EHEDG guideline 欧洲卫生工程设计指引

EHEDG guideline 欧洲卫生工程 设计 领导形象设计圆作业设计ao工艺污水处理厂设计附属工程施工组织设计清扫机器人结构设计 指引 European Hygienic Engineering & Design Group 欧洲卫生工程设计组织 The EHEDG provides guidance on the hygienic engineering aspects of manufacturing of safe and wholesome food.  This is achieved through : Production, publication and updating of guidelines, available in several languages.  To bridge the gap between theory and practice, training modules will be created based on the guidelines. Equipment approval through certification to assist equipment suppliers and food manufacturers. Organisation of conferences, regional meetings and training workshops. Regional activities Advisory function to legislators and standards groups (CEN, ISO, etc) EHEDG has EC support through the thematic network, HYFOMA, which is the European network for Hygienic Manufacturing of Food. Its goal is guideline development and dissemination of information. Production, publication and updating of guidelines, available in several languages. The production of guidelines is assured by the subgroups. To bridge the gap between theory and practice, training modules will be created based on the guidelines. Guidelines   Doc 1 Microbiologically safe continuous pasteurisation of liquid foods, 1992 Doc 3 Microbiologically safe aseptic packing of food products, 1993 Doc 6 The microbiologically safe continuous flow thermal sterilisation of liquid foods, 1993 Doc 8 Hygienic equipment design criteria, 2004 Doc 9 Welding stainless steel to meet hygienic requirements, 1993 Doc 10 Hygienic design of closed equipment for the processing of liquid food, 1993 Doc 11 Hygienic packing of food products, 1993 Doc 12 The continuous or semi-continuous flow thermal treatment of particulate foods, 1994 Doc 13 Hygienic design of equipment for open processing, 1996 Doc 14 Hygienic design of valves for food processing, 2004 Doc 16 Hygienic pipe couplings, 1997 Doc 17 Hygienic design of pumps, homogenisers and dampening devices, 2004 Doc 18 Passivation of stainless steel, 1998 Doc 20 Hygienic design and safe use of double-seat mixproof valves, 2000 Doc 21 Challenge tests for the evaluation of the hygienic characteristics of packing machines, 2000 Doc 22 General hygienic design criteria for the safe processing of dry particulate materials, 2001 Doc 23 Production and use of food-grade lubricants, 2002 Doc 24   The prevention and control of Legionella spp (incl Legionnaires Disease) in Food Factories, 2002 Doc 25 Design of Mechanical Seals for hygienic and aseptic applications, 2002 Doc 26 Hygienic Engineering of Plants for the Processing of Dry Particulate Materials, 2003 Doc 27 Safe Storage and Distribution of Water in Food Factories, 2004 Doc 28 Water treatment in food factories Doc 29 Packing systems for solid foodstuffs Doc 30 Air Handling in the Food Industry Doc 31   Hygienic Engineering of fluid bed and spray dryer plants Doc 32 Materials of construction for equipment in contact with food Doc 33   Hygienic Engineering of Discharging Systems for Dry Particulate Materials Doc 34 Integration of Hygienic and Aseptic systems, March 2006. Doc 35 Welding of Stainless Steel tubing in the food industry Test methods   Doc 2 (Updated) A method for assessing the in-place cleanability of food processing equipment, 2004 Doc 4 A method for the assessment of in-line pasteurisation of food processing equipment, 1993 Doc 5 A method for the assessment of in-line A method for the assessment of in-line steam sterilisability of food processing equipment, 2004 Doc 7 A method for the assessment of bacteria tightness of food processing equipment, 2004 Doc 15 A method for the assessment of in-place cleanability of moderately-sized food processing equipment, 1997 Doc 19   A method for assessing bacterial impermeability of hydrophobic membrane filters, 2000 1、Microbiologically safe continuous pasteurisation of liquid foods, 1992 SG Heat Treatment, 1992) There are many reasons why, in practice pasteurised products sometimes present a microbiological health hazard.  Due to distribution in residence time, not all products may reach the temperature required for pasteurisation or may do so for too short a time.  Further there may be a risk of contamination with a non-pasteurised product, or the cooling medium. This document describes the requirements for the microbiologically safe continuous pasteurisation of liquid foods without particulates.   An update is being prepared. 2、A method for assessing the in-place cleanability of food processing equipment, (SG Test Methods, 2nd edition 2000)  To facilitate the design, testing and maintenance of hygienic food processing equipment, it is important to be able to assess the relative cleanability of various components of the equipment using standardised test procedures. This paper describes a standard test procedure for assessing cleanability.  It is designed to indicate areas of poor hygienic design of equipment in which product or micro-organisms are protected from the cleaning process.  