Guide to aseptic gasket codes and acronyms
The various abbreviations and codes behind industrial products are intended to facilitate communication. Thanks to these linguistic elements, we can to know whether a product in question complies with the regulations, has been certified with a quality seal and/or guarantees the required safety or sustainability standards, for example.
This is particularly important in the pharmaceutical, food and cosmetics sectors, all of which are particularly linked to a wide variety of regulations. For this reason, we have thought it appropriate to prepare this brief guide in which we detail the meaning of the list of acronyms and codes that accompany our aseptic gaskets.
Index
What do the acronyms and codes behind aseptic seals mean?
In the technical specifications of our aseptic seals you will find different acronyms and acronyms; as well as codes referring to standards, regulations and laws... All these references are related to quality management, production control and product traceability. Let's take a closer look at some of the most relevant and common ones:EC 1935/2004
This code makes reference to Regulation 1935/2004 which “establishes the Community legislative framework applicable to materials and articles intended to come into contact with food.” (REGULATION [EC] NO. 1935, 2004)¹. Seals for aseptic joints, O-rings or other types of seals must have this certification if they are to be used in a food manufacturing process. Ultimately, it is the European Community's way of to ensure that these products comply with the quality requirements established for the food industry of the community territory.EC 10/2011
We have seen how the Regulation (EC) 1935/2004 refers to all materials that may be in contact with food, well, plastics have their own regulations, EC 10/2011. When you see this code in the specifications of an aseptic or encapsulated gasket it means that:- - That gasket, or some of its parts, is made of plastic.
- - It guarantees that it is a plastic material suitable for use in contact with foodstuffs.
FDA
This acronym refers to the Food and Drug Administration (All of our aseptic gaskets are manufactured with materials and/or chemicals that have been tested and approved by the U.S. Food and Drug Administration. approved for contact with drugs and food by the FDA.USP Class VI
USP Class VI certification ensures the biocompatibility of the materials from which the aseptic seal has been manufactured. The tests to determine it depend on the United States Pharmacopeia and National Formulary (USP-NF): the body responsible for ensuring that medical devices and dietary supplements are safe and meet established quality standards.Seal 3A
Issued by the American Organization 3-A Sanitary Standards, this seal certifies that the products or equipment comply with the requirements established by the United States for the pharmaceutical and food industries.EHEDG
The hygienic design of installations or equipment is one of the most relevant aspects in the food industry. The European Hygienic Engineering and Design Group (EHEDG), through authorized companies, is the European organization in charge of evaluate the cleanliness of industrial equipment. EHEDG issues two types of certificates: one for equipment that is dry cleaned and one for equipment that is cleaned with liquids. By following these links you can find more information about the evaluation and certification processes of this organization:- • What is the EHEDG evaluation and certification process like?.
- • Detailed outline of EHEDG certification types.