Legislation and directives

Legislation and directives

Pharmaceutical industry

The ATEX directives

ATEX stands for ATmosphere EXplosible. ATEX is an EU directive that describes which mechanical and electrical equipment is allowed in an environment with an explosive atmosphere. An explosive atmosphere can form when vapors, gas, dust or a mist of fine droplets mix with air. For example, flour or sugar can be whirled up in the room, a burst liquor pipe or a spill during bottling.

Food legislation is central to the conditions for producing food, beverages and pharmaceuticals. At Alfotech, we closely follow the development of the legislation in order to always be up to date and provide the best guidance. If you are unsure whether your hoses comply with the right standards, contact us for an informal chat.

At Alfotech, we have special ATEX-approved hoses that comply with the zone classifications. 

EU Pharmacopeia

The EU Pharmacopoeia is one of the bodies that companies that manufacture or process food may be confronted with. The fundamental aim of the European Pharmacopoeia is to promote public health. The institution creates common standards for the whole of Europe with the aim of harmonizing national legislation on the manufacture, circulation and distribution of medicines. This is done, among other things, by controlling the quality of medicines, as well as the substances and components used to manufacture them.

The European Pharmacopoeia, which currently has 38 European member states, was created by the Council of Europe and is supported by the EU. In the past, they have mostly been known for their writings, but in their current form they have the force of law.

At Alfotech, we have products approved by the EU Pharmacopeia.

United States Pharmacopeia (USP)

The United States Pharmacopeia (USP) is one of the standards that companies that manufacture or process food come into contact with and must meet. USP is a non-governmental organization with the goal 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 USP have undergone multiple levels of biological testing and are manufactured to meet stringent requirements. USP does not enforce its standards, but this is done by the FDA and other government agencies in the US and elsewhere.

Alfotech sells special USP-approved products that meet the USP classification.

For further information or concrete solutions for compliance with the ATEX directives, EU Pharmacopoeia, or USP, please contact our Key Account Manager for the pharmaceutical industry, Michael Sørensen. You can reach him on phone +45 2141 4882 or via email at mas@alfotech.dk.

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