GB50457-2019······1

1 總則······11

2 術語······12

3 生產區(qū)域的環(huán)境參數(shù)······16

3.1 一般規(guī)定······16

3.2 環(huán)境參數(shù)的設計要求······16

4 廠址選擇和總平面布置······19

4.1 廠址選擇······19

4.2 總平面布置······19

5 工藝設計······21

5.1 工藝布局······21

5.2 人員凈化······25

5.3 物料凈化······27

5.4 工藝用水······27

6 工藝管道······29

6.1 一般規(guī)定······29

6.2 管道材料、閥門和附件······29

6.3 管道的安裝、保溫······30

6.4 安全技術······31

7 工藝設備······32

7.1 一般規(guī)定······32

7.2 設計和選用······33

8 建筑設計······35

8.1 一般規(guī)定······35

8.2 防火和疏散······35

8.3 室內裝修······37

9 空氣凈化······40

9.1 一般規(guī)定······40

9.2 凈化空氣調節(jié)系統(tǒng)······40

9.3 氣流流型和送風量······47

9.4 風管和附件······48

9.5 監(jiān)測與控制······49

9.6 生產特殊性質藥品醫(yī)藥潔凈室的要求······50

10 給水排水······52

10.1 一般規(guī)定······52

10.2 給水······52

10.3 排水······52

10.4 消防設施······53

11 電氣設計······55

11.1 配電······55

11.2 照明······55

11.3 通信······56

11.4 靜電防護及接地······57

附錄A 藥品生產環(huán)境的空氣潔凈度級別舉例······59

附錄B 醫(yī)藥潔凈室的維護管理······64

附錄C 醫(yī)藥潔凈室的驗證······66

本標準用詞說明······68

引用標準名錄······69

附:條文說明······71

1 總則······74

2 術語······75

3 生產區(qū)域的環(huán)境參數(shù)······76

3.1 一般規(guī)定······76

3.2 環(huán)境參數(shù)的設計要求······76

4 廠址選擇和總平面布置······81

4.1 廠址選擇······81

4.2 總平面布置······82

5 工藝設計······85

5.1 工藝布局······85

5.2 人員凈化······101

5.3 物料凈化······108

5.4 工藝用水······109

6 工藝管道······116

6.1 一般規(guī)定······116

6.2 管道材料、閥門和附件······117

6.3 管道的安裝、保溫······118

6.4 安全技術······118

7 工藝設備······121

7.1 一般規(guī)定······121

7.2 設計和選用······122

8 建筑設計······126

8.1 一般規(guī)定······126

8.2 防火和疏散······127

8.3 室內裝修······130

9 空氣凈化······133

9.1 一般規(guī)定······133

9.2 凈化空氣調節(jié)系統(tǒng)······135

9.3 氣流流型和送風量······157

9.4 風管和附件······161

9.5 監(jiān)測與控制······163

9.6 生產特殊性質藥品醫(yī)藥潔凈室的要求······166

10 給水排水······168

10.1 一般規(guī)定······168

10.2 給水······169

10.3 排水······169

10.4 消防設施······172

11 電氣設計······175

11.1 配電······175

11.2 照明······176

11.3 通信······178

11.4 靜電防護及接地······181