hygienic design of food industry equipment
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GUIDING CRITERIA FOR HYGIENIC DESIGN OF FOODINDUSTRY EQUIPMENTCARLOS ALBERTO COSTA1, MARCOS ALEXANDRE LUCIANO and ANDREI MARCOS PASA
Mechanical Engineering, University of Caxias do Sul, Caxias do Sul, RS, Brazil
1Corresponding author. University of Caxias
do Sul, Mechanical Engineering, Rua Francisco
Getúlio Vargas 1130, 95070560 Caxias do
Sul, RS 95050470, Brazil.
TEL: +55-54-3218-2160,
FAX: +55-54-3218-2168;
EMAIL: [email protected]
Received for Publication June 18, 2013
Accepted for Publication August 13, 2013
doi:10.1111/jfpe.12044
ABSTRACT
Equipment design for food industry should consider, in addition to performance,cost and quality requirements, further aspects regarding to hygiene and foodsafety. This paper discusses how information associated with hygiene aspects canbe used as orientation criteria for equipment design for food industry. The study was based on specialized literature and national and international standards toestablish valuation criteria for hygienic design. Eighty-five criteria were estab-lished, grouped into six orientation classes, as follows: processes, materials, geom-
etry, accessories, sealing and others. The criteria were validated through theirapplication in a company which produces concentrated fruit juice, demonstratinghow problems could have been avoided by using this valuation method.
PRACTICAL APPLICATIONS
This work provides a contribution to food industry equipment in order to under-stand how to identify, classify and store the best practices for hygienic design of food processing equipment. In very specific sectors such as food equipment indus-try, the knowledge related to the equipment design is usually captured in a tacitmanner. This paper provides a reflection on this subject and shows a way to orga-nize this knowledge.
INTRODUCTION
The product development process (PDP) can be understoodas a strategic business process based on market information,requirements and restrictions, where ideas and concepts areorganized and created, resulting in planning, design andmanufacturing of a product. Thereby, this process can betreated as multidimensional and multidisciplinary phenom-ena (Clark and Fujimoto 1991; Salomo et al . 2007).
Techniques such as DFx (Design For “x”) have stood out
as a way to support product design, when different perspec-tives related to each product life cycle phase must be consid-ered (Cooper et al . 2004). In this case, pieces of informationabout these different perspectives have to be structured andavailable for product designers.
When considering the development process of foodindustry equipment, different perspectives and principlesrelated to hygienic design (HD) must be followed in orderto minimize risks related to food contamination (Lawley 2011; Lupo 2011; Porter 2011).
This paper proposes a group of valuation criteria to beconsidered for machines and equipment development forfood industry under HD point of view. Such criteria wereelaborated considering the minimum hygiene conditionsfor processing food with minimum risk. Different aspectsthat support the development of these types of equipmenthave been approached. The study was developed in fourstages as follows: gathering information about HD from dif-ferent sources; grouping information in two parametergroups of design (macro and micro); creating orientation
classes considering mainly the microparameters and, finally,the elaboration of a procedure that contains the valuationcriteria to verify the quality of the equipment. In all, 85 ori-entation criteria were defined. The proposal was validatedconsidering equipment that are currently in use and whichwere not conceived, purchased nor installed according tothe proposed criteria, so it is proved that some of thecurrent problems could have been avoided.
The next section presents a brief review concerning DFx techniques and HD concepts. Then, the developed stages
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within the research method are described, followed by theconcepts validations and, finally, by the conclusion.
THEORETICAL REFERENCES
DFx Supporting Products DesignAccording to Holt and Barnes (2010), DFx techniques canbe separated into two groups: those that improve theproduct having one issue to consider (cost, quality, usabil-ity, etc.), and the ones that improve a product in one par-ticular stage of the life cycle (manufacturing, assembling,recycling, etc.). Agyapong-Kodua et al . (2012) state the dif-ferent interests, relationships and conflicts (trade-offs)between these groups. For Ciechanowski et al . (2007), thebest results are achieved by the combined application of such techniques.
