Equipment Design Equipment Design EHEDG Guidelines No. 8, 10 and 13 No. 8, 10 and 13 Hygienic requirements for food machinery Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Why Sanitary/Hygienic Design? aseptic aseptic sampling sampling ! ! Hygienic requirements for food machinery Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Food-born diseases (1990 10Mio) as a result of not hygienically designed food processing equipment, process lines or plants. food processing equipment, process lines or plants. Side effects: Loss of product (spoilage, quality defect), cleaning Side effects: Loss of product (spoilage, quality defect), cleaning costs, production time . Although manufacturers and food companies comply with the Although manufacturers and food companies comply with the documents Directive 93/43/EC Food Hygiene Directive 2006/42/EG Article 2.1.1b Hygienic Design of Machinery (98/37/EC) Hygienic Design of Machinery (98/37/EC) EN 1672/2 Hygienic Requirements ISO 14159 Safety of machinery and implemented the GMP and HACCP, and implemented the GMP and HACCP, there are two major gaps. Lack of practical guidelines Hygienic requirements for food machinery Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS Lack of practical guidelines educational gap European Hygienic Engineering & Design Group EHEDG Objectives The EHEDG European Hygienic Engineering & Design Group started in 1989 to fill these existing gaps of practical guidelines and educational gaps educational gaps Continue to work voluntary Discussion and further development on Hygienic Design Discussion and further development on Hygienic Design Preparation of scientific and technical orientated guidelines according to State of the Art to comply with the EU legislations Development of test methods to identify weakness of hygienic design Development of test methods to identify weakness of hygienic design Lectures, seminars and workshops on Hygienic Design Strengthen the participation with standardisation bodies like DIN, Strengthen the participation with standardisation bodies like DIN, CEN, ISO, 3A, NSF, JIS etc. Strengthen the cooperation with the EU, i.e. food contact material directive, BAT, traceability, other EU-Projects) Hygienic requirements for food machinery Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee directive, BAT, traceability, other EU-Projects) European Hygienic Engineering & Design Group Structure of the EHEDG President Structure of the EHEDG President Foundation Executive Committee GENERAL MEMBERS Executive Committee Certification Regional Sections Subgroup Clusters Certification Organizations Hygienic requirements for food machinery Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee European Hygienic Engineering & Design Group Executive Committee consists of: President (3 Years) General secretary (EHEDG Foundation) General secretary (EHEDG Foundation) Treasurer (EHEDG Foundation) Members President: Knuth Lorenzen - GEA Past President: Matilda Freud Kraft Foods Members of Food Industries, Equipment Manufacturers, Past President: Matilda Freud Kraft Foods Members of Food Industries, Equipment Manufacturers, Research Institutes, Public Health Authorities, 3-A and NSF Hygienic requirements for food machinery Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee European Hygienic Engineering & Design Group Subgroups Guided by the Chairperson Guided by the Chairperson - Participation from Food Industries, Equipment Manufacturers, - Participation from Food Industries, Equipment Manufacturers, Research Institutes, Public Health Authorities - Meeting two- to three times a Year - Preparation of guidelines (acceptance by the Main group) - Revision of guidelines every 5 Years Actually: 25 Subgroups Actually: 25 Subgroups with corresponding Working Parties (experts): i.e. Equipment and Components, Design Principles, Processing, Services and Utilities, Training and Education Hygienic requirements for food machinery Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee Processing, Services and Utilities, Training and Education European Hygienic Engineering & Design Group Regional Sections - Translation of guidelines into the national language - Information about activity of EHEDG international - Discussion platform, work shops, training seminars - Discussion platform, work shops, training seminars - Organisation of meetings to knowledge transfer - Coordinator between national authorities and the EHEDG - Coordinator between national authorities and the EHEDG - Promulgation of Hygienic Design - PR activities Regional Sections: Belgium, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Poland, Scandinavia, Spain, Switzerland, Thailand, Ukraine Hygienic requirements for food machinery Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee European Hygienic Engineering & Design Group Food Production HACCP, HACCP, Hygienic Hygienic HACCP, HACCP, GMP GMP Hygienic Hygienic Design Design machinery process equipment, components installation production, process product installation function cleanability product personal cleaning cleanability cleaning equipment quality product quality Hygienic requirements for food machinery risk assessment (machinery) risk assessment (product) Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Building Design Hygienic Design Principles && Hygienic Systems Integration Training & Education Pipe & Pipe Couplings Risk Assessment Test Methods Training & Education Air Handling Heat Treatment Electrical Installation Pumps Valves Air Handling Pumps Sensors Conveyors Material of Construction Mechanical Seals Hygienic requirements for food machinery Conveyors Lubricants Mechanical Seals The hygienic integration of these segments to a functional system is the result of Hygienic Design and its Principles and ends up in Hygienic Manufacturing Conditions. European Hygienic Engineering & Design Group Guideline No. 8 Hygienic equipment design criteria Hygienic equipment design criteria second edition, April 2004 second edition, April 2004 (first edition 1993) This document details the principal hygienic This document details the principal hygienic design criteria to be met by equipment for food processing. It gives guidance on how to food processing. It gives guidance on how to design, construct and install equipment so design, construct and install equipment so that it does not adversely affect food quality (safety). Hygienic requirements for food machinery (safety). Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Product contact surface ceiling Product contact surface ceiling leighting hot water steam EHEDG con- densate dust con- densate EN 1672-2, ISO 14159 EHEDG densate densate food con- tact area splash area air apparatus product food product non-food area Hygienic requirements for food machinery product Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Materials of Construction stainless steel stainless steel polymeric materials / elastomers polymeric materials / elastomers adhesives lubricants lubricants thermal insulation materials thermal insulation materials Equipment must be easy to clean and Functional Requirements Equipment must be easy to clean and protect the products from contamination. Hygienic requirements for food machinery protect the products from contamination. Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Tank Emptying Tank Filling Tank Clean Filling Clean CIP RETURN PRODUCT CIP RETURN PRODUCT FEED Product out CIP FEED CIP Hygienic requirements for food machinery CIP System European Hygienic Engineering & Design Group Mixproof intersections Mixproof intersections Mixproof intersections can be designed by a suitable combination of shut-off valves or one Varivent Mixproof valve by a suitable combination of shut-off valves and / or shuttle valves 3 shut-off valves 1 shut-off valve 1 shuttle valve 1 shut-off valve 1 shuttle valve Mixproof valves permit establishing mixproof intersections with the Hygienic requirements for food machinery mixproof intersections with the least possible contamination risk European Hygienic Engineering & Design Group Butterfly valve abrasion on the abrasion on the elastomer elastomer damage of the damage of the surface Hygienic requirements for food machinery Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group surface and geometry, surface finish / roughness Hygienic Design and construction surface and geometry, surface finish / roughness drainability equipment and pipework must be self-draining installation installation avoid condensation equipment and supports must be sealed to surfaces equipment and supports must be sealed to surfaces welding continuous welds continuous welds inert gas welding testing and verification Hygienic requirements for food machinery testing and verification Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Macroscopic Crevices avoidance of areas where soil can accumulate avoidance of areas where soil can accumulate and are not easy to clean and are not easy to clean product area gap (soil) Example: Example: sealed joint Hygienic requirements for food machinery gasket Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group CREVICES in pipe CREVICES in pipe connections connections connections connections Hygienic requirements for food machinery European Hygienic Engineering & Design Group CREVICES in pipe CREVICES in pipe connections connections connections connections Hygienic requirements for food machinery European Hygienic Engineering & Design Group Pipe coupling Corresponding to requirements for static seals: Gasket aligned at the product contact surface fixed compression by axial stop Corresponding to requirements for static seals: fixed compression by axial stop centering (alignment) of the sealing parts aseptic coupling shape B Hygienic requirements for food machinery aseptic coupling DIN 11864 Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Heat damage on o-ring gasket 20C > 100C 20C 20C > 100C 20C Expension of elastomers: 15 times higher than stainless steel Hygienic requirements for food machinery European Hygienic Engineering & Design Group Defined Thermal Expansion Expansion on Expansion on Expansion on product side Expansion on non product side Hygienic requirements for food machinery European Hygienic Engineering & Design Group Pipe coupling Clamp connection Clamp connection no centering no centering gasket not align to the product side possible over compression of the gasket the product side no sealing no sealing direct at the product side Hygienic requirements for food machinery Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Penetration through Equipment Requirement: Penetration from outside into the product must be avoided static seal shaft housing static ring shaft housing static seal shaft housing housing product product spring crevice crevice rotating ring Hygienic requirements for food machinery Reciprocating Movement Rotating Movement rotating ring Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Effects of Flow Requirement: Design due to advantageous flow patterns Requirement: Design due to advantageous flow patterns (avoiding vortices without exchange of liquid, dead areas, flow shadows, areas in- liquid, dead areas, flow shadows, areas in- closing air or gas, not drainable areas) expansion contraction expansion contraction shaft or dead area dead area T-pipe shaft or stem Hygienic requirements for food machinery flow shadow dead leg T-pipe Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Dead end Hygienic requirements for food machinery Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Application of Sensors welded conduit for sensor for sensor srew welded direction of flow srew connection gasket dead welded sensor of flow dead area Hygienic requirements for food machinery Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Self draining vertically Example: centrifugal pump vertically mounted pump outlet horizontally mounted pump outlet inlet
