CA2115069C - Method of checking the rate of removal of pyrogenic substances, in particular viruses, from organic material - Google Patents
Method of checking the rate of removal of pyrogenic substances, in particular viruses, from organic material Download PDFInfo
- Publication number
- CA2115069C CA2115069C CA002115069A CA2115069A CA2115069C CA 2115069 C CA2115069 C CA 2115069C CA 002115069 A CA002115069 A CA 002115069A CA 2115069 A CA2115069 A CA 2115069A CA 2115069 C CA2115069 C CA 2115069C
- Authority
- CA
- Canada
- Prior art keywords
- pressure
- ultrafilter
- ultrafiltration unit
- decrease
- ultrafiltration
- 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 abstract description 54
- 239000000126 substance Substances 0.000 title claims abstract description 13
- 239000011368 organic material Substances 0.000 title claims abstract description 12
- 230000001698 pyrogenic effect Effects 0.000 title claims abstract description 11
- 238000000034 method Methods 0.000 title claims description 42
- 238000012360 testing method Methods 0.000 claims abstract description 32
- 238000000108 ultra-filtration Methods 0.000 claims abstract description 29
- 230000007423 decrease Effects 0.000 claims abstract description 20
- 241001515965 unidentified phage Species 0.000 claims abstract description 7
- 241000714210 Leviviridae Species 0.000 claims abstract description 5
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 18
- 239000000243 solution Substances 0.000 claims description 17
- 239000002510 pyrogen Substances 0.000 claims description 11
- 239000007789 gas Substances 0.000 claims description 10
- 230000001717 pathogenic effect Effects 0.000 claims description 9
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 8
- 239000007864 aqueous solution Substances 0.000 claims description 7
- 230000006641 stabilisation Effects 0.000 claims description 7
- 238000011105 stabilization Methods 0.000 claims description 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 7
- 238000005259 measurement Methods 0.000 claims description 5
- 244000052769 pathogen Species 0.000 claims description 5
- 230000000717 retained effect Effects 0.000 claims description 5
- 239000001307 helium Substances 0.000 claims description 4
- 229910052734 helium Inorganic materials 0.000 claims description 4
- SWQJXJOGLNCZEY-UHFFFAOYSA-N helium atom Chemical compound [He] SWQJXJOGLNCZEY-UHFFFAOYSA-N 0.000 claims description 4
- 239000001257 hydrogen Substances 0.000 claims description 4
- 229910052739 hydrogen Inorganic materials 0.000 claims description 4
- 229910052757 nitrogen Inorganic materials 0.000 claims description 4
- 239000003960 organic solvent Substances 0.000 claims description 4
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims description 3
- 239000000203 mixture Substances 0.000 claims description 3
- 239000001301 oxygen Substances 0.000 claims description 3
- 229910052760 oxygen Inorganic materials 0.000 claims description 3
- 239000003570 air Substances 0.000 claims 2
- 239000012670 alkaline solution Substances 0.000 claims 2
- 125000004435 hydrogen atom Chemical class [H]* 0.000 claims 2
- 238000001914 filtration Methods 0.000 abstract description 43
- 239000000463 material Substances 0.000 abstract description 8
- 239000012620 biological material Substances 0.000 abstract description 3
- 238000004519 manufacturing process Methods 0.000 description 11
- 241000894006 Bacteria Species 0.000 description 8
- 241001465754 Metazoa Species 0.000 description 6
- 239000000706 filtrate Substances 0.000 description 6
- 229920001817 Agar Polymers 0.000 description 4
- 239000008272 agar Substances 0.000 description 4
- 230000002779 inactivation Effects 0.000 description 4
- 238000000746 purification Methods 0.000 description 4
- 238000010200 validation analysis Methods 0.000 description 4
- 238000011109 contamination Methods 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 230000014759 maintenance of location Effects 0.000 description 3
- 239000012528 membrane Substances 0.000 description 3
- 239000000047 product Substances 0.000 description 3
- 239000007858 starting material Substances 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 2
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 230000001580 bacterial effect Effects 0.000 description 2
- 239000012141 concentrate Substances 0.000 description 2
- 230000006378 damage Effects 0.000 description 2
- 230000003247 decreasing effect Effects 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000000284 extract Substances 0.000 description 2
- 239000011261 inert gas Substances 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- 238000011146 sterile filtration Methods 0.000 description 2
- 210000001541 thymus gland Anatomy 0.000 description 2
- 244000000009 viral human pathogen Species 0.000 description 2
- YLZOPXRUQYQQID-UHFFFAOYSA-N 3-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)-1-[4-[2-[[3-(trifluoromethoxy)phenyl]methylamino]pyrimidin-5-yl]piperazin-1-yl]propan-1-one Chemical compound N1N=NC=2CN(CCC=21)CCC(=O)N1CCN(CC1)C=1C=NC(=NC=1)NCC1=CC(=CC=C1)OC(F)(F)F YLZOPXRUQYQQID-UHFFFAOYSA-N 0.000 description 1
- 108091003079 Bovine Serum Albumin Proteins 0.000 description 1
- 241000709738 Enterobacteria phage fr Species 0.000 description 1
- 102000000429 Factor XII Human genes 0.000 description 1
- 108010080865 Factor XII Proteins 0.000 description 1
- 241000282412 Homo Species 0.000 description 1
- 238000012369 In process control Methods 0.000 description 1
- 241000709664 Picornaviridae Species 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 239000003637 basic solution Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 229940098773 bovine serum albumin Drugs 0.000 description 1
- 229940041514 candida albicans extract Drugs 0.000 description 1
- 238000004113 cell culture Methods 0.000 description 1
- 238000012512 characterization method Methods 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000005202 decontamination Methods 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 241001493065 dsRNA viruses Species 0.000 description 1