The design for manufacturing is focused on better inte-
gration between the design, manufacturing and materials,aiming the development of a component that meets thefunctional requirements and which is easy to manufacture,reducing production costs without compromising itsquality (Bralla 1999; Xiao et al . 2007; Selvaraj et al . 2009).According to Andreasen et al . (1988), Boothroyd et al .(2002) and Heemskerk et al . (2009), the design for assembly pursues economy by reducing the number of componentstoward a quality improvement as it decreases the possibility of failure in the simplified design.
According to Pahl et al . (2007), all equipment may have ashorter life cycle due to its use, and failures are unavoidable.
However, the design for maintainability aims to ensure thatthe product can be maintained during its life cycle. Thetechniques of design for maintainability are usually sup-ported by guidance (Kuo et al . 2001) or by tools in order topredict maintenance costs (Slavila et al . 2004). Associatedwith maintenance, there is reliability, which is the probabil-ity of the product operating as planned for a determinedperiod of time, when it is used under specific conditions(Blanchard and Fabrycky 1998; Kuo et al . 2001). Generalguidelines of design for reliability were proposed by Iresonand Coombes (1988) and Minehane et al . (2000).
Another DFx technique that has been broadly used is thedesign for environment , which proposes that PDP considers
all environmental degradation caused through the life cycleand that the product will have a minimum interference onnatural environment (Rossi et al . 2006).
HD
The HD consists in the application of solutions that allow an effective cleanness of manufacturing resources, rangingaccording to the type of food that is produced or that willbe produced (Lawley 2011; Lupo 2011). For HSE – Health &
Safety Executive (2001), the need for HD during specifica-tion, design and manufacturing stages of equipment hasbecome a way to avoid problems related to product loss dueto lack of sanitation. Normally, projects in this area requirecompromising solutions, i.e., conflicting requirements mustbecome compatible in order to obtain sanitarily safe, func-tionally adequate and commercially viable equipment.
Engineers involved in the food industry equipmentdesign have knowledge and experience in designing solu-tions to obtain safe and ergonomic equipment for opera-tors, functionally adequate, considering mechanic andelectric aspects as well as the transfer of mass and heat. Nev-ertheless, in many cases, sanitation and hygiene aspects, dueto their wide range of applications, are not totally known,which can interfere in the microbiologic quality and safety of the equipment. In addition to the sanitation and hygieneaspects, the equipment must guarantee a reduced need of maintenance and cleanness and, thereafter, reduce the
manufacturing costs (Lawley 2011; Lupo 2011; Peter et al .2011).
According to European Hygienic Engineering DesignGroup (EHEDG), aiming for an efficient cleanness andsanitation, there are some features that must be observedduring equipment design for food industry:(a) Materials used (EHEDG Doc32 2005; EHEDG Doc352006);(b) Contact surfaces (EHEDG Doc9 1993; Lelieveld et al .2003);(c) Auxiliary equipment (EHEDG Doc20 2000; EHEDGDoc25 2002; EHEDG Doc14 2004; EHEDG Doc23 2009);
(d) Product geometric features (EHEDG Doc13 2004;EHEDG Doc8 2004; EHEDG Doc10 2007).Therefore, different design standards, patterns and tech-
niques are required and must be considered in the equip-ment manufacturing for the food industry. This paperproposes a unified view of these different aspects as guidingcriteria for professionals who work in this area.
ELABORATION AND DEFINITION OFVALUATION CRITERIA
Research StagesThis study proposes a group of valuation criteria that mustbe considered in the sanitation and hygiene design (HD) of equipment for food industry. Figure 1 presents the fourstages followed by this work in order to develop the valua-tion criteria:(a) Data collection about HD in different research sources;(b) Grouping design parameters (macro and micro);(c) Definition of orientation classes for the design, empha-sizing microtechnological parameters;
CRITERIA FOR HYGIENIC DESIGN FOOD INDUSTRY EQUIPMENT C.A. COSTA, M.A. LUCIANO and A.M. PASA
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(d) Valuation criteria identification in order to identify (orcheck) equipment quality considering the HD.
For the first stage, different sources of information, whichcan influence the HD, were studied, such as: national andinternational regulation and standards, typical client speci-fications, articles, books and procedures of better practicesthat deal with food processing considering different areas of
application and raw materials (food) to be processed,among others. The sources considered for this study arepresented in the next sections.
