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:
Dispensing modes
Tolerances
Label printing
Scale reading
Reverse dispensing
This chapter covers the following topics:
Following is a requirement that customers have for supporting 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.
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:
Displays dispense pending detail reservations based on the parameters used for query.
Lets you acknowledge all instructions defined for dispensing.
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:
Dispensing Process
Label Printing
Reverse Dispensing
Scale Integration
Integration to instructions and e-records
Dispense Dispatch and Dispense History reports
Redispense the dispensed material after a reverse dispense.
Approve dispense operations individually using e-records and e-signatures.
Following summarizes the process to dispense material:
Create a batch.
Create detailed reservation for material that must be dispensed.
Acknowledge the defined instructions.
Weigh materials.
Perform dispensing.
Obtain electronic signatures.
Print labels.
Following presents the dispensing features provided:
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.
Following are dispensing modes offered:
Full Container Dispense mode is used to deliver the total quantity of material present in the source container. The source container is released to the production batch for consumption.
Source Container Dispense mode is used to deliver material from a source container. The whole source container is released to the production batch. Required material is dispensed and consumed by the batch. Any remaining material is physically transferred to a new target container, and returned to the warehouse.
For example, a formula requires 45 kilograms (kg) of material. The source container quantity is 50 kg, and 5 kg is removed to a new container in the dispensing process for return to stock. The remaining 45 kg in the source container is dispensed to the batch.
Target Container Dispense mode is used to deliver material from a target container. Required material is dispensed from a source container to a target container in the dispensing process. The target container material is consumed by the batch. Material remaining in the source container is returned to the warehouse.
Tare weight is the weight of the actual container when it is empty. The tare weight function lets you:
Capture tare weight data
Store the average tare weight for a container in the Item Master
Use tare weight to calculate the quantity to dispense
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 is the permitted variation between requested or planned dispense quantity and the actual dispensed quantity.
The dispensing tolerance is stored in the dispensing setup.
The dispensing tolerance is applied both during dispensing and after confirmation that the dispense is complete. If a batch is only partially dispensed, then the lower tolerance is applicable only to the total quantity and not to the partial quantity dispensed.
It is possible to maintain the tolerance either as a percentage or as a quantity.
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:
Dispense Pallet label to identify a pallet of dispensed materia for a single production batch.
Process Dispense Material to identify the material dispensed.
Process Material label to identify material left over from a dispensing operation. This label assists in returning the excess material to stores.
You can specify the label to print in the manual mode of operation. Labels are preselected for printing in the automatic mode of operation.
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.
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.
Dispensing and reverse dispensing windows are integrated with external devices to read weights directly from scales.
Dispensing and reverse dispensing windows are integrated with Oracle E-Records to capture e-signatures for dispensing, reverse dispensing, and label printing operations.
Generate XML Publisher-based reports to list all the pending dispense operations. These reports are:
Pending Dispense Activity List
Dispense Dispatch
Generate a new XML-Publisher based report to list all completed dispense operations. The reports are:
Completed Dispense
Dispense History
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.
Following is the procedure to search for reserved material to dispense.
To search for reserved material to dispense
Navigate to the Dispensable Material window.
Enter any of the following to narrow your search for reserved material.
Select an Organization. Required. The list displays only the process-enabled organizations.
Search and select a Dispense Area by the Description.
Search and select a Batch. The list displays only the pending and work in process (WIP) batches in the selected organization.
Select a Batch Step number.
Search and select an Ingredient by Name or Description.
Search and select a Product by Name or Description.
Select a From Date and To Date from the calendar to refine the search to the batch material requirement date.
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.
Click Go.
Following is the procedure to view dispense instructions for the material.
To view dispense instructions for the material
Search for a reserved material from the Dispensable Material window. Refer to "Searching for Reserved Material" for detailed information.
Select an item to dispense.
Click Dispense.
Perform tasks as defined in the instructions.
Click Finish to navigate to the Dispense Material window.
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
Navigate to the Dispense Material window.
Enter the Dispense Number. This is the dispense document number. It is valid only if you have configured manual document number entry. Required.
Select dispensing Mode as Full Container.
Search and select the Source Container by Container Name or Description.
