European Hygienic Engineering & Design Group
May 2010 Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee
European Hygienic Engineering & Design Group
Legal Requirements
European Legislation
– EU Hygienic-Regulation
– Directive 2006/42/EC on machinery
Legislation of EU-Member-States
US-Legislation
EHEDG delivers guidance to understand and to follow
May 2010 Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee
European Hygienic Engineering & Design Group
DIRECTIVE 2006/42/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 May 2006
2.1. FOODSTUFFS MACHINERY AND MACHINERY FOR COSMETICS OR PHARMACEUTICAL PRODUCTS
2.1.1. General
Machinery intended for use with foodstuffs or with cosmetics or pharmaceutical products must be designed
and constructed in such a way as to avoid any risk of infection, sickness or contagion.
9.6.2006 EN Official Journal of the European Union L 157/49
The following requirements must be observed:
(a) materials in contact with, or intended to come into contact with, foodstuffs or cosmetics or pharmaceutical
products must satisfy the conditions set down in the relevant Directives. The machinery must be
designed and constructed in such a way that these materials can be cleaned before each use. Where this is
not possible disposable parts must be used;
(b) all surfaces in contact with foodstuffs or cosmetics or pharmaceutical products, other than surfaces of
disposable parts, must:
— be smooth and have neither ridges nor crevices which could harbour organic materials. The same
applies to their joinings,
— be designed and constructed in such a way as to reduce the projections, edges and recesses of assemblies
to a minimum,
— be easily cleaned and disinfected, where necessary after removing easily dismantled parts; the inside
surfaces must have curves with a radius sufficient to allow thorough cleaning;
(c) it must be possible for liquids, gases and aerosols deriving from foodstuffs, cosmetics or pharmaceutical
products as well as from cleaning, disinfecting and rinsing fluids to be completely discharged from the
machinery (if possible, in a ‘cleaning’ position);
(d) machinery must be designed and constructed in such a way as to prevent any substances or living creatures,
in particular insects, from entering, or any organic matter from accumulating in, areas that cannot
be cleaned;
(e) machinery must be designed and constructed in such a way that no ancillary substances hazardous to
health, including the lubricants used, can come into contact with foodstuffs, cosmetics or pharmaceutical
products. Where necessary, machinery must be designed and constructed in such a way that continuing
compliance with this requirement can be checked.
May 2010 Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee
European Hygienic Engineering & Design Group
Standards / Recommendations
European Hygienic Engineering and Design Group (EHEDG) (www.ehedg.org)
Guidelines, seminars and certification of equipment and components
3-A Sanitary Standards (www.3-a.org)
Guidelines and certification of equipment and components
NSF (www.nsf.org)
Certification of equipment and components
May 2010 Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee
European Hygienic Engineering & Design Group
EHEDG Perspective on
Hygienic Design
EHEDG Guidelines
EHEDG Training & Education Material
Doc. 32, Materials
Doc. 35, Welding
Doc.16, Pipe couplings
Doc. 10 Hygienic design of closed equipment
Doc.14 & 20, Valves
May 2010 Knuth Lorenzen, EHEDG President, 3-A Steering Committee, GEA TDS
European Hygienic Engineering & Design Group
Doc. 32, Materials of Construction
Surface characterization
Arithmetic average of roughness Ra, Average distance Rz
Source: Manja Lukesch. Vergleichende Untersuchungen mit modernen optischen Messmethoden zur
Bestimmung der Mikrotopographie von Oberflächen, IPF Dresden
May 2010 6
European Hygienic Engineering & Design Group
Size comparison
• Typical representation of a surface profile of Ra =0,8 µm roughness achieved
by 180-240 grit mechanical polish.
