生物负荷回收验证-介绍

Introduction-The Importance of Bioburden Recovery Validation
介绍—生物负荷复原验证的重要性
The term "Bioburden" is defined as the microbiological population associated with an unsterilized product or component. The product bioburden is related to the cleanliness of the raw materials and components used to manufacture the product, the environment in which the product is manufactured, and the handling of the product during the manufacturing process. Therefore, the product bioburden is a reflection of how the manufacturing process is microbiologically controlled.
“生物负荷”定义为：与未杀菌的产品或者成分相关的微生物群落。产品的生物负荷与用于制造产品的原材料或成分的洁净度、产品所处的环境、以及在生产过程期间对产品的处理有关。因此，生物负荷反映了生产过程中如何控制微生物。

There are two kinds of bioburden encountered following the manufacturing of a product, the "immediate bioburden" and the "retained bioburden." The immediate bioburden exists on the product immediately following the manufacturing process and typically contains not only bacterial spores, Gram positive bacterial rods and cocci, but also Gram negative bacterial rods and fungi. The immediate bioburden represents the greatest variety of microorganisms present on the product, however, many of these organisms will not survive for long periods of time. Therefore, if the product is stored prior to sterilization for several days or weeks, the bioburden population will consist of those types of organisms capable of surviving or growing on the product. This latter bioburden population is referred to as the retained bioburden, and typically consists of bacterial or mold spores and some vegatative Gram positive and negative bacteria. For this reason, time is important to bioburden testing, and the criticality of knowing the magnitude and type of bioburden present on the product is dependent upon the mode of sterilization employed.
在产品的制造过程中，有两种生物负荷，“立即生物负荷”“留存生物负荷”。前者在生产过程中立刻存在于产品上，并且不仅包含细菌孢子、革兰氏阳性菌、球菌，还有革兰氏阴性菌和真菌。立即的生物负荷表明大多数不同种类的微生物出现在产品上，然而，这些微生物中的多数不能长久存活。因此，如果产品在灭菌前存放了几天或几周，污染菌种群将由能够在产品上存活或者生长的微生物构成。后者的生物负荷种群被称为留存生物负荷，是由细菌、霉菌孢子、革兰氏阳性阴性菌构成的。正因如此，时间对于生物负荷检测是很重要的，并且出现在产品上的生物负荷的大小和种类依赖于所使用的灭菌方式。

Medical products requiring sterilization, in general, are manufactured under conditions which are designed to control product bioburden levels. The bioburden level and type of bioburden organisms present have a significant impact on the adequacy of the sterilization process to deliver a sterile product. This is especially true for sterilization processes which are validated based on the "bioburden model approach" rather than on an "overkill approach." Such is the case for many gamma irradiation sterilization processes validated according to the industry guidelines, where the radiation dosage required for device sterilization is based on bioburden population and resistance.
通常，要求灭菌的医疗产品在严格控制产品生物负荷水平的条件下生产。这个生物负荷水平和出现的生物负荷微生物的类型对提供无菌产品的充分杀菌过程有明显影响。对于以“生物负荷模型方法”为基础而不是以“过度杀伤方法”为基础的灭菌过程，这是尤为正确的。像这样的情况，依据产业指导方针，许多γ辐照灭菌过程，设备灭菌所需的辐射量是基于生物负荷种群和抵抗力。

Some manufacturers of sterile products have implemented the concept of bioburden management. Bioburden data are collected, plotted on a periodic basis, and a trend analysis performed to evaluate the effectiveness of the procedures employed for controlling microbiological contamination during the manufacturing process. A bioburden management program such as this provides hard data demonstrating manufacturing process control and information by which to evaluate changes and their impact on microbiological control.
无菌产品的生产已经执行了生物负荷管理概念。收集生物负荷数据，在周期性的basis上标识出来，并做趋势分析以评估制造期间控制微生物污染过程的有效性。生物负荷管理程序通过评估变化和对微生物控制的影响提供确切的数据，并以此解释制造过程的控制和信息。

Consequently, it is important to develop procedures which provide a reliable,accurate, and reproducible measurement of the bioburden population associated with the raw materials and products. Validation of the efficacy of bioburden recovery procedures is an essential step in understanding and measuring product bioburden levels.
因此，对于形成一个可以提供可靠、准确、可再生的生物负荷种群测定方法是非常重要的，这些微生物种群是与原材料及产品相关的。生物负荷复原程序有效性的验证对于理解和测定产品生物负荷水平是必要的。

       文章来源：药品微生物检测

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