"Digital disruption has reached the healthcare sector, and with it comes an imperative for life-science companies to retool core technology to remain competitive,” says McKinsey and Company about the changes underway in healthcare automation.
One manufacturer taking this to heart is Kindeva Drug Delivery (“Kindeva”), with their recent endeavor to implement 18 machines and components into a “one machine concept” for their new metered dose inhaler (MDI) line developed by MGS Machine.
The project began in November 2018, and Kindeva was established as a standalone company in 2020. Kindeva’s business model persists as a contract development and manufacturing organization (CDMO) that develops and manufactures complex drug and combination products for pharmaceutical and biotechnology companies.
Kindeva wanted the one machine concept, taking bulk inhaler canisters all the way through multiple layers of packaging, case packing, and palletizing. With so much to focus on bringing a new inhaler to market, they wanted to collaborate with a company that could deliver the entire packaging line as one.
Their vision was that any operator that walked up to the line would have one common interface, with a cohesive look between each piece of the system including the same buttons, stack lights, programming, messaging, and startup/shutdown procedures. From an operator standpoint, they wanted all 18 machines to “feel” the same.
Selecting a partner
Heading the project was Jeff Annesley, U.S. Engineering Manager at Kindeva, who previously worked at 3M for 15 years as a project engineer for multiple divisions. Annesley says, “This is a very large line that’s very complex. We sent a relatively high-level RFI with product characteristics and process requirements, casting a pretty wide net.” Not only did they need to ensure that the vendor they chose was capable of building this system, but they wanted a level of interest and enthusiasm which helped to narrow it down.
Jeff was introduced to MGS Machine by a colleague who was working on a project with the OEM that was roughly the same size and order of magnitude as the MDI line. “Within a week, I was up there with my manager and that was the first time I met Russell [Kostreba, of MGS]. He had built the machine and asked if we wanted to see it run. He ran the whole line himself by touching one button,” says Annesley. “At that point, I looked over at my manager and said, ‘I think we may have found the vendor.’ Of course there was a lot of due diligence that we went through to get to securing the deal with MGS.”
Having a technical expert at the outset who understood the details of such a complex line (and that it could be done) helped solidify the decision. Annesley notes, “One thing that really puts MGS in a unique position is that in addition to a salesperson, they also have an application engineer to interact with during the RFP.”
After they were awarded the contract, the magnitude of the project led MGS to create a role for a project technical lead, which Russell Kostreba ended up filling.
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Once selected, MGS provided a shop tour to walk through some of the ways that they could integrate smaller projects. “There was a variety of projects out on the shop floor to show different types of capabilities and we introduced people on our team to help Kindeva understand how we would shepherd a project like this. There’s an entire team of people that it takes to make something like this happen, so during that visit, we tried to expose the team from Kindeva to who those people would be, what those technologies might be, and our capabilities,” says Josh Pangier, Director of Project Management at MGS.
OEM sourcing and purchasing
With 18 machines to consider, sourcing was a critical part of the journey. MGS took responsibility for most OEM sourcing, purchasing, installation, and controls. See it in action at the integrated MDI packaging line's video here or scroll below.
“There were some OEMs that we specified—in particular Brooks Machine and Design for the tray unloading station,” explains Annesley. “Coming off of the fill line we have a canister that gets placed into trays, so a strategic decision was made early on to have the same vendor provide the design of the tray loading station on the end of the fill line and the unloading station at the beginning of the packaging line because the common piece there is the trays storing the canisters. We wanted to make sure that there was clear communication and machine design compatibility between the end of the fill line and the beginning of the packaging line.”
Pangier says, “In any type of automation process, no matter where it is on a packaging line, it’s not just about building the machine but about how it interfaces with the commodity and the end users’ processes. We learned all kinds of details between Kindeva, MGS, and Brooks and it took collaboration amongst all the parties to make that part really successful.”
Ultimately, the line combines 18 machines and components from over 10 suppliers into that one machine concept, starting with bulk canisters and ending with aggregation of cases to pallets:
1. Depalletizing & Tray Unloading Module
Purpose: The Depalletizing & Tray Unloading System from Brooks Machine and Design automatically takes bulk canisters stored in trays on pallets and singulates them onto a conveyor.
Details: A vision guided Fanuc robot with MGS programming locates the tray, picks it up, places it onto a conveyor, and inspects to ensure all canisters are present. Once the inspection is valid, the tray enters an inverter where it is rotated 180 degrees to orient the canisters for automated processing. Empty trays are returned to a pallet utilizing the same vision guided robot.
