Key takeaways:
The article outlines the key requirements of EN 1672-2 for hygienic design, material selection, and design solutions that facilitate cleaning and reduce the risk of contamination.
- EN 1672-2 specifies hygiene requirements and the cleanability of machinery for the food industry; adopted by CEN and PKN.
- Food-contact surfaces must be smooth, continuous, and free of cracks and crevices; a surface roughness of Ra ≤ 0.8 μm is recommended.
- Joints, seals, and fasteners must be designed so they do not create uncleanable crevices; continuous welds and sealed joints are preferred.
- The design must support liquid drainage and eliminate dead spaces; materials in the food zone must be corrosion-resistant, non-toxic, and non-absorbent.
- The standard is harmonized with the Machinery Directive 2006/42/EC and aligned with GMP and FDA requirements (21 CFR 174-178); it provides for iterative hygienic risk assessment.
Designing food processing machinery is a highly specialized task. EN 1672-2 is the key standard governing hygiene requirements and cleanability for machinery used in the food industry. Adopted by the European Committee for Standardization (CEN) and approved by the Polish Committee for Standardization (PKN), this standard is intended to ensure that machinery and its components used in food preparation and processing meet the highest hygiene standards, minimizing the risk of contamination, infection, illness, and injury.
Designing machinery in accordance with this standard involves a range of detailed requirements aimed at ensuring hygienic design, ease of cleaning, and safety for both users and consumers.
Design of Food Processing Machinery in Accordance with EN 1672-2
Design of Food Processing Machinery: Food Contact Surfaces
Surfaces that come into direct contact with food must be smooth, continuous, and easy to clean and disinfect. These surfaces must be free of cracks, crevices, and other areas where food residues and bacteria may accumulate. They should have a surface finish with a roughness Ra of no more than 0.8 μm, although higher values are acceptable if adequate cleanliness can be ensured.
| Category | Requirements |
|---|---|
| Hygiene | Food contact surfaces must be easy to clean and disinfect. |
| Materials | Use corrosion-resistant, non-toxic materials that comply with food safety regulations. |
| Design | Machine design should minimize the risk of cross-contamination. |
| Safety | Equipment must be fitted with safeguards against mechanical and electrical injury. |
| Documentation | Comprehensive instructions must be provided for machine operation, maintenance, and cleaning. |
Surface Joints
Surface joints must be designed to minimize the risk of contamination buildup. Continuous welds or sealed, flush joints are preferred.
Where detachable joints are necessary, they must be easy to clean and provide a hygienic fit when assembled.
Design of Food Processing Machinery: Seals and Fasteners
Seals in food contact areas must be positioned so that they do not create gaps that cannot be cleaned. Fasteners such as bolts and nuts should be designed for easy cleaning and must not have exposed threads or crevices that could trap contamination. Preferred solutions include hexagon flange bolts, domed nuts, or flange screws.
Drainage and Dead Spaces
Machines should be designed to ensure self-draining of liquids, for example by using an appropriate slope, or to allow residual liquids to be removed easily by other methods. Dead spaces where product residues or cleaning agents could accumulate should be eliminated or minimized.
Design of Food Processing Machinery: Specific Material Requirements
Materials used in the construction of food processing machinery must be suitable for food contact. In food contact areas, materials must be:
- Corrosion-Resistant: Materials must withstand the chemicals and operating conditions to which they will be exposed in order to prevent corrosion.
- Non-Toxic: Materials must be non-toxic and must not release substances harmful to health.
- Non-Absorbent: Materials must be non-absorbent so that they do not retain substances that could contaminate food.
Accessibility for Cleaning
Machine design must provide easy access to all surfaces that require regular cleaning and maintenance. Components must be designed to allow easy disassembly without the use of specialized tools.
Harmonization with the Machinery Directive, GMP, and FDA
The EN 1672-2 standard is harmonized with the European Union Machinery Directive 2006/42/EC, which means that compliance with its requirements is recognized as compliance with the requirements of that directive. In addition, this standard is aligned in many respects with GMP guidelines and U.S. Food and Drug Administration (FDA) regulations. For a broader legal context, see the changes introduced by Regulation 2023/1230/EU.
GMP and FDA in Food Machinery Design
Designing food machinery in line with GMP requirements includes:
- Hygiene Management: Machines must be designed to minimize the risk of food contamination, in accordance with GMP principles.
- Documentation and Procedures: The manufacturer must provide detailed operating instructions covering cleaning, maintenance, and machine use, in line with GMP requirements for documentation and procedures.
- Personnel Training: Personnel responsible for operating and maintaining the machines must be properly trained in hygiene and GMP procedures.
