January 13th, 2016

Davis-Standard’s Clean Room Considerations for Medical Tubing Manufacturers


As a global supplier of medical tubing equipment used in clean room environments, Davis-Standard is vigilant about essential standards required for meticulous processing conditions. The following clean room considerations are recommended by Davis-Standard’s engineering team for medical tubing manufacturer’s extrusion machinery.

Machine Construction

  • Use of stainless steel or rust corrosion-proof materials where coatings are not practical
  • Ensure wipe-down zones are accessible
  • Minimize potential collection areas for dust and debris stagnation
  • Design containment options for possible fluid or residual lubricant leaks
  • Use compact designs to minimize floor space

Machine Surfaces/Treatments

  • Use water-based or epoxy-based paint in areas not constructed with rust or corrosion-resistant materials
  • Polish surfaces and design with smooth, tapered or round edges for effective wipe-down
  • Use stainless steel surfaces to avoid contamination in product “contact” areas

Extrusion Drive Systems/Control Systems

  • Use direct drive systems where applicable
  • Brushless AC motors
  • Water-cooled motors (eliminate turbulent air movement from cooling blowers)
  • Permanent magent synchronous motors (eliminate the need for gearbox/oils/mechanical drive train; less noise and more energy efficient)
  • Use cooling blower designs that minimize dust generation
  • Route control cabling and wiring for ease of cleaning
  • Consider viewability of control interface monitors from outside cleanroom windows

“We do everything possible to ensure our equipment meets or exceeds clean room production standards,” said Kevin Dipollino, Product Manager of Davis-Standard’s Pipe, Profile and Tubing Systems. “To further support our customers and their development efforts, we recently installed a medical tubing line in a clean room environment at our Technical Center in Pawcatuck, Connecticut. With continued growth in medical tubing applications worldwide, it has already been very well received by customers.”

The line in the Technical Center features two MEDD (medical extruder direct drive) extruders and associated downstream equipment in a climate-controlled environment. Customers are able to test new resins, make parts for proof-of-concept, and conduct downstream R&D prior to making large capital equipment investments. The line is extremely versatile and set up to run multiple resins including high temperature resins such as PEEK and corrosive material like FEP. It also incorporates Davis-Standard’s patented alternate polymer® technology with all components monitored and controlled by the EPIC III® control system.

Dr. Jason Baird, Ph.D., Davis-Standard Process Development Engineer added: “The healthcare segment is an important industry for us and extensive capablities for clean room processing is a big part of that. Having multiple equipment options and a lab to test new processes is essential to serving our customers around the globe.”

For more information about Davis-Standard’s medical tubing capabilities or clean room engineering practices, contact Kevin Dipollino at kdipollino@davis-standard.com or Jason Baird at jbaird@davis-standard.com.

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