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- あつひろ みねむら
- 9 years ago
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1
2 ISO
3 ISO
4 ISO(International Standardization Organization) 135 ISO
5 CD(Committee Draft) DIS(Draft for International Standard) FDIS(Final DIS) ISO ISO ANSI/AAMI RD ANSI/AAMI RD ISO/CD ISO ISO/DIS ISO/CD ISO/DIS
6 ISO/TC150/SC2/WG5 ISO/DIS CD 2nd , 13959, ISO23500 NWI 2 ISO
7 ISO/TC150/SC2/WG5 ISO/DIS CD 2nd , 13959, ISO23500 NWI 2
8 ISO/CD DIS ISO/DIS : Fluids for hemodialysis and related therapies ISO/CD : Concentrates for hemodialysis and related therapies ISO/CD : Water for hemodialysis and related therapies ISO/CD : Water equipment for hemodialysis application NWI ; RD62
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10 CD RO 0.1mg/L ISO/CD mg/L ISO/CD mg/L 1
11 ISO/TC150/SC2/WG5 ISO/DIS CD 2nd , 13959, ISO23500 NWI 2
12 Water for hemodialysis ET cfu/ml EU/L 100 (Action Level 50) 250 ISO 1 Dialysis fluid Ultrapure dialysis fluid Online prepared substitution fluid 100 (Action Level 50) ( ) TGEA, R2A, MEA
13 ISO Dr.Ward 07 5 CD NWI ISO ( )
14
15 ISO/CD23500 Ver. 1.05
16 ET
17 /ml mg/L mg/L mg/L mg/L mg/L mg/L mg/L mg/L mg/L mg/L mg/L mg/L mg/L mg/L mg/L mg/L 10 10mg/L mg/L mg/L mg/L mg/L mg/L mg/L 38 ( ) 300mg/L 14 1,4-0.05mg/L mg/L 15 1,1-0.02mg/L mg/L 16-1,2-0.04mg/L mg/L mg/L mg/L mg/L mg/L mg/L mg/L mg/L 45 (TOC) 5mg/L mg/L 46 ph mg/L mg/L mg/L mg/L 50 2
18 ISO ISO/CD (mg/l) 1. 2(0.1mEq/L) 2. 4(0.3mEq/L) 3. 8(0.2mEq/L) 4. 70(3.0mEq/L)
19 Water for hemodialysis Dialysis fluid Ultrapure dialysis fluid Online prepared substitution fluid ISO ET ET cfu/ml EU/L cfu/ml EU/L 100 (Action Level 50) 100 (Action Level 50) ) ( 10) ( ( ) TGEA, R2A, MEA R2A or equivalent (agar or broth or sheet)
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22 ET 68 ET ET ET 1 (1 15) 10 4 EU/ 250EU/L ( ) ( ) cfu/ml Ex). 15. PDA Journal of GMP and Validation in Japan,6,38-45,2004 Eschrichia coli (dried cell) EU/ 250EU/L E. coli 1800 /ml
23 Imidazoquinolines Flagellin Bcterial DNA (CpG DNA) Mycoplasmal Lipopeptide Peptidoglycan LPS LBP TLR 7 TLR 5 TLR 9 TLR 2 TLR 6 CD14 CD14 MD-2 TLR 4 MyD88 TRAF 6 IRAK Cytokine NF- B DNA
24 m 10nm MDP 400 -D glcan DNA fragment
25 MF
26
27 CFU MF CFU
28 Culture and Non-culture Methods Culture method : Non-culturable cells (Not colony forming VBNC or dead cells) Nucleic acid staining Non-culture method 4,6-diamidino-2-phenylindole (DAPI) Propidium iodide (PI) Intracellular enzyme activity 6-carboxyfluorescein diacetate (6CFDA) 6CF 6CFDA : Culturable cells (Colony-forming ability) Colony Microcolony CTC CTC-formazan 5-cyano-2,3-ditolyl tetrazolium chloride (CTC) Respiratory activity
29 Culture and Non-culture Methods Culture Method Fluorescent Method 5 Fig. Culture for colony Fig. Non-culture Method - Direct Epifluorescent Filtration Technique (Escherichia coli ) Microbial cells stained with DAPI
30 Bacterial number and endotoxin level in dialysis fluids Yamaguchi, N., et al : Rapid monitoring of bacteria in dialysis fluids by fluorescent vital staining
