Toward food safety-driven process design: a systematic review and research agenda.

Process design strategies are important to prevent or reduce food safety risks in production systems. In this sense, the Codex Alimentarius presents a set of principles for good hygiene practices to guide food producers. However, studies in food safety often focus on analyzing and controlling implemented production processes without a policy of designing them with a preventive logic, leading to resource misallocation and noncompliance. This study aims to gather and analyze techniques, drivers, challenges, and research opportunities for food safety-driven process design. A systematic literature review was carried out following three steps: (i) Data collection, including 52 studies; (ii) Bibliometric analysis; and (iii) Content analysis, identifying techniques, drivers, challenges, and research opportunities. Three main themes in the subject were identified: process assessment models, risk assessment, and whole-chain traceability. Eleven design techniques were identified and compared according to their typology, structure, and coverage of themes addressed by the Codex Alimentarius. There is a gap in techniques addressing employee competence and personal hygiene. We suggest developing a tool encompassing the Codex Alimentarius good hygiene practices themes in process design to guide food safety-driven process development.

Application of HACCP for development of quality risk management in a water purification system

Abstract The present work reports the implementation of the Hazard Analysis Critical Control Point (HACCP) methodology to analyze the water purification system of a pharmaceutical site, in order to assure the system quality and prevent failures. As a matter of fact, the use of HACCP for development and implementation of Quality Risk Management (QRM) is not usual in pharmaceutical plants and it is applied here to improve the performance of the water purification system of a polymerization pilot plant used to manufacture pharmaceutical grade polymer microparticles. Critical Control Points (CCP) were determined with the aid of a decision tree and questions were made to characterize whether identified hazards constitute actual CCPs and should be monitored. When deviations were detected, corrective actions were performed and action plans were used for following-up and implementation of corrective actions. Finally, microbiological and physicochemical parameters were analyzed and the obtained results were regarded as appropriate. Therefore, it is shown that HACCP constitutes an effective tool for identification of hazards, establishment of corrective actions and monitoring of the critical control points that impact the process and the quality of the final pharmaceutical product most significantly.

Condiciones higiénico sanitaria nutricional en comedores de Caracas, Venezuela / Hygienic-sanitary-nutritional conditions in canteens in Caracas, Venezuela

Las condiciones higiénicas, sanitarias y nutricionales de comedores institucionales son claves para proteger la salud. Objetivo. El objetivo fue evaluar estas condiciones en comedores del Área Metropolitana de Caracas entre 2016-2017. Materiales y métodos. Mediante una investigación descriptiva, se seleccionaron intencionalmente siete comedores de cuatro municipios, para evaluar sus condiciones higiénico-sanitarias, riesgos potenciales en preparación de alimentos, menús, supervisión y gestión, asimismo educación para la salud. Se emplearon formularios de comparación nacional, Código Alimentario, HACCP y escala de estimación, con observación directa estructurada. Resultados. Los resultados incluyeron cinco comedores en la categoría I, uno en la II y uno en la III, reafirmando que el número de menús, la complejidad de platos y el gran número de comidas/usuarios representan mayores riesgos para la salud, con violaciones críticas permitidas. Se registró una eficiencia higiénico general media satisfactoria (88,02%). Las fallas, enumeradas en orden decreciente fueron: protección en almacenamientos, edificaciones e instalaciones, equipo y utensilios, personal, servicios sanitarios, disposiciones generales y saneamiento ambiental. No aplicaron HACCP; hay deficiencias en buenas prácticas de preparación y manipulación según los riesgos potenciales de elaboración de comidas: control de temperatura, uniformes, hábitos higiénicos, comidas testigos, acciones correctivas. Las temperaturas indicaron control higiénico de alimentos, con mayor riesgo en reposo y pasos de refrigeración; adecuado en cocción. El manejo del menú y la alimentación fue muy bueno, pero la educación para la salud clasificó de regular a malo. Conclusiones. Se concluye que aun en crisis los comedores poseen adecuada gestión, cumpliendo la legislación en cuanto a condiciones higiénicas sanitarias, parámetros y características nutricionales de la alimentación(AU)

The hygienic, sanitary and nutritional conditions of institutional canteens are keys to protecting health. Objective. Evaluate these conditions in canteens in the Metropolitan Area of Caracas between 2016-2017. Materials and methods. Through a descriptive research, 7 canteens from four municipalities were intentionally selected to evaluate their hygienic-sanitary conditions, potential risks in food preparation, menus, supervision and management, as well as health education. National comparison forms, Food Code, HACCP and estimation scale were used, with structured direct observation. Results. The results included five dining rooms in category I, one in category II and one in category III., reaffirming that the number of menus, the complexity of dishes and the large number of meals/users represent greater health risks, with critical violations allowed. A satisfactory average overall hygienic efficiency (88.02%) was recorded. The failures, listed in decreasing order were: protection in storage, buildings and facilities, equipment and utensils, personnel, sanitary services, general provisions and environmental sanitation. They did not apply HACCP; there are deficiencies in good preparation and handling practices according to the potential risks of meal preparation: temperature control, uniforms, hygienic habits, witness meals, corrective actions. Temperatures indicated hygienic control of food, with increased risk at rest and refrigeration steps; suitable in cooking. Menu management and food was very good, but health education classified from regular too bad. Conclusions. It is concluded that even in crisis the canteens have adequate management, complying with the legislation in terms of sanitary hygienic conditions, parameters and nutritional characteristics of the food(AU)

Rapid detection of Salmonella contamination in seafoods using multiplex PCR.

