JP6521351B2 - ウィルス不活化およびサンプリング装置 - Google Patents

ウィルス不活化およびサンプリング装置 Download PDF

Info

Publication number
JP6521351B2
JP6521351B2 JP2014210087A JP2014210087A JP6521351B2 JP 6521351 B2 JP6521351 B2 JP 6521351B2 JP 2014210087 A JP2014210087 A JP 2014210087A JP 2014210087 A JP2014210087 A JP 2014210087A JP 6521351 B2 JP6521351 B2 JP 6521351B2
Authority
JP
Japan
Prior art keywords
liquid drug
drug substance
sampling
line
bag
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.)
Active
Application number
JP2014210087A
Other languages
English (en)
Japanese (ja)
Other versions
JP2016077190A (ja
JP2016077190A5 (enExample
Inventor
伊藤　博史
博史 伊藤
和哉 中川
和哉 中川
洋一 橘田
洋一 橘田
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
TEC Project Services Corp
Original Assignee
TEC Project Services Corp
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by TEC Project Services Corp filed Critical TEC Project Services Corp
Priority to JP2014210087A priority Critical patent/JP6521351B2/ja
Priority to PCT/JP2015/076076 priority patent/WO2016059925A1/ja
Priority to US15/513,778 priority patent/US10391187B2/en
Publication of JP2016077190A publication Critical patent/JP2016077190A/ja
Publication of JP2016077190A5 publication Critical patent/JP2016077190A5/ja
Application granted granted Critical
Publication of JP6521351B2 publication Critical patent/JP6521351B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • 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
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0082—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using chemical substances
    • A61L2/0088—Liquid substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/76—Viruses; Subviral particles; Bacteriophages
    • 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
    • A61L2/24—Apparatus using programmed or automatic operation
    • 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
    • A61L2/26—Accessories or devices or components used for biocidal treatment
    • A61L2/28—Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/12—Apparatus for isolating biocidal substances from the environment
    • A61L2202/123—Connecting means
    • 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
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/15—Biocide distribution means, e.g. nozzles, pumps, manifolds, fans, baffles, sprayers
    • 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
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/21—Pharmaceuticals, e.g. medicaments, artificial body parts

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Virology (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biotechnology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Mycology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
JP2014210087A 2014-10-14 2014-10-14 ウィルス不活化およびサンプリング装置 Active JP6521351B2 (ja)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2014210087A JP6521351B2 (ja) 2014-10-14 2014-10-14 ウィルス不活化およびサンプリング装置
PCT/JP2015/076076 WO2016059925A1 (ja) 2014-10-14 2015-09-15 ウィルス不活化およびサンプリング装置
US15/513,778 US10391187B2 (en) 2014-10-14 2015-09-15 Apparatus for virus inactivation and sampling

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP2014210087A JP6521351B2 (ja) 2014-10-14 2014-10-14 ウィルス不活化およびサンプリング装置

Publications (3)

Publication Number Publication Date
JP2016077190A JP2016077190A (ja) 2016-05-16
JP2016077190A5 JP2016077190A5 (enExample) 2016-06-23
JP6521351B2 true JP6521351B2 (ja) 2019-05-29

Family

ID=55746473

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2014210087A Active JP6521351B2 (ja) 2014-10-14 2014-10-14 ウィルス不活化およびサンプリング装置

Country Status (3)

Country Link
US (1) US10391187B2 (enExample)
JP (1) JP6521351B2 (enExample)
WO (1) WO2016059925A1 (enExample)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3621715A4 (en) * 2017-05-11 2021-01-27 EMD Millipore Corporation MECHANICAL PROCEDURE FOR MAINTAINING TIGHT DISTRIBUTION OF DWELL TIME IN CONTINUOUS FLOW SYSTEMS
CA3062519A1 (en) 2017-05-11 2018-11-15 Emd Millipore Corporation Method of maintaining narrow residence time distributions in continuous flow systems using solid material packet interfaces
DE102017124840B3 (de) 2017-10-24 2018-12-13 Testo SE & Co. KGaA Inkubator, Probenbehälter, Set und Verfahren zur Untersuchung eines Probenmaterials
EP3599275A1 (fr) 2018-07-27 2020-01-29 EMD Millipore Corporation Installation de traitement de liquide biologique
EP3666881A1 (en) 2018-12-12 2020-06-17 AIT Austrian Institute of Technology GmbH Coupled sorting and electric treatment of biological cells
CA3130894A1 (en) 2019-02-20 2020-08-27 Emd Millipore Corporation Device for bind and elute chromatography using membranes, and method of manufacture
BE1029567B1 (fr) * 2021-07-05 2023-02-06 Vesale Bioscience Procede de production de bacteriophages

