{"id":374,"date":"2024-05-09T23:05:42","date_gmt":"2024-05-09T23:05:42","guid":{"rendered":"https:\/\/www.marcorubber.com\/blog\/?p=374"},"modified":"2025-01-24T14:06:00","modified_gmt":"2025-01-24T14:06:00","slug":"sanitary-gaskets-ensuring-safety-and-compliance-in-the-food-and-beverage-industry","status":"publish","type":"post","link":"https:\/\/www.marcorubber.com\/blog\/?p=374","title":{"rendered":"Sanitary Gaskets: Ensuring Safety and Compliance in the Food and Beverage Industry"},"content":{"rendered":"

Sanitary Gaskets: Ensuring Safety and Compliance in the Food and Beverage Industry<\/span><\/h1>\n

Did you know gaskets can influence the color and taste of different food products? Or that they can negatively harm the end users of pharmaceuticals or medical devices?<\/span><\/p>\n

Odds are, yes, you know this.\u00a0<\/span><\/p>\n

But how exactly can <\/span>sanitary gaskets<\/span><\/a> solve these problems? Are they available in enough compounds to stand up to your application?<\/span><\/p>\n

We think the answer is yes. Let\u2019s talk about it.<\/span><\/p>\n

What Are Sanitary Gaskets?<\/span><\/h2>\n

Gaskets are flat pieces of rubber or plastic used between two other flat surfaces to create an air\u2014or liquid-tight seal, depending on the application. <\/span>In the food and beverage<\/a><\/span>, pharmaceutical<\/a>, and other highly regulated spaces, it is critical that sanitary gaskets follow pertinent regulations. A few of the most prominent are FDA 21 CFR 177.2600, USDA 3-A, and USP Class VI.\u00a0<\/span><\/p>\n

FDA 21 CFR 177.2600<\/span><\/h3>\n

The <\/span>materials used in gaskets<\/span><\/a> can be considered indirect food additives. This means that they come into contact with food but should not be mixed into it. In other words: these materials must not make the food unsafe for human consumption.<\/span><\/p>\n

Title 21 of the Code of Federal Regulations Section 177.2600<\/span><\/a> best addresses seals as an indirect food additive.\u00a0<\/span><\/p>\n

If a material is considered safe to touch the food, it is classified as <\/span>Generally Recognized as Safe (GRAS)<\/span><\/a> for use in manufacturing and packaging. 21 CFR 177.2600 identifies acceptable materials for use in o-rings and gaskets, including usage percentages that will minimize the impact on food and water.\u00a0<\/span><\/p>\n

USDA 3-A<\/span><\/h3>\n

USDA 3-A<\/span><\/a> regulations are incredibly important in the dairy industry as well as other specific food and beverage applications.<\/span><\/p>\n

Milk and plant-based hydrocarbons, like edible oils, are known to pull carbon among other ingredients from plastic and rubber components, like o-rings and gaskets. This extraction can quickly discolor fatty foods and oils as well as milk.\u00a0<\/span><\/p>\n

Thus, gaskets and o-rings require \u201cwhite list\u201d elastomers that meet the stringent requirements found in USDA 3-A. These formulations include different proportions of certain ingredients to prevent contamination.<\/span><\/p>\n

To consider a material 3-A compliant, a sanitary gasket manufacturer must receive a Third Party Verification inspection.<\/span><\/p>\n

USP Class VI<\/span><\/h3>\n

USP Class VI<\/span><\/a> is\u00a0 a testing method to determine biocompatibility of materials used in the production of pharmaceutical and medical products. This testing determines if there are no harmful reactions or long-term effects from chemicals found in plastic materials.\u00a0<\/span><\/p>\n

The <\/span>United States Pharmacopeia and National Formulary (USP-NF)<\/span><\/a> carries out three USP Class VI testing methods: system injection test, intracutaneous test, and implantation test. These tests are carried out on specimens using chemicals found in plastic materials.<\/span><\/p>\n

The test conclusions inform plastic and rubber manufacturers what should or should not be used in products that facilitate the medical and pharmaceutical industry.<\/span><\/p>\n

Manufacturing Standards for Sanitary Gaskets<\/span><\/h2>\n

Sanitation and safety are critical components of manufacturing gaskets for use with food and beverages. The best (and really only) way to manufacture a truly sanitary gasket is in a cleanroom.<\/span><\/p>\n

To demonstrate compliance, manufacturers must keep careful production records following ALCOA+ best practices. ALCOA+ stands for:<\/span><\/p>\n

\"\"<\/p>\n

A<\/b>ttributable<\/span><\/p>\n

L<\/b>egible<\/span><\/p>\n

C<\/b>ontemporaneous<\/span><\/p>\n

O<\/b>riginal<\/span><\/p>\n

A<\/b>ccurate<\/span><\/p>\n

C<\/b>omplete<\/span><\/p>\n

C<\/b>onsistent<\/span><\/p>\n

E<\/b>nduring<\/span><\/p>\n

A<\/b>vailable<\/span><\/p>\n

Tracking and recording information according to <\/span>ALCOA+ is required by the FDA<\/span><\/a> as a Current Good Manufacturing Practice (CGMP) in the production of pharmaceuticals. This is a proven method for improving data integrity by improving traceability, expediting certifications, and providing evidence of high-quality management systems.<\/span><\/p>\n

As we enter into <\/span>Industry 4.0<\/span><\/a>, the production, storage, and management of data is more critical than ever before. By properly managing data to demonstrate appropriate manufacturing processes, end users can rest assured that their sanitary gaskets are truly that: sanitary. Manufactured, cleaned, and packaged in a cleanroom, these sanitary gaskets should not present any harmful effects.<\/span><\/p>\n

Common Materials for Sanitary Gaskets<\/span><\/h2>\n

Depending on your application, several materials might work best for you.\u00a0<\/span><\/p>\n

Silicone<\/span><\/h3>\n

Silicone<\/a> is an inorganic, common synthetic polymer known for its versatility and excellent resistance to various obstacles. It is used in a wide range of applications that do not require high tensile strength or tear resistance.<\/span><\/p>\n