Note: Container information is set up in the Oracle Inventory Item Master.
Click Read Measure to measure the container weight. The application calculates the full container quantity.
Enter a Security Tag number.
Select Dispense Label and Material Label to indicate label formats for printing.
View the dispense instructions.
Obtain e-signatures.
Print the labels.
To dispense reserved material using the Source Container mode
Navigate to the Dispense Material window.
Enter the Dispense Number. This is the dispense document number. It is valid only if you have configured manual document number entry. Required.
Select dispensing Mode as Source Container.
Search and select the Source Container by Container Name or Description.
Search and select the Target Container by Container Name or Description.
Note: Click Read Measure to capture readings directly from an integrated device.
The empty target container weight defaults. Modify this weight if required.
Measure or enter the source container weight.
Transfer the excess material into target container.
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.
Remeasure the source container weight to verify the dispensed quantity.
Enter a Security Tag number.
Select Dispense Label and Material Label to print labels.
View the dispense instructions.
Obtain e-signatures.
Print the labels.
To dispense reserved material using the Target Container mode
Navigate to the Dispense Material window.
Enter the Dispense Number. This is the dispense document number. It is valid only if you have configured manual document number entry. Required.
Select dispensing Mode as Target Container.
Search and select the Source Container by Container Name or Description.
Search and select the Target Container by Container Name or Description.
Note: Click Read Measure to capture readings directly from an integrated device.
The empty target container weight defaults. Modify this weight if required.
Measure or enter the source container weight.
Transfer the required material into target container.
Measure the target container weight with the material transferred. The dispensed quantity is calculated and displayed as the tare adjusted target container weight.
Remeasure the source container weight to verify the dispensed quantity.
Enter a Security Tag number.
Select Dispense Label and Material Label to print labels.
View the dispense instructions.
Obtain e-signatures.
Print the labels.
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.
Dispense material.
Optionally, identify the requirement to print labels for dispensed material.
To search for dispensed material
Navigate to the Dispensed Material Activity window.
Enter as many parameters as needed to complete the search:
Select an Organization from the list. Required.
Search and select a Dispense Area from the list by Dispense Area name or Description.
Search and select a Batch from the list. The list displays only the pending and work in process (WIP) batches in the selected organization.
Select a Batch Step number.
Search and select an Ingredient by Name or Description.
Search and select a Product from the list by Name or Description.
Narrow your search by selecting the material dispense date as, From Date, To Date.
Select the reservation Status. The available options include All, Deleted Reservations, and Reverse Dispense Only.
Select Show Zero Net Dispensed Quantity Rows to display all items not yet dispensed.
Note: Deselect this option for reverse dispensing operations.
Click Go.
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:
Determine if all instructions were performed.
View the Reverse Dispense History.
Associate scanned labels to their corresponding label history record. This record becomes part of the Control Batch Record (CBR) when you select the GMO Label category before you upload the scanned label images.
Create dispensable material.
Optionally, run pending instructions, print labels, or scan labels for upload to the dispensed material record.
To view the dispensed material activity details
Search for dispensed material from the Dispensed Material Activity window.
Refer to "Searching for Dispensed Material" for detailed information.
Click Details. The Dispensed Material Activity Details window displays for the selected material:
Organization is the abbreviated name of the context organization.
Organization Name is a brief description of the organization.
Dispense Area is the code that identifies the subinventory where the batch consumes the dispensed material.
Ingredient Description is a brief description of the material dispensed.
Dispense UOM is the unit of measure for the dispensing equipment.
Lot is the code used to identify the
Hazardous Material (Yes or No)
Hazard Class is the classification for a hazardous material.
Material Status is Dispensed or Reverse Dispensed.
Batch is the batch document number.
Batch Step is the batch step identified with this dispense operation.
Operation is the code used to identify the dispense operation.
Line Num is the batch sequence line number for the operation.
Product is the code used to identify the product.
Description is a brief description of the product.
Source Device is code assigned to the source dispensing device.
Description is a brief description of the source device.
Dispense
Dispense Number is the document number assigned to the dispense operation.
Mode is the dispense mode used. Options are Full Container, Source Container, or Target Container.