- 230000007717 exclusion Effects 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 238000010965 in-process control Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 229910052500 inorganic mineral Inorganic materials 0.000 description 1
- 230000010354 integration Effects 0.000 description 1
- 239000013067 intermediate product Substances 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 150000002576 ketones Chemical class 0.000 description 1
- 239000011707 mineral Substances 0.000 description 1
- 150000007522 mineralic acids Chemical class 0.000 description 1
- 239000006916 nutrient agar Substances 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 150000007524 organic acids Chemical class 0.000 description 1
- 235000005985 organic acids Nutrition 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- -1 propaaol Chemical compound 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 238000011896 sensitive detection Methods 0.000 description 1
- UQDJGEHQDNVPGU-UHFFFAOYSA-N serine phosphoethanolamine Chemical group [NH3+]CCOP([O-])(=O)OCC([NH3+])C([O-])=O UQDJGEHQDNVPGU-UHFFFAOYSA-N 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 238000012418 validation experiment Methods 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
- 239000012138 yeast extract Substances 0.000 description 1
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
- B01D61/14—Ultrafiltration; Microfiltration
- B01D61/145—Ultrafiltration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/022—Filtration
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
- B01D61/14—Ultrafiltration; Microfiltration
- B01D61/22—Controlling or regulating
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D65/00—Accessories or auxiliary operations, in general, for separation processes or apparatus using semi-permeable membranes
- B01D65/10—Testing of membranes or membrane apparatus; Detecting or repairing leaks
- B01D65/102—Detection of leaks in membranes
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/70—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
Landscapes
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Water Supply & Treatment (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Immunology (AREA)
- General Health & Medical Sciences (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Physics & Mathematics (AREA)
- Virology (AREA)
- Molecular Biology (AREA)
- Biotechnology (AREA)
- Biophysics (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Engineering & Computer Science (AREA)
- Microbiology (AREA)
- Genetics & Genomics (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Separation Using Semi-Permeable Membranes (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Apparatus Associated With Microorganisms And Enzymes (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE4126034A DE4126034C1 (enrdf_load_stackoverflow) | 1991-08-06 | 1991-08-06 | |
| DEP4126034.1 | 1991-08-06 | ||
| PCT/DE1992/000653 WO1993002714A1 (de) | 1991-08-06 | 1992-08-05 | Verfahren zur kontrolle der abreicherungsrate von pyrogenen substanzen, insbesondere viren, in organischem material |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2115069A1 CA2115069A1 (en) | 1993-02-18 |
| CA2115069C true CA2115069C (en) | 2000-12-19 |
Family
ID=6437804
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002115069A Expired - Fee Related CA2115069C (en) | 1991-08-06 | 1992-08-05 | Method of checking the rate of removal of pyrogenic substances, in particular viruses, from organic material |
Country Status (6)
| Country | Link |
|---|---|
| EP (1) | EP0599981B1 (enrdf_load_stackoverflow) |
| AT (1) | ATE147274T1 (enrdf_load_stackoverflow) |
| AU (1) | AU2473392A (enrdf_load_stackoverflow) |
| CA (1) | CA2115069C (enrdf_load_stackoverflow) |
| DE (2) | DE4126034C1 (enrdf_load_stackoverflow) |
| WO (1) | WO1993002714A1 (enrdf_load_stackoverflow) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE4429558A1 (de) * | 1994-08-19 | 1996-02-22 | Sanorell Pharma Gmbh & Co | Verfahren zur Herstellung von infektionsfreien pharmazeutischen Präparaten und/oder Nahrungsmitteln aus infektiösem Material |
| DE10003811A1 (de) * | 2000-01-28 | 2001-08-09 | Sanorell Pharma Gmbh & Co | Verfahren zur Herstellung eines serumhaltigen Kulturmediums für Zellen sowie dessen Verwendung |
| FR2839897B1 (fr) * | 2002-05-24 | 2004-07-09 | Air Liquide | Procede de separation par impaction,de particules viables et reviviscentes d'un gaz ou d'un melange de gaz en contenant, dispositif et banc d'essai mis en oeuvre |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4808315A (en) * | 1986-04-28 | 1989-02-28 | Asahi Kasei Kogyo Kabushiki Kaisha | Porous hollow fiber membrane and a method for the removal of a virus by using the same |
| DE4003543A1 (de) * | 1990-02-06 | 1991-08-08 | Orpegen Med Molekularbioforsch | Verfahren zur abreicherung von viren in loesungen und zur bestimmung der abreicherungsrate von viren |
-
1991
- 1991-08-06 DE DE4126034A patent/DE4126034C1/de not_active Expired - Fee Related
-
1992
- 1992-08-05 WO PCT/DE1992/000653 patent/WO1993002714A1/de active IP Right Grant
- 1992-08-05 AT AT92918405T patent/ATE147274T1/de active
- 1992-08-05 EP EP92918405A patent/EP0599981B1/de not_active Expired - Lifetime
- 1992-08-05 DE DE59207860T patent/DE59207860D1/de not_active Expired - Lifetime
- 1992-08-05 CA CA002115069A patent/CA2115069C/en not_active Expired - Fee Related
- 1992-08-05 AU AU24733/92A patent/AU2473392A/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| AU2473392A (en) | 1993-03-02 |
| ATE147274T1 (de) | 1997-01-15 |
| EP0599981A1 (de) | 1994-06-08 |
| DE4126034C1 (enrdf_load_stackoverflow) | 1992-09-10 |
| CA2115069A1 (en) | 1993-02-18 |
| DE59207860D1 (de) | 1997-02-20 |
| WO1993002714A1 (de) | 1993-02-18 |
| EP0599981B1 (de) | 1997-01-08 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |