The Practical Reality of Augmented Reality in Pharmaceutical Processing

As Featured in Processing Magazine

In a tight labor market, processors are increasingly using augmented reality to minimize costly downtime and human error and ensure product quality and a safe work environment.

Augmented reality (AR) has quietly transitioned from a tech buzzword promising to revolutionize how workers interact with the manufacturing process into a practical, digital application offering to reduce errors in production, promote consistent product quality, support worker safety and streamline training, maintenance and operations.

AR refers to the computer-assisted addition of virtual elements to reality. AR integrates digital imagery, live action animations, sound effects, voiceovers, and other virtual elements into the real world to create a rich experience that enhances life in the real world. Virtual Reality (VR), by contrast, creates an entirely separate simulation removed from the real world. While VR earns splashy headlines and attention at the consumer level, it is actually AR that is earning attention at the practical level in the pharmaceutical, chemical, and other process industries where even seemingly minor errors must be prevented to avoid major consequences. While VR still requires the use of clunky, cumbersome headsets, AR software may be used while wearing enhanced glasses, or by using a tablet, or even a phone.

Automation Aftermath

Consider how the rise of automation and the renewed usage of continuous processing have minimized the risk of human involvement in the production process, along with their potential for error. Even prior to the lockdowns, most processors were automating as many steps in the production process as possible, primarily pursuing higher line speeds and lower costs given the relatively stable economic and labor conditions at the time. But the shock of the lockdowns and Covid-driven pandemonium triggered a spike in demand for automated machinery as managers frantically tried to compensate for the loss of staff and inability to depend on staff to arrive at the plant each day. Reliable, unattended, 24/7 machine operation and low maintenance needs often replaced higher line speeds and lower costs as the primary goals. Batch processing began to cede share to continuous processing as every step in the process from sourcing and receiving raw materials to delivering finished products were examined as potential opportunities for automation. With cleaning, sanitation, and worker safety moved among the top priorities, automating amid unprecedented workforce turmoil garnered substantial investments at companies large and small.

Yet after major tasks such as bulk material transfer, dosing, mixing, encapsulation, tablet compaction, filling, packaging, and material handling have been automated, a number of manual tasks remain that are impractical to automate but must be performed correctly every time to meet quality and regulatory requirements. Unloading and transferring raw materials from storage without introducing contamination; monitoring, inspecting, and documenting product quality; setting up and operating machinery; and loading wash racks for cleaning and sterilization are among the vital yet mundane tasks that still threaten to derail otherwise state-of-the-art processes with human error. In validated, cGMP processes, minor errors and oversights may invite costly enforcement action, delay production, and negatively affect product quality.

For example, a pharmaceutical manufacturer may invest handsomely in an automated cleaning and disinfection system with a custom-designed wash rack that safely holds a predetermined set of items from glassware for laboratories to transport containers, carts, cages, bottles, and equipment for use in cleanrooms. The wash rack holds each item in its own place to ensure complete cleaning and decontamination without concern for movement or damage during the washing, rinsing, and drying processes. However, a worker lacking training, experience, or focus can mistakenly load items in the wrong place, insert the rack in the washing system, and run a complete cycle. When unloading the washing system, broken components and cracked or shattered glass may be revealed – or worse – intact components that are still contaminated but appear clean and ready for return to service.

But by using an AR training application, the operator may see a full-color, 3D, digital model of the fully loaded wash rack as custom-designed side by side with the actual wash rack to be loaded in real life. Audible guidance and visual cues ensure the operator sets each beaker, barrel, funnel, jug, hose, fitting, bottle, or other item in its proper place. Nearly any vocal style and language may be used based on the specific needs of the facility, department, or of each individual employee. As a supplemental training tool, this type of AR application offers non-stop, visual access to standard operating procedures, operating manuals, and other technical data with verbal coaching exactly at the time when it is practical and most vital for the required knowledge to be available.

Similarly, the machinery for production, filling, packaging, or other processes requires workers to setup the parameters correctly. A seemingly minor error at the touch-screen HMI can render an entire batch or lot as waste and cause costly line downtime, missed production deadlines, and other cascading effects. Yet the lack of skilled, experienced workers only adds to the risk of human error. AR offers visual instruction for machine operation side by side with the actual control panel or as an overlay with expert guidance as if a veteran technician were walking the trainee through the process. Other tasks such as refilling the detergent in a cleaning system, replacing filter elements in a steam sterilizer system or performing a Bowie-Dick Test that are critical to the operation and to meeting stringent regulatory compliance requirements may be supported with AR.

Augmenting Maintenance

The retirement of veteran technicians and the challenge of attracting and retaining the next generation of skilled workers is putting a burden on processors to keep their equipment operating as originally specified. In many cases, processors are either operating with outdated or inefficient equipment or relying on costly, outside services for maintenance. In other cases, entry level workers are being tasked with managing new, automated equipment and, in the event of unplanned downtime, the entire operation may be crippled. Using AR, a worker can correctly perform common preventative maintenance checks with confidence and success. For example, to check steam sterilizer particle filters for accumulated material and assess the need for cleaning or replacement, AR offers an additional layer of insight to safeguard against a mistake. This enhanced visual tool may highlight the filter components, label each one, and provide a side by side comparison of a filter that needs replacement next to a filter that may continue in service to make the decision easy for nearly anyone on staff. Then the proper steps for replacement, if needed, may be presented.

In the event of unplanned machine downtime when a diagnosis and repair assessment is needed immediately, AR can help in-house staff return the line to service without suffering through a costly delay waiting for the outside technician to arrive, or without requiring an outside service call entirely. Interacting within an immersive, animated view of an entire machine, the in-house worker may compare the machine or system in real life to the augmented, labeled view to find a difference or failure and then walk through the repair process step by step. Further, AR can demonstrate how to safely test and/or replace a part or assembly to get the line up and running before an outside vendor can dispatch a service technician. Checking and/or replacing sterilizer door seals, or assessing the remaining life of a drive belt in a tablet counter, among myriad other examples, may be flawlessly and safely performed by less experienced workers armed with the support of AR showing exactly how the inspection and replacement processes are to be performed.

Given the vast range of manual tasks involved in the process industries and the potentially deadly cost of human error, augmented reality offers vital, practical support for training, maintenance, and efficient operation at a time when labor issues raise serious concerns for managers responsible for meeting challenging quality standards and providing a safe work environment.

Jochen Schlag is Director of Marketing, Sustainability and Product Manager in Pharmaceutical Systems Engineering for Belimed Life Science. The company designs, manufactures, and services steam sterilization and automated wash systems, and develops custom augmented reality training aids to help prevent human error. For more information, call 1-585-329-0497 or jochen.schlag@belimed-lifescience.com