Development of a procedure for sterilizing filtration validation

I. Vasilenko, Pavel Romanovich Kozin, Yu. V. Krasnova
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Abstract

Validation of sterilizing filtration is extremely difficult in the realities of a working production. To prevent the negative impact of sterilizing filtration validation on the quality of the environment, a model of the process has been developed in the laboratory. On the basis of the developed model, validation tests were carried out to the extent that allows assessing the stability and reproducibility of the process. The obtained results showed the suitability of the process of sterilizing filtration of sodium luminol, as part of the process of aseptic production of the medicinal product.
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过滤验证灭菌程序的制定
在实际生产中,灭菌过滤的验证是极其困难的。为了防止灭菌过滤验证对环境质量的负面影响,在实验室中开发了该过程的模型。在开发的模型的基础上,进行了验证测试,以评估该过程的稳定性和可重复性。结果表明,将鲁米诺钠灭菌过滤工艺作为该药品无菌生产工艺的一部分是适宜的。
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