In the second stage, the pieces of information gatheredwere divided into two groups of project parameters. Thefirst one, called macro or social parameters, contains broadparameters about use and application of the equipment,such as: laws, market and the insertion of the equipment inthe manufacturing process of the company. The second one,called micro or technological parameters, points out the useand specific application of the equipment. Within themacro group, three parameters were established, which are:
market, law and customer’s needs. For the micro group,functional parameters were set about application and clean-ness. The observance of the two groups of parameters in thedesign process and activities provides a group of valid solu-tions that are also microbiologically safe.
It is important to emphasize that, in spite of these groupsshowing their parameters distributed in different levels of coverage, a macroparameter, for instance, law, may be asso-ciated with microparameters, such as functional or clean-ness requirements, so that it constitutes a dimension to beconsidered during the project.
The third stage comprised the organization of the design,social or technological parameters in one group of classes
that will guide equipment design, manufacturing and instal-lation considering the HD principles. Six orientation classeswere defined including essential areas of knowledge for safeequipment as follows: processes, materials, geometry, acces-sories, sealing and others.
Finally, based on orientation classes defined, it wascreated the design criteria for supporting and guiding thedesign, manufacturing and installation of equipment forfood processing. These criteria must be observed in order towarrant the quality of equipment design under a hygiene
and sanitation point of view. Furthermore, the observanceof these criteria will reduce the range of design solutions,demanding specific set of solutions and, in some cases,unique solution. The next sections show each stage men-tioned above.
Social and Technological Design Parameters
Regarding the development of equipment for food industry,there are two important aspects that lead the HD. One isrelated to the social aspects and another is related to thetechnological aspects. In order to facilitate the under-standing and the visualization of the context, two groupsof parameters (macrosocial microtechnological) wereproposed.
Macroparameter: Legislation. Standards for creatingequipment for food processing have been developed by dif-
ferent organizations, showing small differences, but allintending to guarantee food safety. Ordinance SVS/MS No.326, from July 30 1997, in Addendum I, presents “Technicalregulation about hygiene and sanitation conditions andgood manufacturing practice for food producers and manu-facturers.” The goal is setting general requirements of hygiene and good manufacturing practices regarding foodfor human consumption.
The hazard analysis critical control point is based on aseries of stages, including operations related to the raw material selection until the food consumption, based onthe identification of potential dangerous to the food safety,as well as measures about the control of conditions that
may create danger. The Codex Alimentarius identifies theessential principles of hygiene that may apply to all foodchain (from the primary production to the final consumer)to ensure that food is safe and adequate to humanconsumption.
These standards define what it is expected from equip-ment regarding hygiene and sanitation point of view;however, they do not explicitly define how it is possible toachieve such goals. The following topics establish orienta-tion for the equipment development with ensured quality.
FIG. 1. STAGES FOR VALUATION CRITERIA
ELABORATION
C.A. COSTA, M.A. LUCIANO and A.M. PASA CRITERIA FOR HYGIENIC DESIGN FOOD INDUSTRY EQUIPMENT
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Macroparameter: Client Requirements. Equipmentfor food processing, beyond executing its specific function,must avoid microbiologic contamination. Equipment that isdifficult to clean needs more severe procedures and longercleaning cycles and longer decontamination, resulting inmore costs, limited availability for production, shorter lifecycle and more effluent generation (Lorenzen 2011). Insome cases, because of technical-functional reasons, theHD can be compromised in order to achieve the equip-ment capacity of executing its function. However, in these
cases, such action must be minimized and clearly documented.
The equipment development must also consider the foodprocessing context that can impact on the level of microbiologic contamination (Fig. 2). There are some attri-butes that must be considered, such as: layout, by the properintegration of the equipment with other manufacturingprocesses; production, because it allows the equipment to beoperational and profitable; operation, minimizing humanintervention and eliminating operator-machine-productcrossed contamination; product, obtaining a higher quality product; and cleanness, favoring the cleanness and making
it more difficult to accumulate impurities.
Macroparameter: Market Requirements. Equipmentdesign and manufacturing without risks of contaminationhave to face the stages of risk valuation and determinationof hygiene and sanitation safety level of the equipment.Holah (2011) shows a sequence of steps that help on defin-ing the equipment potential risks. It starts by the definitionof the process for which the equipment is aimed consider-ing whether the equipment is working on a specific function
or several different functions. Such choice depends on aproduct technical and cost valuation, once there may bedifferent options in the market. After that, relevant risksmust be identified as well as the methods that must beused in order to eliminate or reduce them. Finally, it is veri-fied the efficiency concerning the elimination of risksand the precautions that must be taken to operate theequipment.