2. Spray Testing Module
Purpose: The Brooks Spray Testing Module automatically tests each individual canister for proper discharge.
Details: Individual canisters are passed through priming stations and are then tested to ensure proper discharge. Canisters that do not fire (No fire) or continuously discharge (Continuous fire) are rejected. Valid canisters are sent downstream.
3. Canister Checkweigher
Purpose: The Mettler Toledo Canister Checkweigher weighs canisters to ensure that there is an appropriate amount of product to provide patients with a full quantity of doses.
Details: Canisters are passed over a precision weigh cell—underweight and overweight canisters are rejected. Valid canisters are sent downstream.
4. Canister Labeling Module
Purpose: The Accraply Canister Labeling Module applies labels with product information onto each canister.
Details: Each label is printed with a lot code and expiration date. Proper printing is verified using an integrated Optel vision inspection system. Labels with an invalid lot or date are rejected while valid canisters are sent downstream. Labels are wrapped around the canister and a vision system inspects each canister to ensure the label is present and properly applied. Canisters that do not have a properly applied label are rejected. Valid canisters are sent downstream.
5. Inhaler Assembly Module
Purpose: The MGS Inhaler Assembly module assembles individual components into the final inhaler and verifies proper assembly.
Details: Bulk Actuators are dumped into a hopper; a centrifugal bowl is utilized to singulate and orient them. Labels are dispensed and applied to each actuator and placed into a starwheel. A vision system is used to verify label placement and actuator cap presence. Actuators without a cap or proper label do not receive a canister. Canisters from the Mettler Toledo Canister Checkweigher are singulated and placed into a starwheel. A linear servo inserts the canisters into the actuators when the components are properly aligned in the starwheels. The fully assembled inhaler is inspected by a vision system to ensure the dose counter on the actuator has the correct number of doses displayed. Fully assembled inhalers that have passed all inspections are picked up by a robot and placed into the Flow Wrapping Module.
6. Flow Wrapping Module
Purpose: This Campbell Wrapper Flow Wrapping module wraps the assembled inhaler in a sealed foil package that also contains a desiccant pack.
Details: A desiccant feeder dispenses a desiccant pouch and combines it with a fully assembled inhaler. The foil for the pouch is printed with a lot and date code that is inspected by an integrated Optel Vision system. The desiccant and fully assembled inhaler are wrapped and heat sealed into a pouch.
7. Leak Detection Module
Purpose: The Bonfiglioli Leak Detection Module verifies the integrity of the pouch.
Details: Pouches are loaded into a vacuum chamber where a vacuum leak down test is performed. Any pouches that fail the leak down test are rejected, while good pouches are sent downstream.
8. Pouch Checkweigher
Purpose: The Mettler Toledo Pouch Checkweigher weighs pouches to ensure all components are present inside the pouch.
Details: Pouches are passed over a precision weigh cell—underweight and overweight pouches are rejected. Valid pouches are sent downstream.
9. Pouch Accumulation Module
Purpose: The Ambaflex Pouch Accumulation Module provides a buffer of material to absorb the imbalance in product flow that would otherwise impact overall production.
Details: A vertical spiral conveyor is used to provide approximately four minutes of product accumulation.
10. Stealth CT Cartoning Module
Purpose: The MGS Stealth CT Cartoning module automatically loads the finished pouches and two pieces of literature into a carton that is then weighed and serialized.
Details: Two pieces of literature are picked, inspected, and then placed into a conveyor. Finished pouches enter a vision guided Fanuc robotic infeed where they are picked and placed onto the previously placed literature. Cartons are automatically fed, opened, loaded with pouches and literature, glued, and closed. Cartons are then weighed via a Mettler Toledo system to ensure all components are present. Overweight and underweight cartons are rejected. Valid cartons are printed and inspected by a printer and camera controlled by an integrated Optel Serialization system. Cartons that fail the vision inspection are rejected and valid cartons are sent downstream.
11. Stretch Banding Module
Purpose: The Omega Stretch Banding Module combines serialized cartons into one stretch wrapped bundle.
Details: Product enters the module where they are upstacked into a product matrix. The product matrix is discharged through a stretch wrap film and the film is heat sealed to create a completed bundle.
12. MatriX Case Packing and Palletizing Module
Purpose: The MGS Stealth MatriX Case Packing and Palletizing module combines stretch wrapped bundles into groups and loads them into a case. Cases are closed, labeled, serialized, and automatically placed onto a pallet.
