通过在指定培养温度下将一部分培养基培养14天,来确认每一批已灭菌培养基的无菌状态。不得出现微生物生长。
Confirm the sterility of each sterilized batch of medium by incubating a portion of the media at the specified incubation temperature for 14 days. No growth of microorganisms occurs.
每一次灭菌都要有灭菌记录,并作为批产品放行程序的一部分进行批准。
Sterilisation records should be available for each sterilisation run. They should be approved as part of the batch release procedure.
文中的第二部分对湿热灭菌中的热量和质量传递进行了研究,目的是通过理论计算确定湿热灭菌过程中的热穿透时间。
The second part was about heat mass transfer models in moist sterilization process, from which the heat transport time could be theoretically calculated.
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