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Which industry standards such as EHEDG, FDA and GMP are relevant for hygienic mixing of infant formula?

In the manufacture of infant formula, the world's strictest requirements for product safety and plant hygiene apply, owing to the particular vulnerability of the consumer group. The standards and sets of rules EHEDG, FDA and GMP form a complementary system that covers in particular the design of the mixing plant, the choice of materials as well as process management and documentation. In addition, further food hygiene and safety standards (e.g. ISO 22000, HACCP, ATEX) are relevant.

EHEDG (European Hygienic Engineering & Design Group)

The EHEDG guidelines define the constructional requirements for hygienically designed process plants and components. For mixing processes in the manufacture of infant formula – frequently dry mixing processes with powder, vitamins and minerals – the following aspects are of particular importance:

  • Hygienic design of the mixing plant to avoid dead spaces, crevices and areas that are difficult to access.
  • Assurance of cleanability (CIP/SIP for liquid processes, WIP for dry products).
  • Use of suitable materials for product-contact parts (e.g. stainless steel 1.4404 / AISI 316L with a typical surface finish of Ra ≤ 0.8 µm, often even below 0.4 µm).

Typical EHEDG documents drawn upon in the context of the hygienic mixing of infant formula include:

  • Doc. 8 / 10: hygienic design requirements for closed process plants.
  • Doc. 13 / 22 / 44: hygienic design and safe processing of dry powders and particulate materials.

Technical relevance

EHEDG requirements aim to prevent microbial growth and product deposits. This includes optimised surface roughness values, suitable shaft seals, dead-space-free geometries as well as dispensing with open threads or crevices in the product space.

Objective

Physical and technical prerequisites for residue-free cleaning and disinfection, the avoidance of biofilms as well as the minimisation of cross-contamination – particularly with organisms such as Cronobacter sakazakii or Salmonella.

FDA (U.S. Food and Drug Administration)

For manufacturers who export infant formula to the USA or produce it there, FDA requirements are relevant both for the product and for the plant. In plant engineering, the focus is above all on the material suitability of product-contact components:

  • 21 CFR Part 106 / 107: requirements for quality assurance and nutrient content of infant formula.
  • 21 CFR Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls (FSMA).
  • 21 CFR Part 177: requirements for plastics and elastomers with food contact (e.g. seals, sight glasses, hoses).

Technical relevance

All elastomers, plastics and lubricants used in the mixer must be food-grade. They must not migrate any toxic or undesirable substances into the product and must be resistant to cleaning media and process conditions.

Objective

Assurance of the chemical safety of the end product and compliance with international export requirements, particularly for the US market.

GMP (Good Manufacturing Practice)

GMP is a quality-oriented set of rules that structures the entire manufacturing process, the organisation of operations and the documentation. In infant formula production, work is generally carried out in accordance with cGMP (current GMP), in order to reflect the current state of science and technology.

Relevant sets of rules and guidelines include:

  • EU Regulation (EC) No 852/2004: hygiene of foodstuffs.
  • Delegated Regulation (EU) 2016/127: infant formula and follow-on formula.
  • Codex Alimentarius CAC/RCP 66-2008: hygienic practice for powdered infant formula.
  • Codex Alimentarius CAC/GL 21: microbiological criteria.

Technical relevance

GMP comprises requirements for:

  • Process validation (evidence of mixing homogeneity within defined parameters such as time, rotational speed, fill level).
  • Qualification of the plant (IQ/OQ/PQ).
  • Documentation and traceability (batch reporting, release procedures).
  • Validation and requalification of the cleaning processes (CIP/WIP).

Objective

Reproducible product quality, minimised risk of mix-ups or contamination and complete traceability of every batch.

Further relevant standards and sets of rules

Alongside EHEDG, FDA and GMP, the following standards are frequently of significance for the hygienic mixing of infant formula:

  • ISO 22000 / FSSC 22000: management systems for food safety (integration of HACCP into a certifiable management system).
  • HACCP (Hazard Analysis and Critical Control Points): systematic hazard analysis and determination of critical control points, particularly for the control of organisms such as Cronobacter sakazakii and Salmonella.
  • ATEX directives 2014/34/EU: requirements for explosion protection when handling combustible powders (dust explosion in mixers, silos, conveyors).
  • 3-A Sanitary Standards: US hygiene standards for process plants, frequently as a supplement to EHEDG in internationally oriented plants.
  • Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011: requirements for materials and articles with food contact (framework for metal, plastics, elastomers).