Effective monitoring of Salmonella contamination in seafood processing to conform the requirements of HACCP is a great challenge today. Such challenges can be effectively addressed, if the conventional detection methods are replaced with DNA-based molecular methods. Accordingly, it was aimed to develop a robust PCR protocol for specific detection of Salmonella spp. Out of the different primers screened, one pair of primers developed in this study targeting invA gene demonstrated 100% inclusivity for a wide range of Salmonella serotypes and 100% exclusivity for wide range of non-target species. The in silico analysis of the nucleotide sequence obtained from the PCR product suggests its potential as a hybridization probe for genus specific detection of Salmonella spp. contamination. The PCR protocol was sensitive enough to detect 15 cells per reaction using crude DNA prepared within a short time directly from artificially contaminated shrimp tissue. The study demonstrated that the result of PCR reaction can come out on the same day of sample arrival. Incorporation of this pair of primers in a multiplex PCR designed for simultaneous detection of four common seafood-borne human pathogens yielded 147 bp, 302 bp, 403 bp, and 450 bp distinct DNA bands specifically targeting E. coli, toxigenic Vibrio cholerae, Salmonella spp., and V. parahaemolyticus, respectively in a single PCR tube. The PCR methods developed in this study has the potential to be used in the seafood processing plants for effective monitoring of CCPs required for implementation of HACCP-based quality assurance system.

Monitoramento dos pontos críticos de controle aplicado no processamento do leite longa vida em indústria de laticínios de Ji-Paraná / Monitoring of critical control points applied in the processing of long life milk in the dairy industry of Ji-Paraná

O objetivo deste trabalho foi verificar a eficiência do sistema de Análise de Perigos e Pontos Críticos de Controle (APPCC) implantado em indústria de laticínios através do monitoramento dos Pontos Críticos de Controle (PCC) identificados no plano APPCC para a produção do leite longa vida. Foram avaliados os processos produtivos de três caminhões. No PCC-1 realizaram-se testes de acidez titulável, alizarol, fosfatase alcalina, peroxidase e análise de resíduos de antibióticos. No PCC-2 foram analisadas a relação de tempo/temperatura da carta gráfica, bem como as análises de fosfatase alcalina e peroxidase com o intuito de avaliar a eficiência dos processos. No PCC-3 realizaram-se pesquisas de micro-organismos aeróbios mesófilos em três caixas de leite longa vida após incubação de sete dias. Um total de 9 (100%) das amostras indicaram acidez Dornic entre 0,14 e 0,16ºD; 9 (100%) apresentaram resultado negativo ao teste de alizarol; e 9 (100%) mostraram resultado negativo para resíduos de antibióticos. As curvas gráficas mantiveram-se em seu tempo/temperatura correto, encontraram-se entre 74.1ºC-74.2ºC/15-20seg, o leite proveniente de cada caminhão apresentou resultado positivo para as enzimas fosfatase e peroxidase no leite cru, e após as pasteurizações o resultado foi negativo para enzima fosfatase e positivo para peroxidase. As amostras referentes a cada caminhão apresentaram resultado semelhante de <1,0x10º UFC/ml. Os resultados obtidos em cada PCC foram satisfatórios de acordo com a legislação pertinente. Os PCC estão dentro do estabelecido, demonstrando sua efetividade na aplicação do sistema APPCC na indústria de laticínios.(AU)

To verify the efficiency of the Hazard Analysis and Critical Control Points (HACCP) system implemented in the dairy industry by monitoring the Critical Control Points (CCPs) identified in the HACCP plan for the production of long-life milk. The production process of three trucks was evaluated in the PCC-1 titratable acidity tests, alizarol, alkaline phosphatase, peroxidase and antibiotic residue analysis. In PCC-2, the time / temperature relationship of the chart was analyzed, as well as the alkaline phosphatase and peroxidase analyzes in order to evaluate the efficiency of the processes. In PCC-3, we performed surveys of aerobic mesophilic microorganisms in three boxes of long-life milk after incubation for seven days. A total of 9 (100%) of the samples indicated Dornic acidity between 0.14 and 0.16ºD, 9 (100%) presented negative results to the alizarol test and 9 (100%) showed negative results for antibiotic residues. The graphical curves were maintained at their correct temperature / time, between 74.1ºC-74.2ºC / 15-20sec, the milk from each truck presented a positive result for the enzymes phosphatase and peroxidase in the raw milk, after the pasteurisations. Result was negative for enzyme phosphatase and positive for peroxidase. Samples from each truck had a similar result of <1.0x10º CFU / ml. The results obtained in each CCP were satisfactory according to the relevant legislation. The CCPs are within the established, demonstrating their effectiveness in the application of the HACCP system in the dairy industry.(AU)

Monitoramento dos pontos críticos de controle aplicado no processamento do leite longa vida em indústria de laticínios de Ji-Paraná / Monitoring of critical control points applied in the processing of long life milk in the dairy industry of Ji-Paraná

O objetivo deste trabalho foi verificar a eficiência do sistema de Análise de Perigos e Pontos Críticos de Controle (APPCC) implantado em indústria de laticínios através do monitoramento dos Pontos Críticos de Controle (PCC) identificados no plano APPCC para a produção do leite longa vida. Foram avaliados os processos produtivos de três caminhões. No PCC-1 realizaram-se testes de acidez titulável, alizarol, fosfatase alcalina, peroxidase e análise de resíduos de antibióticos. No PCC-2 foram analisadas a relação de tempo/temperatura da carta gráfica, bem como as análises de fosfatase alcalina e peroxidase com o intuito de avaliar a eficiência dos processos. No PCC-3 realizaram-se pesquisas de micro-organismos aeróbios mesófilos em três caixas de leite longa vida após incubação de sete dias. Um total de 9 (100%) das amostras indicaram acidez Dornic entre 0,14 e 0,16ºD; 9 (100%) apresentaram resultado negativo ao teste de alizarol; e 9 (100%) mostraram resultado negativo para resíduos de antibióticos. As curvas gráficas mantiveram-se em seu tempo/temperatura correto, encontraram-se entre 74.1ºC-74.2ºC/15-20seg, o leite proveniente de cada caminhão apresentou resultado positivo para as enzimas fosfatase e peroxidase no leite cru, e após as pasteurizações o resultado foi negativo para enzima fosfatase e positivo para peroxidase. As amostras referentes a cada caminhão apresentaram resultado semelhante de <1,0x10º UFC/ml. Os resultados obtidos em cada PCC foram satisfatórios de acordo com a legislação pertinente. Os PCC estão dentro do estabelecido, demonstrando sua efetividade na aplicação do sistema APPCC na indústria de laticínios.

