Guide to codes and acronyms for aseptic seals

The different abbreviations and codes behind industrial products are intended to facilitate communication. Thanks to these linguistic elements we can know if 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 acquires special importance in the pharmaceutical, food and cosmetic sectors; all of them especially 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 joints.

What do the acronyms and codes behind the aseptic seals mean?

In the technical specifications of our aseptic seals you will find different initials and acronyms; as well as codes that refer 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 refers to Regulation 1935/2004 that “establishes the Community legislative framework applicable to materials and objects intended to come into contact with food” (REGULATION [EC] No. 1935, 2004)¹.

Gaskets for aseptic unions, O-rings or other types of gaskets must have this certification if they are to be used in a food manufacturing process. In short, it is the way that the European Community has of guaranteeing that these products comply with the quality requirements established for the food industry in the Community territory.

EC 10/2011

We have seen how Regulation (EC) 1935/2004 refers to all materials that may be in contact with food, well, plastics have their own regulation, EC 10/2011.

When you see this code in the specifications for an aseptic or encapsulated seal it means that:

•    That seal, or some of its parts, is made of plastic.
•    It guarantees that it is a plastic material suitable for use in contact with food.

FDA

This acronym stands for the US Food and Drug Administration. All of our aseptic seals are made from materials and/or chemicals that have been approved for food and drug contact by the FDA. .

USP Class VI

The USP Class VI certification ensures the biocompatibility of the materials with 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 food supplements are safe and meet established quality standards.

3A 

Issued by the American Organization 3-A Sanitary Standards, it certifies that the products or equipment meet the requirements established by the United States for the pharmaceutical and food industries.

EHEDG

The hygienic design of facilities 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 evaluating the cleanliness of industrial equipment. The EHEDG issues two kinds of certificates: one for dry-cleaned equipment and one for liquid-cleaned equipment.

By following these links you can get more information about the evaluation and certification processes of this organization:

•    How is the evaluation and certification process of the EHEDG.
•    The detailed scheme of the types of EHEDG certification.

As we have seen, the codes and acronyms give us very valuable information to track different very important aspects of aseptic joints and other industrial supplies. We hope that this brief guide will serve as a reference for your future purchases at Epidor Seals and Rubber Technology.

¹REGULATION (EC) No. 1935/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, of October 27, on materials and objects intended to come into contact with food and which repeals Directives 80/590/CEE and 89/109/ CEE, November 13, 2004, Official Journal of the European Union, 338/4 to 338/17.