Compliance with FDA regulations means that machines must meet the following requirements:
- Design and Construction: Machines must be designed and built from materials suitable for food contact, in accordance with FDA regulations on food-contact materials (21 CFR 174-178).
- Sanitation and Control: Machines must allow easy cleaning and disinfection, which is a key FDA requirement for sanitation and control of production processes.
- Contamination Prevention: Machine design must prevent all forms of contamination, in accordance with FDA requirements for contamination prevention.
Hygienic Risk Assessment Process
The standard introduces an iterative hygienic risk reduction process that includes the following steps:
- Hygienic Risk Assessment
- Analysis of hygienic risk, including identification of machine limits, identification of food safety hazards, and estimation of hygienic risk.
- Evaluation of hygienic risk to determine whether further risk reduction is necessary.
- Hygienic Risk Reduction
- Elimination of hygienic hazards or risk reduction through hygienic design.
- Risk reduction through technical measures.
- Risk reduction through cleaning and disinfection.
- Additional measures, where necessary, including personnel hygiene requirements and special training.
Risk Analysis According to EN ISO 12100
Risk analysis according to EN ISO 12100 is the process of identifying, assessing, and eliminating hazards associated with machinery. This process includes:
- Hazard Identification: Identifying all possible hazards that may arise during machine use.
- Risk Assessment: Assessing the likelihood and potential consequences of hazards.
- Hazard Elimination: Implementing measures to eliminate hazards or reduce risk to an acceptable level.
Importance of Hygienic Design
Designing food machinery in accordance with EN 1672-2 is essential to ensure that food products are processed safely and hygienically. Good design practice minimizes the risk of food contamination, which is critical to protecting consumer health.
Combined with GMP and FDA requirements, design in accordance with this standard ensures that machines meet the highest hygiene standards and comply with international regulations.
Industrial Automation and the Food Industry
Industrial automation plays a key role in the food industry, affecting the efficiency, quality, and safety of production processes. Integrating production process automation enables precise control of production parameters, minimizing the risk of human error while improving consistency and product quality. The use of automation systems such as PLC programming (Programmable Logic Controller) makes it possible to adapt production lines quickly and flexibly to changing market requirements and product specifications. Production automation in the food industry also includes the use of POKA-YOKE, TPM (Total Productive Maintenance), and SMED (Single-Minute Exchange of Die), which help increase operational efficiency and reduce downtime. Advanced industrial automation also makes it possible to achieve high OEE (Overall Equipment Effectiveness) and KPI (Key Performance Indicators) values, resulting in better control over food production quality and safety. CE certification of machinery and compliance with harmonized standards such as EN 1672-2 are essential to ensure that automated systems meet the highest hygiene standards and are safe for users. Production process automation not only increases the competitiveness of food companies, but also helps protect consumer health by ensuring that products are manufactured in a safe and hygienic manner.
More on EN 1672-2
The EN 1672-2 standard provides comprehensive guidelines for the design of food processing machinery, which must be hygienic, easy to clean, and safe for users and consumers. Meeting these requirements is essential to ensure food safety and compliance with legal requirements such as the Machinery Directive 2006/42/EC, GMP, and FDA. With its detailed requirements for materials, surfaces, joints, seals, and construction, this standard forms the foundation of hygiene in the food industry. In practice, these requirements are often implemented with support from a specialized design office.
EN 1672-2 is an essential document for anyone involved in the design of food processing machinery, ensuring that production processes comply with the highest hygiene standards. By meeting the requirements for machinery design, manufacturers can ensure food safety and compliance with international regulations, which is crucial for success in the food industry.
Design of Food Processing Machinery in Accordance with EN 1672-2
It specifies hygiene and cleanability requirements for machines used in the food industry. Its purpose is to minimize the risk of contamination, infection, illness, injury, and food contamination.
Surfaces should be smooth, continuous, easy to clean and disinfect, and free of cracks and crevices. A surface finish with a roughness Ra of no more than 0.8 μm was specified, with higher values permitted if adequate cleanliness can be ensured.
Joints should minimize the buildup of contaminants; continuous welds or sealed, flush joints are preferred. Seals must not create gaps that cannot be cleaned, and fasteners should be easy to clean, with no exposed threads or crevices.
The design should ensure automatic drainage of liquids (e.g. by providing an appropriate slope) or allow them to be removed easily by other methods. Dead spaces in which product residues or cleaning agents may accumulate should be eliminated or minimized.
The standard provides for an iterative process: hygienic risk assessment (machine limits, hazards, and risk estimation) and risk reduction through hygienic design, technical measures, and cleaning/disinfection, and, if necessary, additional measures and training. It is harmonized with the Machinery Directive 2006/42/EC, and the risk analysis may be carried out in accordance with EN ISO 12100.