Implementation of an FDA-Compliant Biologics Process Control System
E Tech Group’s process control solutions included a manufacturing execution system for FDA-compliant data collection and reporting, as well as a building management system and other vendor-supplied control systems.
Project: Turnkey Factory Automation for a Biologics Client
E Tech Group implemented a $1.8M process control system (PCS) for the Massachusetts Biologic Laboratories (MBL) state-of-the-art facility in Mattapan, MA. The MBL facility performs cell culture and purification of monoclonal antibodies (MAb) and filling of licensed and R&D stage liquid parenteral (injectable) products that cannot be terminally sterilized. The monoclonal antibody production centers around cell culture and purification.
Solution: Build a Custom, Fully-Integrated Automation System
E Tech Group installed a PLC- and SCADA-based PCS system utilizing redundant Allen-Bradley ControlLogix 5550 processors with 1756 series I/O, 1794 Flex Series I/O, Festo solenoid blocks, and Mettler Toledo scale indicators. The I/O is distributed between 13 control panels which are interconnected with DeviceNet and ControlNet I/O networks. The PCS communicates approximately 400 data points over Ethernet to the various equipment vendor-supplied systems.
The PCS consists of a SCADA/Historian fault-tolerant server, manufacturing execution system (MES) fault tolerant server, web reporting server, 11 portable client workstations, 7 fixed client workstations, and 2 engineering workstations. The 11 portable workstations contain wireless Ethernet capability and are mounted on a portable cart with an onboard battery and barcode scanner.
The following software packages were used as part of the PCS system:
- SCADA – GE/Proficy iFix
- Historian – GE/Proficy Historian
- Data Analysis – GE/Proficy Real Time Information Portal
- Reporting – Crystal Reports
- Manufacturing Execution System – Elan XFP, Oracle database
- Alarm/Event Storage – SQL Server
The following equipment is located in the MAb production area:
- Buffer preparation tank
- Portable pH adjustment tank
- 55L, 500L, and 2500L bioreactors
- Portable Q-eluate tank
- Harvest tank
- Portable nanofiltration tank
- Chromatography skid
- Final bulk tank
- Ultrafiltration / diafiltration skid
- Fill / finish production
- Vial washer, parts washer, and autoclave
- Depyrogenation tunnel and filling line
- Labeling and packaging equipment
The following utility systems are located in the MPL Mattapan Facility:
- Water for injection (WFI) pre-treatment / soft water generation
- Acid day tank
- WFI still, and hot WFI storage tank
- Caustic day tank
- Compressed air generation
- Clean in place (CIP) skid
- Chilled process glycol generation
- Clean steam generation
- Hot process glycol generation and distribution
Results: An Efficient, Compliant, Comprehensive Plant-Wide Control System
Our engineers implemented a PCS to control process and cleaning steps for the buffer preparation tank, harvest tank, pH adjustment tank, Q-eluate tank, and nanofiltration tank through hardwired I/O. The PCS coordinates CIP operations with the CIP skid, controls CIP and WFI distribution, and interfaces with the various equipment vendor-supplied systems over Ethernet. The PCS stores alarms and process data from the skids and hardwired I/O.
The PCS provides a MES that includes material tracking, equipment management, barcode recognition and creation, and electronic work instructions (EWI) for execution of process steps in the MBL facility. Operators use barcode scanners to verify and record raw materials, semi-finished goods, finished goods, and equipment that is created and/or used in the MBL facility.
The system also consists of a number of equipment vendor-supplied control systems and a building management system (BMS). The PCS provides supervisory control and data acquisition (SCADA), batch execution, electronic work instructions, material tracking, equipment management, barcode recognition and creation, historical data collection, and reporting. All data collection is in accordance with 21 CFR Part 11.
With deep domain expertise in the life sciences and biopharma industry, E Tech Group creates process automation solutions that keep you compliant with R&D, production, and quality control regulations while retaining the ability to scale and adapt in this ever-changing industry. Improve processes and reduce costs with strategic, robust building automation.
Provides a MES that includes material tracking, equipment management, barcode recognition and creation, and electronic work instructions (EWI) for execution of process steps in the MBL facility. Operators use barcode scanners to verify and record raw materials, semi-finished goods, finished goods, and equipment that is created and/or used in the MBL facility.
The system also consists of a number of equipment vendor-supplied control systems and a building management system (BMS). The PCS provides supervisory control and data acquisition (SCADA), batch execution, electronic work instructions, material tracking, equipment management, barcode recognition and creation, historical data collection, and reporting. All data collection is in accordance with 21 CFR Part 11.
Increased Flexibility & Better Quality for a Pharmaceutical Manufacturer
E Tech Group’s control system engineers implemented a low-cost Rockwell Automation PlantPAx process automation system to upgrade a single-product semi work facility.
