1 總則······7

2 術(shù)語······8

3 生產(chǎn)區(qū)域的環(huán)境參數(shù)······11

3.1 一般規(guī)定······11

3.2 環(huán)境參數(shù)的設(shè)計要求······11

4 廠址選擇和總平面布置······13

4.1 廠址選擇······13

4.2 總平面布置······13

5 工藝設(shè)計······15

5.1 工藝布局······15

5.2 人員凈化······18

5.3 物料凈化······20

5.4 工藝用水······20

6 工藝管道······22

6.1 一般規(guī)定······22

6.2 管道材料、閥門和附件······22

6.3 管道的安裝、保溫······23

6.4 安全技術(shù)······24

7 設(shè)備······25

7.1 一般規(guī)定······25

7.2 設(shè)計和選用······26

8 建筑······28

8.1 一般規(guī)定······28

8.2 防火和疏散······28

8.3 室內(nèi)裝修······30

9 空氣凈化······32

9.1 一般規(guī)定······32

9.2 凈化空氣調(diào)節(jié)系統(tǒng)······32

9.3 氣流流型和送風(fēng)量······37

9.4 風(fēng)管和附件······39

9.5 監(jiān)測與控制······40

9.6 青霉素等藥品生產(chǎn)潔凈室的特殊要求······41

10 給水排水······42

10.1 一般規(guī)定······42

10.2 給水······42

10.3 排水······43

10.4 消防設(shè)施······43

11 電氣······45

11.1 配電······45

11.2 照明······46

11.3 通信······46

11.4 靜電防護(hù)及接地······47

附錄A 藥品生產(chǎn)環(huán)境的空氣潔凈度等級舉例······49

附錄B 醫(yī)藥潔凈室(區(qū))的維護(hù)管理······52

附錄C 醫(yī)藥潔凈室(區(qū))的驗證······54

本規(guī)范用詞說明······56