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6029150A (ja) * 1983-07-26 1985-02-14 テルモ株式会社 血液採取装置
JP4045475B2 (ja) 1999-09-06 2008-02-13 東洋紡績株式会社 核酸・蛋白質精製装置
ES2184594B1 (es) 2001-01-17 2004-01-01 Probitas Pharma Sa Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.
SI1561756T1 (sl) 2002-09-11 2016-02-29 Chugai Seiyaku Kabushiki Kaisha Postopek čiščenja proteinov
US7055401B2 (en) * 2004-03-15 2006-06-06 Haemonetics Corporation Closed method and system for the sampling and testing of fluid
GB0425266D0 (en) * 2004-11-16 2004-12-15 Norton Healthcare Ltd Pharmaceutical manufacturing process
JP5505853B2 (ja) 2007-02-13 2014-05-28 味の素株式会社 微酸性アルギニンを添加剤とするウイルス不活化法
CN104411820B (zh) * 2012-06-29 2017-05-03 Emd密理博公司 在蛋白纯化过程中灭活病毒的方法

Also Published As

Publication number Publication date
JP2016077190A (ja) 2016-05-16
US20180228927A1 (en) 2018-08-16
US10391187B2 (en) 2019-08-27
WO2016059925A1 (ja) 2016-04-21

Similar Documents

Publication Publication Date Title
JP6521351B2 (ja) ウィルス不活化およびサンプリング装置
EP2943233B1 (en) Method for the filling of containers with autologous fresh blood components
CN105228653B (zh) 整合有吹塑灌装密封机的自动消毒工艺
US20240366849A1 (en) Peritoneal Dialysis Fluid Preparation and/or Treatment Devices Methods and Systems
JP6586427B2 (ja) 送風／充填／シール装置用滅菌システム
US20160368629A1 (en) Systems and methods for aliquoting fluids
JP2016077190A5 (enExample)
JP6986129B2 (ja) 処理装置
US20080058755A1 (en) Method and Apparatus for Sterilely Acquiring and Separating a Fluid
CN102728253A (zh) 外部混合装置
CN111741739A (zh) 用于填充用于透析的溶液袋的设备和方法
US11911547B2 (en) Apparatus and method for manufacturing ready-to-use solutions for peritoneal dialysis
CA2970629C (en) Method for filling containers with fresh blood components
JP6955306B2 (ja) 処理装置
WO1994027645A1 (en) System for packaging and delivering of a sterile powder medium
CN209847880U (zh) 一种塑料安瓿的输液制剂制备系统
CN209468119U (zh) 一种塑料安瓿的输液制剂制备系统
WO1994028944A1 (en) System for packaging and delivering of a sterile powder medium
CN109731109B (zh) 一种塑料安瓿的输液制剂的制备系统及预处理方法
CN117529446A (zh) 一种载体液无菌分装系统及其应用
KR20190111038A (ko) 무균 공정으로부터 비-무균 폐기물의 제거
CN110087483A (zh) 食物配料转移设备
BR112021001436B1 (pt) Método de enchimento de pelo menos um medicamento desgaseificado em recipientes e dispositivo de enchimento de medicamento

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20160302

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20170904

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20180905

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20181019

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20190326

A711 Notification of change in applicant

Free format text: JAPANESE INTERMEDIATE CODE: A711

Effective date: 20190405

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A821

Effective date: 20190405

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20190418

R150 Certificate of patent or registration of utility model

Ref document number: 6521351

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

S531 Written request for registration of change of domicile

Free format text: JAPANESE INTERMEDIATE CODE: R313531

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R350 Written notification of registration of transfer

Free format text: JAPANESE INTERMEDIATE CODE: R350