Electronic Batch Records in Medical Supply Manufacturing

October 30, 2018

Pharma Vile

Overview
A major medical manufacturer of intravenous (IV) solution bags engaged Grantek to upgrade a production line making bags of IV fluids. This company had developed an electronic batch record (EBR) system in-house using Oracle. The production line upgrade project also required that the new equipment provide batch record data compatible with the existing EBR system.

Challenges
As part of the line upgrade effort, Grantek ensured data available from the new line equipment would remain compatible with the in-house developed EBR system. The customer needed to track identification and status for each batch of IV fluid bags produced on the line, by lot and by batch. This was necessary so that alerts coming from the line were associated with the correct lot and batch number.

Grantek configured the new line equipment to send appropriately formatted data records to the Oracle system to indicate successful completion of each batch, and also to send records in the event a batch had to be aborted for some reason or was not fully completed.

Solutions
Grantek, as a system integrator who fully understands how to work with the data available from process equipment, was able to efficiently program the new line equipment to send the data needed by the customer’s legacy EBR system, even though the EBR system was an in-house construct and not a commercially-available software package. Our experience in the pharmaceutical industry and understanding of the data needed for a compliant EBR allowed us to efficiently configure the new equipment to provide the necessary data to the customer’s systems.

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