Influence of aseptic surge tank venting on equipment sterilization
Autor(a) principal: | |
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Data de Publicação: | 2019 |
Outros Autores: | , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Brazilian Journal of Food Technology |
Texto Completo: | http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1981-67232019000100403 |
Resumo: | Abstract Aseptic surge tank (AST) systems are applied to aseptic production in order to store sterile product until aseptic filling, maintaining the commercial sterility condition achieved from previous production steps. To avoid microbial recontamination of the product, a sterility condition must be achieved in the aseptic tank system through the application of a heating, venting, and sterilization cycle. This cycle must follow specific validation protocols to ensure operational integrity - FDA 21 CFR Part 113.40g (ii). The demand for larger capacity systems and the implication of this volume increase on sterilization efficiency require a review of results obtained from current validation protocols. The purpose of this work was to evaluate aseptic surge tank’s venting cycles, studying internal pressure and temperature distribution to better understand this operation and its efficiency. Tests carried out at an industrial setting showed that the venting cycle was insufficient, with 13%-23% of air remaining inside the tank. Consequently, the subsequent sterilization process was not conducted under saturated steam condition. This different condition may change the kinetics for thermal destruction of microorganism spores from a moist heat state to a drier state in which its thermal resistance is higher. This finding raises a question regarding the true efficacy of the sterilization process and validation protocols currently used by the industry. The apparent success of current sterilization processes could be due to the application of excessive temperature and longer times. New operational and validation criteria will result in improvements in product integrity protection and operational cost reductions. |
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Brazilian Journal of Food Technology |
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Influence of aseptic surge tank venting on equipment sterilizationAseptic surge tankSterilizationVentingValidationHeat distributionAbstract Aseptic surge tank (AST) systems are applied to aseptic production in order to store sterile product until aseptic filling, maintaining the commercial sterility condition achieved from previous production steps. To avoid microbial recontamination of the product, a sterility condition must be achieved in the aseptic tank system through the application of a heating, venting, and sterilization cycle. This cycle must follow specific validation protocols to ensure operational integrity - FDA 21 CFR Part 113.40g (ii). The demand for larger capacity systems and the implication of this volume increase on sterilization efficiency require a review of results obtained from current validation protocols. The purpose of this work was to evaluate aseptic surge tank’s venting cycles, studying internal pressure and temperature distribution to better understand this operation and its efficiency. Tests carried out at an industrial setting showed that the venting cycle was insufficient, with 13%-23% of air remaining inside the tank. Consequently, the subsequent sterilization process was not conducted under saturated steam condition. This different condition may change the kinetics for thermal destruction of microorganism spores from a moist heat state to a drier state in which its thermal resistance is higher. This finding raises a question regarding the true efficacy of the sterilization process and validation protocols currently used by the industry. The apparent success of current sterilization processes could be due to the application of excessive temperature and longer times. New operational and validation criteria will result in improvements in product integrity protection and operational cost reductions.Instituto de Tecnologia de Alimentos - ITAL2019-01-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S1981-67232019000100403Brazilian Journal of Food Technology v.22 2019reponame:Brazilian Journal of Food Technologyinstname:Instituto de Tecnologia de Alimentos (ITAL)instacron:ITAL10.1590/1981-6723.12517info:eu-repo/semantics/openAccessScucuglia,MarcioSchmidt,FlávioVitali,AlfredoRos-Polski,Valquiriaeng2019-03-12T00:00:00Zoai:scielo:S1981-67232019000100403Revistahttp://bjft.ital.sp.gov.br/https://old.scielo.br/oai/scielo-oai.phpbjftsec@ital.sp.gov.br||bjftsec@ital.sp.gov.br1981-67231516-7275opendoar:2019-03-12T00:00Brazilian Journal of Food Technology - Instituto de Tecnologia de Alimentos (ITAL)false |
dc.title.none.fl_str_mv |
Influence of aseptic surge tank venting on equipment sterilization |
title |
Influence of aseptic surge tank venting on equipment sterilization |
spellingShingle |
Influence of aseptic surge tank venting on equipment sterilization Scucuglia,Marcio Aseptic surge tank Sterilization Venting Validation Heat distribution |
title_short |
Influence of aseptic surge tank venting on equipment sterilization |
title_full |
Influence of aseptic surge tank venting on equipment sterilization |
title_fullStr |
Influence of aseptic surge tank venting on equipment sterilization |
title_full_unstemmed |
Influence of aseptic surge tank venting on equipment sterilization |
title_sort |
Influence of aseptic surge tank venting on equipment sterilization |
author |
Scucuglia,Marcio |
author_facet |
Scucuglia,Marcio Schmidt,Flávio Vitali,Alfredo Ros-Polski,Valquiria |
author_role |
author |
author2 |
Schmidt,Flávio Vitali,Alfredo Ros-Polski,Valquiria |
author2_role |
author author author |
dc.contributor.author.fl_str_mv |
Scucuglia,Marcio Schmidt,Flávio Vitali,Alfredo Ros-Polski,Valquiria |
dc.subject.por.fl_str_mv |
Aseptic surge tank Sterilization Venting Validation Heat distribution |
topic |
Aseptic surge tank Sterilization Venting Validation Heat distribution |
description |
Abstract Aseptic surge tank (AST) systems are applied to aseptic production in order to store sterile product until aseptic filling, maintaining the commercial sterility condition achieved from previous production steps. To avoid microbial recontamination of the product, a sterility condition must be achieved in the aseptic tank system through the application of a heating, venting, and sterilization cycle. This cycle must follow specific validation protocols to ensure operational integrity - FDA 21 CFR Part 113.40g (ii). The demand for larger capacity systems and the implication of this volume increase on sterilization efficiency require a review of results obtained from current validation protocols. The purpose of this work was to evaluate aseptic surge tank’s venting cycles, studying internal pressure and temperature distribution to better understand this operation and its efficiency. Tests carried out at an industrial setting showed that the venting cycle was insufficient, with 13%-23% of air remaining inside the tank. Consequently, the subsequent sterilization process was not conducted under saturated steam condition. This different condition may change the kinetics for thermal destruction of microorganism spores from a moist heat state to a drier state in which its thermal resistance is higher. This finding raises a question regarding the true efficacy of the sterilization process and validation protocols currently used by the industry. The apparent success of current sterilization processes could be due to the application of excessive temperature and longer times. New operational and validation criteria will result in improvements in product integrity protection and operational cost reductions. |
publishDate |
2019 |
dc.date.none.fl_str_mv |
2019-01-01 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1981-67232019000100403 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1981-67232019000100403 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
10.1590/1981-6723.12517 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
text/html |
dc.publisher.none.fl_str_mv |
Instituto de Tecnologia de Alimentos - ITAL |
publisher.none.fl_str_mv |
Instituto de Tecnologia de Alimentos - ITAL |
dc.source.none.fl_str_mv |
Brazilian Journal of Food Technology v.22 2019 reponame:Brazilian Journal of Food Technology instname:Instituto de Tecnologia de Alimentos (ITAL) instacron:ITAL |
instname_str |
Instituto de Tecnologia de Alimentos (ITAL) |
instacron_str |
ITAL |
institution |
ITAL |
reponame_str |
Brazilian Journal of Food Technology |
collection |
Brazilian Journal of Food Technology |
repository.name.fl_str_mv |
Brazilian Journal of Food Technology - Instituto de Tecnologia de Alimentos (ITAL) |
repository.mail.fl_str_mv |
bjftsec@ital.sp.gov.br||bjftsec@ital.sp.gov.br |
_version_ |
1752128701765517312 |