“Nimble” is an understatement for most life science manufacturers producing COVID-19 test materials, PPE, or treatment this year.
Thermo Fisher Scientific snapped into action and began ramping up production of its viral transport media (VTM) tubes at the outset of the pandemic. Later they received orders from the U.S. government to scale production from 50,000 per week to 10 million per week.
VTM tubes filled with liquid medium are used to store and transport nasal swabs for viruses including SARS-CoV-2. In March, the Thermo Fisher facility in Lenexa, KS, was already filling 10 and 15 mL conical tube configurations. The company ramped to 24/7 operation and retrofitted their lines to run faster at the outset of the pandemic, but it was clear that they needed new machines to meet demand. Considerations beyond speed included:
- Some of the conical tubes are skirted, but the tubes without skirting do not stand up on their own.
- The medium has similar viscosity to water, but Jason Gourley, strategic projects, sr. project engineer at Thermo Fisher Scientific, says, “From a filling perspective it's very similar to water, but if it lands on a surface, drips, or spills and begins to dry, it becomes sticky. If it's not immediately wiped or cleaned, it turns into a goo, similar to spilled soda left to dry.”
This didn’t cause issues with capping, but if a tube happened to spill and medium got on other components—such as the feed screws or labeler—equipment could bind up and cause downtime in cleaning.
VTM lines also needed to be ramped up at Thermo Fisher’s sites in Perth, Scotland, and Wesel, Germany. In both Perth and Wesel, the operation switches between filling VTM and saline, depending on current demand. Gourley explains, “It's the same tube and cap, same fill size. The difference is the liquid itself, the labeling requirements, and different pump settings.”
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When Gourley arrived in Lenexa from his usual Rockford, IL facility in March, the immediate need was to understand the process and determine where automation could increase throughput dramatically.
Speed was key. The Thermo Fisher project team had vendors offering to drive components to the facility—instead of overnight or two-day shipping—because they knew every hour counted.
Gourley suggested working with Morrison Container Handling for high speed integrated lines. “I've worked with Morrison for about three or four years. They've done some screw feeds and integration with a line in Rockford.”
The initial request to Morrison was whether they could create a smaller system within approximately a week. “They immediately hopped on it and followed through. They had a quote ready the next day, working through the night and everything, Some projects take a step-wise approach to implementation. But Gourley says time didn’t allow for that in this case, noting, “This was all at once. We drew it out on a napkin one morning. The next morning, we were putting it together.”
It was difficult to nail down project specifics with a constantly moving target. “Every day something changed. One million per week was the initial goal and it was only going to be for about three or four months,” Gourley says. “Everything started out with, ‘Maybe. But could you do it?’ We had four on order and then the question came down from the government on how we can get 10 million a week and what would it take.”
The original order for machine #1 was placed in early April and the first machine shipped in approximately five weeks. That included design from scratch to manufacturing, build/assembly, and testing. A total of 14 systems shipped to Lenexa and two systems shipped overseas in the next 20 weeks. To put things in perspective, the normal quoted lead time for one system/line can be 20 weeks or more.
The Morrison systems allow Thermo Fisher to orient, contain, move, and support the pointed conical tubes. They are handled from a dual feeder bowl solution to drop into the screws. (R-Tech Feeders Inc. based in Rockford, IL, supplied the tube elevators, feeder bowls, and shuttle dropping mechanism for the tubes into the Morrison screws.) The system then indexes six tubes at a time underneath the filling head, indexes along underneath the cap applicator, and then into a spindle capper. (APEX Filling Systems in Michigan City, IN, supplied the cap sorters and cappers.)
Fill and torque checks are performed by production every 15 min. There is also a no-cap sensor and crooked cap sensor at the discharge of the machine. If a cap issue is detected, the machine will stop, alert the operator to remove that tube, and then the operator is able to reset and start the machine. Every second counts when running at a rate between 120-132 ppm.
Tubes exit the machine in different orientations based on the machine and location.
- Machines #1 and #2 run pointed tubes which don’t stand on their own.
- Machines #3 through #16 run skirted tubes that technically have the ability to stand on their own, but Gourley notes that even the skirted tubes—moving at rate, with liquid—do not stand securely on their own.
Dorner Conveyors move tubes directly from the machine, out of the cleanroom to the labeling machine, autofeeding onto the labeler. There is still an operator to perform quality checks or interventions at the labeler. (Label applicators are supplied by MO-based Pack Leader USA.)
As many business travelers have found, travel restrictions have held up some trips. Gourley says, “Between Chicago and Lenexa, KS, there were still restrictions, but we had higher level approvals due to the critical needs of the project.”
For the sites in Europe, it was a different story. “For Scotland, we tried to go through the embassy and the government to get those supporting individuals on site in Chicago around the 4th of July weekend, to review their machine at Morrison and to be a part of an installation in Lenexa. But we weren’t able to get approval prior to their machine arriving at their site,” he explains.
Gourley and his colleagues performed all 16 factory acceptance tests (FAT) on-site at Morrison. The company performed/recorded virtual FATs for the European sites. He says, “For the first two, we developed/worked through a protocol and had it circulated for approval, so we knew what we were looking for. But we also had timeline restrictions—we already had the plane booked. There's only so many tubes we could run and only so much time we had with the new system.”
