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1 min read

Rulon 641: Performance from Food Processing to Medical Equipment Manufacturing

By Dave Biering on July 16, 2019

Rulon 641: Performance from Food Processing to Medical Equipment Manufacturing

The food and medical manufacturing industries share many commonalities; most notably, they operate in environments with strict regulations for quality, safety and sanitation.  Processing equipment must be of the highest quality and offer contamination resistance.  Rulon® 641 is the only FDA-cleared material for use in food processing that also has USP Class VI approval for medical applications.

Two demanding manufacturing environments, one common material ― Rulon 641.  See our Rulon Comparison Chart to explore the advantages.

Temperature tolerance for food processing

A major food processor approached us seeking a replacement for their virgin-PTFE seals located on the miniature cryogenic valves of the fast-freeze systems. The equipment is used to flash-freeze fruits and other foodstuffs. The PTFE seals were failing from exposure to the cryogenic temperatures and required frequent and expensive change out. Rulon 641 offered our partner a material with superior temperature stability and a longer lifespan for significant savings. Rulon 641 is non-abrasive for use against the systems’ stainless mating hardware, and has maintained good sealability under difficult conditions. 

Superior sterilization for medical manufacturing

We’ve also partnered with the manufacturers of surgical laser devices to replace failing PTFE valves seats with Rulon 641.  Rulon excels in the rotary and oscillating movements required of this application and has a very low coefficient of friction and a superior wear factor.   The material can be lapped using standard procedures to produce extremely good surface finishes in precision valve seats.  And the material’s white, stain-resistant color indicates a sanitary compound for medical environments.  Rulon 641 has USP Class VI approval, and easily tolerates all standard CIP procedures required of both the food and medical industries.

Is Rulon 641 the right material for your application?  Contact our Engineering Experts for a consultation. Or read our free Rulon White Paper to learn about the advantages of Rulon’s processing controls.

Rulon - Quality Assurance Begins With Precision Processing

Topics: Food Rulon Medical
1 min read

Which Plastics are Biocompatible?

By Dave Biering on December 21, 2009

Which plastics are biocompatible?

The growth of plastics in medical devices is growing exponentially around the world. Plastics are regulated like any other materials that may come in contact with human tissue or fluids and that usually falls under testing procedures issued under USP or ISO10993.

There are three time scales for biocompatible devices:

  1. Limited - Less than 24 hour exposure
  2. Prolonged - 24 hours to 30 day exposure
  3. Permanent -  30 days and longer.

When determining biocompatibility, devices are categorized as follows:

  1. Surface Devices - Items such as electrodes for monitoring, contact lenses, catheters, endotracheal tubes, sigmoidoscopes and similar devices.
  2. Externally Communicating Devices - such as laprascopes, blood administration devices, pacemakers, oxygenators and the like.
  3. Implant Devices - such as orthopedic pins or plates, heart valves, grafts, stents and similar devices.

Testing of these devices includes mechanical, thermal, chemical tests as well as systemic injection, intracutaneous and implantation. All of these must be done before a plastic component can be approved.

Typical materials for biocompatible applications include medical grades of PVC and Polyethylene, PEEK, Polycarbonate, Ultem PEI, Polysulfone, Polypropylene and Polyurethane.

For more specific information on biocompatible materials as well as special plasma preparation treatments of all of these materials, contact TriStar Plastics at www.tstar.com and visit our Video Learning Center.

Have a question about surface  modification? Ask our experts!

Topics: Surface Modification Q&A Medical