Customized Validated Critical Monitoring System
E Tech Group supported a biopharmaceutical’s expansion with a new validated control system. The company focuses on serious, debilitating, and genetic diseases.
A biopharmaceutical company committed to bringing to patients novel products for the treatment of rare and ultra-rare diseases, with a focus on serious, debilitating genetic diseases, was looking to expand. When they began building a new pharmaceutical research laboratory at their New England facility with an extremely condensed timeline, they reached out to E Tech Group to provide the qualified automated monitoring and alarm system (QMAS).
The new validated control system would monitor 78 relocated or new pieces of equipment. The critical monitoring and alarm system project completion date was just three months after the project kickoff, which was a very tight schedule for a customized system such as this.
The laboratory equipment to be controlled by the QMAS includes:
- Lab refrigerators
- Lab freezers
- Cryogenic freezers
- Water generation skid
- Glass washer
Our engineers proposed a Rockwell Automation based solution. The off-the-shelf equipment was customized to provide the critical alarming, control, and reporting to the client’s specifications. The hardware provided a single control cabinet containing an Allen-Bradley ControlLogix PLC with ControlLogix I/O. The software platform included a FactoryTalk View SE server with local HMI clients, FactoryTalk Historian, FactoryTalk VantagePoint, FactoryTalk ViewPoint, and WIN-911.
E Tech Group designed a customized, validated QMAS to provide centralized monitoring and alarming for all 78 pieces of equipment, featuring local audio-visual beacons throughout the facility with an email notification system. With the new system, the client no longer has to be present in front of a machine to know it is in alarm. Those employees on site are notified by the beacons alert to check the equipment status. Employees both on- and off-site receive alarm notifications by email. The client created a detailed hierarchy of permissions and multiple notification lists that are triggered by which specific area has the equipment fault. At the facility, notifications are sent by room, and each area beacon covers a group of rooms.
In addition, the system provides data historian and reporting functions. It gathers data from all equipment and stores it for historical reference. To facilitate Cloud data storage, the system includes a hardware module as a local data collection and storage site before it is uploaded. The customer requested a minimum of 24 hours of local data storage, and the hardware module provided is able to capture more than 10 days of data, for redundancy.
E Tech Group built the entire control panel, tested it, and developed all software. Once integrated, the system was tested and implemented on site.
Pre-Validated Control Modules
Control modules developed in-house by E Tech Group based on past experience and projects to reduce development and test time. The functionality of each module has been tested and validated. Taking one day per control module to test, the five pre-validated control modules saved five days of testing.
A Tight Timeline
With the extremely short timeline, An E Tech Project Manager front loaded the project to stay ahead of schedule. The PM outlined the functional specification and got initial customer buy-off to prevent any unwanted surprises later on.
Part of the strategy to condense the schedule was to conduct the factory acceptance test (FAT) on the software functionality at E Tech Gruop. The control panel was tested at the fabricator, then the wiring was tested at the site with the control panel after it was installed.
Along with the tight timeframe, another project challenge was that the laboratory was being constructed concurrently with the development of the QMAS and delivery of the equipment. The laboratory was constructed on one floor of a five-story building and was gutted down to the concrete walls before building began. The space needed to be highly customized for the laboratory, with specialized equipment, air filtration suitable for biopharmaceuticals, and more.
Site Acceptance Testing
The customer notified E Tech that three pieces of laboratory equipment were indefinitely delayed due to the onset of the pandemic. E Tech quickly pivoted to create a cascading site acceptance testing (SAT) schedule, allowing the partially complete system to be validated and functional until the final equipment arrives from overseas.
They were able to break the system apart such that when they incorporated the utility equipment, it did not affect anything that was already tested. They used the modular design of the system with the notification to make a modular test. They also tested the system with all pieces of equipment that arrived on time, such that they will not have to be retested when the remaining three machines arrive. They were able to incorporate the new equipment without impacting any testing that was already done.
With the efforts of the teams at E Tech and the client, the system was constructed, programmed, installed on site and tested in according to the aggressive schedule. Had it not been for unforeseen delays in the delivery of three pieces of laboratory equipment due to the pandemic, E Tech Group would have completed the project according to the initial schedule.
Had it not been for the COVID-19 equipment delay, they would have finished the project on time, exactly three months from the project kickoff. Our team worked very hard and the project went well. The customer is able to run the system even before the last three machines arrive, and they seem very happy with its performance.
With the QMAS in place, future additions to lab and storage equipment can be installed at the customer’s own pace.