EHEDGguideline歐洲衛(wèi)生工程設(shè)計(jì)指引

1、EHEDG guideline歐洲衛(wèi)生工程設(shè)計(jì)指引European Hygienic Engineering & Design Group歐洲衛(wèi)生工程設(shè)計(jì)組織The EHEDG provides guidance on the hygienic engineering aspects of manufacturing of safe and wholesomefood. This is achieved through :Production publication and updating of guidelines, available in several languages T

2、o bridge the gapbetween 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 activitiesAdvisory functi

3、on to legislators and standards groups (CEN. ISO, etc)EHEDG has EC support through the thematic network. HYFOMA, which is the European network for HygienicManufacturing of Food. Ils goal is guideline development and dissemination of information Production publication and updating of guidelines, avai

4、lable in several languages. The production ofguidelines is assured by the subgroups To bridge the gap between theory and practice, training modules willbe created based on the guidelines GuidelinesDoc 1Microbiologically safe continuous pasteurisation of liquid foods, 1992Doc 3Microbiologically safe

5、aseptic packing of food products, 1993Doc 6The microbiologically safe continuous flow thermal sterilisation of liquid foods, 1993Doc 8Hygienic equipment design criteria, 2004Doc 9Welding stainless steel to meet hygienic requirements, 1993Doc 10Hygienic design of closed equipment for the processing o

6、f liquid food, 1993Doc 11Hygienic packing of food products, 1993Doc 12The continuous or semi-continuous flow thermal treatment of particulate foods, 1994Doc 13Hygienic design of equipment for open processing, 1996Doc 14Hygienic design of valves for food processing, 2004Doc 16Hygienic pipe couplings,

7、 1997Doc 17Hygienic design of pumps, homogenisers and dampening devices, 2004Doc 18Passivation of stainless steel, 1998Doc 20Hygienic design and safe use of double-seat mixproof valves, 2000Doc 21Challenge tests for the evaluation of the hygienic characteristics of packing machines, 2000Doc 22Genera

8、l hygienic design criteria for the safe processing of dry particulate materials, 2001Doc 23Production and use of food-grade lubricants, 2002Doc 24The prevention and control of Legionella spp (incl Legionnaires Disease) in Food Factories, 2002Doc 25Design of Mechanical Seals for hygienic and aseptic

9、applications, 2002Doc 26Hygienic Engineering of Plants for the Processing of Dry Particulate Materials, 2003Doc 27Safe Storage and Distribution of Water in Food Factories, 2004Doc 28Water treatment in food factoriesDoc 29Packing systems for solid foodstuffsDoc 30Air Handling in the Food IndustryDoc

10、31Hygienic Engineering of fluid bed and spray dryer plantsDoc 32Materials of construction for equipment in contact with foodDoc 33Hygienic Engineering of Discharging Systems for Dry Particulate MaterialsDoc 34Integration of Hygienic and Aseptic systems, March 2006 Doc 35Welding of Stainless Steel tu

11、bing in the food industryTest methodsDoc 2(Updated) A method for assessing the in-place cleanability of food processing equipment, 2004Doc 4A method for the assessment of in-line pasteurisation of food processing equipment, 1993Doc 5A method for the assessment of in-line A method for the assessment

12、of in-line steam sterilisability of foodprocessing equipment. 2004Doc 7A method for the assessment of bacteria tightness of food processing equipment, 2004Doc 15A method for the assessment of in-place cleanability of moderately-sized food processing equipment, 1997Doc 19A method for assessing bacter

13、ial impermeability of hydrophobic membrane filters, 2000KMicrobiologically safe continuous pasteurisation of liquid foods, 1992SG Heat Treatment, 1992) There are many reasons why, in practice pasteurised products sometimes present amicrobiological health hazard. Due to distribution in residence time

14、, not all products may reach thetemperature required for pasteurisation or may do so for too short a time. Further there may be a risk ofcontamination with a non-pasteurised product, or the cooling medium This document describes therequirements for the microbiologically safe continuous pasteurisatio

15、n of liquid foods without particulates Anupdate is being prepared 2、A method for assessing the in-place cleanab訂ity of food processingequipment,(SG Test Methods, 2nd edition 2000) To facilitate the design testing and maintenance of hygienic foodprocessing equipment, it is important to be able to ass

16、ess the relative cleanability of various components ofthe equipment using standardised test procedures This paper describes a standard test procedure forassessing cleanability. It is designed to indicate areas of poor hygienic design of equipment in which productor micro-organisms are protected from

17、 the cleaning process Il can also be used to compare the in-placecleanability of different equipment designs The method is based on comparing (in the laboratory) theclcanability of a test item with that of a straight piece of pipe.Tlie degree of cleanlmess is based on the removal of a souied niilk s

18、oil containnig bacterial spores and isassessed 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 theperformance of industrial cleaning processes (which depend on the type