To verify the efficiency of the Hazard Analysis and Critical Control Points (HACCP) system implemented in the dairy industry by monitoring the Critical Control Points (CCPs) identified in the HACCP plan for the production of long-life milk. The production process of three trucks was evaluated in the PCC-1 titratable acidity tests, alizarol, alkaline phosphatase, peroxidase and antibiotic residue analysis. In PCC-2, the time / temperature relationship of the chart was analyzed, as well as the alkaline phosphatase and peroxidase analyzes in order to evaluate the efficiency of the processes. In PCC-3, we performed surveys of aerobic mesophilic microorganisms in three boxes of long-life milk after incubation for seven days. A total of 9 (100%) of the samples indicated Dornic acidity between 0.14 and 0.16ºD, 9 (100%) presented negative results to the alizarol test and 9 (100%) showed negative results for antibiotic residues. The graphical curves were maintained at their correct temperature / time, between 74.1ºC-74.2ºC / 15-20sec, the milk from each truck presented a positive result for the enzymes phosphatase and peroxidase in the raw milk, after the pasteurisations. Result was negative for enzyme phosphatase and positive for peroxidase. Samples from each truck had a similar result of <1.0x10º CFU / ml. The results obtained in each CCP were satisfactory according to the relevant legislation. The CCPs are within the established, demonstrating their effectiveness in the application of the HACCP system in the dairy industry.

The implementation of a HACCP system improved the efficiency of a bull semen collection and processing center

Bull Semen Collection and Processing Centers (SCPC) have satisfactory control of sperm quality, but commonly lack standardized quality control of hygiene procedures. This study assessed the impact of implementing a Hazard Analysis and Critical Control Points (HACCP) system in a bull SCPC, comparing microbial counts on various steps of semen processing, semen quality and costs across two periods (before and after the HACCP implementation). After surveying all routine activities of the SCPC, control points were identified, preventive measures were designed and corrective actions were employed, whenever necessary. Six months after HACCP implementation, the system was audited and production data covering two similar periods of two consecutive years were compared. Counts of colony forming units in samples collected from artificial vaginas, flexible tubes from the straw filling machine and from fresh and frozen semen after HACCP implementation were lower than during the previous period (P < 0.05). Improved post-thawing sperm motility, membrane integrity and acrosome integrity (P < 0.0001) and reduced rejection of semen batches and frozen doses were observed after HACCP implementation (P < 0.01), resulting in reduced opportunity costs. Thus, the implementation of a HACCP system in a bull SCPC allowed low-cost production of high-quality semen doses with reduced microbial contamination.(AU)

The implementation of a HACCP system improved the efficiency of a bull semen collection and processing center

Bull Semen Collection and Processing Centers (SCPC) have satisfactory control of sperm quality, but commonly lack standardized quality control of hygiene procedures. This study assessed the impact of implementing a Hazard Analysis and Critical Control Points (HACCP) system in a bull SCPC, comparing microbial counts on various steps of semen processing, semen quality and costs across two periods (before and after the HACCP implementation). After surveying all routine activities of the SCPC, control points were identified, preventive measures were designed and corrective actions were employed, whenever necessary. Six months after HACCP implementation, the system was audited and production data covering two similar periods of two consecutive years were compared. Counts of colony forming units in samples collected from artificial vaginas, flexible tubes from the straw filling machine and from fresh and frozen semen after HACCP implementation were lower than during the previous period (P < 0.05). Improved post-thawing sperm motility, membrane integrity and acrosome integrity (P < 0.0001) and reduced rejection of semen batches and frozen doses were observed after HACCP implementation (P < 0.01), resulting in reduced opportunity costs. Thus, the implementation of a HACCP system in a bull SCPC allowed low-cost production of high-quality semen doses with reduced microbial contamination.

A Model of Risk Analysis in Analytical Methodology for Biopharmaceutical Quality Control.

