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This latter stage is similar to how synthetic pharmaceuticals are manufactured by aseptic processing. During the course of these stages, there is an ongoing need for microbial control to prevent adverse contamination. International regulations state that processes claimed as sterile must be validated to support the sterilization claim. This does not apply, however, to processes claimed as microbially controlled, which also may have zero or low bioburden but have not been validated with a defined SAL. Although the high assurance of sterility provided by validation is required of bulk drug claimed as sterile and of final sterile formulation and filling of injectable drugs and biologics, many preparative stages in bioprocess manufacturing Figure 1 are difficult to sterilize and may not require actual validated sterility. Instead, they are operated under a high degree of microbial control, as can be provided by gamma irradiation without sterilization validation.
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On the other hand, the Poles in private shared their opinion on the Russian Jews in Poland: The best of these Jews are our real enemy. Russian Jews, who had infested Warsaw, Lodz, and other major centers of Poland, brought with them Russian culture, which we do not like. In those years, the Russification of Jews on its territory was highly desirable for the Tsarist government. Russian authorities recognized socialization with Russian youth as a sure method of re education of the Jewish youth to eradicate their hostility toward Christians. Still, this newborn Russian patriotism among Jews had clear limits. The lawyer and publicist I. G. Orshansky specified that to accelerate the process it was necessary to create conditions for the Jews such that they could consider themselves as free citizens of a free civilized country. The above mentioned Lev Levanda, a Jewish scholar living under the jurisdiction of the Governor of Vilnius, then wrote: I will become a Russian patriot only when the Jewish Question is resolved conclusively and satisfactory. A modern Jewish author who experienced the long and bitter 20th century and then had finally emigrated to Israel, replied to him looking back across the chasm of a century: Levanda does not notice that one cannot lay down conditions to Motherland. She must be loved unconditionally, without conditions or pre conditions; she is loved simply because she is the Mother.