It can also be used to compare the in-place cleanability of different equipment designs.  The method is based on comparing (in the laboratory) the cleanability of a test item with that of a straight piece of pipe. The degree of cleanliness is based on the removal of a “soured milk soil” containing bacterial spores and is assessed by evaluating the number of spores remaining after cleaning with a mild detergent.   The method is intended as a screening test for hygienic equipment design and is not indicative of the performance of industrial cleaning processes (which depend on the type of soil).   (See Doc. 15 for a test procedure designed for moderately-sized equipment.) 3、Microbiologically safe aseptic packing of food products, 1993 SG Packing Machines, 1993) This guideline stresses the need to identify the sources of micro-organisms that may contaminate food in the packaging process, and to determine which contamination rates are acceptably low.  It clarifies the difference in risk of infection between aseptic processing and aseptic packing and recommends that aseptic packing machines be equipped with fillers that are easily cleanable, suitable for decontamination and bacteria-tight.  Requirements for the machine interior include monitoring of critical decontamination parameters.  (See also Doc. 21 on challenge tests). 4、A method for the assessment of in-line pasteurisation of food processing (SG Test Methods,1993) Food processing equipment that cannot be or does not need to be sterilised may need to be pasteurised to inactivate relevant vegetative micro-organisms and fungal spores.     It is important to test the hygienic characteristics of such equipment to ensure that it can be pasteurised effectively.  This document describes a test procedure to determine whether equipment can be pasteurised by circulation with hot water. 5、A method for the assessment of in-line steam sterilisability of food processing (SG Test Methods,1993) Food processing equipment may need to be sterilised before use, and it is important to ensure that the sterilisation method applied is effective.  Thus, it is necessary to determine under which conditions equipment can be sterilised.  This paper details the recommended procedure for assessing the suitability of an item of food processing equipment for in-line sterilisation.  It is advisable to conduct in-place cleanability trials (ref. Doc.2) prior to this test in order to verify the equipment’s hygienic design. 6、The microbiologically safe continuous flow thermal sterilisation of liquid foods (SG Heat Treatments, 1993)  Thermal sterilisation is aimed at eliminating the risk of food poisoning and, when used in conjunction with aseptic filling, at achieving extended product storage life under ambient conditions.  Whereas pasteurisation destroys vegetative micro-organisms, sterilisation destroys both vegetative micro-organisms and relevant bacterial spores.  Guidelines on continuous pasteurisation of liquid foods have been published earlier (Doc.1).  This document presents guidelines on the microbiologically safe continuous sterilisation of liquid products.  The technique of Ohmic heating was not considered in this paper but may be included in an update being prepared. 7、A method for the assessment of bacteria tightness of food processing equipment (SG Test Methods, 1993)  This document details the test procedure for assessing whether an item of food processing equipment, intended for aseptic operation, is impermeable to microorganisms.  Small motile bacteria penetrate far more easily through microscopic passages than (non-motile) moulds and yeasts.  The facultative anaerobic bacterium Serratia marcescens (CBS 291.93) is therefore used to test bacteria-tightness or the impermeability of equipment to microorganisms.  The method is suitable for equipment that is already known to be in-line steam sterilisable (see also Doc. 5). 8、Hygienic equipment design criteria (SG Design Principles, Second edition 2004) This Guideline describes the criteria for the hygienic design of equipment intended for the processing of foods. Its fundamental objective is the prevention of the microbial contamination of food products. It is intended to appraise qualified engineers who are designing equipment for food processing with the additional demands of hygienic engineering in order to ensure the microbiological safety of the end product. Upgrading an existing design to meet hygiene requirements can be prohibitively expensive and may be unsuccessful and so these are most effectively incorporated into the initial design stage. The long term benefits of doing so are not only product safety but also the potential to increase life expectancy of equipment, reduce maintenance and consequently lower operating costs. This document was first published in 1993 with the intention to describe in more detail the hygienic requirements of the Machinery Directive (98/37/EC ref.1). Parts of it were subsequently incorporated in the standards EN1672-2 and EN ISO 14159. (13 pages) 9、Welding stainless steel to meet hygienic requirements, 1993 (SG Design Principles, 1993)  This document describes the techniques required to produce hygienically acceptable welds in thin walled (< 3 mm) stainless steel applications.  