问题 单项选择题

100000级适用于

A.大容量注射剂的灌封
B.小容量注射剂的灌封
C.注射剂的浓配
D.口服固体药品的暴露工序
E.直肠用药的暴露工序
根据《药品生产质量管理规范》规定,下列药品生产环境空气洁净度级别

答案

参考答案:C

解析:本题考查《药品生产质量管理规范》中生产环境空气洁净级别。
《药品生产质量管理规范附录》中对不同种类药品的生产环境空气洁净级别作出了规定,归纳如下:
100级(包括局部100级):(1)大容量注射剂(≥50毫升)的灌封;(2)灌装前不需除菌滤过的药液配制;(3)注射剂的灌封、分装材料最终处理后的暴露环境;(4)法定药品标准中列有无菌检查项目的原产药精制、干燥、包装;(5)灌装前不经除菌过滤的生物制品其配制、合并、灌封、冻干、加塞、添加稳定剂、佐剂、灭活剂等;
10,000级:(1)注射剂的稀配、滤过;(2)小容量注射剂的灌封;(3)直接接触药品的包装材料的最终处理;(4)灌装前需除菌滤过的药液配制;(5)供角膜创伤或手术用滴眼剂的配制和灌装;(6)灌装前需经除菌过滤的生物制品其配制、合并、精制、添加稳定剂、佐剂、灭活剂、除菌过滤、超滤等;(7)体外免疫诊断试剂的阳性血清的分装、抗原一抗体分装;
100,000级:(1)注射剂浓配或采用密闭系统的稀配;(2)轧盖,直接接触药品的包装材料最后一次精洗的最低要求;(3)非最终灭菌口服液体药品的暴露工序;(4)深部组织创伤外用药品、眼用药品的暴露工序;(5)除直肠用药外的腔道用药的暴露工序;(6)原料血浆的合并、非低温提取、分装前的巴氏消毒、轧盖及制品最终容器的精洗等;(7)口服制剂其发酵培养密闭系统环境(暴露部分需无菌操作);(8)酶联免疫吸附试剂的包装、配液、分装、干燥;胶体金试剂、聚合酶链反应试剂(PCR)、纸片法试剂等体外免疫试剂;(9)深部组织创伤用制品和大面积体表创面用制品的配制、灌装。
300,000级:(1)最终灭菌口服液体药品的暴露工序;(2)口服固体药品的暴露工序;(3)表皮外用药品暴露工序;(4)直肠用药的暴露工序;(5)其它原料药的生产暴露环境(不低于300,000级);(6)放射免疫分析药盒各组分的制备。

单项选择题
单项选择题

For me, scientific knowledge is divided into mathematical sciences, natural sciences or sciences dealing with the natural world (physical and biological sciences), and sciences dealing with mankind (psychology, sociology, all the sciences of cultural achievements. every kind of historical knowledge).

Apart from these sciences is philosophy, about which we will talk later. In the first place, all this is pure or theoretical knowledge, sought only for the purpose of understanding, in order to fulfill the need to understand that is intrinsic and con-substantial to man. What distinguishes man from animals is that he knows and needs to know. If man did not know that the world existed, and that the world was of a certain kind, that he was in the world and that he himself was of a certain kind, he wouldn’t be man. The technical aspects or applications of knowledge are equally necessary for man and are of the greatest importance, because they also contribute to defining him as man and permit him to pursue a life increasingly more truly human.

But even while enjoying the results of technical progress, man must defend the primacy and autonomy of pure knowledge. Knowledge sought directly for its practical applications will have immediate and foreseeable success, but not the kind of important result whose revolutionary scope is for the most part unforeseen, except by the imagination of the Utopians. Let me recall a well-known example. If the Greek mathematicians had not applied themselves to the investigation of conic section zealously and without the least suspicion that it might someday be useful, it would not have been possible centuries later to navigate far from shore. The first men to study the nature of electricity could not imagine that their experiments, carried on because of mere intellectual curiosity, would eventually lead to modern electrical technology, without which we can scarcely conceive of contemporary life.

Pure knowledge is valuable for its own sake, because the human spirit cannot resign itself to ignorance. Butt in addition, it is the foundation for practical results that would not have been reached if this knowledge had not been sought disinterestedly.

The title which best expresses the idea of this text is()

A. Progress in Pure Science

B. Learning for Its Own Sake

C. Man’s Science and Inventions

D. Difference between Science and Technology