INRA, UMR1014 Secalim, Nantes, F-44307, France; LUNAM Université, Oniris, Nantes, F-44307, France.
Int J Food Microbiol. 2013 Apr 1;162(3):283-96. doi: 10.1016/j.ijfoodmicro.2013.01.021. Epub 2013 Feb 1.
Aseptic ultra-high-temperature (UHT)-type processed food products (e.g., milk or soup) are ready to eat products which are consumed extensively globally due to a combination of their comparative high quality and long shelf life, with no cold chain or other preservation requirements. Due to the inherent microbial vulnerability of aseptic-UHT product formulations, the safety and stability-related performance objectives (POs) required at the end of the manufacturing process are the most demanding found in the food industry. The key determinants to achieving sterility, and which also differentiates aseptic-UHT from in-pack sterilised products, are the challenges associated with the processes of aseptic filling and sealing. This is a complex process that has traditionally been run using deterministic or empirical process settings. Quantifying the risk of microbial contamination and recontamination along the aseptic-UHT process, using the scientifically based process quantitative microbial risk assessment (QMRA), offers the possibility to improve on the currently tolerable sterility failure rate (i.e., 1 defect per 10,000 units). In addition, benefits of applying QMRA are (i) to implement process settings in a transparent and scientific manner; (ii) to develop a uniform common structure whatever the production line, leading to a harmonisation of these process settings, and; (iii) to bring elements of a cost-benefit analysis of the management measures. The objective of this article is to explore how QMRA techniques and risk management metrics may be applied to aseptic-UHT-type processed food products. In particular, the aseptic-UHT process should benefit from a number of novel mathematical and statistical concepts that have been developed in the field of QMRA. Probabilistic techniques such as Monte Carlo simulation, Bayesian inference and sensitivity analysis, should help in assessing the compliance with safety and stability-related POs set at the end of the manufacturing process. The understanding of aseptic-UHT process contamination will be extended beyond the current "as-low-as-reasonably-achievable" targets to a risk-based framework, through which current sterility performance and future process designs can be optimised.
无菌超高温（UHT）型加工食品（例如牛奶或汤）是一种即食产品，由于其较高的质量和较长的保质期，在全球范围内得到了广泛的消费，且不需要冷链或其他保存要求。由于无菌-UHT 产品配方在微生物方面存在固有脆弱性，因此在制造过程结束时需要满足安全性和稳定性相关的性能目标（PO），这是食品行业中要求最苛刻的 PO。实现无菌的关键决定因素，也是无菌-UHT 与包装内灭菌产品的区别，是与无菌灌装和密封过程相关的挑战。这是一个复杂的过程，传统上一直使用确定性或经验性的过程设置来运行。使用基于科学的过程定量微生物风险评估（QMRA）量化无菌-UHT 过程中微生物污染和再污染的风险，为提高目前可接受的无菌失效率（即每 10000 个单位有 1 个缺陷）提供了可能性。此外，应用 QMRA 的好处是：（i）以透明和科学的方式实施过程设置；（ii）无论生产线如何，都开发统一的通用结构，从而使这些过程设置协调一致；（iii）将管理措施的成本效益分析纳入考虑。本文的目的是探讨如何将 QMRA 技术和风险管理指标应用于无菌-UHT 型加工食品。特别是，无菌-UHT 过程应该受益于在 QMRA 领域开发的一些新的数学和统计概念。概率技术，如蒙特卡罗模拟、贝叶斯推断和敏感性分析，应有助于评估制造过程结束时设定的安全性和稳定性相关 PO 的合规性。通过基于风险的框架，无菌-UHT 过程的污染理解将超越当前的“尽可能低”目标，从而可以优化当前的无菌性能和未来的工艺设计。
