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????????????2011
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1. ?? 2. ???? 3. ????
4. ????????? 5. ????
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1.?????? 2.???? 3.??????
- 1 -
??????? 1????
??????????????????????????????????????????????????????????????????????????????
2??????
???????????????????????????????????????????????????????? 3. ?????
4. ????? 4.1 ?????
- 2 -
4.2 ????? 4.2.1?????
4.2.1.1???????????
1????????????100mm?????????300mm?????
??????????????
2??????????150mm??????????
3??????????????????????? 4??????0.25-0.4m/s???
4.2.1.2?????????????
1???????????????????
2????????????????????????????100mm??
?????????????1/4????????3/4????????
3?????????0.5m/s?
4.2.2???????
1???????30min???????? 2???????????????
3???90mm????????????????????????3????????15????????30min?
4??????37????????????????????????48???????????
5????????????????1?/?? 4.2.3?????????
1?????,??30min?
2????????????????????
- 3 -
3???????????
???? ????? ???? ????? ???? ?????
- 4 -
????????????
Shandong Boyuan Pharmaceutical CO., Ltd.
BSC-1300?A2??????????
BSC-1300?A2 Biological safety cabinet Validation Protocol
??
1????? 2?????
3????????? 4???????????? 5?????
5.1 BSC-1300?A2 ?????????? 5.1.1 BSC-1300?A2 ?????????? 5.1.2 BSC-1300?A2 ????????????? 5.2 BSC-1300?A2 ??????????
5.2.1 BSC-1300?A2 ?????????????????? 5.2.2 BSC-1300?A2 ?????????????????? 5.2.3 BSC-1300?A2 ??????????????? 5.2.4 BSC-1300?A2 ??????????????? 5.2.5 BSC-1300?A2 ???????????? 5.3 BSC-1300?A2 ???????????
5.3.1 BSC-1300?A2 ???????????????? 5.3.2 BSC-1300?A2 ?????????????????? 5.3.3 BSC-1300?A2 ???????????????? 5.3.4 BSC-1300?A2 ?????????? 5.3.5 BSC-1300?A2 ??????????
5.3.6 BSC-1300?A2 ??????????????? 5.3.7 BSC-1300?A2 ???????????? 5.4 BSC-1300?A2 ??????????
5.4.1 BSC-1300?A2 ???????????????? 5.4.2 BSC-1300?A2 ???????????????????
5.4.3 BSC-1300?A2 ???????????? 5.4.4 BSC-1300?A2 ???????????
5.4.5 BSC-1300?A2 ??????????????? 5.4.6 BSC-1300?A2 ???????????? 6?????????
7?????????????? 8?????????? 9???
1. ????
BSC-1300?A2 ???????????????????????????????????QC??????????????????????????????????????????????????????????????2011??????????BSC-1300?A2 ????????????????????????IQ???????OQ???????PQ?????? 2. ????
???????????????????????????????BSC-1300?A2 ??????????????????????????
3. ????????
???????????????????????BSC-1300?A2 ?????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????
4. ??????
???????
4.1 ?????
4.1.1?????????????????????? 4.1.2????????????????????? 4.1.3?????????????????????
4.1.4???????????????????????????? 4.1.5????????????SOP????
4.1.6??????????????????????????????? 4.2 ?????
4.2.1?????????????????
4.2.2????????????????????????????????????? ?????????????????
4.2.3?????????????????????????? 4.3?????
4.3.1???????????????????
4.3.2??????????????????????????????????? 4.3.3??????????????
4.3.4???????????????????????????????? ????????????????????
4.3.5??????????????????????????????? ???????????? 4.4????
4.4.1??????????????????????? 4.5????????????
4.5.1???????????????????????? 4.5.2?????????????????????? 4.6????
4.6.1 2011?????????????????? 4.6.2 ????????
????????????1
?????????
?????? 1???
?????????????????????????????????????????????????????????????????????????????? ?????
2?????
????????????????????????????????????????????????????????
3?????????????????????????????? 4????????
5?????
6????? 6.1????
?????XXX?????????????????
6.1.1????
????
?????
6.1.2????
????
?????
6.1.3????
?????????
6.2 ????????????????????????????? 6.2.1 ??????????????????? 6.2.3 ????????
?????????????????
7?????
7.1.1?????
???? ?????
7.1.2????? 7.1.2.1????????
1?????????????????????????????????400?????????????????????????????????????????????????100%????????????20ug/L?
????????????????????????PAO????
???????????????????100%???0%?????????????????5mm?50mm/s?????????????20-30????????????????????????????????????????????????????????????????????????????????????
2???? ????????????0.01%???????????1%?????????5%??????3?????????? 7.1.2.2???????????
1????????????100mm?????????300mm ???????????????????
2??????????100mm??????????
3??????????????????????? 4??????0.25m/s~0.5m/s?0.025m/s??? 7.1.2.3?????????????
1???????????????????
2????????????????????????????100mm???????????????1/4????????3/4??????????14?????
3?????????0.5m/s?0.025m/s? 7.1.2.4???????
1???????30min???????? 2??????????????
3???90mm????????????????????????3????????15????????30min?
4??????37????????????????????????48???????????
5????????????????1?/?? 7.1.2.5?????????
1????????30min?
2????????????????????
3??????????
???? ?????
???? ?????
???? ?????
??????
1???
??????????BHC1300IIA2??????????????????????????????????????????
??????????????????
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发表于 2019-9-13 23:46:11