Rubber Seals for use with Dairy & Food
The organization known as 3-A Sanitary Standards, Inc. (3-A SSI) formulates sanitary standards and accepted practices for the hygienic design, fabrication, installation and clean-ability of dairy and food equipment or systems used to handle, process and package consumable products where a high degree of sanitation is required. These sanitary standards and accepted practices are developed through the cooperative efforts of industry experts. 3-A Sanitary Standards provide material specifications, design criteria and other necessary information for equipment types to satisfy public health concerns.
Precision Associates’ facility has been audited and approved for the processing of 3-A materials. Forty-two PAI compounds comply with the 3-A Sanitary Standard 18-03. Materials included are NBR, FKM, Silicone, EPDM and Urethane. Manufacturers of equipment for use in these industries can save time and money by specifying rubber components that are produced from 3-A compliant materials. It’s one less worry in the qualification process!
Many customers ask for compounds that are FDA Approved but the Food & Drug Administration does not specifically approve rubber compounds. The FDA in Title 21, Part 177.2600 of the Code of Federal Regulations, specifies rubber compound ingredients that are considered to be non-toxic and non-carcinogenic when used in specified amounts. Many refer to this code as the FDA “White List”. There is no audit or test conducted by the agency but compounds must pass extraction tests outlined by the FDA. Compliance is the responsibility of Precision Associates’ Laboratory. Materials compounded from ingredients on the list are said to “meet the requirements of the FDA”. PAI has one hundred and sixty plus materials that meet this criteria and can manufacture standard seals or custom shapes from Nitrile, Neoprene, Fluorocarbon, Silicone, Ethylene Propylene, Highly Saturated Nitrile, and Butyl.
Whereas, the FDA regulates the list of ingredients suitable for compounding food grade rubber materials within the US, the European Union has their own regulation known as EC1935/2004. It governs the use of 17 materials and articles that may come in contact directly or indirectly with food. Rubber is not specifically covered by this legislation so this allows member countries to create standards for approval for food contact within their nation. EC1935/2004 regulation compliance is more difficult in that rubber sealing materials must be tested to specific requirements that are determined by each country.
The regulation also demands compliance with good manufacturing practices to ensure traceability throughout the manufacturing process. It also provides marketing directives for labeling, advertising, and presentation that is not misleading to consumers.
Precision Associates compound 623717 is a 70 durometer EPDM material that is formulated with FDA approved ingredients and is compliant with EC1935/2004 regulations.