Electronic Signatures/Electronic Records

Case History
Pharmaceutical Batch Management


Project
Develop a PLC-based batch engine and recipe management system for pharmaceutical manufacturing and address required aspects of 21 CFR Part 11.

Architecture

  • Single reaction vessel, two preparation vessels, and other miscellaneous equipment.
  • One Wonderware InTouch HMI node
  • Allen-Bradley 5/80E PLC
  • A Microsoft SQL Server for recipe management database.

ES_ER Graphic
Implementation
A custom, PLC-based batch engine was developed to replace a commercial batch management system. The control system included a single Allen-Bradley 5/80E PLC, two Wonderware operator stations, and a SQL server. I/O included approximately 200 points. Provisions were made to address required aspects of 21 CFR Part 11 for electronic records on a closed system. ACE provided FRS, HDS, SDS, IQ, and OQ documentation and executed the IQ and OQ protocols.

Status
The system has been successfully validated and is currently in operation.