Medical Grade Compounds

 

PSI distributes a number of compounds that are suitable for use in medical applications requiring body or body fluid contact. These materials have been tested by independent laboratories or our material suppliers to assess their ability to meet requirements as defined by several standards organizations. The definitions of our medical grades are listed below. PSI compounds that meet these requirements are outlined on the back of this document.

USP VI Grade:
The United States Pharmacopeia (USP) is an official public standards setting authority for medicines and other health care products manufactured or sold in the United States. Pressure Seals Inc. rubber compounds have been tested to meet USP <87> and <88> Biological Reactivity Tests for Class VI materials and USP <661> Physicochemical Tests for plastics. Additionally, PAI USP VI compounds are formulated with materials sanctioned under the FDA Code of Federal Regulations, Title 21, Part 177.2600. Each lot undergoes physical property testing.

Any Medical Grade Compounds can be molded to these specifications or molded to any special shape that you require. Please email us for further information or consult these shapes and sizes:

O-Rings l X-Rings/Multiseals l U-Cups l Ground Balls l Molded Balls l Rubber Backup Rings l Figure 8 Dynamic Seals

Medical Grade Compound Data: 

USP VI Materials: Fluoroelastomer  
Durometer  White  Black            
70  48725           
USP VI Materials: EPDM 
Durometer   White   Black             
70  423725           
Platinum Cured Silicone Compounds 
Durometer    Clear  White Black  Red Blue Green Yellow
50  49526  49525 49529 49559 49562 49523 49556
60  49626  49625 49629 49659 49662 49623  49656 
70  49726  49725  49729  49759  49762  49723   49756  
80  49826 49825  49829  49859  49862  48623   49856  
               
Biomedical Grade Materials 
Platinum Cured Silicone Compounds 
Durometer    Clear  Red   Black   Blue        
45  49470       
60  49670   49549       
75  49770   49742  49767       
85  49870   *        
               
Peroxide Cured Silicone Compounds 
Durometer     Clear   Red    Black    Blue         
35  49350  *    *    *         
60  49650  *    *    *         
70  49750  *    *    *         
† Colored silicone compounds use applicable grade polymer and colorants tested to meet USP VI and ISO 10993 

To contact us for more information immediately, please call (860) 282-9100 in Connecticut,
1-877-PSI-SEAL toll-free outside of Connecticut or fax (860) 282-9001. If you prefer, you may request more information via our easy online quick quote form.