After the risk valuation, it is possible to attribute the levelof safety to the equipment according to its original func-
tion, to the existent resources, to the required productionlevel and to the desired cleanness process (Holah 2011). Theequipment can be classified from the ones that attend theminimum safety requirements according to its purpose tothe ones that are designed for a specific chemical treatmentor decontamination temperature so that microorganismswound not enter the machine (ascetical ones).
Microparameter: Functional Requirements. Theproject of equipment for food industry must consideraspects such as materials and contact surfaces, auxiliary equipment and equipment geometric features.
Materials in contact with the product (food) must beinert to the food as well as to detergents and sanitationproducts. They must also be resistant to corrosion, non-toxic, nonabsorbent, mechanically stable, and its surface fin-ishing can not be altered in normal usage conditions(Lelieveld et al . 2003; EHEDG Doc32 2005).
Any welding in direct contact with the food product mustbe continued, free of imperfections and polished. Weldingthat is not in contact with the product must be continuedand allow a good cleanness (EHEDG Doc09 1993).
FIG. 2. INTEGRATION BETWEEN HYGIENIC
DESIGN AND THE MANUFACTURING
PROCESS
(Source: Adapted from Lorenzen 2011).
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Materials used for thermal insulation must be coveredwith stainless steel to prevent air inflow or humidity reten-tion (EHEDG Doc8 2004). Another characteristic is that theequipment must be designed in such a way that the lubri-cants do not contact the food product. In the event of anaccidental contact, lubricants must be food grade type(EHEDG Doc23 2009). These are some examples of requirements that have an impact on the conception of equipment and, therefore, in its functionality.
Microparameters: Application Requirements. Goodcommunication between the equipment manufacturer andthe food producer results in a risk minimization for trans-ferring danger to the final product (food) during equipmentmanufacturing. It also allows to produce the equipment in amore economic and efficient way. Thus, Holah (2011) statessome aspects to be observed during equipment design: typeof food product to be processed and its limitations regard-ing contamination and equipment materials to be used;main application of the equipment, i.e., for a specificpurpose or for a wide range of products; the degree of sub-sequent transformation of the food product, i.e., if theproduct to be processed by the equipment will be later sub-mitted to a new process or not; the level of cleanness andinspection related to the frequency; and the conservationand the frequency of equipment utilization.
Microparameters: Cleanness Requirements. Equip-ment manufacturers, food producers and cleaning chemical
product suppliers have an important responsibility in clean-ing and sanitizing the equipment, to ensure an adequatehygiene state, according to the product that will be pro-cessed. There are three important recommendations to beconsidered. First, the manufacturer of the equipment mustrecommend cleanness and disinfection procedures, as well
as the indication of acceptable cleaning products based onthe chemical resistance of the materials used. Second, themanufacturer of chemical cleaning products, in agreementwith the equipment supplier and the food producers, mustrecommend the products for cleanness and sanitization,and the best methods for their application. The last one isrelated to the food manufacturer regarding the definition of an adequate cleaning program (level of cleanness and fre-quency) verifying its performance.
Considering the macro- and microparameters, the HDcan be used in different situations, which include: duringthe development of equipment to analyze a new configura-tion or concept; after the design, to demonstrate the confor-mity to the applicable legislation; as a technique of quality control during the process of equipment manufacturing; asa way to exempt the manufacturer or designer from respon-sibilities after the installation of the product; and as part of the selection process by the client. Orientation classes pro-
posed in this work consider such different situations.
ORIENTATION CLASSES FOR HD
The quality of the equipment according to HD has, as aresult, the quality of the final product, i.e., food processed.Orientation classes were defined, taking different aspectsrelated to the design, manufacturing and installation in con-sideration. These different aspects were grouped into maintopics to be taken into account during HD. Thus, this study proposes a structure of six orientation classes, namely pro-cesses, materials, geometry, accessories, sealing and others
(Fig. 3).
