December 1, 2016 (Vol. 36, No. 21)
Barbara Paldus Ph.D. CEO Finesse
Bruce Blau Technical Communications Manager Finesse
SmartParts Are a New Paradigm in Automation
In the mid-1970s, businesses were modernizing their processes by investing in the latest advancement sweeping the country—the mainframe computer. Because computers of that era were not general purpose devices, each one had to be customized to its purpose. Consultants were then hired to make software or hardware modifications, attach external devices, and create documentation or training modules.
Although mainframe computer customization services thrived into the next decade, the paradigm of business computing was shifting in a big way. Personal computers, as well as off-the-shelf software applications, were now far cheaper, and users could install external devices themselves. After-market consultants became an option, rather than a necessity.
Today’s computer technology is almost unrecognizable from that time. But, the paradigm has significantly evolved for laptops, tablets, and smart phones: affordability, hot-pluggable expandability, and intuitive ease-of-use.
When Finesse Solutions was formed in 2005, we recognized that the biopharmaceutical industry was operating in the computer industry’s original paradigm. Creating a biotech drug was an intensely sophisticated process, marked by advancements in bioprocessing: fermentation, filtration, and purification. Manufacturing equipment, however, was lagging far behind.
Era of Customization
Ads for bioprocessing equipment can present an image of cutting-edge, forward-thinking technology. But contrary to the computer industry’s evolution, biopharma equipment manufacturers still build products almost entirely to order in a highly customized manner.
The rationale is understandable: customized equipment equals future income, as equipment is eventually expanded or modified. New components and capabilities require changes to software.
Regulatory requirements make the customization business model even more lucrative. The FDA and other international agencies carefully scrutinize every aspect of the biopharmaceutical manufacturing process. Customized hardware components and their control software must be validated and commissioned, after which they become increasingly difficult to replace. Any improvements must be justified in the context of regulatory risk.
Software documentation requirements include outlined Functionality Requirements Specifications (FRS) and detailed design specifications (DDS) for every module. For most cGMP facilities, the software is completely bespoke and is written using libraries of modules for each application. After development, engineers perform and log tests to verify the software documentation. Formal validation testing is required for all software modules, even those that seem identical.
We recognized that one way to address the inefficiencies inherent in the existing paradigm was to create better, “smarter,” equipment. Finesse invented and patented a line of SmartParts to both increase bioprocessing efficiency and challenge the status quo of customization. It was vital that Finesse develop a complete set of actuators and transmitters to enable its SmartController product line:
• SmartPumps—Designed for highly precise liquid delivery, the pumps feature encoders that instantly “brake” the pumps on command, which enables a clean stop to dosing, rather than just prompting a gradual slowdown.
• SmartMFCs—Mass flow controllers with “hit-and-hold” solenoids to enhance flow control, reduce potentially dangerous heat production, and operate in a matrixed gas manifold.
• SmartAgitators—High torque, high resolution encoder-based motors for glass and single-use bioreactors.
• SmartValves—Plug-and-play pinch valves for use in downstream processing.
• Smart Transmitters—TruFluor®, TruTorr™, TruSens™, and SmartScale™ transmitter blades within Finesse bioreactors transmit digitally for faster, more accurate communication.
• Single-Use Sensors—TruFluor pH and DO, SmartReader, TruPCT, and TruTorr, which have a built-in base level calibration.
One essential feature that Finesse wanted to introduce with the SmartParts was plug-and-play. Just as a Mac or PC immediately recognizes a printer when it is plugged in, Finesse SmartParts, such as the SmartRocker, instantly show up in TruBio® DV software with the correct graphics displayed. While the instant recognition, alone, saves money over the expense of hiring contract labor for integration, Finesse had a goal to ease the documentation and validation burden, too.
A full set of cGMP-compliant documents accompanies every Finesse product and the documents are upgraded and modified with each new version of software. The Smart Products are tested and validated as part of the larger system, thereby minimizing that expense.
When designing SmartParts, it was important to Finesse that increasing the sophistication in their components should not recreate the very paradigm they were trying to change: the complexity of customization. A company using steel equipment that suddenly finds they need to reconfigure their process is faced with time-consuming and expensive cutting and welding.
Finesse embraced the single-use paradigm early on its evolution and realized that using materials and tubing sets that can be readily customized in the field provides significant flexibility with the ability to integrate new sensors and even reconfigure an entire process with consumable materials. Changes can be made quickly and inexpensively using aseptic connectors and tube welders.
And, while companies seek to be more flexible with their processes, the automation systems have to just as flexible. Less than 10 years ago, most bioprocessing companies used four pumps—acid, base, antifoam, and media. Today, with perfusion systems the need can total or exceed eight pumps—with additional pumps used for chemical activators/additives, harvest, and a bleed line.
The modular nature of SmartParts adds even more flexibility to automation. They enable the use of dosing towers and SmartCarts that can be used for both filtration and perfusion. This modular flexibility is a vital feature for companies that intend to do continuous processing, or whose processes are evolving in productivity over time.
Another often overlooked benefit of SmartParts is their ability to enhance the fundamental DCS control framework within which they operate. They provide extremely fast response times, similar to the programmable logic controller (PLC), which is used by some of the industry’s larger manufacturers, except that SmartParts with a Smart DCS system are more configurable and easier to use.
The response times are particularly useful in downstream processing applications and where micro-seconds are important compared to hundreds of milliseconds to seconds. Specifically, this becomes important for low-volume process control in personalized medicine and continuous processing applications.
Finesse’s G4 controller, available beginning in early 2017, will embody several facets of the new paradigm. G4 eliminates the point to point wiring that is often seen in bioprocessing automation systems in favor of cables, advanced communication protocols, and a modern, industrial chipset that allows for enhanced features both for the end-user and for internal manufacturing. Finesse fully supports quality by design and is looking to G4 and SmartParts to allow true modern computer like configure to order systems.
Not only does component installation become far easier with the G4, but service of the units, as well. The chips plugged into the G4 will be precharacterized with essential information about the corresponding component. So, if a problem occurs at a customer site, a service technician can often provide accurate diagnosis of the issue remotely, simply by logging into the network remotely.
Finesse looks at the G4 as similar to another paradigm shift taking place now—the emergence of the smart car. Before we know it, our highways will be largely populated by cars that will make us wonder how we tolerated the ones we drive today. Like the smart car, the G4 will interact with the user, allow modular plug-and-play expandability, and require very little maintenance. In fact, many will liken the G4 to a self-driving car, once the process “destination” (final product recipe) is set.