The main objective is to convey the reasons and requirements for hygienic welding and to provide information on how this may best be achieved.  Common weld faults are discussed in relation to the hygienic risks they create and guidelines describe what constitutes a weld of hygienic quality. (The general safety aspects of welding are beyond the scope of this document.) 10、Hygienic design of closed equipment for the processing of liquid food, 1993 (SG Design Principles, 1993) Using the general criteria for the hygienic design of equipment identified in Doc 8, this paper illustrates the application of these criteria in the methods of construction and fabrication of closed process equipment.  Examples, with drawings, are given to show how to avoid crevices, shadow zones and areas with stagnating product, and how to connect and position equipment in a process line to ensure unhampered cleaning in-place and draining.  Attention is drawn to ways of preventing problems with joints, which might otherwise cause leakage or contamination of product. 11、Hygienic packing of food products, 1993 (SG Packing Machines, 1993)  Products with a short shelf-life, or whose shelf life is extended by cold storage or in-pack heat treatments, do not have to conform to such strict microbiological requirements as aseptically packaged foods (Doc 3 discusses aseptic packing.)   This paper discusses the packing of food products that do not need aseptic packing but which nevertheless need to be protected against unacceptable microbial contamination.   Guidelines are provided for the hygienic design of packing machines, the handling of packing materials and the environment of the packing machines.  (See also Doc 21) 12、The continuous or semi-continuous flow thermal treatment of particulate foods (SG Heat Treatment, 1994)  Thermal sterilisation is a process aimed at eliminating the risk of food poisoning and, when used in conjunction with aseptic filling, it aims to extend product storage life under ambient conditions.  This is achieved by the destruction of vegetative micro-organisms and relevant bacterial spores.  Earlier papers presented guidelines on continuous pasteurisation (Doc 1) and sterilisation (Doc 6) of liquid products without particles.   This paper presents guidelines on the design of continuous and semi-continuous plants for the heat treatment of particulate foods.  Liquid foods containing particulates are inherently more difficult to process than homogenous liquids due to heat transfer limitations in particulate-liquid mixtures and the additional problems of transport and handling. Although this document concentrates on sterilisation processes, the principles are consistent with other heat treatment processes.  Ohmic heating techniques are not covered. 13、Hygienic design of equipment for open processing, 1996 SG Design Principles, 1996)  For food processing, it is important that the plant design takes into account factors affecting the hygienic operation and cleanability of the plant.  (See also previous guidelines on hygienic design criteria Doc 8, hygienic welding Doc 9, and the hygienic design of equipment for closed processing Doc 10.) The risk of contamination of food products with relevant micro-organisms during open processing increases with the opportunity to grow in poorly designed equipment, as well as with the concentration of the micro-organisms in the environment.  This means that in open plants, environmental conditions, in addition to appropriate equipment design, have an important influence on hygienic operation.  Furthermore, the type of product and the stage of the manufacturing process must be taken into consideration.  Open processes incorporate many different types of equipment, including machines for the preparation of dairy products, alcoholic and non-alcoholic drinks, sweet oils, coffee products, cereals, vegetables, fruit, bakery products, meat and fish. This paper deals with the principal hygienic requirements for equipment for open processing.  It describes methods of construction and fabrication, giving examples as to how the principal criteria can be met in open process equipment. 14、Hygienic design of valves for food processing, 1996 (SG Valves, 1996)  Valves are essential components of all food processing plants, and the quality of the valves used strongly influences the microbiological safety of the food production process.  Valves for food contact use must therefore comply with strict hygienic requirements This paper discusses the basic requirements for hygienic and aseptic valves.  The guidelines apply to all valves used in contact with food or food constituents that are to be processed hygienically or aseptically.  