Both Perth and Wesel received their machines with only instructions, videos, and the ability to call for support. Yet each site respectively had their first machine received, installed, and running at rate in five to six days.
By then, Lenexa staff had installed about seven machines in the U.S., so they had plenty of lessons learned, videos, PowerPoints, instructions on the sequence, and items to pay attention to. “We were a part of the complete build, the complete runoff, and the complete disassembly in creating these specific systems. We went through rolls and rolls of blue tape, putting on notes, alignment features, noting all the dimensions, anything we learned from the first several machines. It is wild to think that we shipped machines around the world to sites that had never physically seen or ran the equipment. A lot of thanks go to those receiving individuals for their patience and perseverance,” Gourley says.
The company made use of Microsoft’s HoloLens program for live video feeds from the augmented reality headsets. “We were able to see their troubleshooting issues live, and they were able to live-view their machine during validation and ask as many questions as possible. “We built up the files and everything to have immediately available, so if they had a question and they were viewing it right in their headset, I had the pictures, dimensions, and videos available to pull right onto their screen and into their viewpoint to do a direct comparison,” Gourley explains.
One of the toughest parts of the remote work was not the machine integration itself, but the time differences between sites—six hours to Perth and seven hours to Wesel. Which site worked during business hours and which worked off-shifts? “Everybody did everything. It was 24-hour support,” he says.
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The largest regulatory hurdle that they had to overcome was making sure they met all the CE mark requirements—mandatory for equipment in Europe to demonstrate safety conformance—for the Perth and Wesel units. Gourley says, “As soon as possible, we brought in a third party to fully understand the CE standards and additional safety requirements. We immediately started talking with both sites’ environmental heaslth and safety teams to ensure that we were going to comply not only with CE, but also be aligned with their site safety expectations.”
After ramping up 20,000%, you might think it would be time to relax. The facility in Lenexa now has 14 lines installed (as of Aug. 25), with the capacity to produce 10 million VTM tubes per week.
But the work continues. Thermo Fisher has ordered 14 more systems —four for Lenexa and 10 for Scotland. “A lot of credit goes to the teams at Morrison and supporting vendors to start from scratch and build 30 systems between March and the end of the year. It was really a team effort with a lot of credit to Thermo Fisher personnel—including the engineering and procurement groups—between R Tech, Apex, and many sub-contractors. There was definitely a lot of collaboration,” he says.
It’s too soon to really talk efficiency, particularly with the rapid increase in staffing and training, but they are averaging over 100 tubes/min per machine. Gourley explains, “The machines run very well and they're well over the OEE that we were anticipating. Now we’ve gotten the initial kinks out of the way and the operators are a lot more familiar with the operation.”
Staff and facility expansions
Understandably, Thermo Fisher ran into space issues, especially as they looked at the supply chain to get tubes, caps, and media to the machine. “Machine #1 is a much smaller footprint than Machines #2 through #16— it's shorter in height, length, and width to fit in the room. It's still a screw feeder, but the cap delivery, and exit are different,” he says.
When they ran out of space in the existing facility, they needed to build out an entire second facility in Lenexa for filling lines, packaging and more. Over 300 new employees were hired and the site is looking to hire over 100 more additional employees. The new $40 million facility is strictly dedicated to VTM production and quality control, and it will serve a role going forward for flu and other viral products. Deemed Project Patriot, the 120,000 sq ft build-out and tube production can be viewed in action here.
“When we signed the lease on May 18th, this was an empty shell, and by July 4th, our country’s Independence Day—our milestone for Project Patriot—the first production units coming off the line were achieved,” said Bret Johnson, vice president of global operations for Thermo Fisher’s specialty diagnostics business.
The Lenexa team learned a lot along the way, especially with Machine #1 since it was a completely new system in some ways for Thermo Fisher, Morrison, and everyone involved. “For Machine #2 through #16, we took a ton of lessons learned and worked to implement on the fly. We've gone back and implemented some on #1 also,” says Gourley.
The collaboration between Morrison, Thermo Fisher, and other vendors was key. He adds, “We were getting the Morrison machine ready on Monday, receiving vendor components on Tuesday, running the full system on Wednesday, and FAT-ing and shipping on Thursday and Friday. At one point we shipped three systems in one week and one of them was international.”
The team continues to investigate more streamlined processes and automation to help aid in inspection and packaging. Currently operators perform a visual inspection for media content and cap, and check for wrinkles, damage, and legibility of the label. Then tubes are passed to an operator who populates 72-count boxes in Lenexa.
Each machine produces a lot of approximately 24,000 tubes every three and a half to four hours—about a pallet and a half worth of material. At peak, with 12 machines running, it’s a pallet approximately every four minutes, so there’s considerable volume to handle thanks to the new machines.
Gourley comments, “The Morrison machines, along with the efforts of all of the other vendors, and all of the dedication of the Thermo Fisher individuals were key in enabling us to deliver on the federal government contract. Overall, we've met our commitment with a lot hard work and with everybody invested 110% in making these test kits available for society.”