关于Percoll/Percoll PLUS的灭菌

发布：2023-06-27  更新：2023-06-27

“Percoll/Percoll PLUS在生产时经过了高压灭菌。 然而，由于瓶子的性质，仅在 113℃ 下进行高压灭菌。 为了补偿较低的温度，我们在受监控的高压釜中将程序延长至一个小时。 ...如果此程序对客户来说足够了，则无需进一步高压灭菌。 如果客户想要应用进一步的灭菌，产品可以在 0.2μm 下进行无菌过滤，并在 122℃ 下高压灭菌（只是不在那个瓶子中）。”

    “……要声称无菌，需要进行验证。 客户需要制定自己的无菌验证测试计划，以确定 Percoll/Percoll Plus 满足其无菌要求。 我们建议，113 摄氏度的温度持续 1 小时将是一个很好的起点。 然而，这只是一个起点，因为我们不熟悉进行高压灭菌的设备和场地……”

原文：

"The product is still autoclaved upon production. Due to the nature of the bottles however we only autoclave at 113℃. To compensate the lower temperature we extend the procedure to an hour in a monitored autoclave. … If this procedure is sufficient for the customer there is no further autoclaving neccessary. If the customer wants to apply further processing steps the product can be sterile filtered at 0.2μm and also autoclaved at 122℃ (just not in that bottle)."

  " … To claim sterility, validation would be required. The customer would need to develop their own sterility validation test plan in order to deem that Percoll Plus meets their sterility requirements. We can recommend that the temperature of 113 degree Celsius for 1 hr would be a good starting point. However, this is only a starting point as we are not familiar with the equipment and site where this is autoclaving is being performed…"

基于Percoll/Percoll PLUS厂家的说明书为同一份，我们也和厂家技术支持人员确认过，从而译文在原文基础上增加了也适用于Percoll。

以上信息来自Cytiva/思拓凡（原GE Healthcare）厂家技术支持，仅供参考。

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