Aside from general requirements with regard to materials, drainability, microbial impermeability and other aspects, additional requirements for specific valve types are also described. (See also Doc. 20 on double-seat mixproof valves.) 15、A method for the assessment of in-place cleanability of moderately-sized A method for the assessment of in-place cleanability of moderately-sized food processing equipment, 1997 (SG Test Methods, 1997)  A standard test procedure for assessing the in-place cleanability (i.e. suitability to be cleaned without dismantling) of relatively small equipment (such as pumps, valves and flowmeters) was earlier produced by this subgroup (ref Doc 2). This document describes a test procedure for assessing the in-place cleanability of moderately sized equipment, such as homogenisers.  The degree of cleanliness is based on the removal of a fat spread soil, and is assessed by evaluating the amount of soil remaining after cleaning by visual inspection and swabbing of the surface.  This method is not as sensitive as the microbiological method described in Doc 2. 16、Hygienic pipe couplings (SG Pipe Couplings, 1997)   This document identifies and defines critical design parameters for for pipe couplings which show the following characteristics : easily cleanable in-place; easily sterilisable  in place; impervious to micro-organisms, ease to install and reliable.  Its scope is limited to welded pipe couplings. Gaskets of various types were tested for reliability and hygienic aspects using EHEDG cleanability test methods and repeated sterilisation. The objective was to provide a reliable dismountable joint which is bacteria-tight at the product side under the conditions of processing, cleaning and sanitation. 17、Hygienic design of pumps, homogenisers and dampening devices SG Pumps, edition 2, 2004) The objective of this guideline is to provide a set of minimum requirements for pumps, homogenisers and dampening devices for hygienic and aseptic applications, to ensure that food products are processed hygienically and safely. Special demand is made on pumps, homogenisers and dampening devices used in the food processing and pharmaceutical industry with regard to CIP-capability, gentle product handling and ease of maintenance. In addition to this, pumps, homogenisers and dampening devices require good mechanical, hydraulic and thermal efficiency, a technically perfect construction and low-cost manufacture. These requirements, their implementation and thereto related design principles are handled in detail in this guideline. The guideline applies to all pumps intended for use in food processing, including centrifugal pumps, piston pumps, lobe rotor pumps, peristaltic pumps, diaphragm pumps, water ring pumps, progressive cavity pumps, screw pumps, gear pumps and also to homogenisers, dampening devices and shall include any valves integral with the pump head and the complete homogeniser head. Differences between the EHEDG Guidelines (Europe) and the 3A standards (USA) are indicated, where appropriate. 18、Passivation of stainless steel, 1998 (EHEDG, 1998)  Passivation is an important surface treatment that helps assure the successful corrosion resistant performance of stainless steel used for product contact surfaces (eg tubing/piping, tanks and machined parts used in pumps, valves, homogenisers, de-aerators, process monitoring instruments, blenders, dryers, conveyors, etc). The purpose of this document is to provide manufacturers, users and regulatory personnel with basic information and guidelines relative to equipment passivation.  The complete passivation process is described and environmental, as well as safety, concerns are discussed. 19、A method for assessing bacterial impermeability of hydrophobic membrane filters (SG Test Methods, 2000) Research over the last years has shown that the currently used hydrophobic membrane filters, with a pore size of 0.22祄, do not retain micro-organisms under all process conditions. Investigations have been conducted into risk assessment of sterilising hydrophobic membrane filters, evaluating the performance of the filters under a range of operating conditions. To validate the  bacterial retention ability of sterilising grade hydrophobic membrane filters, a bacterial aerosol challenge test methodology was developed. 20、Hygienic design and safe use of double-seat mixproof valves SG Valves, 2000) Today, food process plants incorporate various multifunctional flow paths. Often one piping system is cleaned while another still contains product. This simultaneous cleaning can potentially result in the dangerous situation where product and cleaning liquid are separated by just one single valve seat. Any cleaning liquid that leaks across such a seat will contaminate the product. Therefore, often two or three single seat valves in a "block-and-bleed" arrangement are applied.   Single-body double-seat butterf