19、 of soil). (See Doc.15 fora test procedure designed for moderately-sized equipment.)3. Microbiologically safe aseptic packing of food products, 1993SG Packing Machines, 1993) This guideline stresses the need to identify the sources of micro-organisms thatmay contaminate food in the packaging process

20、, and to determine which contamination rates are acceptablylow. It clarifies the difference in risk of infection between aseptic processing and aseptic packing andrecommends that aseptic packing machines be equipped with fillers that are easily cleanable, suitable fordecontamination and bacteria-tig

21、ht Requirements forthe machine interior include monitoring of critical decontamination parameters (See also Doc 21 onchallenge tests)4、A method for the assessment of in-line pasteurisation of foodprocessing(SG Test Methods.1993) Food processing equipment that cannot be or does not need to be sterili

22、sed may needto be pasteurised to inactivate relevant vegetative micro-organisms and fungal spores 1( is importantto test the hygienic characteristics of such equipment to ensure that it canbe pasteurised effectively. This document describes a test procedure to determine whether equipment can bepaste

23、urised by circulation with hot water.5NA met hod for the assessment of in-line steam sterilisab ility of foodprocessing(SG Test Methods,1993) Food processing equipment may need to be sterilised before use, and it is importantto ensure that the sterilisation method applied is effective Thus, it is ne

24、cessary to determine under whichconditions equipment can be sterilised This paper details the recommended procedure for assessingthe suitability of an item of food processing equipment for in-line sterilisation. It is advisable to conductin-place cleanability trials (ref Doc 2) prior to this test in

25、 order to verify the equipment1s hygienic design.6. The microbiologically safe continuous flow thermal sterilisation ofliquid foods(SG Heat Treatments, 1993) Tiicrmal sterilisation is aimed at eliminating the risk of food poisoning and, whenused in conjunction with aseptic filling, at achieving exte

26、nded product storage life under ambient conditions Whereas pasteurisation destroys vegetative micro-organisms, sterilisation destroys both vegetativemicro-organisms and relevant bacterial spores. Guidelines on continuous pasteurisation of liquid foods havebeen published earlier (Doc.l ) This documen

27、t presents guidelines on the microbiologically safe continuoussterilisation of liquid products. The technique of Ohmic heating was not considered in this paper but may beincluded in an update being prepared 7、A met hod for the assessment of bac teria tightn ess of food processingequipment(SG Test Me

28、thods, 1993) This document details the test procedure for assessing whether an item of foodprocessing equipment, intended for aseptic operation, is impermeable to microorganisms Small motilebacteria penetrate far more easily through microscopic passages than (non-motile) moulds and yeasts Thefaculta

29、tive anaerobic bacterium Serratia marcescens (CBS 291. 93) is therefore used to test bacteria-tightnessor the impermeability of equipment to microorganisms The method is suitable for equipment that is alreadyknown to be in-line steam sterilisable (see also Doc 5).8. Hygienic equipment design criteri

30、a(SG Design Principles, Second edition 2004) This Guideline describes the criteria for the hygienic design ofequipment intended for the processing of foods. Its fundamental objective is the prevention of the microbialcontamination of food products It is intended to appraise qualified engineers who a

31、re designing equipmentfor foodprocessing with the additional demands of hygienic engineering in order to ensure themicrobiological safety of the end product. Upgrading an existing design to meet hygiene requirements can beprohibitively expensive and may be unsuccessful and so these are most effectiv

32、ely incorporated into the initialdesign stage The long term benefits of doing so are not only product safety but also the potential to increaselife expectancy of equipment, reduce maintenance and consequently lower operating costs This documentwas first published in 1993 with the intention to descri

33、be in more detail the hygienic requirements of theMachinery Directive (98/37/EC ref. 1). Parts of it were subsequently incorporated in the standards EN1672-2and EN ISO 14159. (13 pages)9、Welding stainless steel to meet hygienic requirements, 1993(SG Design Principles, 1993) This document describes t

34、he techniques required to produce hygienicallyacceptable welds in thin walled ( 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 orin-pack heat treatments, do not have to conform to such strict microb

35、iological requirements as asepticallypackaged foods (Doc 3 discusses aseptic packing.) This paper discusses the packing of food products that donot need aseptic packing but which nevertheless need to be protected against unacceptable microbialcontamination. Guidelines are provided for the hygienic d

36、esign of packing machines, the handling of packingmaterials and the environment of the packing machines (See also Doc 21)12 The continuous or semi-continuous flow thermal treatment ofparticulate foods(SG Heat Treatment, 1994) Thermal sterilisation is a process aimed at eliminating the risk of food p

37、oisoning and when used in conjunction with aseptic filling, it aims to extend product storage life under ambient conditionsTliis is achieved by the destruction of vegetative micro-organisms and relevant bacterial spores. Earlier paperspresented guidelines on continuous pasteurisation (Doc 1) and ste

