無菌操作法指針.
Contents
1.2.
3.
4.
5. CIP
6. 8
7. 2 5
8. Y 2
9. Se 3
10. S 2
11. 38 13 2 3 1 2 3 4 5 6 7 8 9 10 11 12 13 BI
12. E m i
13. t 5 13 13 1 2 1
14. H 2000 3750lx O
15. 14
16. A 17
17. 2 1 R
18. ha 10 11 12
19. A5 2 5 A5 2 5 83
20. 19 3 1 59
21. 41 9 sterilization dose audit 13 5 4 CIP CIP
22. Brevundimonas diminuta ATCC 19146 cm 10 17 1 4 1
23. 3 4 ICH Q5A E 5
24. A2 7 1 2 3 75 4 5 6
25. Bowie Dick 39 for the selection use and interpretation of results SS 13 2 4 1 2 3 4 5 6 13 1 2 3
26. 2 A3 2 1 2
27. 1 100
28. 3 5 000
29. Sr 4
30. MSDS 77 A4 3 4 14 2009 2010
31. 4 E
32. 1 A5 2 A5 2 1 1 PDE Permitted Daily Exposure ADE Acceptable Daily Exposure ADI Acceptable Daily Intake
33. E i
34. 3 A
35. A5 2 2 82
36. pS F B
37. 3 E 1 2 3 4 5 6 7 8 9 A5 A5 1
38. 8 2 1 2 3 8 3 1 2
39. A2 3 6 TOC TOC TOC A2 4
40. e N
41. 9 10 3 1 2 H SU 28 3 4 1
42. TOC 9
43. 3 4 5 6 57 7 8 10
44. E 40 4 13 3 1
45. 12 8 9 10 3 11 12 13 14 15 lt E f i i nn E
46. 6 Double Tube Double Tube Sheet Type 70 7
47. 7 8 SUS316
48. E 9 19 2 RABS Restricted Access Barrier System RABS
49. 4 1 6 H gt
50. 2 28 IQ installation qualification 2 29 Gndirect support areas 2 30 direct support area B 2 31 D value
51. 3 25 9 9 1 9 1 1 1 2 3
52. ug Em ON 3 1 r H
53. 4 5 SS 6 9 2 2 1 2
54. pi pi 15 4 5 6 7 8 9 SO a uh j 3
55. 13 2 1 2
56. HEPA 7 2 1 7 2 2 NO RR 1 2
57. 63 4 5 6 7 8 20 1 2 3 4 5 6 20 3
58. SIP 1 7 wx 8 46 SIP B
59. 31 4 5
60. 2 1m3 30 1
61. 36 3 4 5 1 1 6 7
62. b EX 13 3 3
63. 18 19 HEPA 20 21 22
64. gt HH 74 1 2 3 4 5 6 7 gt ad
65. RABS SIP 19 1 RABS SIP CR yj H
66. 67 b 9 10 T 6 3 11 12 Hl A2 1 1
67. 7 5 2 1 2 V _ dd 3 4 5 17 A
68. 62 fj 20 20 1 2 20 2 2 1 3
69. 4 5 53
70. 2 3 4 5 6
71. 14 15 16 17 18 19 0 f lt E
72. 2 2 1 Gisolator HEPA ULPA ultra low penetration air filter 2 2 RABS Restricted Access Barrier System HEPA I 2 3
73. 2 OE 2 3 4 5 A6 1 2
74. 3 2 OD H
75. 9 CIP SIP F 10 SIP 11 12 13 20 20 1
76. 0 2 0 22 m Rupture Disc Valve
77. 4 hi Ul lt HH 10 11 3 1 3 2 3 3 4 1 4 2 4 3 5 1 5 2 6 1 7 1 7 2 7 3 HEPA a 8 1 8 2 8 3 9 1 9 2
78. 1 2 3 4 5 19 1 HEPA HEPA 17 5 1 4
79. 0 20um 0 22um 2 51 ntesrity test for containers 2 52 eak test 3 GMP 11
80. H
81. 1 2 3 4 5 6 7 2 3 6 EF 19 3 2 1
82. 2 10 PQ performance qualification 2 11 environmental monitor ing program 2 12 cleanliness level 0 5um
