BioTech Manufacturing Scale-Up

A promising biotech startup with drug candidates progressing from stage 2 to stage 3 clinical had limited automation staffing. The startup turned to E Tech Group to transition their processes to full-scale manufacturing.

Project: Create Scalable, Integrated Controls out of a Piecemealed Automation System

The plant selected for production of clinical material and initial launch had islands of automation that often predated 21 CFR part 11 requirements from numerous OEM manufacturers that were not designed to be integrated into a plant network. Some of the equipment did not even have Ethernet connectivity.

Through a collaborative effort, the automation team designed a highly-scalable system for the biotech client by starting small to fit into their budget. This system can be expanded to a large multi-site manufacturing network when the drugs are approved.

Although the new Data Historian system is currently licensed for only 3000 tags, the underlying infrastructure is designed so that the system can expand to 100,000 tags with only license upgrades and integration of the new tags and systems.

Because of the diverse disparate OEM systems in the plant, OSIsoft’s PI was chosen as the plant historian as it has documented success for integrating the required systems. For the cGMP HMI plant SCADA system backbone, Rockwell’s Factory Talk View Site Edition (ViewSE) was chosen because of the installed base of Rockwell controlled equipment in the plant and the migration path of PanelView HMIs to a 21 CFR Part 11 compliant system.

Solution: A Scalable SCADA System that Keeps Up With Compliance Specs

E Tech Group designed and implemented a new 21 CFR Part 11-compliant SCADA system that is scalable and sustainable for the biotech manufacturing plant.

  • The centralized server/thin client architecture facilitates authentication and logging of operator actions in a cGMP environment.
  • This SCADA system utilizes a SCADA server that hosts a Data server, an Alarm & Event server and a Terminal server that hosts thin client sessions for the day to day HMI operations.
  • The Terminal server also hosts Rockwell’s ThinManager software that is used to setup and manage the thin clients.
  • An Engineering Workstation (EWS) hosts the configuration tools for Rockwell and PI software.
  • All servers run as virtual machines under VMWare for ease of maintenance by the biotech client’s IT department and so that resources can seamlessly be reallocated as the system grows.

User Requirements Specification(URS), Functional Specification(FS) and Software Design Specification (SDS) were developed for the new SCADA system and will serve as living documents for future integrations.

As part of this effort, the E Tech Group automation team replaced a legacy PanelView HMI with a thin client HMI and converted the legacy Panel Builder software to ViewSE. We also converted a legacy SLC 504 controller to a new CompactLogix controller integrated with the new plant SCADA system. Components that were not converted properly by the conversion tools were documented and manually modified to fit the new configuration.

In the HMI conversion process, features of the converted HMI were enhanced by cleaning out the legacy tag database of obsolete tags and revamping the graphics to be compatible with touch screen with easily readable modern fonts. Built-in security features of ViewSE such as autologin logout were implemented and integrated with Windows Active directory. Screen security was also implemented based on domain logins.

In the PLC program conversion process, all the key rungs in the legacy ladder logic were commented with the appropriate descriptions in the new program which will aid in code comprehension and maintenance.

Result: End-to-End System Support for Plant-Wide Coverage

E Tech Group provided total support during the installation and commissioning of the new controller and the HMI panel. We also performed the Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) on the complete SCADA system and controller installation and supported validation activities adhering to GMP.