Details: Stretch wrapped bundles are inspected by an integrated Optel camera that aggregates cartons into bundles. Stretch wrapped bundles are upstacked and organized into a specific matrix. Cases are automatically opened and fed to a load station where the specified matrix is inspected by an Optel camera that aggregates the bundles into a case. The fully loaded case is closed and discharged to a labeling station. The integrated Label-aire labeler dispenses and applies a serialized case label that is subsequently inspected by another integrated Optel Camera. An MGS palletizer robot picks up the cases and positions it in front of another Optel Camera for final aggregation of the case to the pallet.
13. Central Control System with Marquee Monitoring
Purpose: True to its name, the MGS Central Control System provides a central control and monitoring station for the entire line as well as final integration of the Optel Serialization System.
Details: The MGS Central Control System allows a single person to control the entire system if local module control is not desired. Functionality includes the ability to start/stop, monitoring production and maintenance data, set and change recipes, initiate product integrity challenges, and perform final pallet labeling and aggregation. The Central Control System also controls the Marquee Display Monitors that allow operators to see real time data for the entire system.
The original plan was to design and build the MGS portion of the line “in parallel with sourcing a number of components from OEMs and then integrating them all together at one time. That looked good on paper—and then reality hits and you end up working through issues,” Pangier says.
Some product and process development went on concurrently according to Annesley, with MGS playing a key role in some instances. For example, the original pouch didn’t fit into its carton so they couldn’t get started on system design until that was sorted. “We may not be experts at trying to fit products in cartons, but MGS is and that’s a key strength,” he notes.
“Meanwhile, we’re off sourcing other parts of the project that were solid. I think we did nine or 10 revisions of the schedule over that two-year period,” says Pangier. “It’s all about hitting the end user’s market window—if they’re not successful, we’re not successful. We spent a lot of time collaborating on schedule adjustments or pivots. Throw in the global pandemic and it was even more challenging. The leak tester and the front-end Brooks components ended up being the last pieces in that were most affected by the pandemic.”
MGS helped OEMs integrate requirements into their machines so the operators would have the aforementioned similar feel to each component. In cases where MGS saw that an OEM wasn’t solving an issue, they took on the challenge internally. Some pieces of equipment were thought to be turnkey, but as the team found gaps, MGS made their own alterations to ensure a better result.
Part of the success came from personnel at Kindeva. Kostreba says, “Jeff is excellent at project management, and management of people and meetings. Everything’s informative and the people he selected were great at their jobs. So from our standpoint, I felt like we had an army of Kindeva experts to keep us on our toes because they would help to find gaps and then we would fill the gaps with our own little army of experts. Probably the best part of the project is the number of experts doing their job well, working like we were one team instead of two companies.”
The central control system (CCS) operates, as the name implies, as a master control system while every machine operates in the background as its own machine. The programming for the modules remains in the modules themselves.
The CCS monitors what each machine is doing and communicates back and forth. Kostreba explains, “Machines upstream and downstream communicate with each other individually for stop or wait commands, and the central control system can also start and stop machines, go to dispatch configuration, half speed, full speed, etc. Then it reports all of that information for everybody in the room to know what’s going on.”
Annesley says, “A requirement from the beginning was that these equipment modules all have to operate as a single unit. In order to do that, you have to have an orchestrator so there can be that level of coordination between each module. That was something that I would say uniquely positioned MGS because they understood that from the very beginning. This wasn’t necessarily the case with all vendors—there are different ways you can approach this. MGS also had very capable technical employees, their control staff had a great understanding of the standards that needed to be put into place and communicated to each one of these OEMs so that they can speak the same language and be coordinated by a single central control station.”
Operators can start and stop the system from the CCS or locally at the machine. MGS had to develop programming to ensure that this is done safely. Local maintenance can be done on one module without stopping the entire system.
As was mentioned above, a key goal of the project was to have each OEMs’ technology shine in its particular role, while still ensuring that an operator at Kindeva could walk up to a machine and see the basic control was the same as for other machines. Each machine has its own HMI. MGS did not ask OEMs to change their HMIs—their core standards are the foundation of their equipment—but messaging and content look the same to make the operator experience as easy as possible.
“We were adamant that it had to have a certain kind of button layout, and very standardized controls when it came to basic start and stop functions. Then laid over the top of that was the central control system, which gives visibility to the whole line,” Pangier explains.
OEMs have different ways of interfacing with the CCS. “From a technical standpoint, we had to translate that. We designed an interface box and sent it to the OEMs and said, ‘Put this box in and interface in this way, and give us this information and we’ll handle the rest.’ Everything uses Ethernet for communication. We had to lay out that expectation, otherwise I think that each of the OEMs would have provided what they provide through their own lens,” says Pangier.