• No surface defects or damage. Source: Andy Timperley, Timperley Consulting
May 2010 7
European Hygienic Engineering & Design Group
Surface characterization
Topography respectively real topography
May 2010
European Hygienic Engineering & Design Group
Doc. 35, Welding of Stainless Steel Tubing
May 2010 Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee
European Hygienic Engineering & Design Group
Doc.16, Design of pipe couplings
EHEDG certified EHEDG Recommended Pipe Connection
DIN 11864-2
•Easy in-place cleanable
•Sterilisable in place
•Impervious to micro-organisms
•Easy installation
•Reliable
Not recommended DIN 11864-1
DIN 11851
May 2010
European Hygienic Engineering & Design Group
Doc. 10 Hygienic design of closed equipment for the processing of liquid food
0 10
bar
STATE OF THE ART
Inline Access Unit
DEAD ENDS in pipe connections
May 2010 Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee
European Hygienic Engineering & Design Group
Fluid motion in a dead space
Federal Institute of Milk Research, Kiel
Dr. Grasshoff
L
rel. dead space depth dn
May 2010 Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee
European Hygienic Engineering & Design Group
CIP operating time
Hygiene Installation versus the Common Way
(State of the Art)
Example 1: Dairy Installation with Example 2: Dairy Installation with
4.500 Tuchenhagen Valves 4.500 Γ- and Τ-shape Valves =
and 5.000 m pipe line DN 80 4.500 sockets = 360 m length of pipe
and 5.000 m pipe line = 5.360 m pipe line DN 80
CIP time per circuit (assumption)
5 Min. Pre rinse, 20 Min. caustic, 10 Min. Acid, efficiency to clean Γ- and Τ-shape valves versus
5 Min. Final rinse, 20 Min. Disinfection = Tuchenhagen valves = 15 % (see graph Dr. Grasshoff)
60 Min total CIP time
5.000 m = 60 Min. = 100 % 5.360 m = 60 Min. = 100 % (5.000 m = 93 %, 360 m = 7 %)
5.000 m straight pipe will be cleaned in 55,8 Min.,
360 m Γ- and Τ-shape sockets will be cleaned in 28 Min.
(60 Min. divided by 0,15% = 400 Min. x 7% = 28 Min.)
Total CIP time = 60 Min. Total CIP time = 83,8 Min.
Total CIP circuits per day = 500
Because of the Γ- and Τ-shape valves, there is a surplus
length of the pipe of 7%, and a surplus cleaning time of
23,8 Min. which results to 40% more CIP time and less
production time.
May 2010 Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee
European Hygienic Engineering & Design Group
Mix-matched housing combination
Risk of remaining soil
We are talking about Hygienic Design – we mean much more
May 2010 Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee
European Hygienic Engineering & Design Group
Examples: Closed processes
Sensors in pipelines
Hygienically Annular dead zone Dead section
May 2010 Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee
European Hygienic Engineering & Design Group
LIVELY
DEAD
AREAS EASY TO AVOID!!
May 2010 Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee
European Hygienic Engineering & Design Group
Doc. 14, Valves
Metallic stops – put into practice
- Doc. 14, Figure 3, 4
• Defined deformation of the
seal
• FEM calculations allow for
optimal design of the seal
• No stroke variation
• Long lifetime of the seals
May 2010 Knuth Lorenzen, GEA Tuchenhagen DS, EHEDG President, 3-A Steering Committee
European Hygienic Engineering & Design Group
Hygienic Design
Prevention of stagnating product
Hygienic equipment Technology
+
Hygienic application Good Engineering
=
HYGIENIC DESIGN
Good material is not enough ……
Good design with good engineering is essential !
May 2010 Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee
European Hygienic Engineering & Design Group
EHEDG Website
May 2010 Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee
European Hygienic Engineering & Design Group
Guideline Downloads / Webshop
May 2010 Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee
European Hygienic Engineering & Design Group
Webshop
May 2010 Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee
European Hygienic Engineering & Design Group
Subgroup Download Section
May 2010 Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee
European Hygienic Engineering & Design Group
EHEDG Tasks and Objectives
• To fill existing gaps of practical guidelines and education
• Continuation of voluntary work
• Discussion and further development of Hygienic Design issues
• Preparation of scientific and technical guidelines on all aspects of state-of-the-
art hygienic design requirements and in accordance to EU legislation
• Development of test methods to identify and eliminate HACCPs of equipment
used in food production
• Offer lectures, seminars and workshops on Hygienic Design
• Strengthen the participation in standardisation bodies like CEN, ISO, DIN, JIS,
3-A and NSF etc.
