Plugging the manufacturing cracks

Sept. 22, 2020
How to ensure COVID learnings are put into practice for good

COVID-19 has shined a spotlight on the cracks in pharmaceutical manufacturing. Even before the pandemic, life sciences experts had warned about the risks of a globally concentrated supply chain where pockets of raw materials and active pharmaceutical ingredient (API) suppliers in other regions of the world left pharma companies and patients particularly vulnerable to a sudden manufacturing stoppage. Any production disruptions, they said, could have catastrophic effects on human health.

Their concerns were borne out with the sudden emergence of the novel coronavirus, which not only disrupted manufacturing but also led to widespread supply chain shortages as the pharma sector was focusing its attention on developing new therapeutics and vaccines for COVID-19. However, in an industry where companies make drugs that are life-saving, downtime is not an option.

Technology that can make data actionable in real-time has been a boon to pharma companies during COVID-19. It has helped them keep employees healthy and safe, adjust to smaller teams and react to issues faster. But that technology should not be tucked away in a server closet once the pandemic subsides. It solves issues that pharma manufacturers can no longer ignore.

Initial effects and lessons

COVID-19 dealt a blow to pharma manufacturers that were already facing a skilled labor shortage and running reduced crew shifts. As the virus spread, these reduced work crews became skeleton crews as many employees either became sick or were hesitant to come into facilities because they feared infection. Manufacturers were forced, for social distancing reasons, to reduce staffing even further, keeping non-laboratory and plant-floor workers at home. 

The new distance requirements, while a safety necessity, inevitably slowed down production processes. A McKinsey poll of more than 300 research and development functional leaders, including chief medical officers from over 50 global companies in the sector, estimated that productivity has declined by 25-75 percent due to remote working. As companies adjust to remote work environments along with reduced lab capacity, clinical and product development pipelines are suffering.

Pharma companies continue to scramble to come up with employee protection solutions to mitigate health risks so their people can return to work safely.

In the face of a virus that spreads rapidly when people work in close quarters, pharma companies improvised an assortment of stopgap protection measures such as routine temperature checks, staggered shifts, and limits on personal interaction where sites remained open. This was trial-and-error in real time because employees working in laboratories and manufacturing sites were on the front lines with the pandemic threatening their own health.

Real time is the new normal

As the industry looks to apply lessons learned, one clear takeaway is the need for solutions that will improve business resiliency. It’s no longer enough to rely on traditional safeguards companies put in place during “normal times” to ensure general safety standards and protect workers doing the delicate work of biologic manufacturing against standard illnesses. COVID-19 has reminded us there is nothing standard about a pandemic.

In the past, pharma companies weren’t under such pressure to respond to issues in real time. They were accustomed to taking the necessary time required to collect and review data on their products or the performance of their equipment. In the face of challenges like COVID-19, that timetable needs to speed up. An employee with a fever that goes undetected risks triggering an outbreak that could lead to a total shutdown of the manufacturing site. Such information is critical, and manufacturers need to be able to have it immediately so they can respond quickly and with agility.

For comparison’s sake, consider the unfortunate example of the meat-packing industry which was relatively slow to react to the new health risks posed by COVID-19. Several meat and poultry processing facilities suffered multiple outbreaks that led to closures as thousands of workers got sick with the virus.

Had those sites been equipped with effective contact tracing technology, they would have been able to understand how employees were moving through their environment. Technology would have helped them learn where people had been, who they interacted with, which rooms they spent time in, and whether they adhered to physical distancing rules.

Further, they would have been in a stronger position to enforce safety compliance, making sure that employees wore masks or were sanitizing their hands correctly.

Many companies are now connecting thermal imaging cameras into their Internet of Things (IoT) network to measure body temperatures and monitor employees as they enter the facility. As people walk through the door, the systems can flag anyone with a high temperature for further evaluation. Importantly, this occurs in the moment, not after someone has been walking around for an hour and interacting with other workers. The upshot: Facility managers will be able to detect and respond to potential trouble in minutes, not hours.

All in all, such a system contributes toward achieving the larger goal of creating a safer, more secure environment for employees.

Situational awareness

Situational awareness isn’t just for pandemics, however. It is no easy feat, as it depends upon collecting information from the environment, focusing on events taking place in real time and then converting that data into actionable insights.

As the pharma industry considers how to develop better business resilience in the post-COVID-19 era, situational awareness needs to remain a critical component of any recovery strategy.

Real time is part of the broader digitalization trend underway the last few years as more organizations connect to IoT and deploy sensors and devices that collect information from their environments.

ven gateways and edge devices now have logic running anywhere and everywhere. With this extraordinary amount of data, companies can apply artificial intelligence to extract meaningful understanding to be more proactive when it comes to operations and strategy.

