GB50457-2019······1

1 總則······11

2 術(shù)語······12

3 生產(chǎn)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(shè)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(shè)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(shù)······31

7 工藝設(shè)備······32

7.1 一般規(guī)定······32

7.2 設(shè)計和選用······33

8 建筑設(shè)計······35

8.1 一般規(guī)定······35

8.2 防火和疏散······35

8.3 室內(nèi)裝修······37

9 空氣凈化······40

9.1 一般規(guī)定······40

9.2 凈化空氣調(diào)節(jié)系統(tǒng)······40

9.3 氣流流型和送風(fēng)量······47

9.4 風(fēng)管和附件······48

9.5 監(jiān)測與控制······49

9.6 生產(chǎn)特殊性質(zhì)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(shè)施······53

11 電氣設(shè)計······55

11.1 配電······55

11.2 照明······55

11.3 通信······56

11.4 靜電防護(hù)及接地······57

附錄A 藥品生產(chǎn)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(hù)管理······64

附錄C 醫(yī)藥潔凈室的驗證······66

本標(biāo)準(zhǔn)用詞說明······68

引用標(biāo)準(zhǔn)名錄······69

附:條文說明······71

1 總則······74

2 術(shù)語······75

3 生產(chǎn)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(shè)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(shè)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(shù)······118

7 工藝設(shè)備······121

7.1 一般規(guī)定······121

7.2 設(shè)計和選用······122

8 建筑設(shè)計······126

8.1 一般規(guī)定······126

8.2 防火和疏散······127

8.3 室內(nèi)裝修······130

9 空氣凈化······133

9.1 一般規(guī)定······133

9.2 凈化空氣調(diào)節(jié)系統(tǒng)······135

9.3 氣流流型和送風(fēng)量······157

9.4 風(fēng)管和附件······161

9.5 監(jiān)測與控制······163

9.6 生產(chǎn)特殊性質(zhì)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(shè)施······172

11 電氣設(shè)計······175

11.1 配電······175

11.2 照明······176

11.3 通信······178

11.4 靜電防護(hù)及接地······181