One key quality control parameter for biopharmaceutical products is the analysis of residual cellular DNA. To determine small amounts of DNA (around 100 pg) that may be in a biologically derived drug substance, an analytical method should be sensitive, robust, reliable, and accurate. In principle, three techniques have the ability to measure residual cellular DNA: radioactive dot-blot, a type of hybridization; threshold analysis; and quantitative polymerase chain reaction. Quality risk management is a systematic process for evaluating, controlling, and reporting of risks that may affects method capabilities and supports a scientific and practical approach to decision making. This paper evaluates, by quality risk management, an alternative approach to assessing the performance risks associated with quality control methods used with biopharmaceuticals, using the tool hazard analysis and critical control points. This tool provides the possibility to find the steps in an analytical procedure with higher impact on method performance. By applying these principles to DNA analysis methods, we conclude that the radioactive dot-blot assay has the largest number of critical control points, followed by quantitative polymerase chain reaction, and threshold analysis. From the analysis of hazards (i.e., points of method failure) and the associated method procedure critical control points, we conclude that the analytical methodology with the lowest risk for performance failure for residual cellular DNA testing is quantitative polymerase chain reaction.LAY ABSTRACT: In order to mitigate the risk of adverse events by residual cellular DNA that is not completely cleared from downstream production processes, regulatory agencies have required the industry to guarantee a very low level of DNA in biologically derived pharmaceutical products. The technique historically used was radioactive blot hybridization. However, the technique is a challenging method to implement in a quality control laboratory: It is laborious, time consuming, semi-quantitative, and requires a radioisotope. Along with dot-blot hybridization, two alternatives techniques were evaluated: threshold analysis and quantitative polymerase chain reaction. Quality risk management tools were applied to compare the techniques, taking into account the uncertainties, the possibility of circumstances or future events, and their effects upon method performance. By illustrating the application of these tools with DNA methods, we provide an example of how they can be used to support a scientific and practical approach to decision making and can assess and manage method performance risk using such tools. This paper discusses, considering the principles of quality risk management, an additional approach to the development and selection of analytical quality control methods using the risk analysis tool hazard analysis and critical control points. This tool provides the possibility to find the method procedural steps with higher impact on method reliability (called critical control points). Our model concluded that the radioactive dot-blot assay has the larger number of critical control points, followed by quantitative polymerase chain reaction and threshold analysis. Quantitative polymerase chain reaction is shown to be the better alternative analytical methodology in residual cellular DNA analysis.

The implementation of a HACCP system improved the efficiency of a bull semen collection and processing center.

Bull Semen Collection and Processing Centers (SCPC) have satisfactory control of sperm quality, but commonly lack standardized quality control of hygiene procedures. This study assessed the impact of implementing a Hazard Analysis and Critical Control Points (HACCP) system in a bull SCPC, comparing microbial counts on various steps of semen processing, semen quality and costs across two periods (before and after the HACCP implementation). After surveying all routine activities of the SCPC, control points were identified, preventive measures were designed and corrective actions were employed, whenever necessary. Six months after HACCP implementation, the system was audited and production data covering two similar periods of two consecutive years were compared. Counts of colony forming units in samples collected from artificial vaginas, flexible tubes from the straw filling machine and from fresh and frozen semen after HACCP implementation were lower than during the previous period (P < 0.05). Improved post-thawing sperm motility, membrane integrity and acrosome integrity (P < 0.0001) and reduced rejection of semen batches and frozen doses were observed after HACCP implementation (P < 0.01), resulting in reduced opportunity costs. Thus, the implementation of a HACCP system in a bull SCPC allowed low-cost production of high-quality semen doses with reduced microbial contamination.

Diseño de un programa de análisis de peligros y puntos críticos control (HACCP) para la producción de toxoide tetánico / Design of a program of hazard analysis and critical control point (HACCP) for production of Tetanus Toxoid

El toxoide tetánico es una neurotoxina modificada que induce la formación de una antitoxina protectora contra la enfermedad denominada tétanos. Este antígeno es obtenido a partir de procesos fermentativos con la bacteria anaerobia Clostridium tetani y es utilizado para la formulación de vacunas simples y combinadas inactivadas. Con el propósito de atender a las recomendaciones y regulaciones de la Organización Mundial de la Salud (OMS), el objetivo de este trabajo fue diseñar un Programa de Análisis de Peligros y Puntos Críticos de Control (HACCP) en la producción del antígeno Toxoide Tetánico, desde la recepción de la cepa certificada en el área de producción hasta el almacenamiento del toxoide tetánico purificado. Para ello, inicialmente se evaluó el cumplimiento de los prerequisitos (BPM, POES, BPL). Posteriormente, se procedió al diseño del plan HACCP mediante la ejecución de las 5 tareas preliminares y la aplicación de los 7 principios, conforme a la metodología descrita por la OMS. A partir del análisis de peligros en todas las etapas del proceso de producción del toxoide tetánico se identificaron 3 puntos críticos de control: detoxificación, filtración estéril final y almacenamiento de toxoide tetánico purificado. Se establecieron los límites críticos, los procedimientos de vigilancia, las acciones correctivas, los procedimientos de verificación y de documentación. La propuesta tiene como fin garantizar la calidad e inocuidad del producto elaborado, la protección del personal involucrado en el proceso y del medio ambiente con miras a la obtención de la certificación como laboratorio productor de vacunas

Tetanus toxoid is a modified neurotoxin that induces the formation of protective antitoxin of the disease called tetanus. This antigen is obtained from fermentation processes with anaerobic bacteria Clostridium tetani and it is used to formulate simple and combined inactivated vaccines. In order to meet the recommendations and regulations of World Health Organization (WHO), the aim of this work was to design a Program of Hazard Analysis and Critical Control Points (HACCP) in the production of antigen Tetanus Toxoid, starting from the receipt of the certified strain in the production area through the storage of purified tetanus toxoid. For this, initially fulfilling the prerequisites (GMP, SSOP and GLP) was evaluated. Subsequently, we proceeded to design HACCP plan by running 5 preliminary tasks and application of the 7 principles, according to the methodology described by WHO. From the hazard analysis at all stages of the production process of tetanus toxoid three critical control points were identified: detoxification, final sterile filtration and storage of purified tetanus toxoid. Critical limits, monitoring procedures, corrective actions, verification and documentation procedures were established. The proposal aims to assure the quality and safety of the final product, the protection of personnel involved in the process and the environment, with a view to obtaining certification as a vaccine production laboratory

Condições higienicossanitárias das instalações e dos procedimentos de elaboração e distribuição de fórmulas infantis em um lactário de um hospital de Itajaí, SC

