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For manufacturers in highly-regulated industries, such as pharmaceutical and biopharmaceutical manufacturing, it is critical to keep track of raw materials as part of the production records. To minimize or avoid waste, it’s also important to use the first-to-expire raw materials from inventory.

I caught up with Emerson’s Lynn Richard about his experiences to help a manufacturer solve this challenge and increase overall productivity.

In addition to the first-to-expire allocation rule, some other ones required include:

• Using full containers from warehouse, as needed, to minimize operator weighing and loading
• Allocating raw materials that have already received Quality Control (QC) team’s accepted status
• Using open containers in the dispensary when less than a full container is needed
• Sending a full container to the dispensary for partial use only if all that material in the dispensary has been used
• Using raw materials in the customer sample laboratory exclusively for customer samples
• Making potency adjustments before allocation

To address these challenges and requirements, Lynn and the project team developed an allocation component in the Syncade manufacturing execution system. A mixture of lot and container allocation with lot properties including QC status and warehouse location was designed. The container properties included the location in dispensary and location in customer sample laboratory.

Key logic steps performed in this allocation component include:

1. Checks all the raw materials in the production order to see if enough inventory is available (i.e. not already allocated, QC accepted status, not in customer sample laboratory) to fulfill the order. Alerts operator if there is a shortage.
2. Checks the quantity for each material to see if one or more full containers can be used, adjusts for potency from laboratory information management system (LIMS) interface, and allocates full containers from the first to expire lot in the warehouse.
3. Checks the remaining quantity for each material to see if the inventory in the dispensary can be used, adjusts for potency, and allocates some (from first-to-expire) or all the dispensary inventory.
4. Checks if there is a remaining quantity for each material and if so, allocates a container from the first to expire lot in the warehouse to be sent to the dispensary and adjusts for potency.

Lynn noted that a pick list report could be generated from this allocation. Sections from the report include:

• Full containers from the first to expire lot with location(s) of that lot for each material to be staged at the loading area for transfer to the clean zone.
• A full container from the first to expire lot with location(s) of that lot for each material (where needed) to be transferred to the dispensary in the clean zone.
• Materials in the dispensary to be weighed for the order.

By having the raw material data stored in the system and having logic in the manufacturing execution system check the current status of the raw materials, mistakes and less than optimal decisions could be avoided.

Also, having an electronic record of these additions were important for the electronic batch record created with the batch produced. This allowed products to be released for sale sooner by removing delays associated with manual record keeping and rework from issues discovered after the fact.

You can connect and interact with other pharmaceutical, biotech and manufacturing execution system experts in the Life Sciences and Operations Management groups in the Emerson Exchange 365 community.

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