31 Rapid and Automated Bacterial Detection Systems asu, M. (2006): JP s standpoint for chapters on rapid microbiological methods presented in New microbiology chapters of the European armacopoeia - Session II: Alternative methods for control of microbiological quality (Part 1). Strasbourg, France. 2-3 Oct
32 Water for hemodialysis ET cfu/ml EU/L 100 (Action Level 50) 250 ISO 1 Dialysis fluid Ultrapure dialysis fluid Online prepared substitution fluid 100 (Action Level 50) ( ) TGEA, R2A, MEA
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34 (SAL:Sterility assurance level) D *D SAL *D SAL 10 6
35 ISO
36
37 (DQ Design Qualification) 5. (IQ:Installation Qualification) 6. (OQ:Operational Qualification) 7. (PQ:Performance Qualification)
38 (PQ:Performance Qualification) (a) (b) (c) Phase 1 / RO Phase 2 1 Phase 2,
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40 Ver. 1.05
41 RO RO RO ETCF Ca
42 h 50 75%
43 ET 2 70% 50%
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45
46
Fig. 1. Structures of NM394, NAD-358 and NAD-245 Fig. 2. Typical HPLC chromatograms of NM394 in human plasma by organic solvent extraction method (a): Blank plasma (b): Plasma spiked with NM394 and internal
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MBL CD8 CD4 8.1 8.2 5.20 8.3 8.4 8.5 8.6 8.7 8.8 8.9 8.10 8.18 B7 CD28 CD28 B7 CD28 8.13 2.22 NK Toll(TLR) LBP! LPS dsrna ssrna TLR1/2/6! TLR4 TLR5 TLR3 TLR7/9 CD14! JNK/p38! MyD88! IRAK! TRAF! NFκB! TNF-α
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Quantitative Risk Assessment on the Public Health Impact of Pathogenic Vibrio parahaemolyticus in Raw Oyster 1 15 5 23 48 2 21 1 16 1 16 1 11 3 1 3 4 23 1 2 16 12 16 5 6 Hazard IdentificationExposure
CHEMOTHERAPY APR Fig. 1 Chemical structure of cefotetan (CTT, YM09330)
CHEMOTHERAPY APR. 1982 Fig. 1 Chemical structure of cefotetan (CTT, YM09330) VOL.30 S-1 CHEMOTHERAPY Fig. 2 Comparison of standard curves of CTT on various test organisms by cylinder plate method Column
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ACQUITY UPLC H-Class ACQUITY QDa Mark E. Benvenuti, Dimple Shah, and Jennifer A. Burgess Waters Corporation, Milford, MA, USA MS ACQUITY QDa UPLC HPLC UV ACQUITY QDa LC EC 1925/26 CFR 21 HPLC 1 LC-MS ACQUITY
86 楢村ほか : 透析液中の細菌に対する各種メンブレンフィルター法の測定精度の検討 緒 言 近年, 米国 ANSI/AAMI における透析液水質のガイドラインが ISO 基準案に色濃く反映され, 本邦においても細菌基準を含めた新たな管理基準の作成と臨床での細菌検査の実施が奨励されている 1,2).
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Rep. Nat l Food Res. Inst No 報 文 3M TM Molecular Detection System を用いた Listeria monocytogenes の 簡易迅速遺伝子検査法の評価 Evaluation of 3M Molecular Detection System for detecting Listeria monocytogenes from food
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資料 3 ISO 22000 改訂状況について FCP 第 4 回国際標準に関する勉強会 2015 年 11 月 27 日 ( 金 ) 東京海洋大学先端科学技術研究センター教授湯川剛一郎技術士 ( 総合技術監理部門 農業部門 ( 食品化学 )) 1 目次 1. 現行のISO 22000について 2. 規格検討の経緯 3. 改訂の背景 4. 改訂に係る議論 5. 今後の予定 2 1 現行の ISO 22000
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