Este estudo objetivou avaliar as condições higienicossanitárias das instalações e dos procedimentos de elaboração e distribuição de fórmulas infantis em um lactário de um hospital de Itajaí/SC. Foi aplicado um checklist de inspeção sanitária dividido em dados gerais e setorizados e o desenvolvimento do sistema de Análise de Perigos e Pontos Críticos de Controle (APPCC). Como complemento, foram analisadas microbiologicamente as mãos de todas as lactaristas e cinco bicos de mamadeiras coletados aleatoriamente. Os resultados obtidos demonstraram que o grupo “dados gerais” obteve o percentual de conformidade de 88,18%, classificando-se como bom. O resultado do grupo“dados setorizados” alcançou 70,76% de conformidade, com classificação regular. As contagens de micro-organismos mesófilos aeróbios confirmaram a eficácia do processo de esterilização dos bicos das mamadeiras. As contagens de Staphylococcus aureus nas mãos demonstraram que 50% (n=2) das lactaristas apresentaram colônias acima do limite estabelecido. As informações obtidas do fluxograma das mamadeiras permitiram a identificação dos Pontos Críticos de Controle - PCC nas etapas de cocção, resfriamento,manutenção 1, manutenção 2 e distribuição com base na avaliação dos ingredientes e nas etapas do processo desde o recebimento até a distribuição. Conclui-se que a contaminação microbiológica nas mãos das lactaristas, além do não respeito ao tempo de 1 hora entre a etapa de manutenção 2 e distribuição, não garante a segurança higienicossanitária necessária das mamadeiras, possibilitando possíveis surtos de Doenças Transmitidas por Alimentos (DTAs) aos lactentes. Sugere-se maior rigor na supervisão do processo, capacitação em higiene pessoal e de utensílios,além da implantação do controle de tempo principalmente nas etapas citadas.(AU)

This study aimed to evaluate the hygienic and sanitary conditions of facilities and procedures for the elaboration and distribution of infant formulas in a hospital milk dispensary in Itajaí - SC. A sanitary inspection checklist was applied, divided into general and sector data,and the development of the Hazard Analysis and Critical Control Point(HACCP) system. As a complement,the hands of all food handling and five randomly collected bottle nozzles were microbiologically analyzed.The results obtained showed that the general data group obtained the compliance percentage of 88.18%,being classified as good. The result of the group sectorized data reached 70.76% of conformity, with regular classification. The counts of aerobic mesophilic microorganisms confirmed the effectiveness of the sterilization process of the bottle nozzles Staphylococcus aureus counts in the hands showed that 50% (n = 2) of the food handling had colonies above the established limit. The information obtained from the flowchart of the bottles allowed the identification of Critical Control Points (CCP), in the steps of cooking, cooling, maintenance¹,maintenance² and distribution based on the evaluation of the ingredients and in the steps of the process from the receipt to the distribution stage. It is concluded that the microbiological contamination in the hands of the food handling, besides not respecting the time of 1 hour between the stage of maintenance 2 and distribution, does not guarantee the necessary hygienic and sanitary safety of the bottles, allowing possible outbreaks of Foodborne Diseases(FBD) to infants. It is suggested a greater rigor in the supervision of the process, training in personal hygiene and utensils, besides the implementation of time control mainly in the mentioned steps.(AU)

Condições higienicossanitárias das instalações e dos procedimentos de elaboração e distribuição de fórmulas infantis em um lactário de um hospital de Itajaí ­ SC / Sanitary and hygienic conditions of the facilities and the procedures of elaboration and distribution of infant formulas in a lactara of a hospital of Itajaí ­ SC

Este estudo objetivou avaliar as condições higienicossanitárias das instalações e dos procedimentos de elaboração e distribuição de fórmulas infantis em um lactário de um hospital de Itajaí/SC. Foi aplicado um checklist de inspeção sanitária dividido em dados gerais e setorizados e o desenvolvimento do sistema de Análise de Perigos e Pontos Críticos de Controle (APPCC). Como complemento, foram analisadas microbiologicamente as mãos de todas as lactaristas e cinco bicos de mamadeiras coletados aleatoriamente. Os resultados obtidos demonstraram que o grupo "dados gerais" obteve o percentual de conformidade de 88,18%, classificando-se como bom. O resultado do grupo "dados setorizados" alcançou 70,76% de conformidade, com classificação regular. As contagens de micro-organismos mesófilos aeróbios confirmaram a eficácia do processo de esterilização dos bicos das mamadeiras. As contagens de Staphylococcus aureus nas mãos demonstraram que 50% (n=2) das lactaristas apresentaram colônias acima do limite estabelecido. As informações obtidas do fluxograma das mamadeiras permitiram a identificação dos Pontos Críticos de Controle - PCC nas etapas de cocção, resfriamento, manutenção 1, manutenção 2 e distribuição com base na avaliação dos ingredientes e nas etapas do processo desde o recebimento até a distribuição. Conclui-se que a contaminação microbiológica nas mãos das lactaristas, além do não respeito ao tempo de 1 hora entre a etapa de manutenção 2 e distribuição, não garante a segurança higienicossanitária necessária das mamadeiras, possibilitando possíveis surtos de Doenças Transmitidas por Alimentos (DTAs) aos lactentes. Sugere-se maior rigor na supervisão do processo, capacitação em higiene pessoal e de utensílios, além da implantação do controle de tempo principalmente nas etapas citadas.(AU)

Panorama sobre a regulamentação do sistema APPCC em estabelecimentos de carne de aves sob inspeção federal / The regulation of the HACCP system in poultry establishments under federal inspection

Desde 2006, o Ministério da Agricultura, Pecuária e Abastecimento (MAPA) vem desenvolvendo regulamentação específica para aplicação do sistema de Análise de Perigos e Pontos Críticos de Controle (APPCC) nos matadouros de aves sob inspeção federal, incluindo diretrizes para a implantação desse programa de qualidade nas indústrias. Este artigo apresenta um panorama sobre a evolução dessa regulamentação, atualmente estagnada, e os métodos vigentes para fiscalização da aplicação do sistema APPCC em estabelecimentos de carne de aves. Dessa forma, os autores buscam facilitar a compreensão do processo regulatório por pesquisadores e técnicos da área e, com isso, incentivar esses profissionais a contribuir para o aperfeiçoamento das diretrizes governamentais.

