Material Management in Highly Regulated Facilities

by | May 9, 2006 | Industry, Life Sciences & Medical

Highly regulated industries like those in which Life Sciences manufacturers operate need efficient solutions manage and properly document their production and use of materials in the manufacturing process.
The production process usually includes both manual and automated operations. The automated part is typically controlled with process control systems with batch software like the DeltaV system.
I spoke with Principal Engineer Todd Ham who coauthored a paper with Senior Technologist Dick Seemann, both in our Life Sciences industry organization. The paper, A Model for Integrating Material Management in a Production Environment, was presented at a past ISA Automation West Conference.
The paper generically describes a solution that Todd and our Life Sciences industry experts implemented at a biotech manufacturing facility. A manufacturing execution system managed the materials for manual parts of the operation.
Todd said the key to the solution was defining an integrated material management model which included support for the processes: batch campaign creation, raw material weigh-and-dispense, manual material charges, and automated material charges.
In their solution, the first step is campaign and batch creation. A unique campaign ID is established which all material information related to the campaign will connect. Also the batch report manager in the process control system can access this campaign ID, to bring in all the material information into a complete electronic batch record, needed for the release of final product. This information is included with the batch history, alarms, events, operator actions, and other data collected by the process control system.
Todd describes a manual weigh-and-dispense operation. An operator logs into a handheld personal data terminal/barcode reader. The system checks and verifies that he has authority and the up-to-date training to perform the weigh-and-dispense procedure. The operator selects the campaign, is presented with the appropriate and available weigh booths, and scans a weigh booth ID barcode. Next the operator selects an intermediate batch container which has been verified by the system as being the correct size, being clean, etc.
With everything properly validated the operator selects from a list of materials presented on the handheld device connected to the warehouse inventory system. Once the material has been retrieved and barcode scanned it is validated for expiration dates, lot numbers, and any other required quality measures. The operator dispenses and confirms the measured weight within the allowed tolerances.
A label containing all this information, as well as an electronic copy for the electronic batch record is available for the production environment. Similar integrated material management processes are available for manual material charging, automated material charging, and the creation of the batch report.
These integrated manufacturing procedures provide enforced compliance for the manual production activities. And overall cycle times can be reduced since the records captured from these procedures are available in the overall batch record instead of collecting and signing off papers after the fact.

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