83. 1 CIP SIP j E TU r 34 E E 12 2 1 2 3 4 5
84. SOO OO OO 56 2 3 4
85. 2 3 HEPA 1 1 1 13 4 y y 1 2
86. SIP FE H SIP SIP gy
87. 4 5 B A A 6 A B 7 8
88. 1 CIP 18 18 1 2 3 4 5 6 7 1 fH A A H FE
89. ICHQ9 A5 3 1 2 A A6 A6 1 A6 1 1 1
90. tk E 1 12 C D 13
91. A4 4 BSL1 1 2 A4 5 BSL2 1 HEPA HI
92. A2 1 2 2 1 3 RO UF
93. E f 4 1 12 1
94. 5 15 4 SIP Ct 15 5 SIP 1 SIP SIP 2 SIP 3 45 16 16 1 1
95. 2 H A gt NN 4 I 1 3 2 1 2 3 4 5 4 h
96. E 1 HH 7 8 9 10 11 12 13 i URS 4
97. 3 j C 5 8
98. SOP 2 lt
99. sh RN f ji ICHQ9 1 H ICH Q9 81
100. 1 2 3 4 5 6 7 8 9 10 11 E 3 4
101. A2 3 4 H A2 3 5 H
102. 4 2 6
103. Rad 2 3 4 10 2 2 1 2
104. E 3 UE 1 E E E 3 ul
105. 2 1 66
106. 3 um 4 KE 76 SG Rk 6 A3 3 1 2 3 4
107. 52 18 2 1
108. Sa 6 4 LT A1 2 1
109. E T E E 1 2 3 4 5
110. 3 log 10 10 1 1 2
111. Al A2 A1 1 A1 2 A1 3 A2 1 A2 2 A2 3 A2 4 A2 5 A2 6 A2 7 A3 A3 1 A3 2 A3 3 A4 A4 1 A4 2 A4 3 A4 4 A4 5 A4 6 A4 7 A4 8 BSL1 BSL2 BSL3 rt rt 2 rt A5 A5 1 A5 2 A5 3 A6 A6 1 A6 2 A6 3
112. 6 7 8 9 HEPA TI HEPA 10 11 2 12 13
113. E 0 2 m 0 22g m 17 2 2 1 50 E
114. HH HH AQL 5 A6 4 2 1 2
115. 4 F 20 35C 14 2 5C 7 7 5
116. 1 2 3 4 5 10 BI SIP SIP E i 3 SIP 3 oo BI
117. 4 78 E E A4 3 BSL2
118. H 2 A A Im A
119. 13 2 1 1 2 3 4 5 6
120. 2 1m 0 5 m 3 520 A 100 ISO 5 3 3 20 4 5
121. 1m 3 520 000 D 0 5m 4 C 7 2 i NN
122. Phase 3 mm 72 8
123. 2 A A lt 19 3 3
124. 0 2 0 22 gt m 17 1 2 1 2 3
125. 27 x
126. CIP CIP 1 2 3 4 5 6 pH TOC 7 C 14 4 IP CIP CIP 1 CIP 2 CTP 3 CIP
127. 1 F 1
128. RABS 19 2 2 RABS 1 2 3 RABS 4 5 RABS 6 19 3 3
129. C Y 3 NN 4 5 6 STP
130. E f EX 18 4 1 E
131. 5um i ST
132. E 5 HH H En 2 40 ntegrity test for ters
133. 10 UV UV UV UV 254nm UV 71 UV
134. 2 49 3 4 5 6 7
135. 22 6 7 8 9 HEPA E 20 30
136. E RABS pe ISO DIS 14644 1 ISO E
137. se 35 12 1 2 3 4 5 6 12 1 2 3 4 5 6 3 1
138. ul RE 1 20 6 1 2 3
139. 10 15Pa 6 1 26 3 4 A B RABS 0 45m sec 20 5
140. 2 41 process simulation media fillls 2 42 change controD 10 GMP 14 2 43 HEPA high effciency particulate arr filter 0 3um 99 97 2 44 sterile 2 45 aseptic flling
141. 1 2 3 4 5 6
142. 23 24 25 26
143. H E 73 2
144. 3 4 5 6 7
145. 3 A3 1 3 4 E
146. 9 3 log 9 2 9 2 1 1 2 3 amp 26
147. ul 11 3 2 3 1 2 3 C D
148. 0 5um RABS 3 520 7 1 3 C D 1 2 3 1 E
149. amp 4 2 1 2 4 3 1 2 3
150. 5 HEPA HEPA 8 8 1 1 2
151. 61 FT 7 8