Panorama sobre a regulamentação do sistema APPCC em estabelecimentos de carne de aves sob inspeção federal

Desde 2006, o Ministério da Agricultura, Pecuária e Abastecimento (MAPA) vem desenvolvendo regulamentação específica para aplicação do sistema de Análise de Perigos e Pontos Críticos de Controle (APPCC) nos matadouros de aves sob inspeção federal, incluindo diretrizes para a implantação desse programa de qualidade nas indústrias. Este artigo apresenta um panorama sobre a evolução dessa regulamentação, atualmente estagnada, e os métodos vigentes para fiscalização da aplicação do sistema APPCC em estabelecimentos de carne de aves. Dessa forma, os autores buscam facilitar a compreensão do processo regulatório por pesquisadores e técnicos da área e, com isso, incentivar esses profissionais a contribuir para o aperfeiçoamento das diretrizes governamentais.(AU)

The Ministry of Agriculture, Livestock and Supply (MAPA), in other to fulfill sanitary agreements between Brazilian government and other countries that imports poultry meat, set guidelines for the implementation of the Hazard Analysis and Critical Control Point (HACCP) system in poultry slaughterhouses plants under official government inspection and a generic HACCP model with four critical control points (CCPs), which includes a chemical CCP. However, due to the flaws detected by European auditors, some of the plants had to review their HACCP plans, and the MAPA have the need to realize a new hazard analysis on the poultry slaughter and meat processing procedures. This article seeks to enhance the development of guidelines for chemical PCC in poultry slaughterhouses plants of the genus Gallus.(AU)

Qualidade microbiológica de mamadeiras de fórmula láctea antes e após a implantação do sistema de análise de perigos e pontos críticos de controle em lactário hospitalar / Microbiological quality of bottles of formula milk before and after the implementation of hazard analysis and critical control points in lactary hospital

o presente trabalho teve por objetivo avaliar a qualidade microbiológica das mamadeiras de fórmulas lácteas antes e após a implantação do sistema APPCC. Considerando as Boas Práticas na produção de fórmulas lácteas como pré-requisitos na implantação do sistema APPCC, estas foram avaliadas por meio de um checklist adaptado ao lactário. Para a implantação do sistema APPCC a rotina do estabelecimento foi observada desde o recebimento da matéria- prima até a distribuição das mamadeiras aos pacientes. Utilizou-se a ferramenta árvore decisória para as análises das etapas e determinações dos PCCs. Os resultados das análises microbiológicas encontrados não apresentaram valores estatisticamente significativos para nenhum dos micro-organismos analisados nos dois momentos. Comprovando-se, através da verificação das boas práticas, que antes da vigência do sistema APPCC correspondiam a um total de 87,5% de conformidades e 10,23% de não conformidades, obtendo-se 94,26% de conformidades e 3,48% de não conformidades, após a implantação do sistema APPCC. (AU)

This study aimed at evaluating the microbiological quality of feeding bottles of lacteal formulas before and after the implementation of the HACCP system. Considering the Good practices in the production of lacteal formulas as pre requisite in the implementation of HACCP, it was evaluated by means of a checklist adapted to the milk dispensary. For the implementation of the HACCP system, the routine of the establishment was observed from the moment the raw material is received to the distribution of the feeding bottles to the patients. The decisive tree was the tool used for analyses of the stages and determinations of PCCs. The results of microbiological analyses found did not present statistically relevant values to any of the microorganisms analyzed in both moments. Proving through verification of good practices which before the presence of the HACCP system corresponded to a total of 87,5% of conformities and 10,23% of non-conformities, obtaining 94,26% of conformities and 3,48% of non-conformities, after the implementation of the HACCP system. (AU)

Análise de perigos e pontos críticos de controle na elaboração de salada de batatas, em Unidade de Alimentação e Nutrição / Hazard Analysis and Critical Control Points in the preparation of potato salad, in Food and Nutrition Unit

A avaliação constitui-se em um dos parâmetros mais importantes para se determinar a qualidade e a sanidade dos alimentos e é igualmente importante para verificar se padrões e especificações microbiológicas nacionais e internacionais estão sendo atendidos adequadamente. As cozinhas estão mais voltadas para a produção de alimentos seguros, sendo o APPCC - Análise de Perigos e Pontos Críticos de Controle, uma ferramenta mundialmente difundida para a atuação preventiva. Este trabalho avaliou a manipulação da salada de batatas em uma cozinha institucional no Município de Belém-PA, baseada nos princípios do sistema APPCC e concluiu-se que a mesma não aplica as Boas Práticas de Fabricação durante a manipulação do alimento para os funcionários da unidade avaliada, o que pode acarretar sérios riscos à saúde dos usuários. (AU)

The evaluation is one of the most important parameters for determining the quality and healthfulness of food, and it is also important to verify that standards national and international microbiological specifications are being met adequately. The kitchens are more focused on the production of safe food, and the HACCP - Hazard Analysis and Critical Control Points, a tool for the worldwide spread preventive action. This study evaluated the handling of the potato salad in an institutional kitchen in the city of Belém-PA, based on the principles of HACCP system, and found that it does not have Good Manufacturing Practices when handling food for the employees of the unit evaluated, which can cause serious food poisoning risks to public health of users. (AU)

