JP4785725B2 - 膜型ウイルス除去フィルターの完全性試験自動測定装置及びその制御方法 - Google Patents
膜型ウイルス除去フィルターの完全性試験自動測定装置及びその制御方法 Download PDFInfo
- Publication number
- JP4785725B2 JP4785725B2 JP2006336649A JP2006336649A JP4785725B2 JP 4785725 B2 JP4785725 B2 JP 4785725B2 JP 2006336649 A JP2006336649 A JP 2006336649A JP 2006336649 A JP2006336649 A JP 2006336649A JP 4785725 B2 JP4785725 B2 JP 4785725B2
- Authority
- JP
- Japan
- Prior art keywords
- virus removal
- removal filter
- membrane
- tank
- filtrate
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
- 241000700605 Viruses Species 0.000 title claims description 140
- 239000012528 membrane Substances 0.000 title claims description 86
- 238000000034 method Methods 0.000 title claims description 24
- 238000012061 filter integrity test Methods 0.000 title claims description 15
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 claims description 125
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 117
- 239000000706 filtrate Substances 0.000 claims description 84
- 239000000243 solution Substances 0.000 claims description 82
- 238000002835 absorbance Methods 0.000 claims description 54
- 238000012360 testing method Methods 0.000 claims description 42
- 239000007788 liquid Substances 0.000 claims description 31
- 239000012530 fluid Substances 0.000 claims description 26
- 238000005259 measurement Methods 0.000 claims description 23
- 239000011550 stock solution Substances 0.000 claims description 21
- 238000001914 filtration Methods 0.000 claims description 17
- 238000011481 absorbance measurement Methods 0.000 claims description 15
- 230000005484 gravity Effects 0.000 claims description 7
- 239000002245 particle Substances 0.000 claims description 4
- 239000002699 waste material Substances 0.000 claims description 4
- 239000007789 gas Substances 0.000 description 59
- 239000000463 material Substances 0.000 description 19
- 239000012510 hollow fiber Substances 0.000 description 9
- 239000012085 test solution Substances 0.000 description 7
- 238000005406 washing Methods 0.000 description 7
- 229960000074 biopharmaceutical Drugs 0.000 description 6
- 238000005194 fractionation Methods 0.000 description 6
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- 239000011347 resin Substances 0.000 description 6
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- 239000000428 dust Substances 0.000 description 5
- 238000004519 manufacturing process Methods 0.000 description 5
- 239000011521 glass Substances 0.000 description 4
- 229910001220 stainless steel Inorganic materials 0.000 description 4
- 239000010935 stainless steel Substances 0.000 description 4
- 238000012549 training Methods 0.000 description 4
- 238000011016 integrity testing Methods 0.000 description 3
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- 229910052710 silicon Inorganic materials 0.000 description 3
- 239000010703 silicon Substances 0.000 description 3
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- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 241000711549 Hepacivirus C Species 0.000 description 2
- 241000725303 Human immunodeficiency virus Species 0.000 description 2
- -1 antibodies Proteins 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 238000004140 cleaning Methods 0.000 description 2
- 238000011109 contamination Methods 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 238000010828 elution Methods 0.000 description 2
- 238000004382 potting Methods 0.000 description 2
- 230000037452 priming Effects 0.000 description 2
- 230000001105 regulatory effect Effects 0.000 description 2
- 102000015081 Blood Coagulation Factors Human genes 0.000 description 1
- 108010039209 Blood Coagulation Factors Proteins 0.000 description 1
