Abstract
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.
Highlights
Aseptic processing is a food preservation technology in which product and package are continuously sterilized in separated events; canning is performed in a sterile controlled environment conducted and maintained under commercial sterility condition (Chambers & Nelson, 1993).The aseptic process provides several benefits, like better quality and reduced nutritional losses when compared with traditional retort process, independence of refrigeration upon the end of shelf life, and versatility (Bockelmann, 1998; GEA Procomac Process Engineering, 2008)
One of the main steps of the Aseptic Surge Tanks (AST)’s operation is the pre-sterilization, where the internal surfaces in contact with the sterile product and the filter elements that will feed the tank with sterile air/nitrogen are brought to a commercial sterility condition by heating with saturated steam
This confirms that the proposal of changing the venting success criteria could improve sterilization process
Summary
The aseptic process provides several benefits, like better quality and reduced nutritional losses when compared with traditional retort process, independence of refrigeration upon the end of shelf life, and versatility (Bockelmann, 1998; GEA Procomac Process Engineering, 2008) It requires additional controls in all process steps to protect product and package from microbiological recontamination after sterilization (Burton, 1988), resulting in the need for robust automation and quality system. Intermediate Aseptic Surge Tanks (AST) are applied in Aseptic System to allow accumulation of sterilized product, maintaining its commercial sterility as a “buffer” prior to send to the aseptic filling machine (Burton, 1988) In addition to this flexibility, this device prevents the product recirculation, reducing nutritional and quality losses. One of the main steps of the AST’s operation is the pre-sterilization, where the internal surfaces in contact with the sterile product and the filter elements that will feed the tank with sterile air/nitrogen are brought to a commercial sterility condition by heating with saturated steam
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