Not every OEM was as understanding, so in some cases, MGS stepped in and fixed a system’s programming themselves instead of debating about scope. With such a large system and a set deadline, the project team would hold status meetings with OEMs. If an issue was difficult to resolve, MGS would say, “Let’s work on it for this long and if we can’t break through, here’s the stop point” in which the MGS controls department would take over to remain on schedule, according to Pangier.
Case in point: Nearing the deadline, there was an error in handling emergency stops with bad product in process. The source of the issue was a conveyor running through the checkweigher, which came from an outside supplier. “We found an error in that could let bad product downstream. This required pulling in that supplier’s engineering team in Europe to get them to understand what we wanted, but their solution was that we needed to expand everything by about four feet. Of course, there wasn’t room to expand that much with walls on both sides,” says Kostreba. “It was already built on our shop floor when this was happening. So our controls people used the CCS to monitor the safety network. We installed mechanisms to make sure that bad product never made it through. So we solved the problem because their solution was going to take months and our solution took days.”
Ultimately, MGS absorbed all the delays and challenges and delivered the machine a week early, during COVID-19.
Monitors save millions
Adding strategically placed monitors on the line may sound like a small add-on. But Kostreba estimates that the TV/monitor information display system they installed for another customer saves $26 to $52 million per year, based on the product running and time saved.
In a larger system, operators are working in various locations and don’t necessarily have visibility into other areas. There can be considerable downtime caused by an operator who’s stopped and assumes they’re waiting on someone else when the issue is actually at their part of the system. Diagnosing takes time, too, in realizing there’s a problem, and walking back and forth between HMIs and machines. Says Kostreba, “If you go in real operator speeds trying to figure out what’s going on—not being an expert—it can take a minute and a half. We timed this just watching operators at a different facility. Every problem is different, of course. But when you take that one minute or a minute and a half saved on one stop, all you have to do is save five minutes an hour to get those millions saved on that specific customer’s process. Five minutes per hour saved is pretty realistic. When you start having big machines, long distances to walk, and complicated mechanisms where you forget what’s going on, or people stand and stare at something thinking it’s not their problem, five minutes an hour is really easy to save.”
The monitors give a line-level view of everything that’s happening—machine data, errors—so operators can just look up. They are located in such a way that from almost anywhere in the room, they can see a monitor and know what’s happening in other parts of the line. Saving even seconds on each error means big savings annually.
“So they naturally, by looking at the monitors, can kind of check each other. Every customer has a goal that they’re trying to produce a certain amount of product and our information display system helps them without having to walk around to know where they need to go in the system,” says Pangier. After a while, when the machine stops, everybody looks up and immediately knows what to do.
Many people may not understand the value of such monitors right away. “I knew that it was something that would be of benefit, but I didn’t realize how useful it would be and how the operators would respond to it,” says Annesley. “Once the operators saw that it would allow them to understand about the other areas of the line, it just became the line that everybody wants to work on because they’re informed, and the machine functions in a way that they can understand. That makes everybody’s job that much more enjoyable because they’re not confused and frustrated when they’re working on a machine. That was when it clicked for me, even though this was a scope change and added cost, I realized this is really going to help these operators.”
If people feel like they’re productive and able to address issues— rather than being confused and frustrated—the end result is going to be higher productivity, which is the ultimate goal. (On a project for another customer, MGS had installed the carefully placed monitors on a second line. Operators clamored to work on that line, so much so that the customer retrofitted monitors on their first line as well.)
Collaboration for problem solving in real-time
Kindeva benefitted from MGS’ collaborative approach to projects where engineering, sales, and machine builders all work hand-in-hand. Less emphasis was placed on titles—it was more about everyone at both companies working together to get the project done.
“When we had a couple of commodity problems such as getting materials into the facility, I dealt with a lot of people I wouldn’t expect to in the procurement process. I texted somebody that worked at the factory to get a measurement for me—that was three minutes instead of three weeks of emails,” Kostreba notes. “I met with one of Jeff’s employees and the manufacturer of the labels about the adhesive. I was directly in contact with their vendor to handle label issues.”
From an operator to a packaging engineer to someone responsible for the adhesive on the MDI labels, everyone had a seat at the table rather than having to have everything flow through Annesley, Kostreba, and Pangier to get distributed. Says Pangier, “Things get lost that way, so it would have taken much longer under a different format especially with a project of this magnitude. A lot of it hinges on how teams are structured and whether you’ve got that level of collaboration. It’s not just about the equipment—it’s the equipment, the process, and the people—and then putting that all together.”