Medical devices provide critical care and diagnostic applications through patient contact. Sterility assurance level (SAL) may be defined as the probability of a single viable micro‐organism occurring on an item after a sterilization process. Sterilization microbiology often relies upon using an overkill validation method where a 12‐log reduction in recalcitrant bacterial endospore population occurs during the process that exploits conventional laboratory‐based culture media for enumeration. This timely review explores key assumptions underpinning use of conventional culture‐based methods in sterilization microbiology. Consideration is given to how such methods may limit the ability to fully appreciate the inactivation kinetics of a sterilization process such as vaporized hydrogen peroxide (VH2O2) sterilization, and consequently design efficient sterilization processes. Specific use of the real‐time flow cytometry (FCM) is described by way of elucidating the practical relevance of these limitation factors with implications and opportunities for the sterilization industry discussed. Application of FCM to address these culture‐based limitation factors will inform real‐time kinetic inactivation modelling and unlock potential to embrace emerging opportunities for pharma, medical device and sterilization industries including potentially disruptive applications that may involve reduced usage of sterilant.

中文翻译：

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应用流式细胞术进行实时细菌细胞分析以促进灭菌微生物学发展的机会

医疗设备通过与患者的接触提供重症监护和诊断应用。无菌保证水平（SAL）可以定义为灭菌过程后物品上出现单个存活微生物的概率。灭菌微生物学通常依赖于使用过度杀伤力的验证方法，在此过程中，利用传统的实验室培养基进行枚举的过程中，顽固性细菌内生孢子种群减少了12个对数。这份及时的综述探讨了在灭菌微生物学中使用传统的基于培养的方法的关键假设。考虑了此类方法如何限制充分认识灭菌过程（如汽化过氧化氢（VH2O2）灭菌）的失活动力学的能力，因此，设计有效的灭菌过程。通过阐明这些限制因素与所讨论的灭菌行业的意义和机会之间的实际相关性，描述了实时流式细胞术（FCM）的特定用途。应用FCM解决这些基于文化的局限性因素将为实时动力学失活建模提供信息，并释放潜力，以涵盖制药，医疗设备和灭菌行业的新兴机会，包括可能涉及减少灭菌剂使用的潜在破坏性应用。