四百三十八章 纯化水验证(1 / 1)

粗品水溶液过超滤,最后一道工序就是喷干了,虽然说各步清洁工作都做得十分到位,并经多人检查确认,为以防万一,杨芳淑还是把超滤液取样送检。

内毒素的检测不象液相,可以直接读出数据,而是与配成一定值的鲎试剂对比确定它的范围,本次鲎试剂设定了二个值,一个是合格的参考值5个单位,一个是上次不合格时的值20个单位,测定结果大出所有人的意料,内毒素大于20。清洁消毒肯定比上次更严格,结果却比上次更差,不可思议!杨芳淑没了主意。

“我们推测可能的原因有两个,一个是碘克沙醇洗脱用水量大,由水带入的细菌混到产品的数量多,纳滤无去除内毒素的能力,带入粗品的内毒素基数高。另一个是碘克沙醇分子量大,与内毒素分子量比碘海醇等更接近,易与产品一起透过超滤膜。

我们的解决方案是接纯化水管路到碘克沙醇合成区,过树脂全用无菌的纯化水降低内毒素基数。”技术分析会上,王近之与章海良亮出自个的观点。

“纯化水进入一般生产区,验证范围会大幅度地扩大,本来只是精烘包内有限的几个取水点要进行验证,这么一来,多了二十多个取水点,更复杂化的是纯化水在精烘包车间,卫生管理比较容易,现在,一下子通到普通生产区,这卫生要求怎么管理呀。更复杂的是我们要重新做验证。”方案一经提出,立即遭到徐总的强烈反对。

“这跟验证有关吗?纯化水的设计能力为每小时二十吨,精烘包实用水量每天不到一百吨,我们产品每天过柱的用水量只有七十吨,产能上完全能满足我们的需要,大贮罐本来就有一个底阀的,从这接管到生产区配制罐,精烘包内一个取水口也没增加啊。

就这么个比方吧,我拿消毒好的三十个吨桶向精烘包车间运水到一般生产区是卫生的,现在,不用吨桶一桶一桶地接,一次性打到一个大贮罐反而不卫生了?”王近之根据自个理解,据理力争。

“跟你无法沟通的,你没搞过原料药与成品药,自个学习一下GMP知识吧。”徐总也不知道该如何向王近之解释为什么这样做是不对的,搬出了GMP作挡箭牌。

“我把所有贮罐与管道内表面钝化一次并进行消毒,你把纯化水送过来,不需做验证,总比用饮用水细萄要低吧。”章海良也声援王近之的意见,心中暗想,GMP是个指导原则,得灵活应用,当年,碘海醇没精烘包,我们俩不也用士办法把内毒素做合格了吗。

又是吴总的支持下,纯化水接到了碘克沙醇大贮罐中,每天分时分段地把纯化水送过来。

第二批料经返工一次后,内毒素指标也合格并顺利发货了。据测算,改造的碘克沙醇产线一个月也能生产个七百多千克成品,利润比碘海醇高得多。公司最后决定,给开发部与所有参于试车的成员发了三万奖金。

这次牵涉的人多,刨去请客后课题组平均每人也就二千不到些,为收买人心,王近之自个只拿了一份平均值。

回到办公室,却见四个做泥水活的残疾人等在那里,其中一个代表说:“王部长,你欠我们的奖金呢,大家全给了,也得给我们了吧?”

还欠几个残疾人奖金?王近之实在想不起这事,听了他们叙说经过,才想起工程土建时,当时与陈总豪言允许下来的,如他们的加班考勤办公室不给,由奖金中计算,谁知陈总与我都签了字,到最后办公室还是不认。

罢罢罢,也就十六个考勤八百元的钱,交涉起来太复杂了,自个掏腰包把这事了了吧。见到几个哑巴指手划脚的,王近之感到既头痛又同情。

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