What requirements do German food standards place on hygienic mixing plants and their documentation?
German food standards require mixing plants to be designed, operated and documented in such a way that safe and hygienic food production is assured. The decisive requirements arise above all from food hygiene legislation, the HACCP principle and the requirements for materials, cleanability, traceability and operational safety.
Legal and normative basis
The essential legal bases are the German Food and Feed Code, the German Food Hygiene Ordinance, Regulation (EC) No 852/2004 and the rules on food-contact materials. Depending on the product, standards, guidelines and industry standards such as DIN EN 1672-2, EHEDG, IFS Food or FSSC 22000 are added.
Constructional requirements
Mixing plants must be of hygienic design. This includes freedom from dead spaces, easily drainable geometries, smooth and closed surfaces, hygienic connection technology as well as seals and bearings that do not create zones on the product side which are difficult to clean.
Product-contact surfaces should consist of suitable, corrosion-resistant materials that comply with food law. The aim is to minimise build-up, residues and microbiological risks as far as possible.
Cleanability and validation
Mixing plants must be demonstrably cleanable for their intended use. This concerns in particular suitability for CIP or at least for defined manual or semi-automated cleaning procedures. Cleaning success is typically verified by riboflavin tests, microbiological examinations or other suitable evidence.
Documentation requirements
Documentation includes declarations of conformity, material certificates, welding documentation, surface records, cleaning and maintenance schedules as well as evidence of cleaning effectiveness. Operating instructions, SOPs and complete traceability of the components used are important in addition.
Hygienic risk assessment and HACCP
A hygienic risk assessment is required before commissioning and during ongoing operation. It forms the basis for the operational HACCP concept, in which potential sources of hazard are identified, measures defined and critical control points established.
These are the standards amixon® meets – and this is how compliance becomes demonstrable
On request, amixon® meets the hygienic design requirements relevant for food applications and evidences these through design, manufacture and trial documentation. What is decisive is not only conformity with standards but practical demonstration at the amixon® pilot plant with the original product under realistic conditions. On request, amixon® provides the qualification evidence required for pharmaceutical applications in a form that complies with the standards.
The plants are of hygienic design, for example with dead-space-free areas, product-contact zones with few or no crevices, hygienic inspection openings and solutions suitable for CIP/WIP. For sensitive applications, amixon® supports the validation of mixing quality, residual discharge, cleanability and scalability before delivery.