The 3-A Sanitary Standards are American standards related to the design and production of equipment intended for contact with food. The aim of the 3-A Sanitary Standards is to protect consumers from potential risks of food contamination. The primary purpose of the 3-A Sanitary Standards is to ensure that all the parts of an equipment are properly cleaned and sanitized in order to avoid any creation of bacterial charge. As part of the equipment, rubber or plastic hoses enter into this type of evaluation and find in the 3-A Sanitary Standards dedicated chapters and testing methods.
Does the 3-A Sanitary Standards certification offer superior benefits over the FDA?
The compliance with the FDA is the primary requirement for achieving the 3-A certification. The formulation of compounds and the migration testing according to the methods required by the FDA (Food and Drugs Administration) must first prove that the ingredients of compounds are those approved by the FDA. Instead, the purpose of the 3-A is to verify that the hose material is able to withstand repeated cleaning and sterilization cycles.
What is the objective of the 3-A Sanitary Standards?
Tests for compliance with 3-A are carried out through the use of simulants that reproduce the most popular cleaning and sterilization methods but at accelerated working conditions. The goal is to verify the behavior of the rubber or plastic materials tested in contact with these agents.
Some MTG products have been tested 3-A Sanitary Standards 18-03 while other products fall under standard 20-27. What do these two standards represent and why is this distinction made?
The “Standards” of the 3-A are many and divided by product categories. For example, the 18-03 Multiple use Rubber and Rubber-like Materials is a standard specifically developed for testing rubber and/or silicone rubber compounds. Instead, the 20-27 Multiple use Plastic Materials standard is intended for plastics such as perfluoropolymer tubing. Although these two standards are equally complex, the testing methods are different because the two materials are different in terms of both chemical composition, resistance to mechanical stress and temperature.
Why does the 18-03 Rubber and Rubber-like materials standard divide polymers into different classes?
Chapter 18-03 of the 3-A Sanitary Standards distinguishes 4 different categories of rubber compounds based on chemical resistance and temperature. In particular, categories I and II identify compounds that can more easily withstand high temperatures or steam sterilization, i.e. respectively 150 °C and 121 °C. However, all classes of compounds are required to withstand cleaning and antibacterial treatment with chemical solutions up to + 82 °C (CIP cleaning). All compounds must respond positively to tests with distilled water, aging tests in hot air, simulants with fat content and simulants based on alkaline and chlorine chemicals. The rubber compounds classified in categories I and II must pass the test with nitric acid, which is chemically more corrosive compared to the other agents.
What is the difference between the two testing methods: one for rubber compounds and the other for plastic materials like the Standard 20-27?
Considering that the Standard 20-27 is specifically developed for testing plastic materials, this norm combines cycles of complex substances with a greater oxidizing action and acids that are more aggressive. While the purpose of the Standard 18-03 is to verify the change in the mechanical values of the rubber compounds and their deviation from the standard values, the aim of the Standard 20-27 is to verify the weight loss and the status of material surface. To prove the product conformity, a maximum value of loss in weight is set for each different material.
Is there any European Standard comparable to the American 3-A Sanitary Standards?
Right now, in Europe, we do not have any similar Standard and the Norm 3-A is representing the only standard that takes into consideration and analysis the resistance of materials to cleaning and sterilization processes. The European Regulation EC 1935/2004 also focuses on materials and objects intended to be exposed to food products with the aim to prevent from potential contamination. However, the Regulation EC 1935/2004 simply provides some general guidelines without entering into details about cleaning and sterilization procedures and testing methods.
What are the benefits of 3-A Sanitary Standards certification for hose users?
The purpose of the 3-A certification is to guide the customer in choosing the polymer and as a consequence the most appropriate hose for the application. The goal is to produce accurate and comparable data for a complete hose assessment. The 3-A classifies the material based on chemical-physical resistance and as a consequence to repeated cleaning and sterilization cycles. The aim is to guarantee a better sanitization of the equipment and a longer hose life over time.
To discover the range of MTG products with 3-A Sanitary Standards certifications, receive a copy of the Cleaning and sanitizing procedures for hoses, or to receive advice on the application of the products, please contact the MTG Technical Department at the following email address: firstname.lastname@example.org.