Rulon 641 and Rulon 1439 are certified for biocompatibility

For years, medical device and drug manufacturers have depended on a variety of plastic bearings to run their equipment with the belief that the materials were FDA-compliant. But in reality, most acetals and polyesters had not been tested for biocompatibility.  Rulon® bearing materials are the exception.  There are now two formulas ―Rulon 641 and Rulon 1439 ―which have achieved USP Class VI compliance for direct contact with human tissue and fluids.  In fact, Rulon 641 was the first, fully-wettable bearing material to receive FDA compliance.  

But as medical manufacturers look to incorporate more plastic bearings on their equipment, questions remain.  Why is USP testing important?  What are the advantages of Rulon in a medical environment?    How do I select the right formula for my medical application?  TriStar’s Engineering Experts have the answers:

What is USP testing and why is it important?
The United States Pharmacopeia (USP) testing process is conducted by an independent lab and is a widely-accepted industry standard.  Testing has different classifications for intracutaneous toxicity, with Class VI compounds indicating the highest standards have been met for “clean” compounds. 

Why should I consider Rulon bearings for medical applications?
Rulon is a self-lubricating material which promotes a hygienic manufacturing environment by eliminating the need for manual greasing.  The material resists corrosive sanitation fluids, will not swell, corrode or seize-up, and tolerates high temperatures.  And in an industry facing the pressures of managed care and shrinking margins, Rulon bearings provide exceptional ROI.  

What are the differences between Rulon 641 and 1439?
There are more than 300 different blends of Rulon, each with application-specific attributes. Rulon 641 received USP compliance several years ago; Rulon 1439 more recently.  Both materials are a stain-resistant white color to promote sanitation.  Rulon 1439 excels in wet and fully-submerged applications, such as steady bearings in a mixing application.  Rulon 641 is a good fit for dry environments, including medical picking and packaging equipment.  Both materials also excel in food and beverage processing. 

As the exclusive North American distributor, only TriStar can guarantee the true performance of Rulon materials.  Download our Rulon technical paper to learn how Quality Assurance Begins with Precision Processing.   Or visit the Materials Database for technical specs.  Our team has experience in over 70 industries and can answer any questions!