Ensuring Compliance and Performance with Food-Safe Gaskets

When foam and rubber gaskets are used in food processing, packaging, or any other application involved in the handling and conveying of food, the part’s reliability is not just a matter of performance. It’s also a component of food safety, not to mention a compliance and liability issue for manufacturers and processors. It is critical to ensure the parts you use are considered “food-safe,” not just by industry experts but also by the regulatory bodies who govern your industry. 

Gaskets form seals between two surfaces in food processing and packaging machinery, so they must be designed to meet rigorous health and safety standards to prevent food contamination. This creates an additional critical factor in their design—the parts must be made of materials that can safely come into contact with food regularly. 

What does it mean for a gasket to be FDA compliant? What are the regulations and requirements that govern their use in the food industry? Which material is right for your application? 

Understanding Basic FDA Compliance for Gaskets

For a gasket to be considered appropriate for use in food-related applications, it must comply with the U.S. Food and Drug Administration (FDA) regulations. FDA compliance is categorized into two types: 

  • Indirect Food Contact: applies to gaskets that do not directly touch food but are used in machines that process food. These materials must not transfer harmful substances to food in any detectable amount. 

  • Direct Food Contact: refers to materials that are expected to come into direct contact with food substances. On top of not transferring harmful substances, these materials also must not affect the food's composition, taste, color, or safety under normal usage conditions.  

Gaskets that meet these standards must be made from materials approved by the FDA, which ensures they do not transmit harmful chemicals into the food. 

Additional Capabilities Required for Food-Safe Gaskets

Gaskets in food processing and packaging applications must be able to withstand harsh environments, including exposure to extreme temperatures, corrosive cleaning agents, continual mechanical pressure, and more. A failed gasket not only disrupts operations and lowers productivity, it can also compromise food safety, leading to significant health risks and regulatory consequences. 

Selecting the right material for food-safe gaskets involves the material make up: 

  • Resistance to bacterial growth: materials must be non-porous and must be inert to prevent bacterial contamination. 

  • Chemical compatibility: gaskets should resist degradation from food products and the aggressive chemicals used in cleaning and sanitation. 

  • Temperature variations: materials must maintain their integrity across the normal operating temperatures of food processing applications. 

  • Durability and mechanical stress: when moving parts are involved, gaskets can frequently become compressed, expanded, and returned to their normal state. Gaskets should be able to withstand repeated stress and pressure without losing their effectiveness. 

  • No impact on food quality: as stated by the FDA, materials must not impart any odor, taste, or contaminants to the food product. 

  • Pressure resistance: the gasket material should maintain a seal under high pressure to prevent leaks and contamination. 

Regulatory Framework for Gaskets

The manufacturing and selection of food-safe gaskets are governed by several regulations, primarily FDA guidelines and the Code of Federal Regulations (CFR), which specify the materials that are safe for food contact and the conditions under which they can be used. Compliance ensures that gaskets do not pose a contamination risk during normal operations. 

Some FDA regulations that govern the gasket materials include: 

The National Sanitation Foundation (NSF) also sets standards for public health protection, including the certification of materials used in drinking water system components. An NSF certification is a mark of compliance and safety, and NSF/ANSI 61: Drinking Water System Components, which dictates the joining and sealing materials (gaskets, adhesives, lubricants) that can be used in water systems. 

Designing Custom Gaskets with Compliance in Mind

Material selection is at the core of design when it comes to food safe gaskets. There are many materials that meet both the industrial demands of various application as well as compliance with FDA and NSF food safety standards: 

  • Silicone Foam, Silicone Sponge & Silicone Rubber: known for its excellent thermal stability, flexibility, and chemical inertness. Silicone resists microbial growth and does not impart taste or odor. Silicone is ideal for sealing applications in food processing due to its ability to withstand extreme temperatures, from very low to very high. Depending on your application, you can choose from silicone foam, silicone sponge, or silicone rubber. 

  • Nitrile Rubber (Buna-N): has a good resistance to oils and fats, excellent abrasion resistance, and high durability. Certain grades are used in applications and food processing environments where oil resistance is crucial. 

  • Ethylene Propylene Diene Monomer (EPDM): has excellent resistance to weathering, ozone, UV, and aging. It also has good chemical resistance, especially to mild acids, detergents, and alkalis. It’s an excellent material if it needs to be rigorously cleaned frequently. Certain grades are available for indirect food contact 

  • Polytetrafluoroethylene (PTFE): performs exceptionally well in high temperatures and has excellent resistance to chemicals and corrosion. It’s often used in harsh chemical environments and where product purity is critical, such as in pharmaceutical and food processing. 

  • Ultra-High Molecular Weight Polyethylene (UHMW): features high abrasion resistance and excellent impact strength. It is also odorless, tasteless, and resistant to moisture. 

  • Neoprene Rubber: has good chemical stability and flexibility over a wide temperature range. It’s also resistant to UV, ozone, and weather damage. Neoprene foam is often used in seals and gaskets in refrigeration units and HVAC systems within food processing facilities. Certain grades of rubber are available for indirect food contact 

  • PE Foams: lightweight with good cushioning properties, resistance to moisture, and excellent thermal insulation. PE foams have good sealing and insulation properties and can be used in food contact and packaging applications. 

Find the Right Food Safe Gasket for Your Application

If you are evaluating your food processing equipment's safety and compliance, contact our gasket experts today. We specialize in designing and manufacturing custom gaskets that meet stringent industry standards and specific applications needs, ensuring your operations run safely, smoothly, and according to the regulations in your industry. 

Matt Tempelis