By Bruce Geiselman
US Extruders and Graham Engineering introduced new extruders at NPE2024 designed for demanding clean-room environments and tailored to meet the stringent demands of medical applications.
US Extruders’ new single-screw extruder for medical tubing is designed for manufacturers requiring precise quality control, according to the company.
The Med-Ex Reflow extruder will meet the needs of contract manufacturers in the med tech ecosystem that are producing tubing for medical device OEMs. The tubing typically is used to deliver modern therapies and drugs to patients, for neurovascular aspiration catheters (to remove blood clots in the brain), and similar critical operations. Several different materials are used to produce the tubing depending on the product specifications. The Med-Ex Reflow is designed to be efficient in a low-volume, high-mix ecosystem.
“This machine allows those contract manufacturers that are doing a lot of changeovers the ability to run all of those materials with one screw design,” said Steve Maxson, US Extruders’ innovation & business development manager. “It allows them the flexibility to move that machine from one line to another, and it gives them a lot of flexibility.”
The Med-Ex Reflow extruder features a new screw design that can process Pebax (a thermoplastic polymer), nylon 12 and PU equally well, Maxson said.
It can be a challenge to design a single screw that can handle that variety of materials, he said.
“It’s a specific design that was tested on all three of those materials that gives us optimal pressure stability, within plus or minus 2 or 3 PSI, which translates to high dimensional stability in the tubing,” he said.
The Reflow has a screw diameter of 1 inch. It also features a new streamlined design that includes a lower control panel that allows for better visibility in a cleanroom.
“It doesn’t have a big, tall panel on it,” Maxson said. “One of the problems in cleanrooms is when people bring customers on a tour and they’re looking through a window into a cleanroom, they can’t see the cleanroom because tall control panels block the view.”
The Reflow extruder includes the latest ProControl controller, which features a more user-friendly interface, Maxson said.
“It has a digital touchscreen interface that allows us to control and monitor all the parameters on the extrusion system,” he said. “We can trend some of the critical parameters, see trend charts and store recipes. If an operator nails down the process for a particular tube size — temperatures, pressures, speeds, vacuum levels — all those key parameters can be stored, and the next time they run it, they just download that recipe, and they’re up and running.”
The newest version of the ProControl features a graphics interface similar to what people have become accustomed to on smartphones.
“The ProControl graphics have been updated to more mimic tablet and iPhone graphics — it’s user-friendly,” said John Brunelle, president of ProSystems Integration, which developed the controller for US Extruders. “We have web client availability if you want to remote into the machine on a phone or home PC. All manuals are now located on the machine, prints, bill of materials. It’s one place to get all information needed for the machine, whether it’s maintenance, data logging or recipes.”
US Extruders also unveiled its new Med-Ex Quench, the first water tank developed by US Extruders. The Quench can be used with the Med-Ex Reflow extruder, or any extruder producing tubing.
There is a need for precision when producing certain medical tubing, such as that used inside the body to deliver stents or a heart valve or to aspirate blood clots in the neurovascular system. The processes for producing this tubing must be precise and repeatable.
“This tank is designed for that precision,” Maxson said. “It is made out of all stainless steel. There is no vibration. We can track the temperature. We can track the amount of water input into the tank. It’s developed for precision medical tubing. There’s a void in the industry for tiny, small tanks for these applications. That’s what we developed it for … Everything is very intricate. We can dial things in to the very minute tolerance level. We can monitor the temperatures and the water flow. It’s very accurate and very repeatable. We’re also monitoring the dosage of the UV that we put in to kill bacteria.”
US Extruders displayed a prototype of the water tank at an earlier show, but the final version was unveiled at NPE.
“We brought it to the MD&M West show in February, and the purpose was to get feedback on the design,” Maxson said. “Overwhelmingly, we received positive feedback, but there was some constructive feedback. We implemented those changes, and we’re proud to release this tank now.”
Compact Modular MD designed for clean rooms
Graham Engineering Co. at NPE 2024 showcased its new American Kuhne-brand stainless steel Compact Modular MD extruder, designed for medical and pharmaceutical applications where stainless steel wipe-down surfaces are required.
The stainless steel version of the Compact Modular MD extruder is easier to clean and designed for clean-room environments. It is offered in addition to the traditional Compact Modular MD, which has a special urethane-based medical paint that is chip-resistant and does not yellow over time.
The stainless steel Compact Modular MD extruder is available with screw diameters from 0.5 inch to 1.75 inches.
Both the stainless and traditional versions of the Compact Modular MD extruder include an optional enhancement that allows for easier adjustment of the extruder, vertically and horizontally, for alignment to downstream equipment.
“You can raise and lower the extruder from a single point,” said Justin Kilgore, VP of engineering. “It’s a wheel that turns that allows you to raise and lower it. They also have side-to-side adjustment of the extruder itself to better align the discharge end with the tank.”
The new extruder is equipped with Graham Engineering’s XC300 Navigator control system.
“There are some additional features that we've added to the Navigator platform to facilitate integration to the downstream equipment by pulling additional data,” Kilgore said. “You have a single source, single connection point to be able to pull data, performance data or production data, for the entirety of the line.”
For example, the latest version of the XC300 Navigator control system can pull data from puller/cutters, cooling tanks and coilers, he said.
“We’ve also added some additional integration for upstream,” Kilgore said. “We have a communication interface that pulls data and can actually push batch recipes upstream to things like blenders, and we have developed an interface to temperature control units from Mokon or Advantage [or any major brand that offers an optional communication interface] ... We have expanded the number of downstream/upstream suppliers that we can seamlessly integrate with.”
Contact:
Graham Engineering Co. LLC, York, Pa., 717-848-3755, www.grahamengineering.com
US Extruders, Westerly, R.I., 401-584-4710, www.us-extruders.com