152. 10 1 10 2 10 3 10 4 11 1 lt 12 19 14 15 16 17 18 11 2 11 3 12 1 12 2 12 3 12 4 13 1 13 2 13 3 _ 13 4 y 13 5 CIP 14 1 CIP 14 2 14 3 CIP 14 4 B 14 5 14 6 SIP 15 1 15 2 a 15 3 Hi 15 4 15 5 16 1 16 2 16 3
153. CIP CIP 14 1 CIP CIP CIP 1 CIP nl SE IN 3 CIP 4 SS E IN
154. A FC gt C 1 3 A 1 ar
155. SOOO 17 2 17 2 1
156. E HEPA 1 4 6 log 55 4 6
157. 68 3 UV UF RO UF 000Da UF H RO UF
158. 48 4 OO 17 1 3 1 2
159. 15 20 7 3 HEPA 7 3 1 1 2 HEPA A PAO Poly alpha olefin 1 1 7 3 2 1 HEPA HEPA 23 B 0 3um 99
160. 2 3 79 4 5
161. 58 6 RABS RABS 7 RABS RABS RABS 8 ISO5
162. E 4 x A2 3 3 H
163. E E 0 E B 1 1m 3 520 000 2 0 5m 352 000 21 C 100 000 ISO 8
164. 19 19 1 19 1 1 1 2 3 4 5 7 D HHI 7 HHT
165. 2 3 hn E 4 HH
166. 2 46 SAL sterility assurance leveD 10 2 47 aseptic processing 2 48 APA aseptic processing area 2 49 steriization 2 50 sterilizing flter
167. 4 y 2 RO RO RO RO RO
168. E 5 14 2 1 2 3 3 4 42 14 3 CIP CIP
169. 1 2 3 84 A6 2 A6 2 1 1 2 3
170. 64 I A1 Al 1 1 DNA 0 2
171. SIP _ 2 17 a 1 1 2 3 3
172. EX lt 4 5 gt HO 6 33 CFU 5 lt 1 5 mK 1 H
173. 1 a m3 a y 1 0 5um 5 0 m 0 5m 5 0gm a A SO 5 3 520 20 3 520 20 B SO 7 3 520 29 352 000 2 900 C SO 8 352 000 2 900 3 520 000 29 000 me NN EeeN 3520 000 29 000 D 2 2 1 ISO 2 7 1 1 A 1
174. RABS NY kk RABS H B 19 2 1 1 2 3 4 5 RABS E HEPA g RABS RABS B
175. 9 1 8 A2 3 A2 3 1 E A2 3 2 4
176. unit 2 18 terminal sterilization 10 2 19 working shit 1 12 2 20 sanitation sanitization 2 21 action leveD
177. 2 22 critical area A 2 23 critical processing 2 24 disinfection critical processing area 2 25 decontamination 2 26 clean area 2 27 DQ design qualification
178. 3 CFU 24 30cm lt 1 5 25 50 12 12 1 1 4 H 1 2 HVAC 3 EX 3 2
179. 8 a E49 24 9
180. 3 4 5 6 7 8
181. NN 4 2
182. 60 1 2 Bacllus atrophaeus B atrophaeus ATCC9372 D 0 89 1 22 1 22 2 07 3
183. HEPA 14 15
184. E 12 2 14 A4 1 LT 5 4 BSL 1 3 RE 1 1 BSL1
185. EF 9 GMP 1 10 TH E ml EE 16 2 1 2 I N NyY gt 1
186. A C D E a E 29 3 4 5 6 7 0 5 m
187. UF 4 HH Turnover
188. 47 1 4 17 17 1 17 1 1 OS
189. A2 5 1 2 3 4 5 6 7 T A2 6
190. 2 2 BSL2 FC BSL1 3 BCG 3 3 BSL3 A4 2 1 2
191. 3 B 2006 7 2011 4 gt 86
192. O 4 9 1 2 1 2 3 4 5 gt E
193. 0 Phase 2 3 1 1 Phase Phase2 Phase 3
194. E 7 1 2 B 1 2 3 30cm 352 000 H 2 10 000 ISO 7 4 1m
195. A5 2 3 NN ON 0 ADE CN A5 2 4 v a
196. 28 19 29 7 7 1 0 5 m 5 0 m 1