- 102000004127 Cytokines Human genes 0.000 description 1
- 108090000695 Cytokines Proteins 0.000 description 1
- MYMOFIZGZYHOMD-UHFFFAOYSA-N Dioxygen Chemical compound O=O MYMOFIZGZYHOMD-UHFFFAOYSA-N 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 102000003951 Erythropoietin Human genes 0.000 description 1
- 108090000394 Erythropoietin Proteins 0.000 description 1
- 241000700721 Hepatitis B virus Species 0.000 description 1
- 102000015696 Interleukins Human genes 0.000 description 1
- 108010063738 Interleukins Proteins 0.000 description 1
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 description 1
- BZHJMEDXRYGGRV-UHFFFAOYSA-N Vinyl chloride Chemical compound ClC=C BZHJMEDXRYGGRV-UHFFFAOYSA-N 0.000 description 1
- 230000005856 abnormality Effects 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- NIXOWILDQLNWCW-UHFFFAOYSA-N acrylic acid group Chemical group C(C=C)(=O)O NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 description 1
- 239000003513 alkali Substances 0.000 description 1
- 239000003114 blood coagulation factor Substances 0.000 description 1
- 229940019700 blood coagulation factors Drugs 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
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- 229940105423 erythropoietin Drugs 0.000 description 1
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- 239000000203 mixture Substances 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
- OXCMYAYHXIHQOA-UHFFFAOYSA-N potassium;[2-butyl-5-chloro-3-[[4-[2-(1,2,4-triaza-3-azanidacyclopenta-1,4-dien-5-yl)phenyl]phenyl]methyl]imidazol-4-yl]methanol Chemical compound [K+].CCCCC1=NC(Cl)=C(CO)N1CC1=CC=C(C=2C(=CC=CC=2)C2=N[N-]N=N2)C=C1 OXCMYAYHXIHQOA-UHFFFAOYSA-N 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
Images
Landscapes
- Separation Using Semi-Permeable Membranes (AREA)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2006336649A JP4785725B2 (ja) | 2006-12-14 | 2006-12-14 | 膜型ウイルス除去フィルターの完全性試験自動測定装置及びその制御方法 |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2006336649A JP4785725B2 (ja) | 2006-12-14 | 2006-12-14 | 膜型ウイルス除去フィルターの完全性試験自動測定装置及びその制御方法 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2008149205A JP2008149205A (ja) | 2008-07-03 |
| JP2008149205A5 JP2008149205A5 (https=) | 2010-02-12 |
| JP4785725B2 true JP4785725B2 (ja) | 2011-10-05 |
Family
ID=39651998
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2006336649A Expired - Fee Related JP4785725B2 (ja) | 2006-12-14 | 2006-12-14 | 膜型ウイルス除去フィルターの完全性試験自動測定装置及びその制御方法 |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP4785725B2 (https=) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2019229872A1 (ja) * | 2018-05-30 | 2019-12-05 | 旭化成メディカル株式会社 | リーク検出装置およびリーク検出方法 |
| CN111474311B (zh) * | 2020-04-30 | 2025-04-25 | 深圳安吉尔饮水产业集团有限公司 | 病原微生物加标试验舱 |
| US12076721B2 (en) * | 2021-05-03 | 2024-09-03 | Asahi Kasei Bioprocess America, Inc. | Systems and methods for testing the integrity of a virus removal filter |
| KR102851184B1 (ko) * | 2024-01-05 | 2025-08-27 | 한국캠브리지필터 주식회사 | 필터 완전성 테스트 자동화 시스템 |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP3328857B2 (ja) * | 1993-11-10 | 2002-09-30 | 旭化成株式会社 | ウイルス除去膜のインテグリティテスト方法 |
| US6730227B2 (en) * | 2002-03-28 | 2004-05-04 | Nalco Company | Method of monitoring membrane separation processes |
| JP2005040756A (ja) * | 2003-07-25 | 2005-02-17 | Asahi Kasei Pharma Kk | ウイルス除去及び洗浄、完全性試験のシステム |
| JP2006055784A (ja) * | 2004-08-23 | 2006-03-02 | Asahi Kasei Corp | 多孔性分離膜の洗浄方法 |
-
2006
- 2006-12-14 JP JP2006336649A patent/JP4785725B2/ja not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| JP2008149205A (ja) | 2008-07-03 |
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