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| October 5, 2021

E Tech Group’s Life Sciences East Division is CSIA Certified for the Eighth Consecutive Time

E Tech Group is part of an elite group of system integrators achieving the highest level of certification in the Control System Integrator Association’s Certification program and the first to pass its eighth consecutive certification audit as required every three years. Seabrook, NH – October 5, 2021 – E Tech Group, a leading 3-decades-old control system integrator of custom industrial automation and IT solutions with 400+ engineers across the country, today announced the company has successfully renewed its Control Systems Integrators Association (CSIA) Certification. CSIA Certified control system integrators must pass an intensive audit every three years to demonstrate that they meet stringent performance standards. Jose M. Rivera, CEO of the CSIA said, “Congratulations to [E Tech Group] for their successful CSIA re-certification. They lead the pack as the only system integrator with eight consecutive certification rounds to date. I congratulate [E Tech Group] for their leadership and for having made the CSIA Best Practices part of their company culture. Keep it up! By supporting the CSIA Certification program [E Tech Group] is not only advancing their company, they are also elevating the playing field for the entire control systems integration community.” Qualifications of Elite Control System Integrators The intensive CSIA audit process is conducted by an independent third-party consulting firm measuring criteria in general management, financial management, project management, quality management, technical management, human resources, and business development. CSIA Certification ultimately provides benefits to end-users of automation technology by ensuring CSIA Certified control system integrators are financially healthy companies capable of completing projects in a professional and technically sound manner. In addition to being eight-time certified by CSIA, E Tech Group has passed over sixty quality management and validation audits and is both a Rockwell Automation Solution Partner and Siemens Automation Solution Partner. In June of 2020, E Tech Group announced the company had also qualified as an OSI Soft Solution Partner. Some of E Tech Group’s specialized expertise is in the biotech and life sciences industries. The company specializes in complex FDA validated automation systems. We offer coast-to-coast capabilities with multiple locations in the biotech and life science hubs of New England and California. E Tech Group’s 400+ engineers at 18 … Continued

Increased Flexibility & Better Quality for Pharmaceutical Manufacturer

| October 4, 2021

How to Perform a Risk Assessment

– By Tony Schalk, Functional Safety Engineer (TÜV Rheinland), Automation Systems Engineer, E Technologies Sophisticated companies know that safety is a journey, not a destination. It is a part of their strategic and ongoing growth. As more and more companies look to implement safety programs, questions about budget, time, effort, and feasibility come into play. Larger companies may already employ a safety engineer or even a safety team, with well-established metrics and objectives each year. If you don’t fall into that category, don’t be discouraged. The most important thing you can do on any journey is to start. To begin your safety journey, you start with a risk assessment. In the United States, when an accident originates from machinery, the owner of the machine is responsible for the safety, not just the manufacturer of the machine. This means that if something happens, it’s technically your responsibility. If that doesn’t scare you, it should. The beauty of the risk assessment is that it is your education on what could happen with the machinery in your facility. What you choose to do with your newfound knowledge is up to you; however, in the immortal words of G.I. Joe, “Now you know, and knowing is half the battle.” There are a few caveats. Although companies could self-perform their risk assessments, it isn’t a job that just anyone in your plant can do. A TÜV certification is needed, as well as an understanding of ISO 13849 or IEC 62061 standards. Anyone could pick up the standard and follow the process, but it’s hard to implement a standard and its many details if you’re new to safety. This is where having a safety professional can be very beneficial for efficiency’s sake. He or she can walk into a situation and quickly identify what needs to … Continued

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.

Learn More About E Tech Group’s Life Science Capabilities

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.

Learn More About E Tech Group’s Services for Life Sciences