outlet vertical Hygienic requirements for food machinery outlet horizontal (self-draining) Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Self draining Example: pipelines Example: pipelines hazards by fitting residues gas inclosure hazards by fitting pipelines to buildings inclosure Hygienic requirements for food machinery bending residues Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Self draining not able to drain the pipeline Hygienic requirements for food machinery Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Guideline No. 10 Hygienic design of closed equipment for Hygienic design of closed equipment for the processing of liquid food the processing of liquid food first edition, 1993 (second edition 2007) (second edition 2007) This paper illustrates the application of these criteria (doc. 8) in the methods of criteria (doc. 8) in the methods of construction and fabrication of closed construction and fabrication of closed process equipment. Hygienic requirements for food machinery Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Hygienic Design of Closed Equipment for the Processing of Liquid Food Joints Processing of Liquid Food Joints Seal design Seal design Dynamic seals Drainability Drainability Dead areas Internal angles and Internal angles and corners Screw threads Thermal insulation Hygienic requirements for food machinery Thermal insulation Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Mix-matched housing combination Risk of remaining soil Hygienic requirements for food machinery European Hygienic Engineering & Design Group Drainability (a) product area, (b) concentric reducer, (c) eccentric reducer, long version, (d) eccentric reducer, short version, (e) potential shadow zone Hygienic requirements for food machinery Transition of pipe diameters Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Dead Areas (a) product area, (b) dead leg with residual soil (a) product area, (b) dead leg with residual soil Position of dead legs with reference to the flow of product and cleaning liquids. Short dead legs (13.1, 13.2) will be cleanable, long ones not (13.3, 13.4). Dead leg position in (13.4) is better than in (13.3) due to the direction Hygienic requirements for food machinery 13.4). Dead leg position in (13.4) is better than in (13.3) due to the direction of the flow. Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Screw threads (a) product area, (b) metal supported elastomeric seal, (c) metal, (d) elastomer (a) product area, (b) metal supported elastomeric seal, (c) metal, (d) elastomer Hygienically acceptable screwed connections. (20.1) elastomer sealed; (20.2) continuous metal surface. Hygienic requirements for food machinery Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Guideline No. 13 Hygienic design of equipment for open Hygienic design of equipment for open processing first edition, 1996 first edition, 1996 (second edition 2007) This paper deals with the principal hygienic requirements for equipment for open requirements for equipment for open processing. It describes methods of construction and fabrication, giving examples construction and fabrication, giving examples as to how the principal criteria can be met in open process equipment. Hygienic requirements for food machinery open process equipment. Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Hygienic Design of Open Equipment for Processing of Food Joints Processing of Food Joints Drainability Top rims, covers Top rims, covers Arrangement of ancillary equipment equipment Shaft ends and couplings Bearings Bearings Belts Mesh, screens, gridirons, perforated sheets perforated sheets Cladding, framework Installation Hygienic requirements for food machinery Installation Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Joints Joints (c) (e) (d) (e) (a) product area, (b) step, (c) sloped edge, (d) intermittent welding, (e) continuous welding, (f) crevice due to metal-to-metal contact (1.1) (1.2) (1.3) Welded joints. (1.1) Overlapped sheets with intermittently welded seams create crevices and metal to metal contact areas between the seams; (1.2) improved design of overlapped sheets must have continuous welds and sloped edges for easy cleaning; (1.3) correct design is characterised by smooth continuously welded Hygienic requirements for food machinery cleaning; (1.3) correct design is characterised by smooth continuously welded sheets. Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Drainability Drainability R (6.1) (6.3) (6.4) R (6.1) (b) (a) product area, (b) residual soil (6.2) (6.6) (6.5) (b) (a) product area, (b) residual soil Principles of equipment drainability. (6.1, 6.2) Discharge outlets above the lowest level of equipment will prevent self-draining; (6.3 - 6.6) demonstrate self-drainable designs with discharge outlets at the lowest level, sloped Hygienic requirements for food machinery self-drainable designs with discharge outlets at the lowest level, sloped bottoms, and well-rounded corners. Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Arrangement of ancillary equipment Arrangement of ancillary equipment (c) (d) (d) (e) (a) product area, (b) contamination [condensate, lubricants], (c) motor with fins [dead (12.1) (12.2) (a) product area, (b) contamination [condensate, lubricants], (c) motor with fins [dead areas], (d) thrower ring, (e) self-draining protection sheet with upstand [dismountable] Protection of product. (12.1) Equipment mounted above any exposed product can contaminate it by soil, condensate or lubricants; (12.2) protection sheets, Hygienic requirements for food machinery can contaminate it by soil, condensate or lubricants; (12.2) protection sheets, covers, and cowls must be arranged to protect the product. Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS European Hygienic Engineering & Design Group Bearing Bearing (c) (d) (a) gap, (b) foot, (c) groove, (d) bearing (15.1) (15.2) (a) gap, (b) foot, (c) groove, (d) bearing Design of foot bearings. (15.1) tight clearance in the bearing itself, and too little clearance between it and the base, may impede cleaning; (15.2) shaft with grooves in the bearing area to facilitate both lubrication by fluid Hygienic requirements for food machinery Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS with grooves in the bearing area to facilitate both lubrication by fluid products and cleaning. European Hygienic Engineering & Design Group Thank you for your attention. Thank you for your attention. Hygienic requirements for food machinery Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS