四百三十七章 又是内毒素(1 / 1)

事事可验证,时时有证据,从管理理念上,王近之认可方总,可实际执行中,技术成熟度远没有这么高,并且如果主管的人员认错解决问题的方向,验证无从谈起。

难题抛过来了,王近之与章海良得接住并在几天内实施,不然,拖延试生产进程,无法向客户交货的责任担不起,两人吩咐工人把柱子用百分之七十的甲醇及百分之三的氢氧化钠水溶液反复再生三个轮回,洗出的液体放置二小时后观察有无絮状物产生,可所有洗液都是无色透明的。这个清洗结果是否到位了?两人面面相觑。

第二釜反应液均出六分之一用单柱吸附洗脱吧,如不行就再洗再试,两人硬着头皮作出决定。洗脱喷干中试精制结果表明,粗品水溶六小时后,没有变浑浊,剩下的反应液进柱分离后,一次性地得到了澄明度合格的粗品,这一关总算这么过去了。

经过一周的沉淀,第一批碘克沙醇水溶液里浑浊的白色固体慢慢地凝成絮状物,经加活性碳过滤后也得到透明的水溶液,经过讨论,公司决定两批合并后一起进入精烘包,制备出成品,完成六百千克的商业订单。

水溶,活性碳脱色,树脂调节电导率,喷雾干燥,碘克沙醇的精烘包生产过程与碘海醇的一模一样,借用的又是碘海醇精烘包生产线与生产工人,在主任杨芳淑的指挥下,试生产一气呵成,得到七百十一千克成品。

事关项目成败,自从样品送到药分部检测后,王近之每隔几小时就跑一次赵定岳那里,打听检测结果,液相合格,澄明度合格,游离芳香胺合格....,一项指标报过来,王近之的心就稳定了一些,终于,所有理化指标都出来了,全部合格,可细菌指标与内毒素指标还需等待好几天,需要在无菌室进行培养呢。

忐忑不安中,赵定岳走到王近之的办公室说:“很可惜,这一批碘克沙醇的内毒素指标不合格。空户标准五个单位,我们实测达到二十个单位。”

分析会上,王近之有些生气地提出:“中试车间是一般生产区,无法有效控制细菌与内毒素指标,出现这个质量问题,精烘包车间得全面检讨,分析原因。”

“可是,精烘包生产碘海醇一年内没出过任何问题,这次切换产品,我们是消毒又消毒,清洁又清洁了,质管部卫诚与质量副总徐总都可以作证!”杨芳淑的理由也同样的十分充足。

合成没失误,精烘包生产也没失误,产品不合格却摆明放在桌面上,是谁的失误?原因分析又一次走入死胡同中。

“这批料在精烘包车间作返工处理,直到内毒素与细菌指标合格,下一批在责任上作这样的分工,化学指标不合格由开发部负全责,电导率与生物指标不合格由精烘包车间负全责。”讨论到最后,吴总宣布了集体决议。

好在这一批产品虽然内毒素指标不合格,可超标四倍也并不是特难处理,返工一次,重新超滤后再喷干即可得到成品,只是损失了几个百分点的收率,没有担误向客户交货。

二十天后,第三批第四批的粗品又出来了,检测分析结果相当不错,特别是澄明度,比之前已批更好,很显然,经过几批生产与再生后,树脂中的不明成份已被全部洗脱,不再对产品产生影响,碘克沙醇粗品已达到产业化的要求。

“下个月能不能拿奖金就看你们了。”粗品转移到精烘包车间时,章海良向杨芳淑扮了个鬼脸。

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