The Project: Accomplish Two Automation Capabilities at Once
AMPAC Fine Chemicals (AFC) A California pharmaceutical manufacturer hired E Tech Group to upgrade the process control system of a single-product semiwork facility. During the project, the client asked E Tech to also convert the equipment to a flexible midscale, multi-product production facility… with no increase in project budget.
This presented several obstacles for our automation engineers; we needed to implement a multi-purpose and comprehensive control system that would accomplish both goals for the client while staying within budget and deadline constraints.
The Solution: Kill Two Birds with… Rockwell’s PlantPAx?
The existing hard-coded control system was built in the 1990s, and was not capable of handling the flexible manufacturing desired. Our automation engineers designed and installed an updated process control system that met the strict FDA regulatory requirements and high level of security required for the production of active pharmaceutical ingredients (APIs). This approach to their integration upgrade was a cost-effective alternative to a traditional server-based batch solution.
E Tech’s engineers selected the PlantPAx process automation system from Rockwell Automation for the complete control system upgrade. PlantPAx provided a control solution that allowed the flexibility to easily change the manufacturing schedule and produce more than one product on the equipment.
Rockwell’s PlantPAx software is industry-leading in terms of plant-wide controls integration, scalability, adaptability, and perhaps most important of all in pharmaceutical automation, consistency. With support from Allen Bradley automation products, we created an integrated control system that won’t require entire retrofits each time it needs an upgrade, saving the client money.
Additionally, the use of PlantPAx Logix Batch & Sequence Manager allowed a controller-based solution and saved money by removing the need for costly custom code or additional server infrastructure. FactoryTalk View Site Edition software was chosen so that personnel can configure recipes directly in the controller.
Technology We Used:
- PlantPAx
- PlantPAx Logix Batch & Sequence Manager
- FactoryTalk View Site Edition
- EtherNet/IP network
- Allen-Bradley FLEX I/O modules
- Allen-Bradley IntelliCENTER motor control center
- Allen-Bradley PowerFlex VFDs
The Results: Efficient, Scalable, Versatile Pharmaceutical Automation
The new control system has improved the quality, consistency and speed of manufacturing the client’s APIs by automating processes that were once manual. The new system has reduced reliance on paper-based documentation, which offers additional cost savings. The success and quick ROI of this project has led to the client pursuing additional upgrade projects with E Tech Group and Rockwell Automation in other plants.
“With the automated batch solution from Rockwell Automation, we’re improving the quality and consistency of our APIs, and avoiding the delays that naturally occur during manual operations,” said Director of Automated Systems and Calibration, for our client. “The Rockwell Automation solution allows us to meet customer needs more quickly than our competitors while still staying in full compliance with industry regulations.”
The director continued, “We need to align ourselves with leading partner companies in order to be competitive and each project we complete with [E Tech Group] and Rockwell Automation is a perfect example of that strategy.”
An industry leader in control systems integration and industrial automation, E Tech Group offers comprehensive controls system services for clients across a wide breadth of industries. With deep domain expertise in the life sciences industry, we provide pharmaceutical manufacturers with turnkey factory automation solutions that look toward the future of the company and the industry, so our clients can stay competitive, no matter how active the market.
Bringing Back Large-Scale Electrical & Mechanical Safety Standards
A global battery supplier reached out to E Tech Group with their initiative to bring 99 machines into compliance with the most recent electrical and mechanical safety guidelines. Our automation engineers performed thorough risk assessments and mitigation.
The Project: Surpass OSHA and Plant Standard Expectations
Plant operations require not only thorough automation systems to operate at their best; there are rigid operational and safety standards they must adhere to – both industry- and OSHA-based. As guidelines develop and standards are raised, complications arise with machinery and control system platforms that may become obsolete, or at least need updated.
A global battery supplier was facing this exact dilemma when they reached out to E Tech Group to perform risk assessments and implement a mitigation plan to bring their facility up to current standards.
At the start of the project, 79 of the 99 machines had already been assessed and had design bases defining the mitigation scope of work. The remaining 20 machines still required this work to be completed. E Tech Group was responsible for risk assessments for 20 machines, and implementing the safety mitigation work on all 99 machines.
The Challenge: Manage the Unpredictable
There were several challenges associated with the successful completion of this project, ranging from working around unpredictable downtime, to the sale of the brand mid-project. E Tech Group’s engineers remained flexible throughout this multi-year project to accommodate the customer’s needs. The challenges included:
- After E Tech Group automation engineers began the risk assessments, it became apparent that the previously-completed risk assessments were not comprehensive, nor were they accurate. E Tech Group held meetings with the client to create and approve new design documents, which all machines were assessed against.
- Because there were many initiatives occurring within the plant simultaneously, the decision makers were rarely focused on the risk assessment logistics. Flexibility and patience were key in getting customer personnel in place to support the efforts.