Source Device or Target Device is the name of the device used for the dispensing operation.
Description is a brief description of the source or target device.
Requested Quantity is the total quantity needed for the dispensing operation in the selected dispense mode.
Material Loss is the quantity of material lost due to a problem other than the actual dispensing operations, such as spillage or equipment failure.
Reverse Dispensed Quantity is the quantity of material removed from the container holding the dispensed material for adjustment purposes.
Net Dispensed Quantity is the actual quantity of material dispensed in the selected mode.
E-record is the e-record associated to the dispensing operation.
Containers
Source Container or Target Container is the item code associated to the container.
Description is a description of the container.
Source Container Tare or Target Container Tare is the tare weight of the source container or target container.
Measures
Measure of Source Container is the number of times the source container was measured.
Quantity Dispensed is total quantity dispensed from the source container.
Measure of Target Container is total quantity dispensed from the source container.
Quantity Dispensed is total quantity dispensed from the source container.
Labels
Security Tag is the alphanumeric tag used to label the dispensed material.
Dispense Label indicator is used to select the dispense label for printing.
Material Label indicator is used to select the material label for printing.
Pallet Label indicator is used to select the pallet label for printing.
Note: Select the labels to print and click Print Labels.
Dispense Instructions
Instruction Set is the name of the instruction set for the dispensed material activity.
Description is a brief description of the instruction set.
SOP is the standard operating procedure associated to this dispensed material activity.
Instruction
Click Details to display complete instruction information.
Status is the instruction status. xxx
Instruction Num is the instruction number. This number is assigned when you set up the application numbering.
Instruction Type is the instruction type.
Instruction Text is the instruction text entered.
Label Printing History
Label Type is the type of label printed. Seeded label types include: Material Label for Raw Materials, Product Label Sample Label, Dispensed Ingredient Label, and Pallet Label.
Print Count is the total number of labels printed for the label type associated to this dispensing operation.
Print Date is date this label type was printed.
Printed By is the name of the resource that printed the labels.
Status is the print status for this label type.
E-record is the e-record associated to printing this label type.
Attachments are the graphical representations of this label.
Reverse Dispense History
Item is the material dispensed as it appears on the inventory Item Master.
Description is a brief description of the material.
Reverse Dispense Number is the reverse dispense document number. It is valid only if you have configured manual document number entry.
Lot is the item lot associated to this reverse dispense action.
Batch is batch associated to this reverse dispense action.
Batch Step is the batch step associated to this reverse dispense action.
Operation is the operation in the listed batch step that is associated to the performance of this reverse dispense action.
Quantity is the quantity of material reverse dispensed.
UOM is unit of measure of the quantity.
Reverse Dispensed Date is date and time stamp of the reverse dispense action.
Click Details for detailed information on this reverse dispense number.
Following is the procedure to view reverse dispensing instructions.
Enter reverse dispense instructions.
Dispense material.
To view reverse dispense instructions for the dispensed material
Search for a dispensed material from the Dispensed Material Activity window.
Refer to "Searching for Dispensed Material" for detailed information.
Select an item for reverse dispensing.
Click Reverse Dispense.
Perform tasks as defined in the instructions.
Click Finish.
There are several reasons to perform reverse dispensing in production operations. Some typical reasons are:
A parent batch is cancelled or scaled down after material is dispensed.
To perform quality testing on material subjected to adverse conditions during transit to the shop floor.
Following is the reverse dispensing procedure.
Dispense material.
Optionally, run pending instructions, print labels, or scan labels for upload to the dispensed material record.
To reverse dispense reserved material using the Full Container mode
Navigate to the Reverse Dispense Material window
Enter the Dispense Number. This is the dispense document number. It is valid only if you have configured manual document number entry. Required.
Select dispensing Mode as Full Container.
Search and select the Source Container by Container Name or Description.
Note: Container information is set up in the Oracle Inventory Item Master.
Click Read Measure to measure the source container weight. The reverse dispense weight is calculated.
Enter a Security Tag number.
Select Dispense Label and Material Label to indicate label formats for printing.
View the reverse dispense instructions.
Obtain e-signatures.
Print the labels.
