问题 问答题 简答题

若无菌灌装设备的传送带在A级与B级之间进行了穿越,这与附录1第36条规定:“除传送带本身能连续灭菌(如隧道式灭菌设备)外,传送带不得在A/B级洁净区与低级别洁净区之间穿越。”是否相违背?灌装密封后的产品由B级区进入包装区时,穿墙处如何防护才能保护B级区?(FL1)

答案

参考答案:

所提的问题脱离了一个关键要素,即产品是否完成了最终密封,而离开了这个大的前提,谈A级与B级之间的所谓传输是没有意义的。我们知道,隧道式灭菌设备分为三段,预热、去热原、冷却,这三段的传输带是不断被干热灭菌的,它有三个独立的风机组。隧道式灭菌器是由D级进B级的,这与A和B之间的所谓穿越不能相提并论的。另需注意,A级区内不直接接触产品的表面也只能消毒,不可能灭菌,当产品没有完全密封时,传送带一直处于A级保护之下,所提问题的风险在哪里?

灌装并密封后的产品由B级区进入外包区时通常要局部保护(类似A级送风),在国际上,一般控制区没有A级送风的提法,因此采用了ISPE中“局部保护”来表述。不同的产品及设备,风险各不相同,不要简单地用一种技术手段去包括所有的操作,换言之,应通过验证,用数据说话。

阅读理解

Do you have any foreign friends? Do you know their characteristics(特征)?

The Germans are very quiet and they always keep calm. They don’t like to speak more words. They look very serious. They like different kinds of amusements. The Germans are very hard—working. They like tidiness, especially the women, who always keep their home clean.

In some ways, the Englishmen look the same as the Germans. They are very quiet and never talk too much with the strangers. They are really polite, so we often hear they say “Thank you.” Or “Sorry.” The gentlemen are also the Englishmen.

The French’s holidays are very long. They like traveling and usually spend their long time staying in other countries. The Frenchmen are more outgoing than the Germans. It is very easy to make friends with them.

Compared to the Frenchmen, the Americans are more outgoing. And they are even opener than all of the Europeans. They don’t like to depend on others. So it is very common that the students do part-time jobs in their free time. And in Americans’ eyes, success is an important part in their life.

小题1:According to the passage, ______are very quiet.

A.only the Germans

B.only the Englishmen

C.only the Frenchmen

D.both the Germans and the Englishmen小题2: What does the underlined word “tidiness” mean in Chinese?

A.整洁

B.安静

C.时尚

D.随意小题3:In the writer’s eyes, the gentlemen are______.

A.the Germans

B.the Frenchmen

C.the Englishmen

D.the Americans小题4:What can we learn about the Frenchmen from the passage?

A.They are more outgoing than the Americans.

B.It is very easy to make friends with them.

C.They like traveling in their own country.

D.They look serious and are always hard-working.小题5:Which is the best title of the passage?

A.Foreigners’hobbies.

B.Who are more outgoing?

C.Characteristics of the foreigners.

D.Success is an important part in Americans’life.

单项选择题