Yearbook 2013/2014 - ehedg

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Cleanability test of a hygienic design-compatible washer 121 To ensure that the results are representative, the cleanability test is conducted a total of four times. In the case of the new seal, none of the four tests showed a yellow discolouration following the incubation of the agar coating covering the bolt and dome nut. The yellow discolouration in the reference pipe was present in an average of 13 percent of its inner surface, which is within the tolerance range of +5 to +30 percent stated in EHEDG Guideline Doc 2 and corresponds to an acceptable level of contamination after the very mild (test method) cleaning cycle. As such, the new design clearly demonstrated better cleanability than the reference pipe. In June 2012, the TUM (Forschungszentrum für Brauund Lebensmittelqualität) at Weihenstephan (Germany) declared officially that the new design, which Process Seals has named “Hygienic Usit,” meets the Hygienic Equipment Design Criteria of the EHEDG. Fig. 2. The Hygienic Usit combines metallic flat seal and elastomeric ring in one component. References 1. U.S. Pharmacopeia, USP 29, General Chapter Biological reactivity tests, in vivo, USP 29 – NF24, page 2526. 2. European Hygienic Engineering and Design Group (EHEDG). EHEDG Guideline Nr. 2, Method for Assessing the In-place Cleanability of Food Processing Equipment, 3rd Ed, July 2004, (Revised June 2007). 3. European Hygienic Engineering and Design Group (EHEDG). EHEDG Report 01: Cleanability Test, Hygienic Usit with Bolt. Weihenstephan Research Center for Brewing and Food Quality, TU Munich. December 5, 2011. Fig. 1. The Hygienic Usit provides simple and FDA-compliant sealing for threaded connectors with flanges, while also fulfilling the criteria of hygienic design.
European Hygienic Engineering & Design Group Aspects of compounding rubber materials for contact with food and pharmaceuticals Equipment and equipment components made with rubber materials that come into contact with food in processing lines must comply with regulatory requirements such as FDA’s Code of Federal Regulations (CFR), 3-A Sanitary Standards, and US Pharmacoepia (USP) Class VI standards. It is also necessary to consider the working conditions in which the gasket will be used, including what products are produced, the cleaning and sterilization agents utilized in those processes, and temperatures or other factors that may impact the efficiencies of equipment and components throughout the process line. In order to maintain a high hygienic standard, a very good cleanability of any equipment component with a rubber surface must be achieved and thorough documentation provided. Anders G. Christensen, Sales and R&D Director, AVK GUMMI A/S, Mosegaardsvej 1, DK-8670 Laasby, Denmark, email: avk@avkgummi.dk, www.avkgummi.dk For many years the food processing industry has referred to regulatory guidelines and standards that cover the use and compliance of rubber materials that come into contact with food. Among these are rules outlined in the U.S. Food and Drug Administration (FDA) 21 CFR 177.2600 (Rubber articles intended for repeat use) and the recommendations of the German BfR XXI (Commodities based on natural and synthetic rubber) or XV (silicone oil, resins and rubber requirements). Recently, 3-A Sanitary Standard 18-03 also has become a de facto standard for many food processing sectors beyond the dairy industry from which it originates. This standard not only regulates rubber materials that come into contact with food, but also the manufacturing conditions, taking hygienic standards and traceability into consideration. EN 1935/2004 is an attempt to have a common set of rules within the European Union (EU). While this regulation is fully operational with regard to metals and plastics, it is still a work-in-progress with regard to rubber materials. Until positive lists of approved ingredients that can be used in food-contact rubbers and associated testing methods are in place, the FDA and BfR lists, together with extraction tests, appear to be the most relevant regulations for food-contact rubber materials. The member states have now begun to turn this framework into statutory instruments; however, this may be at the cost of uniformity and transparency. Other standards-related developments are affecting require ments as well. For example, the Danish Ministry of Food is enforcing the rules of traceability and good manufacturing practices (GMPs) by means of third-party inspection of manufacturers’ facilities and process lines. For pharmaceuticals, normally Class VI under the USP Monograph 88, testing is required. Alternatively, the customer can ask for in vitro testing, either according to USP Monograph 87 or International Standards Organisation (ISO) 10993-5. In addition, end users require documentation for cleanability of equipment surfaces. Most often this is provided by means of an European Hygienic Equipment Design Group (EHEDG) cleanability test of the component in which the rubber part is present. Except for the geometry and the corresponding flow profile, the rubber surface is typically the most critical material when conducting any hygienic test. For this reason, it is important to consider the affinity between rubber compounds, products and cleaning agents. Long-term field studies, such as those conducted by AVK GUMMI, have been conducted and have led to easy-to-clean formulation of compounds within the families of ethylene proplene rubber (EPDM), hydrogenated nitrile (HNBR), fluorocarbon (FPM) and silicone. Material performance In addition to ensuring that food-contact rubber materials have the relevant approvals, meet appropriate compliance requirements and have traceability documentation, it is important to consider material performance. No two formulations are equal. Even if two manufacturers develop a compound for the same application, the end user will experience different performances with each due to variabilities ranging from the food being produced, the production line systems, and the level of hygienic operations in the processing plant and performed on equipment, among others. The reason for this is shown in Figure 1: Figure 1. Example comparison of good quality compounds versus low-cost compounds as recipes for an EPDM 70 Sh A material.
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EHEDG Yearbook 2013/2014 European H
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4 Contents EHEDG Guidelines 154 EHE
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32 Particle and VOC emissions, chem
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44 Hygienic design of floor drainag
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46 Hygienic design of floor drainag
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48 Hygienic design of high performa
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58 Spray cleaning systems in food p
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62 Environmentally friendly water b
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64 Environmentally friendly water b
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68 Flow behaviour of liquid jets im
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Page 85 and 86: 84 Practical considerations for cle
Page 87 and 88: 86 Integrated hygienic tamper-free
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Page 112 and 113: A cleaner, healthier future. Cleani
Page 114 and 115: Examination of food allergen remova
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Page 126 and 127: New developments for upgrading stai
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Page 130 and 131: International Hygienic Study Award
Page 132 and 133: EHEDG Regional Sections 131 MEXICO
Page 134 and 135: EHEDG Regional Sections 133 In Octo
Page 136 and 137: EHEDG Regional Sections 135 EHEDG D
Page 138 and 139: EHEDG Regional Sections 137 EHEDG G
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EHEDG Subgroups 171 It will address
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EHEDG Subgroups 173 EHEDG Subgroup
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EHEDG Subgroups 175 Chairman: Andy
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EHEDG Subgroups 177 EHEDG Subgroup
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EHEDG Secretariat Lyoner Strasse 18
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