• Strengthen the cooperation with the EU, i.e. food contact material directive,
BAT, traceability and other EU-Projects)
• Improve PR activities to disseminate Hygienic Design know-how
May 2010 Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee
European Hygienic Engineering & Design Group
Test Methods
- A method for the Assessment of in-place cleanability of
food processing equipment, Doc. 2
- A method for the Assessment of in-line pasteurization of
food processing equipment, Doc. 4
- A method for the Assessment of in-line sterilisability of
food processing equipment, Doc. 5
- A method for the Assessment of bacteria tightness of
food processing equipment, Doc. 7
May 2010 Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee
European Hygienic Engineering & Design Group
Certification of Equipment
In compliance with the hygienic equipment designs criteria (Doc. 8)
and the confirmation of „successfully“ conducted cleanability test
NEW
• Contact EHEDG authorised
Institutes for design evaluations
and equipment classification.
** If necessary, other special
guidelines, e.g. doc 25 about
mechanical seals, could be used
to get more clearness about
essential requirements to get an
easy to clean design.
May 2010 Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee
European Hygienic Engineering & Design Group
Test Institutes for EHEDG-Certification
The EHEDG authorise the use of the certification logo on equipment
or components which corresponds to the relevant EHEDG guidelines.
The following institutes are accredited to test
and authorised to certify:
TU München Danish Technological Institute
Forschungszentrum Weihenstephan Mr. H. Classen
für Brau- und Lebensmittelqualität Holbergsvej 10
Dr. F. Jacob DK-6000 Kolding
Alte Akademie 3 Denmark
D-85354 Freising Tel. +45 7220 1943
Germany Fax +45 7220 1919
Tel. +49 8161 71 3331
Fax +49 8161 71 4181
May 2010 Knuth Lorenzen,Knuth
GEA, EHEDG
Lorenzen, GEA,President & 3-Aand
EHEDG President Steering Committee
3-A Steering Committee
European Hygienic Engineering & Design Group
Test Institutes for EHEDG-Certification
CCFRA Technology Ltd TNO Certification B.V.
Mr. A. Timperley Mr. M. Keiser
Chipping Campden P.O. Box 541
Glos, GL55 6LD NL-7300 AM Apeldoorn
U.K. Netherlands
Tel. +44 1386 842000 Tel. +31 55 549 34 68
Fax +44 1386 842100 Fax +31 55 549 32 88
Purdue University
Dr. M. Morgan
745 Agriculture Mall Drive
West Lafayette, Indiana 47907-2009
USA
Tel. +1 765 494 1180
Fax. +1 765 494 7953
May 2010 Knuth Lorenzen,Knuth
GEA, EHEDG
Lorenzen, GEA,President & 3-Aand
EHEDG President Steering Committee
3-A Steering Committee
European Hygienic Engineering & Design Group
May 2010 Knuth Lorenzen,Knuth
GEA, EHEDG
Lorenzen, GEA,President & 3-Aand
EHEDG President Steering Committee
3-A Steering Committee
European Hygienic Engineering & Design Group
Other EHEDG Activities
• Annual conference with workshop
• Training courses
• Training material
Website
www.ehedg.org
May 2010 Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee
European Hygienic Engineering & Design Group
Please contact us:
EHEDG Secretariat
c/o VDMA
Lyoner Strasse 18
60528 Frankfurt
Germany
Susanne Flenner Juliane Honisch
susanne.flenner@ehedg.org/ juliane.honisch@ehedg.org
secretariat@ehedg.org Phone: +49 69 6603 1430
Phone: +49 69 6603 1217
May 2010
European Hygienic Engineering & Design Group
Thank you for your attention.
May 2010 Knuth Lorenzen, GEA, EHEDG President and 3-A Steering Committee