197. 15 3 1 SIP CIP SIP SIP SIP 2 SIP SIP SIP SIP SIP SIP 3 SIP 4 SIP
198. E me my E f 1 E lz CL EE 3 Oe F 1 E
199. EX 18 3 1 gt he 2 ce E E
200. A E 2 3 4
201. E A E H E HH 10 4 F E
202. 2 65 3 4 5 6 7 8 pHI
203. A6 2 2 A6 3 A6 3 1 1 2 3 4 amp 5 A
204. 1 8 11 1 2 3 24 30cm 2 A 1 1m 90mm 4
205. 2 2 D 20 3 en 1 2 3
206. pH 5 6 A2 A2 1
207. 5 19 1 5 1 2 3 4 5 6 7 8 I 19 1 6 1 2
208. 17 1 17 2 18 1 18 2 HE 19 20 18 3 18 4 19 1 19 1 1 19 1 2 19 1 3 19 1 4 19 1 5 19 1 6 19 2 RABS 19 2 1 19 2 2 19 3 19 3 1 19 3 2 19 3 3 19 3 4 20 1 20 2 20 3 20 4 20 5 20 6
209. 7 1 32 2 3 J 2 1 3 gt CFU m9 lt 1 10 100 200 3 E 1 2 1 Ff 2 CFU plate lt 1 5 50 100
210. 1 6 6 6 1
211. 15 2 1 2 3 4 5 6 SIP i 44 C 7 8 9 SIP 10 SIP
212. 2 20 4 1 1 2 3
213. overkill sterilization D 10 1 0 10 12 12D 2 8 MSDS Material Safety Data Sheet MSDS 2 9 gas filter
214. 1f E E 2 18 14 15 16 17 C
215. unidirectional airHow 2 4 OQ operational qualification 2 5 air lock 4 E 2 6 endotoxin 2 7
216. E 23 4 20 4 18 7 4 22 22
217. 16 A4 7 A4 7 1 lt lt ly 80 1 2 TT 3 4 A4 7 2 1 2 3 A4 8
218. 19 3 4 1 2 4 6 CIP SIP CIP jx SIP
219. j 17 1 4 E 17 1 4 A H C
220. 17 1 3 E E 4 BB SI 4 E lt E 4 17 2 5
221. 90 2 32 bioburden 2 33 BI biological indicator 2 34 culture condition 2 35 barrier 2 36 microorganis m 2 2 37 pure steam E 2 38 SOP standard operating procedure 0 2 39 quality system 4 H E
222. 2 3 4 A4 6 BSL3 1
223. 69 5 80C UV
224. 2 20 E 2
225. A2 2 I 1 2 3 4 DQ 5 Q 6 OQ PQ Phase 1
226. 11 lt Y NN i 4 11 1 1 2 B
227. 16 5 5 1 1 6 1
228. 7 37 13 1 2 3 4 5 6 7 8 9 10 11 12 13 2 2 E gt
229. a 1 7 F 2 3 E gE 16 3 1 2 E i
230. 3 4 A 5 10 2 10 2 1 27 1
231. HH 1 17 2 3 17 2 4 WFI E 4 E 51
232. 4 CIP 5 CIP 6 CIP 7 CIP 8 CIP CIP 9 CIP 14 5 CIP CIP 14 6 CIP 1 CIP CIP 2 CIP 4 E 43 3 15 SIP SIP 15 1
233. 3 1 1 2 3 4 5 6 7 EK Es E
234. A 2 13 HVAC system 2 14 alert level 4 1m 2 15 CI chemical indicator 1 2 16 process parameter 2 17 cfu colony forming A D Rt N Wr b E
235. BI BI Biological indicators Guidance 8 BI ISO 14161 Sterilization of health care products
236. SIP tk A1 3 1 2 3 4 Re
237. 6 3 2 1 2 A6 4 A6 4 1 1 2 3 85 4 5 6 7
238. 97 1 1 IEPA a HEPA E 1 1 1 2 2 A HEPA 3 HEPA 4
239. A6 4 B 1 FE 16 fs 4 E 179 GMP
240. log 6 7 8 6 log 19 1 2 19 1 3 A
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