Interplay of the standards in the mixing process

When mixing infant formula – typically blends of milk powder, whey powder, fats, vitamins and minerals – the sets of rules mentioned interlock:

  • EHEDG / 3-A provide the constructional specifications for hygienically designed, dead-space-free and cleanable mixing plants.
  • FDA and EU regulations define the substance-related and product-specific requirements (nutrient contents, product purity, material conformity).
  • GMP, HACCP, ISO 22000 / FSSC 22000 structure the organisational sequences, the hazard analysis, the process monitoring and the documentation.

For manufacturers operating internationally, parallel conformity with EU, FDA and the relevant standards (EHEDG, ISO 22000, ATEX etc.) is customary in the market and an essential part of the certification and audit strategy.

FAQ aspects for technical application

Why is FDA conformity alone not sufficient?

FDA regulations primarily address the material safety of product-contact components, but not the geometric execution of the plant. A mixer may well use FDA-compliant materials and yet still have dead spaces and areas that are difficult to clean, in which organisms can establish themselves. Only the combination of FDA-compliant materials and an EHEDG-compliant hygienic design ensures that the mixer is both safe in health terms and hygienically cleanable.

What significance does GMP have for the mixing process?

GMP requires that the mixing plant demonstrably achieves the required homogeneity and that cleaning and disinfection processes are validated. Every batch must be traceable without gaps via batch documentation, records and release procedures. This has direct effects on:

  • Sensors (e.g. temperature, humidity, rotational speed, fill level),
  • Automation and control technology (formulation management, batch logging),
  • Cleaning concepts (automated CIP/WIP cycles with documented parameters).

How is the surface finish defined for hygienic mixers?

Product-contact stainless steel surfaces are usually mechanically ground or electropolished in order to achieve a mean roughness of Ra below 0.8 µm – in infant formula production frequently below 0.4 µm. This minimises the build-up of powder particles and markedly improves the efficiency of cleaning. These requirements are anchored in EHEDG guidelines and common industry standards.

These are the standards amixon® meets – and this is how compliance becomes demonstrable

International standards and conformity

On request, amixon® industrial mixers meet international standards. These include EHEDG (dry and wet cleaning), FDA, 3-A Sanitary Standards, USDA, GMP and ATEX. Pressure vessels are executed in accordance with ASME and the EU Pressure Equipment Directive where required. Vertical and cone mixers (VM, HM, AM, SH, KS, GM) can be used FDA-compliantly as sterile mixers and reactors.

Hygienic design as the foundation

Certifiability is based on consistent hygienic design. The mixing chamber and mixing tool are welded and ground free of joints. The mixing tool is mounted only at the top, without a lower shaft passage. All standard connections are of dead-space-free design. The discharge flap works without product deposits. Clever-Cut® inspection doors have a permanently dead-space-free OmgaSeal® seal. Integrated washing lances enable effective CIP/WIP with programmable target-jet washing nozzles.

Materials for the highest requirements

Product-contact parts are made of austenitic stainless steels (e.g. 1.4301, 1.4404, 1.4539) or high-alloy materials such as Alloy 59 and Hastelloy-C22.

Engineering, qualification and documentation

amixon® supplies complete solutions. Every mixer is designed as a one-off on the basis of the URS and manufactured in its own works. amixon® assists on request with DQ, IQ and OQ. Documentation and execution follow, on request, EU GMP and FDA 21 CFR Part 11. Integration follows the operator's validation concept.

Depth of manufacture and quality assurance

All components are manufactured in Germany. Production takes place exclusively at the amixon® works in Paderborn. As a certified welding company, amixon® holds European, Japanese, Korean and American qualifications. Every statement of conformity is demonstrable down to component level. Spare parts remain reproducible in the long term.

Product-protecting mixing technology

amixon® mixers work at low circumferential speeds of approximately 0.8 to 3.5 m/s. Helical mixing tools in SinConcave®/SinConvex® geometry convey the product upwards on the outside and downwards on the inside. No throwing, impact or crushing zones arise. No measurable heating occurs. Sensitive structures, coatings and agglomerates are preserved. Living microorganisms can also be mixed in gently.

Validation in the pilot plant

Trials are carried out in advance in the amixon® pilot plant. In Paderborn, 35 test units are available. Further locations exist worldwide. Tests with the original product deliver a robust basis for decision-making on investments.