Legislation & directives, pharmaceutical industry

Directives & Pharmacopoeias.

The ATEX Directives

ATEX stands for ATmosphere EXplosible (ie. explosive atmosphere).

ATEX is an EU directive that describes what mechanical and electrical equipment is permitted in an environment with an explosive atmosphere. An explosive atmosphere can be formed when vapours, gas, dust, or a mist of fine droplets are mixed with air. It can e.g. be if flour or sugar can be whirled up into the room in case a liquor pipe breaks, or by spillage during bottling.

At Alfotech, we have special ATEX-approved hoses that comply with the zone classifications. If you are interested in further information or specific solutions for complying with the ATEX directives, please contact us on directly.

Food legislation is central when producing food, beverages, and medicines. At Alfotech, we follow developments in legislation very closely to always be up to date and be able to provide the best guidance. If you are in doubt about whether your hoses comply with the right standards, contact us for an informal chat.

EU Pharmacopeia

The purpose of the European Pharmacopeia is fundamentally to promote public health. The institution creates common standards for the whole of Europe with the aim of harmonizing national laws on the manufacture, circulation, and distribution of medicinal products. This is done, among other things, by controlling the quality of medicine, as well as the substances and components used to manufacture them.

The European Pharmacopoeia has been prepared by the Council of Europe and is supported by EU. They have been mostly known for their writings in the past, but in their current form, they have legal force.

At Alfotech, we have products approved by EU Pharmacopeia. If you are interested in further information or specific solutions for compliance with EU Pharmacopoeia, please contact us for an informal chat.

United States Pharmacopeia (USP)

The United States Pharmacopeia (USP) is a non-governmental organisation with the aim of promoting public health by developing standards to ensure the quality of, for example, public health, medicines, and food ingredients. USP sets standards for quality, purity, strength, and consistency. Products approved by the USP have undergone several biological tests at various levels and are manufactured to meet stringent requirements.

The USP is enforced by the FDA and other government agencies in the United States and elsewhere.

Alfotech sells special USP-approved products that meet the USP classification. If you are interested in further information or are interested in specific solutions for how to comply with USP, please contact us.