Valuation Criteria of the HD
Considering the orientation classes defined, 85 valuationcriteria were elaborated and distributed as follows:
FIG. 3. PROPOSED ORIENTATION CLASSES
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Source: EHEDG DOC13 (2004, p.13).
Source: EHEDG DOC35 (2006, p.12).
Misalignment
Are the surfaces in contact with the product made with stainless steel of series AISI300?Are the surfaces in contact with the product made with stainless steel of series AISI300?
Was the maximum misalignment acceptable for a s anitary welding respected?
Less than 15% of depth (t) of t ube, external diameter up to 29 mm.
Less than 20% of depth (t) of tube, external diameter from 29 mm to 85mm.
Less than 0.6 mm for tubes with external diameter bigger than 85 mm.
Are the edges properly rounded and the horizontal surfaces have a minimum inclination of 3°
for a good drainage and cleanness?
A 1.5
B 1.2
C 2.5
D 2.2
Do the joints have a coaxial alignment, axis limitation for controlled compression of the seal,
and room for sealing thermal expansion?
Product area, (b) misalignment, (c) slit, (d) harmful space, (e) elastomeric sealing,
(f) elastomeric sealing of the rect angular section before installation, (g) trapezoidal
elastomeric sealing (Source: EHEDG DOC10 [2007, p. 8])
Was the coefficient of thermal expansion of elastomer taken in consideration?
Product area, (b) elastomeric sealing, (c) heating, (d) cooling, (e) microorganisms, (f) gap
Source: Adapted from EHEDG DOC10 (2007, p. 10).
E 1.3
F 3.3
Source: EHEDG DOC13 (2004, p. 21)
Did the equipment respect the minimum distance of 300 mm from the general structures and
from other equipment?
FIG. 4. EXAMPLES OF VALUATION CRITERIA OF HD
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(a) “Processes Class”: 10 criteria for welding (A1.0 to A1.9)and 4 for surface finishing (A2.1 to A2.4);(b) “Materials Class”: 5 criteria (B1.1 a B1.5);(c) “Geometry Class”: 5 criteria for dead points (C1.1 aC1.5), 5 for draining (C2.1 a C2.5), 4 for covers (C3.1 aC3.4), 3 for borders (C4.1 a C4.3), 7 criteria for joints (C5.1a C5.7), 4 to evaluate structures and supports (C6.1 a C6.4)and 1 criterion for the axis edges and linkages (C7.1);(d) “Accessories Class”: 3 criteria for unions (D1.1 a D1.3),6 for valves (D2.1 a D2.6), 2 for sprinklers (D3.1 a D3.2)and 4 for bearings (D4.1 a D4.4);(e) “Sealing Class”: 3 criteria for static seals (E.1.1 a E1.3)and 3 for dynamic seals (E.2.1 a E2.3);(f) “Others Class”: the distribution of criteria is related tothermal insulation (F1.1 a F1.6), auxiliary equipment (F2.1a F2.3), installation (F3.1 a F3.5) and lubrication (F4.1 aF4.2).
Figure 4 presents examples of criteria to be verified
during the process of HD as follows:(a) Processes (welding): misalignment between the parts tobe welded (A 1.5);(b) Materials: associated to the types of materials used(B1.2);(c) Geometry: project of outputs of discharge and autocleaning (C2.5);(d) Accessories: alignment of joints (D 2.2);(e) Sealing: elastomers for sealing (E 1.3);(f) Others: equipment accessibility (F 3.3).
In Fig. 4, there are three columns. In the left column, it islisted the criteria code. In the central column, each criterion
itself is presented, which must be observed during HD. Theright column lists the possible alternatives for valuation, C(according to), NC (disagreement), NA (don’t apply), whichcan be considered at the moment of the design (P), manu-facturing (F) and installation of the product (I).
VALUATION CRITERIA VALIDATION
Equipment Under Valuation
The HD valuation criteria were validated using operationaland installed equipment in a concentrated fruit juicecompany. The validation allowed identifying that someproblems could have been avoided through the criteriaobservation during equipment design, manufacturing and
installation phases. For that matter, it has been evaluated astainless steel piping, a blend tank and an aroma extractiontank.
The piping (Fig. 5) makes the connection between the
blend tank and the heat exchanger (pasteurizer). In the pas-teurizer, the juice is heated under a temperature of 74C and,after that, passes through a stage of standing by, where itremains under this temperature for at least 20 s, and then itis cooled down to a temperature between −2 and −5C.
