Transforming Bioburden Risk with Digital Asset Intelligence

Asset intelligence gives cGMP manufacturers a new way to harness the information they need to prove manufacturing compliance

By Tim Butler, CEO, Tego Inc.

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The concept of a “smart asset” means different things to different people, but the way we think of it is simple: an asset is able to add business value by telling its story, digitally, to anyone with a smartphone-based reader and proper security credentials. In many ways, smart asset technology is a matter of “RFID redefined.”

In the context of aseptic pharmaceutical manufacturing, the smart asset approach serves a dual role for risk management: 1) it allows for automated, touchless environmental monitoring to support sterilization surety during production; and 2) it provides traceability and pedigree data from sterile processing through manufacturing to support FDA regulated facilities so that products can be released to inventory at a higher frequency, and with minimized risk due to contamination.

DATA ON AN ASSET'S PHYSICAL LAYER MATTERS

Conventional wisdom in the world of aseptic pharmaceutical manufacturing has long stated that the “perfect” intervention is the one that eliminates humans from the process. Of course, anyone who works in a cGMP facility knows that manual aseptic processes necessitate human involvement, which in turn increases the risk factors for bioburden. Exhibit 1 shows us the potential financial impact of a bioburden incident.

Aseptic manufacturers are already required to deliver meaningful information about the quality of the processing environment; they must demonstrate to regulators that proper controls are in place, and they must retain the right data to support root cause analysis in the event of a downstream recall. Yet they still face challenges to a) gather this data, and b) do so in a way that minimizes the potential for human-caused contamination in the sterile environment.

To address this issue, the simple step of putting digital data directly onto the physical components that must be sterilized reduces the number of human touches, provides a digital pedigree of manufacturing processes and stages and thus limit the chance that a contaminated environment may lead to a flagged or wasted production run.

A SHIFT IN IOT MINDSET: FROM “I” TO “T”
How do you turn physical assets into compliance and integrity oversight devices? Advances in computer miniaturization and the steady march of Moore’s Law have made it possible for rugged semiconductor chips to be attached to, or embedded within, any given sterile asset. These data-carrying chips require no batteries or wired connections — instead, they harvest their power from radio frequency (RF) signals that interact with the asset when communicating with it.

In a pharmaceutical manufacturing environment, the intelligent assets we’re talking about are varied. They could include biologic collection containers and packages, or the myriad of components used to monitor airborne particulates, active viable air, passive viable air, equipment surfaces and facility personnel themselves. Whenever a drug or biologic goes through its given process or stage of production, the components gather digital records and time-stamped details about the manufacturing stage, location or condition of the environment, which can include chain-of-custody and integrity information needed for regulatory compliance. These assets become the literal digital thread for the regulatory and compliance database that helps personnel perform their jobs better and improve outcomes. Operators, laboratory technicians and managers can digitally access and sync component data to bring about better documented production outcomes and safer drugs released into the marketplace.

Granting an asset better intelligence (or data) at its physical layer is no doubt a novel approach, a departure from typical sensor-based IoT thinking that centers upon the “I” (or, connected) part of the IoT. It is our belief the focus has skewed far too heavily toward promoting a need to connect everything with a sensor, all the time, and then streaming the information to the enterprise cloud. When you start having to account for the variables and infrastructure required to maintain always-on connectivity, the value proposition for the solution gets lost amidst very real expense-to-return ratio concerns.

However, when you flip the mindset toward putting reliable, rugged, compliance data on assets themselves, not only do you remove the necessity for a corporate-wide, networked software environment, but you open the door to new workflow efficiency from unexpected places. For example, today’s barcoding standard requires tracking each asset individually, which relies on frequent scanning, necessitates manual intervention by work crews and becomes a bottleneck to productivity. With the asset intelligence approach, however, there’s significant work reduction within the touchless process itself. Instead of scanning individual containers, one at a time, it is now possible to gather all manufacturing and product information with much less operator interaction. This results in measurable improvements by a factor of 20: Not 20 percent, but a reduction to one-twentieth of previous time and effort required. A shipment that used to take eight hours to process with barcodes can now be received and catalogued in roughly 30 minutes. The expense-to-return ratios are more palatable.


WHERE ASSET INTELLIGENCE COMES TO LIFE
Getting data onto assets is a relatively easy concept to grasp. The aseptic industry understands, however, that any data traveling with a biologic product or monitoring an injectable drug through manufacturing must be able to survive exposure to radioactive sterilization processes. Without a doubt, there’s a long-held understanding that electronic radio-frequency data is unable to maintain its stability and reliability when exposed to harsh sterilization such as gamma rays and eBeam. Fortunately, asset intelligence has upped its game on this front.

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