- The brand was sold to another corporation during the course of the project, which required some refocusing of priorities and realignment with the new owner’s practices and procedures.
- The biggest challenge was the project schedule, which required working around production needs that fluctuated based on weather events around the world. Getting windows of downtime for installation was hit-or-miss.
E Tech Group utilized our brand of communicative and collaborative project management to ensure, throughout all this unpredictability, nothing slipped through the cracks, as this project was vital to the integrity and compliance of plant operations.
The Solution: Automation Mitigation
After writing and approval of the new design documents, E Tech Group conducted risk assessments on all of the machines. The mitigation plan included:
- New mechanical guarding
- New electrical panels
- New E-stop circuits
After the new automation equipment was installed, the machines were validated against our written protocols. Safety maps, Lock-Out-Tag-Out procedures, “One Point Lessons,” and safety training were completed for the customer. Some of the 99 machines were removed from scope due to changes in priorities and capital decisions to replace machines instead of upgrading, and the rest are safe and compliant to OSHA and plant standards.
The Results: New Relationships, New Projects
During this project, E Tech Group developed a close working relationship with the customer thanks in part to our excellent communication, flexibility and work ethic. Since the completion of this project, E Tech Group has completed multiple additional projects for safety guarding both at the original plant, and in other locations.
E Tech Group is a national automation system integrator creating tailored, cutting-edge control systems that exceed client expectations by increasing the security, consistency and output of a facility’s operations. We serve clients across industries, including control system builds, upgrades and IT support for food and beverage producers, biotech entities, alternative protein startups, and many more.
Increasing Throughput Capacity at a Global Parcel Hub
A global parcel service reached out to E Tech Group when they were asked to increase their throughput. Our engineers helped them meet peak-season demand through our turnkey material handing controls systems to improve the capacity of one of their more dated hubs.
The Project: End-to-End Automation System Upgrades
A global parcel service reached out to E Tech Group after being tasked with increasing throughput capacity in one of their older hubs prior to the peak season for shipping. The turnkey project involved upgrades to 70% of the site’s control systems, along with expansion of the control room and package handling systems.
E Tech Group was responsible for every aspect of this building-wide automation upgrade, including:
- Engineering design
- Software design
- Procurement and installation of all electrical hardware
- Start-up and validation of the updated control systems
Once the new systems were implemented, integrated facility-wide and validated, our automation team provided ongoing support through the course of their peak period.
Challenges
- The project start date was delayed condensing the original schedule down from 9 months to 5 months
- The scope of work had to be planned sequentially because each upgrade was dependent on the previous one
- The mechanical upgrades had to be completed prior to control system completion, further limiting installation and start-up windows
- All installation and start-up work had to be completed during weekly downtime windows that started Saturday mornings and ended at 11:00 AM on Monday
- Both mechanical and electrical equipment deliveries were “just in time” and sometimes late, requiring a very agile installation and start-up team
- While the customer had very detailed specifications, many exceptions were allowed so that the new installations would match the existing operation. This required more rigor during definition to review prior precedents set at the hub.
Solution
A dedicated E Tech Group project team was deployed to the site to complete definition through both audits and reviews. The project team produced a highly-detailed report with a list of exceptions to the customer’s specifications. These exceptions were submitted to the customer for approval prior to the start of the design.
Our automation engineers worked with the customer’s mechanical consultants to develop and then continuously refine plans to sequentially install the control system upgrades in scope blocks that could fit into short downtime windows. In several instances, multiple E Tech Group teams were deployed to the site simultaneously to work in different areas.
Our engineering design team also worked to standardize new electrical panel designs so they could easily be adjusted from one area to another with minimal notice, if required. The automation software was also standardized across the facility to make it more easily supportable during deployment and ongoing.
Once installation began, our engineers deployed full site management to the hub to oversee all deliveries and installation activities. E Tech Group’s site manager was also the single point of contact for the hub manager and the mechanical consultant, creating a seamless communication channel from the customer to the E Tech Group project team.
There were several challenges associated with the successful completion of this project, ranging from tightly-scheduled downtime to dealing with delayed equipment deliveries. Our engineers closely managed the project and evolved the highly-detailed schedule to accommodate the customer’s needs.
The Results: Exceeding the Client’s Automation Expectations
This turnkey systems upgrade required rigorous planning and constant communication, making thorough and collaborative project management essential. After completing this project on time and on budget despite all the obstacles, E Tech Group has been awarded several other projects with this customer at the same facility.
For manufacturers with multiple locations, finding an automation company you can rely on for projects across facilities is key to operational integrity and consistency in each plant. E Tech Group cultivates these symbiotic long-term relationships through a unique brand of project management, focused on close collaboration with the client and strategic control system design that allows the facility to improve, adapt and scale.