The blend tank (Fig. 7) is located in the company bottlingsector, where the product (fruit juice) patterning, based onclients’ needs, is elaborated. The product can come from the
juice evaporators (the sector where the juice is concentratedthroughout the elimination of most of the water, normally 70% is fruit and 30% is water) as well as from the chillingrooms where the semi-elaborated product is kept. After theconcentration process, the juice keeps its natural color andunaltered flavor. In the patterning tanks, the product ishomogenized according to the desired quality standards,and then it is chilled and sent to bulk storage.
The aroma extraction tank (Fig. 9) allows that, during theprocess of the product evaporation, the aroma in liquidstate is separated and then used in the next stages.
Valuation Criteria of Process Class
Figure 6 shows some issues related to welding on apipework for fruit juice when HD valuation criteria are con-sidered. Such problems could have been identified both by the equipment manufacturer and the company that pur-chased the equipment according to the criterion A1.1.
FIG. 5. INTERNAL WELDING IN DISAGREEMENT TO HD
FIG. 6. CRITERIA OF PROCESS CLASS
ASSOCIATED TO WELDING
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The criterion A1.1 (Fig. 6) enables to identify the failureassociated to the surface quality of the welded region incontact with the product, which may result in residual accu-mulation, requiring a more aggressive and slower cleannessprocess. This criterion should have been identified in the
equipment manufacturing process.
Valuation Criteria of Accessories Class
Figure 7 shows the cleaning system of the blend tank. Thisequipment shows problems regarding sprinklers whichcould have been previously identified throughout a spreadsheet of verification.
The criteria D 3.2 and D 3.3 (Fig. 8) are not in confor-mity during project and manufacturing stages because thesprinklers used are not rotating and do not reach 360 of amplitude. Such item may also have been identified duringequipment installation.
Valuation Criteria of Geometry Class
The aroma extraction tank (Fig. 9) shows an inconsistenceon the cover geometry which does not prevent the entranceof dirt in its opening. This could have been easily identifiedthroughout item C 3.4.
Criterion C 3.4 (Fig. 10) examines whether “the coversare designed to inhibit the entrance of foreign bodies onthem in the event of its opening.” This item could have beenidentified with the use of the spreadsheet in the project,manufacturing and installation.
CONCLUSION
This paper has proposed a group of valuation criteria to
support and guide HD for food industry equipment consid-ering the manufacturing and installation points of view.
Different sources of information were researched such asregulations and national and international standards,typical client specifications, papers, books and proceduresof better practices which deal with food processing in searchof guidance to the criteria development for HD.
Information was divided into two groups, one of themwith a wider range, named macro or social, which involvedthree parameters: the market, the law and each client’sneeds. Other, more specific and punctual, was named microor technologic, which focuses on functional aspects of
application and cleanness.The parameters of design were grouped into six orienta-tion classes named processes, materials, geometry, accesso-ries, sealing and others. These include essential knowledgeareas for the obtainment of hygienically safe equipment.
Considering different classes of orientation, 85 criteriawere generated, which must be verified so that they help onthe prevention and valuation of potential risks in equip-ment associated with microbiologic safety.
The conjunction of these criteria in the design processallows that the group of developed solutions be valid andmicrobiologically safe, which guarantees the quality of theequipment regarding hygiene and sanitation.
FIG. 7. SHOWS A CLEANING SYSTEM OF PATTERNING TANK
FIG. 8. INCONSISTENCIES IN THE CLEANING
SYSTEM OF PATTERNING TANK
FIG. 9. PROBLEM IN THE DESIGN OF A TANK COVER
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Eventually, the criteria can be considered as a supporttool for quality programs in food industry, as well as goodmanufacturing practices, serving as basis for the improve-ment of the equipment which the companies have already had.
The study validation has shown how problems couldhave been avoided/noticed if there was a procedure of valu-ation to be followed.
A suggestion for further studies is the creation of a verifi-cation spreadsheet where it is possible to set values or
grades for each evaluated criterion. Such action makes thevaluation less conservative and decreases the chances of reproving or reworking equipment due to some detail thatdoes not interfere directly on the final quality of theproduct.
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