To reverse dispense reserved material using the Source Container mode
Navigate to the Reverse Dispense Material window.
Enter the Dispense Number. It is valid only if you have configured manual document number entry. Required.
Select dispensing Mode as Source Container.
Search and select the Source Container by Container Name or Description.
Search and select the Target Container by Container Name or Description.
Note: Click Read Measure to capture readings directly from an integrated device.
Measure or enter the source container weight.
Click Reverse Dispense to remove the excess material.
Measure the target container weight with the material transferred. The reverse dispensed quantity is calculated and displayed.
Remeasure the source container weight to verify the reverse dispensed quantity.
Enter a Security Tag number.
Select Dispense Label and Material Label to print labels.
View the dispense instructions.
Obtain e-signatures.
Print the labels.
Run any pending instructions, or reprint the reverse dispense labels. Following is the procedure to view the reverse dispensed material activity details.
Reverse dispense material.
To view the reverse dispensed material activity details
Navigate to the Dispensed Material Activity Details window.
View the Reverse Dispense History of an item.
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.
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
Navigate to the Submit a New Request window:
Select MES for Process Manufacturing Administrator: Request : Run.
Select the request type as Single Request.
Select OK.
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.
Complete the other fields on the window. See: Overview of Standard Request Submission, Oracle E-Business Suite User's Guide
Select the various parameters such as Plant, Dispense Area, Batch, From and To dates.
Select Submit Request.
Following is the output of the Dispense Dispatch report:
Organization
Search Criteria
Batch is the batch document number.
Plant is the name of the production facility where the material is dispensed.
Dispense Area is the inventory source for the dispensed material.
From Date is the start date for this report.
To Date is the end date for this report.
Dispensable Material
Item is the material dispensed as it appears on the inventory Item Master.
Description is a brief description of the material.
Lot is the item lot associated to this dispense action.
Batch No is the batch document number.
Batch Step is the batch step associated to this dispense action.
Operation is the operation in the listed batch step that is associated to the performance of this dispense action.
Required Quantity is the prescribed quantity for the dispense operation.
UOM is the unit of measure for the dispensing equipment.
Required Date is the date and time the dispense operation is required.
To run and print the Dispense History report
Navigate to the Submit a New Request window:
Select MES for Process Manufacturing Administrator: Request : Run.
Select the request type as Single Request.
Select OK.
Enter Dispense History Report as the request Name.
Complete the other fields on the window. See: Overview of Standard Request Submission, Oracle E-Business Suite User's Guide
Select the appropriate parameters for the report such as Plant, Dispense Area, Batch, From and To dates.
Select Submit Request.
To submit another request, select Yes.
Following is the output of the Dispense History report:
Organization is the abbreviated name of the context organization.
Dispense Area is the code that identifies the subinventory where the batch consumes the dispensed material.
Search Criteria
Batch is the batch document number.
Plant is the name of the production facility where the material is dispensed.
Dispense Area is the inventory source for the dispensed material.
From Date is the start date for this report.
To Date is the end date for this report.
Operator is the name of the person who performed the dispensing operation.
Dispensed Material
Item is the material dispensed as it appears on the inventory Item Master.
Description is a brief description of the material.
Dispense Number is the dispense document number. It is valid only if you have configured manual document number entry.
Lot is the item lot associated to this dispense action.
Batch is the batch document number.
Batch Step is the batch step associated to this dispense action.
Operation is the operation in the listed batch step that is associated to the performance of this dispense action.
Line Number is the batch sequence line number for the operation.
Net Dispensed Quantity is the actual quantity of material dispensed in the selected mode.
Dispensed Date is the date and time stamp of the dispense action.
Required Quantity is the prescribed quantity for the dispense operation.
Dispense Mode is the dispense mode used. Options are Full Container, Source Container, or Target Container.
Dispense UOM is the unit of measure for the dispensing equipment.
E-record ID is the e-record associated to this dispense operation.
Quantity Reverse Dispensed is the quantity of material reverse dispensed using the dispense mode indicated.
Material Loss is the quantity of material lost due to a problem other than the actual dispensing operations, such as spillage or equipment failure.
Operator is the name of the person who performed the dispensing operation.