1. 23/12/2009 Matthias Schuetzeberg Slide 1 E+H hygienic technology

2. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 2 Goal of this training session Why is hygienic designed equipment demanded? What are the basic requirements for a hygienic installation? How should equipment that is used in food look alike? How does hygienic design looks at wetted parts and housing? What to remind due to installation? Which process connection fits into what kind of application? Please remind, that hygienic design is just a step to improve the hygienic behaviour of a plant. You will never reach 100%. Target is, to stay on a acceptable level.

3. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 3 Agenda of this Training Session What does “Hygiene” means ? Clean ability and surface roughness Hygienic constructions Regulatory Laws, Agencies & Standards Hygienic Process connections

4. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 4 What is the meaning of “Hygiene” Hygiene refers to the set of practices associated with the preservation of health and healthy living. Hygiene is a concept related to medicine, as well as to personal and professional care practices related to most aspects of living, although it is most often associated with cleanliness and preventative measures. Washing one's hands, a form of hygiene, is the most effective overall way to prevent the spread of infectious disease.infectious disease

5. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 5 Culinary hygiene “Food Safety” Culinary practices include: Cleaning and sterilization of food-preparation areas and equipment (for example using designated cutting boards for preparing raw meats and vegetables). Cleaning may involve use of chlorine bleach, ethanol, ultraviolet light, etc. for sterilization. Careful avoidance of meats contaminated by trichina worms, salmonella, and other pathogens; or thorough cooking of questionable meats. Washing of hands thoroughly before touching any food. Not using the same utensils to prepare different foods. Proper storage of food so as to prevent contamination by vermin. Refrigeration of foods (and avoidance of specific foods in environments where refrigeration is or was not feasible). Labeling food to indicate when it was produced (or, as food manufacturers prefer, to indicate its "best before" date).

6. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 6 What is the reason to use hygienic instrumentation? The product quality! and money: Longer production cycles between the CIP cycles.  higher yield of the plant. Easier to clean means less water, less cleaning agents, lower temperature and faster cleaning.  saving money More flexible plants due to easier and faster phase change between two products or flushing water and product. Certified technology is saving time in certified processes!

7. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 7 Clean ability - Why do we need a smooth surface? E-coli Proteine Bacteria Finger print Yeast Grease particle Dust particle Biofilm with grease, dirt and yeast Human Hair Cracks and crevices Micro organism Surface Roughness

8. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 8 Surface Finish - Conversion 3-A requires Ra 0,8µm (32µ-Inch) or better. For purified water systems: Ra of 0,4µm (15µ-Inch) is typically required Ra is the Roughness Average, after Polishing. Ra is usually expressed in Micro-Inch (u-inch) or Micro-Meters (Microns). Surface final finish is sometimes measured in Roughness RMS (Root Mean Squared). Micro-inches x 1.11 = roughness RMS.

9. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 9 polishing of metal surfaces Polishing is achieved in different ways: mechanical buffing, electropolishing or forming Electropolishing removes material from uneven surfaces Reduces surface areas Provide a hygienic surface finish Cleans the surface Passivates the surface of stainless steel with a chromium layer Removes impurities trapped below folded layers Mechanical polishing in combination with electropolishing produces the best results

10. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 10 Cracks and Crevices Static seals shall be cleanable and drainable with minimum crevices, gaps, and horizontal surfaces O-rings shall be flush with pipe wall and be self-aligning and self- positioning EHEDG study shows that protrusion of less than 2mm (1/12”) is not cleanable Seals must be resistant to CIP solutions and tolerate SIP temperatures Gaps and dead ends must be self draining/ cleanable. Rule of thumb: diameter 2 times larger than depth Example: Tank fitting DN50/ 2” 25mm 1”

11. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 11 Hygienic Construction: seals Metal to metal sealing is, according to EHEDG, not fully hygienic.

12. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 12 Hygienic Construction: seals If the O-Ring is to far from the process, the danger of building up reservoirs for product and micro organisms is high. heating cool down Material stretching product or micro organism

13. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 13 Hygienic Construction: seals Fixed by hand Fixed by tools gap Weak points for hygienic Milk pipe connection (DIN 11851) Hygienic T-ring screwing (ISO 2853) centering stop no deep gap.

14. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 14 Spectrum Of user Requirements Keep in mind to establish what different needs a plant have for different processes and products. Some areas in raw material may have a lower need for hygienic design. You can often estimate the hygienic requirements simply by understanding how fast or easy a product will spoil. Milk and dairy products have among the shortest shelf life vs. for example the very long shelf life for dry grain products. All processes can be improved by using hygienic design. Users oftens don’t recognize the possibilities to improve the safety of their process. If you talk to the engineers they often satisfied to stick with what they have. If you have the opportunity to point out to a quality manager the benefits of for example using a fully drainable straight flow tube vs. a U-tube your opportunity is much greater.

15. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 15 Promag H – gasket design Example of good gasket design, compression and extrusion of gasket is controlled. No cracks or crevices are created.

16. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 16 Who takes care of this topic What has an effect: Material Surface Design, inside and housings Installation European /American organisations

17. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 17 EHEDG–European Hygienic Engineering and Design Group Organization established in mid 1990’s to by larger European food producers and equipment mfg. To establish uniform requirements for Europe Provides recommendations to ISO for hygienic standards design Equipment has to pass test to qualify as EHEDG compliant

18. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 18 3-A hygienic Standards Not true regulations - only standards Applicable to “Grade A” milk and milk products Manufacturer self-certification with third party verification conformance to the standards 3-A does not approve anything – a device “meets with 3-A hygienic standards” 3-A hygienic standards are recognized by the FDA 3-A is a legal requirement in Dairy operations, many other food branches request it as it is seen as good practice. People in brewing or beverage or food production may never have heard about 3-A www.3-A.org

19. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 19 Defines direct additives and indirect food additives (fill fluids) Defines GRAS materials (Generally Recognized As Safe) Defines cGMP (current Good Manufacturing Practice) for processing Defines food product names/required ingredients Regulates production of Dairy products Pasteurized Milk Ordinance (PMO) Published by: US Dept. of Health and Human Services Public Health Service Food and Drug Administration Milk Safety Branch FDA – Food and Drug Administarion Food recalls http://www.fda.gov/opacom/7alerts.html

20. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 20 Pasteurized Milk Ordinance legal control of milk pasteurization PMO heat-exchanger

21. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 21 Hygienic Process connections Dairy Connection acc. to DIN 11851 Aseptic connection acc. to DIN 11864 SMS - connection DRD Welding adapter Varivent connections APV connections Welding adapter for Deltapilot S Tri-Clampacc. to DIN 32676/ISO 2852 NEUMO BioConnect & Aseptic NEUMOBioConnect Welding adapter „F“ for Liquiphant Process connection DN 25 Ingold I - Line Clamp - Fitting ; Cherry Burell Rosemount/Foxboro tank spud KingGage / Anderson Tank Spud KingGage +++

22. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 22 Tri-Clamp (DIN 32676/ISO 2852) The Tri-clamp connection is common in the food industry and was originated and designed by the company Tri-clover. The sensors can either be placed at tanks or in pipes. The advantage of that system is the easy installation of the sensors. The parts of the clamp system are put together via clamps. Pressure rated to 600psi with standard clamp (1000psi with high pressure clamp) up to 2“ only Sizes from ½“ to 6“ ½“ + ¾“ – same clamp 1“ + 1-1/2“ – same clamp Parts of the Tri-clamp connection: 2 x Clamp parts, Clamp, seal Tri-clamp process connection Pay attention when selecting clamp option; there are ISO, DIN std and Tri-Clamp. Style is not critical for “dead end” connections such as for pressure, temperature but is critical for “flow-through”. The ID is slightly different that can cause cleaning problems

23. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 23 Cherry-Burrell I-Line Similar to Tri-clamp but have male and female connectors, making alignment easier.

24. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 24 DIN 11851, DIN 11864 and SMS DIN 11851 (Milk Coupling) Older European std. Being slowly phased out by 11864 DIN 11864 Aseptic Coupling Very good hygienic seal design SMS coupling Common in Scandinavia and France

25. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 25 Tuchenhagen Varivent The Varivent - Inline housing must be used together with a Varivent flange. With the inline housing a hygienic flush mounting is reached. The Varivent parts are held together with a clamp

26. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 26 Tuchenhagen Varivent options Tank Adapter Form - T - Tankmount or pipe mount. 4 sizes 17mm 50mm 68mm 114mm

27. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 27 APV connections Similar concept as the Tuchenhagen Varivent, Mounts with screws. More commonly seen on brewing skids from Europe

28. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 28 DRD – Flush weld fitting DRD flange – common in Europe for brewing, wine and juice Large diameter + bolts make it less practical CO 2 - head pressure measurement at the fermentation tank in the brewery with Deltapilot S DRD-flange

29. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 29 Ingold 25mm The Ingold process connection 25 mm is most common in the pharmaceutical industry for the implementation of pressure transmitters, analytical instrumentation and level switches in fermenter. Available from E+H for: pH-assembly CPA 442, 465, Cleanfit Cerabar M PMP 45 Liquiphant M

30. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 30 NEUMO Aseptic and Bio Connect The aseptic connection NEUMO was especially designed by the company NEUMO for hygienic applications and is simliar to the DIN 11864. The aseptic connection BioConnect was designed for hygienic and aseptic processes in the pharmaceutical industry and is similar to the DIN 11864 and the aseptic connection from NEUMO. NEUMO Aseptic NEUMO Aseptic BioConnect

31. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 31 Anderson, KingGage, Continental and Tankmate Commonly seen in dairy and beverage industry KingGage Long 8”, medium 6”,short 2.5” - 1.26” diameter Anderson Long 6.5” and short 2.2” – 2.2” diameter E+H Deltapiot S DB50S or FMB70 with Anderson fitting

32. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 32 Rosemount tank spud Referred to as 2” or 6” version large diameter of 3.63” use a 4”clamp for mounting. Primarily used hydrostatic pressure tank level applications Available on FMD 78, PMP46 and with adapter for FMB70 (Cerabar M PMC 45 is available as TSP) Seen here in reference to 2” tri-clamp

33. 23/12/2009 Food-BTM_Hygiene Matthias Schuetzeberg Slide 33 Endress+Hauser Weld fittings Endress+Hauser offers weld fittings to provide hygienic flush connections of several products Weld spud for: Deltapilot S FMB 70 Cerabar M PMC 45 Liquicap FMI 51 Levelflex FMP41C NA Connect – Tri-Clamp compatible weld fitting – Shown here when used with FMR245 Weld spud for Liquiphant M