Control system installed at pharmaceutical site

Servelec has continued its successful record in pharmaceutical control system implementations with a major plant expansion and upgrade project for Eli Lilly and Company, Speke Operations

Servelec has continued its successful record in pharmaceutical control system implementations with a major plant expansion and upgrade project for Eli Lilly and Company, Speke Operations.

The system involved Allen-Bradley PLC5 processors interfacing to package equipment and utilizing both Ethernet and Data Highway Plus communications networks to three RSView32 operator workstations.

Design activities included detailed analysis of the existing system, followed by significant new code development and enhancements to the control philosophies to integrate retained and new hardware, doubling the product output capacity.

Key to the success of the project was the very close co-operation between Servelec and the client's engineering and production staff forming an integrated team.

A close working relationship allowed Servelec's systems expertise to ideally compliment the process and site knowledge of the client's personnel.

Working together, all the project challenges were achieved within agreed time and cost budgets.

The manufacturing process includes multi-route complex batch procedures with full validation requirements, batch tracking and custom reporting to satisfy the requirements of the Food and Drugs Administration (FDA).

Integral to the validation process was the implementation of electronic records and signatures compliant with Title 21, Chapter I of the Code of Federal Regulation, part 11 (21 CFR part 11).

Servelec worked closely with the client's team to devise appropriate methods of implementing 21 CFR Part 11 compliance within the RSView and PLC5 software application.

Advanced software techniques were required to achieve the necessary data validation and secure recording.

This was the first application of 21 CFR Part 11 at the Lilly site and the importance of electronic signatures is clearly recognised by all parties.

The FDA is actively looking for manufacturers to implement electronic signature solutions and the reduction in paperwork, improved efficiency, and controlled accuracy of recordings, is all clearly beneficial to an industry where the integrity of their data and product traceability is of major importance.

Servelec has many years experience in advanced process system design and are in a leading position to address pharmaceutical applications of 21 CFR Part 11 in both new plant and systems refurbishments.

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