Biocoat Case Study
Biocoat® Incorporated, Horsham, PA
Biocoat® is a global leader in the development of hydrophilic coatings for medical devices. A processing line of custom engineered equipment was not operating to the exacting standards they had specified. Vortechs Automation designed and built an entirely new control system that performs beyond expectations and aligns with industry standards.
Background
Biocoat's hydrophilic coatings keep insertable medical devices lubricated so that they will not cling to or cause friction against tissue.
In 2019 Biocoat® commissioned custom engineered equipment to automate their process for applying their specialized coatings to catheters. They had plans to scale up their services applying coatings for client companies and to produce similar equipment so client companies could apply Biocoat solution in their own medical device production facilities. A lot was riding on the proper performance of this one process line, but the equipment never quite performed with the reliability and functionality expected in the medical device industry.
In their attempts to service the equipment, though, they encountered unconventional control systems and opaque PLC programming. It was time to call in the experts.
Automation Company Search
They found a handful of automation companies via internet search. Of the ones that responded in a timely manner, Vortechs had the experience and resources to give the job the attention it deserved, and the Biocoat team appreciated the added convenience of collaborating with a local company.
Biocoat asked Vortechs to assess the processing line and put together a proposal to remedy its shortcomings.
Vortechs found that the inputs and outputs were spread across 9 different PLCs, a separate one for each of the major components of the process line, a control strategy that is not in keeping with automation industry best practices. Furthermore, the front-end software was a custom-made one-off application. Consequently, it would be difficult to impossible to work with the existing automation system.
Vortechs' assessment determined that the system was mechanically sound, but the controls needed a complete do-over. The team at Biocoat agreed. Vortechs got to work immediately.
At the start of the project we outlined some things that we wanted the machine to do and when we got to the finish line we had all the features that we were looking for and some of those features were new to the machine and were provided by the programming.
The Process
The process is relatively simple in concept: dip the long narrow catheters into the Biocoat solution, allow the excess to drip off, cure the solution coating using heat, repeat as needed. But parsing simple concepts into discrete logic steps quickly reveals just how complex "simple" can be.
At each step along the way, sensors monitor and confirm the position, timing, and motion of the catheter pallets. All the while, conditions within the equipment enclosure are monitored for temperature, humidity, and other process parameters. From the infeed to the outfeed, the whole process required 67 inputs and outputs, 17 motion axis, and 24 stepper motors.
Process Automation and System Integration
They ended up streamlining it to one PLC running all the components of the machine, cleaned up some of the communication routes for the different components to communicate better, and then reprogrammed the entire system.
Vortechs consolidated all the I/O into a single PLC. They wrote new, open-architecture PLC programming following automation industry standards so that any future service technicians can readily access and understand the program. They paired the system with controls displayed on a touchscreen computer running industry standard HMI software.
The new Vortechs system not only controls the process, but logs all the data as well, which conveniently supports Biocoat's existing QC practices. More specifically, for those familiar with FDA standards, Vortechs' front-end software is CFR 21 Part 11 compliant.
For their own troubleshooting and for client accountability, knowing that they can instantly trace the who, what, when, and where, of any potential defects lets them efficiently resolve the why and how so it won't happen again. It also demonstrates an enhanced degree of quality and accountability to Biocoat's medical device client base.
We are already talking with Vortechs about supporting another one of our existing machines and we may have them do a similar function for it.