38、rilisation (Doc 6) of liquid products withoutparticles This paper presents guidelines on the design of continuous and semi-continuous plants for the heat treatmentof particulate foods Liquid foods containing particulates are inherently more difficult to process thanhomogenous liquids due to heat tra

39、nsfer limitations in particulate-liquid mixtures and the additional problemsof transport and handling Although this document concentrates on sterilisation processes, the principles are consistent with other heattreatment processes Ohmic heating techniques are not covered 13 Hygienic design of equipm

40、ent for open processing, 1996SG Design Principles, 1996) For food processing, it is important that the plant design takes into account factorsaffecting the hygienic operation and cleanability of the plant. (Sec also previous guidelines on hygienic designcriteria Doc 8, hygienic welding Doc 9, and th

41、e hygienic design of equipment for closed processing Doc 10.)The risk of contamination of food products with relevant micro-organisms during open processing increaseswith the opportunity to grow in poorly designed equipment, as well as with the concentration of themicro-organisms in the environment.

42、 This means that in open plants, environmental conditions, in addition toappropriate equipment design, have an important influence on hygienic operation Furthermore, the type ofproduct and the stage of the manufacturing process must be taken into consideration. Open processesincorporate many differe

43、nt 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, meatand fish.This paper deals with the principal hygienic requirements for equipment for open processing It de

44、scribesmethods of constmction and fabrication, giving examples as to how the principal criteria can be met in openprocess 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 valvesused

45、 strongly influences the microbiological safety of the food production process Valves for food contactuse must therefore comply with strict hygienic requirementsThis paper discusses the basic requirements for hygienic and aseptic valves The guidelines apply to all valvesused in contact with food or

46、food constituents that are to be processed hygienically or aseptically. Aside fromgeneral 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 mixproofvalves

47、.)15、A method for the assessment of in-place cleanability ofmoderately-sizedA method for the assessment of in-place clcanability 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 becleaned

48、 without dismantling) of relatively small equipment (such as pumps, valves and flowmeters) was earlierproduced by this subgroup (ref Doc 2).This document describes a test procedure for assessing the in-place cleanability of moderately sizedequipment, such as homogenisers The degree of cleanliness is

49、 based on the removal of a fat spread soil, andis assessed by evaluating the amount of soil remaining after cleaning by visual inspection and swabbing of thesurface This method is not as sensitive as the microbiological method described in Doc 2.16. Hygienic pipe couplings(SG Pipe Couplings, 1997) T

50、his document identifies and defines critical design parameters for for pipecouplings 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

51、 various types were tested for reliability and hygienic aspects using EHEDG cleanability test methodsand repeated sterilisation The objective was to provide a reliable dismountable joint which is bacteria-tight atthe product side under the conditions of processing, cleaning and sanitation 17 Hygieni

52、c design of pumps, homogenisers and dampening devicesSG Pumps, edition 2, 2004) The objective of this guideline is to provide a set of minimum requirements forpumps, homogenisers and dampening devices for hygienic and aseptic applications, to ensure that foodproducts are processed hygienically and s

53、afely.Special demand is made on pumps, homogenisers and dampening devices used in the food processing andpharmaceutical industry with regard to CIP-capability, gentle product handling and ease of maintenance Inaddition to this, pumps, homogenisers and dampening devices require good mechanical, hydra

54、ulic andthermal efficiency, a technically perfect construction and low-cost manufacture These requirements, their implementation and thereto related design principles are handled in detail in thisguideline The guideline applies to all pumps intended for use in food processing, including centrifugal

55、pumps,piston pumps, lobe rotor pumps, peristaltic pumps, diaphragm pumps、water ring pumps, progressive cavitypumps, screw pumps, gear pumps and also to homogenisers, dampening devices and shall include any valvesintegral with the pump head and the complete homogeniser head Differences between the EH

56、EDG Guidelines (Europe) and the 3A standards (USA) are indicated, whereappropriate 18% Passivation of stainless steel, 1998(EHEDG 1998) Passivation is an important surface treatment that helps assure the successful corrosion resistantperformance of stainless steel used for product contact surfaces (

57、eg tubing/piping, tanks and machined partsused in pumps, valves, homogenisers, de-aerators, process monitoring instruments, blenders, dryers,conveyors, etc).The puipose of this document is to provide manufacturers, users and regulatory personnel with basicinformation and guidelines relative to equip

58、ment passivation. The complete passivation process is describedand environmental, as well as safety, concerns are discussed 19. A method for assessing bacterial impermeability of hydrophobicmembrane filters(SG Test Methods, 2000) Research over the last years has shown that the currently used hydroph

59、obicmembrane filters, with a pore size of 0.22從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 th

60、e bacterial retention ability of sterilising grade hydrophobic membrane filters, a bacterial aerosolchallenge test methodology was developed.20、Hygienic design and safe use of double-seat mixproof valvesSG Valves 2000) Today, food process plants incorporate various multifunctional flow paths. Often one