That means any organization can now receive alerts for everything from an industrial accident to an active shooter on site, to the previous example: identifying someone who may be carrying a virus onto the plant floor. This situational awareness can be connected to DEFCON-style modifications in plant operations, orchestrating near-instant changes to policies, systems, and workflows with a single button click.

All of these developments are shifting the capabilities of businesses as they enter a new age of the real-time enterprise. The inputs can come from current existing enterprise business systems, mobile devices, web browsers or other inputs. These myriad pieces of sensory data reveal a lot about the work environment. It might be about a particular machine’s status or conditions related to the broader business environment. The information gets contextualized, combined and correlated so that the organization can apply best practices and truly operationalize its data.

What’s more, these new applications don’t require a database and so, don’t suffer performance hits that might arise if they were required to store data for subsequent analysis. And since they are built to leverage IoT, AI and edge technologies, they can literally sense and react to events as they take place.

Paper is dead — or it should be

Digital is still a long way from becoming central in life sciences interactions.

Indeed, many pharma manufacturers still rely on paper records for batch processes. However, paper can get lost, and a batch without a record cannot be sold. Currently, a review of paper records requires someone to be present at the facility. That’s not a recipe for increased speed and agility.

Moving to real-time technology systems does not require ripping out or completely replacing enterprise systems. But manufacturers need to be able to cross-pollinate and better orchestrate their current systems to foster smarter coordination and accelerate average response times. As we reimagine work processes in a post-COVID world, anything that can reduce unnecessary physical contact is worthwhile. Ideally, companies should be able to build an alert that notifies a reviewer when a completed batch record’s exceptions are ready to be reviewed digitally. However, as the future takes shape, it will feature increasing reliance upon digital tools that provide greater situational awareness.

Doing more with less

Another lesson learned from COVID-19 is technology’s ability to do more with less. That must continue, even as staff come back on site. Nowhere is this need more pronounced than when it comes to maintenance teams. While pharma manufacturers have traditionally counted on their maintenance teams being able to travel to multiple facilities, the quarantines, lockdowns and limitations on travel has hampered flexibility.

Here’s where technology compensates for the loss of physical manpower. Solutions that allow remote monitoring of assets and bring together data associated with those assets will transform how maintenance teams do their jobs. They’ll now have clear insight into how the machines on the plant floor are functioning. What’s more, operators on plant floors will be able to use mobile forms built into the platform to augment the total picture — including descriptions of what they’re hearing, seeing, and even smelling from their equipment. All of that feedback would get routed to the appropriate maintenance team.

Pharma learned hard lessons in the past several months. But while this pandemic may be unique, the experience vividly underscores the need for comprehensive solutions that combine automation and human interaction.

There’s been much conversation about what adapting to the new normal will require as manufacturers shift to recovery mode. Pharma companies that are equipped to respond quickly and take the proper steps are going to be the winners —and smarter, situational technology solutions will be key.

5 Benefits of working in real time

1. Workforce health and safety

Businesses making use of real-time data now have a way to ensure the wellbeing of their workforce. Instead of waiting until an employee falls ill before sending them home — at that point, you’re already behind the infection curve. IoT-based monitoring solutions that send back real-time data allow managers to track the health of employees, based on up-to-the-minute data. Managers can act preventively to send home employees showing early signs of fatigue or illness.

2. Workplace health and safety

Real-time data also allows the early detection of any hazardous conditions that could potentially harm the safety of the workforce. In the event of an incident, such as a carbon monoxide leak or a fire, management can gather instantaneous updates on the status of the problem and location of workers in the facility. Real-time information also helps with the oversight of more routine safety-related norms around the maintenance and sanitization of equipment.

3. Minimizing production downtime

Instead of waiting for something to break, companies can now spot early signs of technical malfunction, mobilizing repair teams as needed to intervene before a situation worsens and systems and machines break down. Organizations reap additional cost and health benefits since they no longer need to staff as many technicians on site. At the same time, they reduce potential health risks that may arise since fewer employees are required to work in a facility.

4. Integrated maintenance

Manufacturers often find themselves running disparate systems where it’s hard to communicate and share data internally. But with real-time data, the deployment of sensors and devices around a site will immediately inform managers of any urgent operational decisions they need to make — from DEFCON-1 emergencies down to nuts and bolts situations, such as whether to keep the power on in a room or shut off a piece of equipment for the night.

5. Resource management and efficiency

In any complex factory, there are so many steps in production that a single change can affect operations at all the other points on the assembly line. Based on real-time data collected along each point on that line — for instance, an alert that a particular piece of equipment needs maintenance — managers can adjust any step or multiple steps in order to improve performance.

About the Author

David Sprinzen Director of Marketing | VANTIQ; Bryan DeBois Director of Industrial Artificial Intelligence