Gaskets and seals for pharmaceutical applications are usually made from materials that conform to US FDA and USP Class VI requirements, or other equivalent national standards. These requirements define criteria for material toxicity that assures the seals will not be harmful to human health.
Gaskets are considered to be FDA compliant if they possess two characteristics. First, the gasket must be generally regarded as safe. This criterion may be met either through testing or through proven safe use in FDA-type applications. Secondly, the material from which the gasket is made should conform to current FDA or equivalent regulations and directives. For example, perfluorocarbon resins and PTFE elastomers are found in FDA requirement Method 21 CFR 177.1550.
The United States Pharmacopeia (USP) is a non-government public health organization that establishes standards designed to safeguard the quality of medicines and other health care technologies. The USP is concerned primarily with the pharmaceutical and bio-technology industries and sets classes of standards for material quality, purity, strength and consistency. USP Class IV products must undergo a series of biological tests, while USP Class VI compounds must be made from ingredients that are biocompatible and resistant to leaching.
Gaskets for Pharmaceutical Applications from CRG
CRG supplies fluorosilicone and PTFE gaskets for pharmaceutical applications. These gaskets are produced from fluorosilicone as well as filled and non-filled PTFE sheet that conforms to the FDA directives as noted above.
Fluorosilicone gaskets are often used as static seals in the processing equipment making up tablet coating and solid dosage production lines. CRG supplies gaskets cut from fluorosilicone-formulated kSil™ and NeutraSil™ sheet. kSil™ silicone sheet is FDA approved and pharmaceutical manufacturers can be confident that gaskets fabricated from kSil™ are safe should they come into contact with product. In addition to kSil™ sheet, we also fabricate silicone gaskets from neutraSil™ sheet. NeutraSil™ is an antimicrobial silicone rubber that has been independently proven to prevent the growth of E-Coli, MRSA and Salmonella bacteria. The antimicrobial qualities of neutraSil™ make it highly suited to end-use applications in industries such as pharmaceuticals, as well as dairy, food, and beverage production.
PTFE gaskets for pharmaceutical applications are often used in mixers, pumps, valves, and flanged joints in piping and transfer equipment. These gaskets combine excellent dielectric properties with a very low coefficient of friction and an ability to service a wide range of operating temperatures, from -240°C (-400°F) to 260°C (500°F). A key advantage of PTFE gasket material is that is among the most chemically resistant materials known. The ability to resist chemical attack makes PTFE sheet the material of choice for many pharmaceutical sealing applications.
CRG supplies PTFE gaskets that are made from TEALON™ molded sheets supplied by Teadit. TEALON™ sheet is a restructured PTFE sheet that provides excellent torque retention and sealing performance. The primary advantage of TEALON™ gaskets over ordinary PTFE gaskets is their exceptional resistance to distortion (creep, relaxation and cold flow). TEALON™ sheet been tested and found to be in conformance with FDA requirement Method 21 CFR177.2260. Gaskets made from TEALON™ sheets are suitable for pharmaceutical and other food-grade applications.
We also supply gaskets and seals for pharmaceutical applications that are made from expanded QUIMFLEX 24SH sheet, also from Teadit. This FDA-approved PTFE gasket material is made from 100 per cent multi-directionally expanded PTFE and is dimensionally stable. It is fully conformable to a variety of flange shapes and offers superior performance over conventional PTFE. Expanded PTFE possesses excellent chemical resistance, is resistant to cold flow and creep, and is ideal for limited flange load applications. QUIMFLEX SH will seal all aggressive chemicals over the entire 0-14 pH range except for molten alkali metals and elemental fluorine. Made from 100 per cent virgin PTFE, QUIMFLEX 24SH gaskets not only resist chemical attack, but they will not contaminate or discolor end products.
All gaskets and seals CRG produces are made to customer specifications using the latest manufacturing technologies and practices in our ISO 9001:2008 certified facility. If you are sourcing gaskets and seals for pharmaceutical applications, or other food-grade uses, CRG’s experienced sales team will be please to review and discuss your needs.
To speak with a member of our sales team, please contact us directly at crg@canadarubbergroup.com.