Implementación del análisis de riesgo en la industria alimentaria mediante la metodología AMEF: enfoque práctico y conceptual / Implementing Risk Analysis in Food Industry through Modal Analysis of Effects and Failures (MAEF): Practical and Conceptual Approach / Implementação da análise de risco na indústria alimentícia mediante a Análise Modal de Efeitos e Falhas (AMEF): enfoque prático e conceitual

El análisis de riesgo mediante el Análisis Modal de Efectos y Fallas (AMEF) se aplicó y se incorporó en conjunto con el Análisis de Peligros y Puntos Críticos de Control (HACCP) para establecer la evaluación de riesgos en una maquiladora de pavo deshuesado. En este trabajo se calculó y se predijo, por medio de la significancia del riesgo, la importancia de establecer medidas preventivas en las etapas de proceso más vulnerables. El cálculo de la significancia se realizó obteniendo el Índice de Criticidad (IC). Los puntos críticos de control se establecieron con la metodología del árbol de decisiones, que se enfocó en aquellas etapas que mostraron tener los valores más altos relativos al IC. Las principales causas posibles que generan una desviación de los puntos críticos de control fueron enlistadas y analizadas a través de un análisis causa-raíz, con el uso del diagrama de Ishikawa. La integración del análisis de riesgo dentro de un plan HACCP demostró proveer amplias ventajas que facilitan el control de los procesos de manufactura y el aseguramiento de la salud pública a los consumidores finales, al generar alimentos inocuos y de alta calidad, al tiempo que mejora el desempeño operacional del ciclo productivo. Se identificaron las etapas de almacenamiento y descongelación como los principales segmentos con tendencia a mostrar altos valores de IC. Las acciones correctivas sugeridas bajaron notablemente los valores del IC por debajo del límite aceptable. Los resultados del presente estudio muestran claramente la importancia de la incorporación de un buen sistema de control sistemático para la gestión de riesgos en la industria avícola.

Risk Analysis through the Modal Analysis of Effects and Failures (MAEF) was applied and incorporated together with the Hazard and Critical Control Points Analysis (HCCPA) in order to establish the assessment of risk in a maquiladora of boneless turkey. Through risk significance, the importance of establishing preventive measures during the most vulnerable stages of the process was calculated and predicted in this paper. Significance was calculated by obtaining the Criticality Index (CI). The critical control points were established using the decision tree methodology, which was focused on those stages showing the highest values related to the CI. The main possible causes that generate a deviation from the critical control points were listed and analyzed through a root-cause analysis, using Ishikawa's diagram. The integration of risk analysis in a HCCPA plan proved to offer advantages that facilitate the control of manufacturing processes and the assurance of public health to final consumers, by generating innocuous and high quality food products and at the same time improving the operational performance of the productive cycle. The storing and thawing stages were identified as the main segments tending to show high CI values. The suggested corrective actions significantly lowered the CI values below the acceptable limit. The results of this study clearly show the importance of incorporating a good system of systematic control for risk management in the poultry industry.

A análise de risco mediante a Análise Modal de Efeitos e Falhas (AMEF) se aplicou e se incorporou em conjunto com a Análise de Perigos e Pontos Críticos de Controle (HACCP) para estabelecer a avaliação de riscos em uma maquiladora de peru desossado. Neste trabalho se calculou e se previu, através da significância do risco, da importância de estabelecer medidas preventivas nas etapas de processo mais vulneráveis. O cálculo da significância se realizou obtendo o Índice de Criticidade (IC). Os pontos críticos de controle se estabeleceram com a metodologia árvore de decisões, que se focou naquelas etapas que mostraram ter os valores mais altos relativos ao IC. As principais causas possíveis que geram um desvio dos pontos críticos de controle foram elencadas e analisadas através de uma análise causa-raiz, com o uso do diagrama de Ishikawa. A integração da análise de risco dentro de um plano HACCP demonstrou prover amplas vantagens que facilitam o controle dos processos de manufatura e a garantia da saúde pública aos consumidores finais, ao gerar alimentos inócuos e de alta qualidade, ao mesmo tempo em que melhora o desempenho operacional do ciclo produtivo. Identificaram-se as etapas de armazenamento e descongelação como os principais segmentos com tendência a mostrar altos valores de IC. As ações corretivas sugeridas bajaram notavelmente os valores do IC por baixo do limite aceitável. Os resultados deste estudo mostram claramente a importância da incorporação de um bom sistema de controle sistemático para a gestão de riscos na indústria avícola.

Segurança e qualidade na produção de massa alimentícia frescal / Safety and quality in production from fresh pasta

Massa alimentícia é o produto não fermentado, apresentado sob várias formas, recheado ou não, obtido pelo empasto, amassamento mecânico da mistura de farinha de trigo ou sêmola de trigo durum, e/ou farinha de outros vegetais, adicionado ou não de outros ingredientes e acompanhado ou não de temperos e ou complementos, isoladamente ou adicionados diretamente à massa. Devido à sua alta umidade, as massas frescas possuem um ambiente propício à multiplicação de micro-organismos patogênicos. A ocorrência de amostras de massas frescas industrializadas com resultados microbiológicos considerados insatisfatórios evidencia que algumas indústrias não estão mantendo um controle de qualidade eficaz. Esta falha poderia ser corrigida com a implantação efetiva do programa de Boas Práticas de Fabricação (BPF), como também da adoção do plano de Análise de Perigos e Pontos Críticos de Controle (APPCC). O objetivo do presente estudo foi elaborar um plano APPCC, com aplicabilidade em uma empresa processadora de massa fresca do tipo espaghetti. Ao final da elaboração do plano APPCC, quatro pontos críticos de controle (PCC) foram delineados, de acordo com o fluxograma proposto: a recepção /estocagem da farinha de trigo, o peneiramento, a mistura/trefilação e o empacotamento. A qualificação de fornecedores, o armazenamento adequado da matéria-prima, o uso de peneiras íntegras, um controle eficaz da higienização da masseira e o uso de detector de metais constituem as medidas de controle necessárias à segurança e qualidade do produto. (AU)

