USP Class VI Seal Materials

A new line of inflatable seals which meet US Pharmacopoeia (USP) Class VI certification is now available. The CVI™ Series meets the specific needs of pharmaceutical equipment manufacturers who seek the assurance of USP Class VI compound certification for their inflatable seals.

The CVI Series combines use of the right materials for biocompatibility with the unique characteristics needed for inflatable seals, including temperature and/or chemical resistance. These compounds address a growing trend among pharmaceutical equipment manufacturers towards use of materials that are certified to USP Class VI, the most stringent protocol for classification of compounds used in most medical and other healthcare applications. Among many advantages certification offers is an added level of confidence that assures favorable compatibility results, reducing the burden of regulatory compliance.

S60121 Silicone Material Characteristics

Industry proven biocompatibility
Clean, low bleed
Excellent cycle life (see report)
Available in white (opaque) extrusion or mold grade versions

Physical Properties

Compound - S60121 Silicone
Color - Opaque
Specific Gravity - 1.16
Durometer (Shore A) - 62
Tensile Strength (ppi) - 1300
Elongation (%) - 600
Tear Strength, Die C - 275
Compression Set (22 hrs @ 175oC) - 29%

Note: these results are typical for our CVI inflatable silicone compound

The U.S. Pharmacopoeia (USP) is a scientific, non-profit organization that sets quality standards for food ingredients, dietary supplements, pharmaceuticals and their associated supply chains. Testing and certification were provided by Toxicon Corp., Bedford, Mass.
All information supplied by or on behalf of Pawling Engineered Products, Inc. in relation to its products, whether in the nature of data, recommendations or otherwise, is believed reliable, but Pawling Engineered Products, Inc. assumes no liability whatsoever in respect of application, processing or use made of the information, or any consequences thereof.