Processes used in pharmaceutical, biotechnological, and food production are subject to stringent standards and regulatory oversight and control. Gaskets and seals for pharmaceutical and food applications must provide maximum biological safety and sanitary performance, preventing product contamination and ensuring compliance with regulations.
Standards that must often be supported by gaskets and seals for pharmaceutical and food applications include FDA regulations, Good Manufacturing Practices (GMP) issued by regulatory agencies, and standards issued by independent bodies, such as the 3-A Sanitary Standards.
Gaskets and Seals for Pharmaceutical and Food Applications: Selection Criteria
When selecting gaskets and seals for pharmaceutical and food applications, process engineers and buyers should consider the following:
- The life expectancy of the gasket or seal. Sealing materials vary in the expected life expectancy they can provide within a given application. Because shorter life cycles mean more frequent seal replacements, it is better from a total cost perspective to choose a material which has a longer life expectancy within a given application.
- Resistance to chemical attack. Because gaskets and seals for pharmaceutical and food applications are often exposed to aggressive media, it is important to select sealing materials that can withstand the chemical attack without breakdown or degradation.
- Ability to support regulatory compliance. As noted above, sealing materials should be chosen which support compliance to applicable regulations and standards.
Gaskets and Seals for Pharmaceutical and Food Applications: Materials
CRG can produce precision cut gaskets and seals for pharmaceutical and food applications from the following materials. These materials satisfy the three selection criteria noted above:
- Kalrez®. This is a DuPont material which is excellent for producing gaskets and seals for demanding applications. Kalrez® is a perfluoroelastomer (FFKM). Gaskets and seals from Kalrez® resist over 1,800 different chemicals, while offering the high temperature service (327°C) and stability of PTFE. Kalrez® gaskets and seals provide low outgassing in vacuum-sealing applications. FDA-compliant seals are also available for food, beverage or pharmaceutical processes. The long-term, proven performance of Kalrez® gaskets and seals can mean less frequent seal changes, repairs and inspections, increasing process and equipment uptime for greater productivity and yield.
- 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 and food manufacturers can be confident that gaskets fabricated from kSil™ are safe should they come into contact with the product stream during processing. In addition to kSil™ sheet, CRG 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 and seals for pharmaceutical and food 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 a material of choice for many sealing applications in the pharmaceutical and food industries.
CRG can produce gaskets and seals for pharmaceutical and food applications from the above materials, as well as others that we have in our material portfolio. CRG sales specialists will be pleased to review your application and provide guidance on selecting the most appropriate material. All gaskets and seals CRG produces are custom fabricated using the latest CNC production equipment in our ISO 9001-certified facility. To find out more about CRG gaskets and seals for pharmaceutical and food applications, please contact our sales team at firstname.lastname@example.org.