Pasta is a unfermented product, submitted in many forms, filled or not, obtained by impasto, mechanical kneading of the mixture of wheat jiour or semolina of durum wheat, and/or others vegetables flours, with or without other ingredients and accompanied or not by spices and complements, alone or added directly to the mass. Because of its high humidity, the fresh pasta has a favorable environment for the multiplication of pathogenic micro-organisms. The occurrence of industrial samples of fresh pasta with unsatisfactory microbiological results shows that some industries are not maintaining an effective quality control. This fact could be corrected with the effective implementation of the program of "Good Manufacturing Practices" (GMP), as well as the adoption of the plan, the "Hazard Analysis and Critical Control Points" (HACCP). Therefore the objective of this study was to develop a HACCP plan, with applicability in a company that processes fresh pasta, like spaghetti. At the end of the development of the HACCP plan, four critical points of control (CPC) were designed according to the flow diagram proposed: the receiving/storage of wheat flour, the sieving, the mixture/drawing and the packaging. The suppliers qualification, proper storage of raw material, the use of undamaged screens, the effective control of the trough hygienization and the use of metal detectors are the control measures necessaries for safety and quality products. (AU)

Isolamento de Salmonella na tecnologia de abate de suínos como subsídio para o sistema appcc / Salmonella isolation in a pig slaughtering technology as allowance for the system haccp / Aislamiento de Salmonella en la tecnología de matanza de porcinos como subsidio para el sistema appcc

A Salmonella pode estar presente em carcaças suínas ao final da tecnologia de abate, sendo que não existem procedimentos de inspeção especificamente direcionados para o controle desta bactéria, consideradas um risco potencial para a saúde pública. O objetivo do trabalho foi verificar a presença de Salmonella em carcaças suínas e caracterizar os pontos críticos de controle (PCCs) da tecnologia de abate como subsídio ao sistema APPCC. Foram realizados swabs de carcaças após a escaldagem/depilação, antes da evisceração, após evisceração e serragem da carcaça e após 24 horas de refrigeração, gerando 120 amostras (30 carcaças de cinco lotes). Isolou-se Salmonella em 53,3% dos PCs analisados, sendo 40% antes da eviscerarão e 30% após a escaldagem/depilação e evisceração/serragem. Nas carcaças resfriadas por 24 horas não foi isolada Salmonella. Os sorovares identificados foram Typhimurium (96,7 %) e Panama (3,22%). O isolamento de Salmonella reforça a necessidade de programas de monitoria da bactéria, desde as granjas até os abatedouros, enquanto o não isolamento nas carcaças resfriadas indica a importância da lavagem final e adequação da cadeia do frio, o que minimiza a contaminação pela intensificação das medidas de higiene e controle de pontos críticos para subsidiar o sistema APPCC.(AU)

Salmonella can be present in swine carcasses at the end of slaughtering and there is no specifically guided inspection procedure for the control of this bacterium, considered a potential risk for public health. The objective of this paper is to verify the presence of Salmonella in carcasses and to characterize the critical points of control (CPCs) of the slaughtering technology as a subsidy to the HACCP system. The carcasses were swabbed at different points during the slaughtering process, ant after 24 hours of refrigeration, generating 120 samples (30 carcasses from five different batches). Salmonella was isolated in 53.3% of the CPs analyzed, being 40% before evisceration and 30% after scalding/depilation and evisceration/ sawing. No Salmonella was isolated in the carcasses refrigerated for 24 hours. Typhimurium (96.7%) and Panama (3.22%) were the serovars identified. Salmonella isolation indicates the need of programs to monitor the bacterium from the farms to the slaughterhouse, while the non-isolation in the refrigerated carcasses shows the relevance of the cold chain, which minimizes the contamination by the intensification of hygiene measures and the control of critical points to subsidize the HACCP system.(AU)

La Salmonella puede estar presente en carcasas porcinas al final de la matanza, siendo que no existen procedimientos de inspección específicamente direccionados para el control de esta bacteria, consideradas un riesgo potencial a la salud pública. El objetivo del trabajo ha sido verificar la presencia de Salmonella en carcasas porcinas y caracterizar los puntos críticos de control (PCCs) en la tecnología de matanza como subsidio al sistema APPCC. Se han realizado swabs de carcasas tras escaldadura/depilación, antes de evisceración, después de la evisceración y serrín de la carcasa y después de 24 horas de refrigeración, generando 120 muestras (30 carcasas de cinco lotes) Se ha aislado Salmonella en 53,3% de los PCs analizados, siendo 40% antes de evisceración y 30% después de la escaldadura/depilación y evisceración/serrín. En las carcasas enfriadas por 24 horas no se ha aislado Salmonella. Los serovares identificados fueron Typhimurium (96,7%) y Panama (3,22%). El aislamiento de Salmonella refuerza la necesidad de programas de monitoria de la bacteria, desde las granjas hasta los mataderos, el no aislamiento en las carcasas enfriadas indica la importancia del lavado final y adecuación de la cadena del frío, lo que minimiza la contaminación por la intensificación de las medidas de higiene y control de puntos críticos para subsidiar el sistema APPCC(AU)