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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.
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.
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.
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.
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.
E Tech Group is proud to partner with Acorda Therapeutics to bring an expanded manufacturing process online.
E Tech Group implemented a control system for the expansion of the Acorda Therapeutics facility in Chelsea, Massachusetts. The control system is used to automate process and cleaning steps for the Feed and Spray Drying Systems, the clean-in-place (CIP) System, and the supporting Ethanol Supply, USP Purified Water Supply, and Waste Systems using four PLC processors. The control system coordinates CIP recipes with a SQL database and interfaces with various equipment vendor-supplied systems over Ethernet. The control system stores alarms, process data and user actions, and provides a user interface for the operation and visualization of automated sequences and equipment.
The system also consists of a number of equipment vendor-supplied control systems and an expansion of existing Controlled Area Monitoring System (CAMS). The control system provides Supervisory Control and Data Acquisition (SCADA), recipe management, historical data collection, and reporting.
The following equipment is located in the process area:
The following equipment is located in the utility areas:
The following equipment is located in the tank farm:
The control system is a PLC- and SCADA-based system utilizing Allen-Bradley ControlLogix L73 and L75 processors with 1719 Ex Series intrinsically safe I/O, 1734 Point Series I/O, Festo solenoid manifolds, and Allen-Bradley PowerFlex VFDs. The I/O is distributed between 18 control panels which are interconnected with Ethernet/IP networks. The control system communicates over Ethernet to the various equipment vendor-supplied systems.
A separate Emergency Stop system monitors for Master, USP Purified Water, CIP, Spray Dryer and Tank Farm safety stop conditions and shuts equipment down via hard-wired interlock circuits.
The SCADA servers are a set of virtual machines hosted on redundant physical servers. The virtual machines consist of a Directory server, redundant HMI servers, redundant Data servers, a Terminal server, an Engineering Workstation server, a Historian server, an Engineering Development server, an Asset Management server and a View Only server.
The operator interface consists of nine fixed thin client workstations located throughout the process and utility areas, two dual thin client fixed workstations located in the control room, and two large monitor thin client displays located in the control room.
The following software packages were used as part of the control system:
The project manager reflects on the talented group of 12 automation engineers who have worked on the project. “From a personal standpoint, the team I’m working with here at [E Tech] is one of the most talented groups of people that I’ve ever worked with in my career. It’s been extremely rewarding being able to work with this group, and everyone is doing an amazing job. We’ve got a really good combination of very experienced engineers, and we also have some new engineers who are really enthusiastic, eager to learn and apply themselves, and who are also extremely intelligent. It’s been a great experience.”
An American biotechnology company knew their legacy control systems were approaching end-of-life, making an upgrade essential for their site in California. E Tech Group provided several control system upgrades to their automated systems.
An American biotechnology company knew the truth – their vintage control systems were approaching end-of-life, making an upgrade essential for their site in California. Our client was grappling with key questions such as:
The company recognized the issues they had with their aging systems, their own limited resources to dedicate to this evaluation, and the one thing they themselves could not do: have an outsider’s perspective with an industry-wide viewpoint.
The client made the decision to bring in that outsider perspective and partnered with E Tech Group for their controls platform retrofit. Our team of automation engineers brought with them 30+ years of biopharma experience, as well as knowledge of automation platforms and biotechnology systems. For a project of this importance, creating a strong partnership between client and consultant was crucial.
Our team included seasoned engineers who have experienced large-scale control system platform selection. We’ve also experienced conversion projects as owners and supported similar decisions for other biopharma clients as consultants. This allowed us to bring unique points of view to the project scope, coming in with an understanding of the specific needs of biotech automation.
E Tech Group and the client’s team went through a process of requirements definition and user group meetings with the company’s current and future site and global needs in mind. E Tech Group supported workshops with all of their stakeholders:
To ensure the facility-wide control system improvements provided our client with the resources and ROI to continue to grow, our automation team brought several leading control system supply partners into the discussion.
The E Tech Group team challenged the biotechnology company to think beyond basic requirements from a technical and business perspective. Engaging the team together in workshops enabled cross-functional groups to learn about how others within the client’s company would be using the system. Our team was uniquely positioned to objectively facilitate an effective conversation and align their various perspectives through industry knowledge and expertise.
At the conclusion of the process, multiple control system platform solutions were evaluated against the newly defined requirements – the team considered PLC/HMI and DCS-based systems and single-vendor/multi-vendor PLC/HMI platform options. E Tech Group worked with the internal stakeholders at the company to objectively evaluate the options and assess how the different platforms could best support the business needs.
In collaboration with our client, E Tech Group supported the development of a decision matrix to quantify the analysis of the different platforms. Additionally, we worked closely with the decision analysis team to develop financial and statistical models to help them determine the best option from a technical, financial and risk perspective.
Through this process, the stakeholders reached a unanimous decision on the future platform for the site. The client, E Tech Group and the control platform vendor continued to collaborate to develop the long-term roadmap to support the upgrade/conversion of the site to the new platform. The updated control system allows the client to optimize current operations as well as lay the ground work for them to reach future goals and industry benchmarks.
When approaching an upgrade of your aging control system, focusing on the execution of the upgrade is natural. Often overlooked is the time and effort it takes to choose the right platform and approach for the upgrade. The upfront investment can have a tremendous payoff when you take a long-term view and consider all stakeholders’ needs from the system.
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