5. Search and select the Target Container by Container Name or Description.

    Note: Click Read Measure to capture readings directly from an integrated device.

  6. The empty target container weight defaults. Modify this weight if required.

  7. Measure or enter the source container weight.

  8. Transfer the required material into target container.

  9. Measure the target container weight with the material transferred. The dispensed quantity is calculated and displayed as the tare adjusted target container weight.

  10. Remeasure the source container weight to verify the dispensed quantity.

  11. Enter a Security Tag number.

  12. Select Dispense Label and Material Label to print labels.

  13. View the dispense instructions.

  14. View the Partial Dispense History report.

  15. Obtain e-signatures.

  16. Print the labels.

Searching for Dispensed Material

Use the Dispensed Material Activity window to find dispensed materials and print labels for them. You can reverse dispense from this window. Following is the procedure to search for dispensed material.

Prerequisites:

To search for dispensed material

  1. Navigate to the Dispensed Material Activity window.

  2. Enter as many parameters as needed to complete the search:

  3. Select the reservation Status. The available options include All, Deleted Reservations, and Reverse Dispense Only.

  4. Select Show Zero Net Dispensed Quantity Rows to display all items not yet dispensed.

    Note: Deselect this option for reverse dispensing operations.

  5. Click Go.

Viewing the Dispensed Material Activity Details

Run any pending instructions, print labels, and reverse dispense from the Dispensed Material Activity Details window. Following is the procedure to view the dispensed material activity details. Use this window to:

Prerequisites:

To view the dispensed material activity details

  1. Search for dispensed material from the Dispensed Material Activity window.

    Refer to "Searching for Dispensed Material" for detailed information.

  2. Click Details. The Dispensed Material Activity Details window displays for the selected material:

Viewing Reverse Dispense Instructions

Following is the procedure to view reverse dispensing instructions.

Prerequisites:

To view reverse dispense instructions for the dispensed material

  1. Search for a dispensed material from the Dispensed Material Activity window.

    Refer to "Searching for Dispensed Material" for detailed information.

  2. Select an item for reverse dispensing.

  3. Click Reverse Dispense.

  4. Perform tasks as defined in the instructions.

  5. Click Finish.

Performing Reverse Dispensing

There are several reasons to perform reverse dispensing in production operations. Some typical reasons are:

Following is the reverse dispensing procedure.

Prerequisites:

To reverse dispense reserved material using the Full Container mode

  1. Navigate to the Reverse Dispense Material window

  2. Enter the Dispense Number. This is the dispense document number. It is valid only if you have configured manual document number entry. Required.

  3. Select dispensing Mode as Full Container.

  4. Search and select the Source Container by Container Name or Description.

    Note: Container information is set up in the Oracle Inventory Item Master.

  5. Click Read Measure to measure the source container weight. The reverse dispense weight is calculated.

  6. Enter a Security Tag number.

  7. Select Dispense Label and Material Label to indicate label formats for printing.

  8. View the reverse dispense instructions.

  9. Obtain e-signatures.

  10. Print the labels.

To reverse dispense reserved material using the Source Container mode

  1. Navigate to the Reverse Dispense Material window.

  2. Enter the Dispense Number. It is valid only if you have configured manual document number entry. Required.

  3. Select dispensing Mode as Source Container.

  4. Search and select the Source Container by Container Name or Description.

  5. Search and select the Target Container by Container Name or Description.

    Note: Click Read Measure to capture readings directly from an integrated device.

  6. Measure or enter the source container weight.

  7. Click Reverse Dispense to remove the excess material.

  8. Measure the target container weight with the material transferred. The reverse dispensed quantity is calculated and displayed.

  9. Remeasure the source container weight to verify the reverse dispensed quantity.

  10. Enter a Security Tag number.

  11. Select Dispense Label and Material Label to print labels.

  12. View the dispense instructions.

  13. View the Partial Dispense History report.

  14. Obtain e-signatures.

  15. Print the labels.

Viewing the Reverse Dispensed Material Activity Details

Run any pending instructions, or reprint the reverse dispense labels. Following is the procedure to view the reverse dispensed material activity details.

Prerequisites:

To view the reverse dispensed material activity details

  1. Navigate to the Dispensed Material Activity Details window.

  2. View the Reverse Dispense History of an item.

  3. Click Details to display the material activity details.

    Note: Refer to "Viewing the Dispensed Material Activity Details" for explanations of the fields displayed on the Reverse Dispensed Material Activity Details window.

Running Reports for Dispensing Operations

The Dispense Dispatch report lists all the pending dispenses. The Dispense History report lists all the completed dispense operations.

To run and print the Dispense Dispatch report

  1. Navigate to the Submit a New Request window:

    Select MES for Process Manufacturing Administrator: Request : Run.

  2. Select the request type as Single Request.

  3. Select OK.

  4. Enter Dispense Dispatch Report as the request Name.

    If you are submitting a request set, then enter the Request Set name in the Submit Request Set window.

  5. Complete the other fields on the window. See: Overview of Standard Request Submission, Oracle E-Business Suite User's Guide

  6. Select the various parameters such as Plant, Dispense Area, Batch, From and To dates.

  7. Select Submit Request.

    Following is the output of the Dispense Dispatch report:

To run and print the Dispense History report

  1. Navigate to the Submit a New Request window:

    Select MES for Process Manufacturing Administrator: Request : Run.

  2. Select the request type as Single Request.

  3. Select OK.

  4. Enter Dispense History Report as the request Name.

  5. Complete the other fields on the window. See: Overview of Standard Request Submission, Oracle E-Business Suite User's Guide

  6. Select the appropriate parameters for the report such as Plant, Dispense Area, Batch, From and To dates.

  7. Select Submit Request.

    To submit another request, select Yes.

  8. Following is the output of the Dispense History report: