WO1991016410A1 - Procede de nettoyage minutieux de dispositifs medicaux - Google Patents

Procede de nettoyage minutieux de dispositifs medicaux Download PDF

Info

Publication number
WO1991016410A1
WO1991016410A1 PCT/US1991/002379 US9102379W WO9116410A1 WO 1991016410 A1 WO1991016410 A1 WO 1991016410A1 US 9102379 W US9102379 W US 9102379W WO 9116410 A1 WO9116410 A1 WO 9116410A1
Authority
WO
WIPO (PCT)
Prior art keywords
choline
weight
concentration
present
surfactant
Prior art date
Application number
PCT/US1991/002379
Other languages
English (en)
Inventor
E. Wayne Ahlstrom
Original Assignee
Mallinckrodt Specialty Chemicals Company
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 Mallinckrodt Specialty Chemicals Company filed Critical Mallinckrodt Specialty Chemicals Company
Priority to JP91507454A priority Critical patent/JPH05506049A/ja
Publication of WO1991016410A1 publication Critical patent/WO1991016410A1/fr

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/43—Solvents
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/16—Organic compounds
    • C11D3/26—Organic compounds containing nitrogen
    • C11D3/30—Amines; Substituted amines ; Quaternized amines

Definitions

  • the present invention relates to the field of cleaning medical devices prior to use. Description of the Background Art
  • Modern medical devices such as heart valves, pacemakers, medical parts and tubing, surgical equipment, and the like, are constructed of materials such as stainless steel, pyrolytic carbon, titanium, silicon, butyl rubber, and various plastics such as polyethylene, polypropylene, polyurethane, and the like.
  • the surfaces of such medical parts often become contaminated with particulate material such as carbon and polish residues, as well as endotoxins and various organic contaminants such as cytotoxic fatty acid residues.
  • the surf ces of medical parts can also become contaminated with ions, and may also require depyrogenation.
  • Hot hydrogen peroxide has been used in the depyrogenation of medical parts, but has not been shown to be particularly effective therefor.
  • Hot sodium hydroxide 5. has also been used for this purpose.
  • US 4,592,856 (Shin-Etsu Chemical/Kobayashi; 86.06.03) discloses a liquid detergent composition comprised of a 5 halogenated hydrocarbon solvent including e.g. a quatenary ammonium hydroxide such as choline (see col. 3) for use in cleaning shaped plastic articles or the glass or metal molds for the preparation of resin articles.
  • a 5 halogenated hydrocarbon solvent including e.g. a quatenary ammonium hydroxide such as choline (see col. 3) for use in cleaning shaped plastic articles or the glass or metal molds for the preparation of resin articles.
  • US 4,239,661 (Tokyo shibaura Elec./Muraoka; 80.12.16) 0 and US 4,339,340 (Tokyo Shibaura Elec./Muraoka; 82.07.13) disclose a surface-treating agent formed of an aqueous solution containing 0.01-20% by weight of trialkyl (hydroxyalkyl)ammonium hydroxide for the removal of organic or inorganic contaminants on the surfaces of intermediate 5 semiconductor products.
  • trialkyl (hydroxyalkyl)ammonium hydroxide for the removal of organic or inorganic contaminants on the surfaces of intermediate 5 semiconductor products.
  • a method for precision cleaning of medical devices comprises contacting a medical device with a cleansing agent comprising choline, so as to remove pyrogens from the medical device.
  • the present invention utilizes choline to solve various cleaning problems incurred during the manufacture and final packaging of medical devices such as heart valves, pacemakers, invasive devices such as surgical instruments, catheters, tubing for life supporting fluids such as blood, serum, glucose solutions, and the like, manufactured from such materials as stainless steel, pyrolytic carbon, titanium silicon, butyl rubber, and various plastics such as polyethylene, polypropylene, polyurethane , etc.
  • medical devices such as heart valves, pacemakers, invasive devices such as surgical instruments, catheters, tubing for life supporting fluids such as blood, serum, glucose solutions, and the like, manufactured from such materials as stainless steel, pyrolytic carbon, titanium silicon, butyl rubber, and various plastics such as polyethylene, polypropylene, polyurethane , etc.
  • the choline can be present in a solution which may be aqueous or non-aqueous.
  • aqueous or non-aqueous solvents which may be utilized to form choline solutions in accordance with the present invention include methanol, ethanol, and propanol.
  • Non-aqueous choline- containing cleansing agents for use in the present invention may also contain surfactant at concentrations of from about 0.01% to about 2% by weight, in addition to the choline and non-aqueous solvent.
  • choline When utilizing aqueous solutions, choline generally is present in the solution at a concentration of from about 0.01% to about 20% by weight, preferably at a concentration of from about 0.05% to about 4% by weight, and most preferably at a concentration of from about 0.1% to about 2% by weight.
  • Aqueous choline- containing cleansing agents for use in the present invention may also contain surfactant at concentrations of from about 0.01% to about 2% by weight, in addition to the choline and aqueous solvent.
  • an aqueous choline solution for use in accordance with the present invention includes a surfactant at a concentration of from about 0.05% to about 0.5% by weight.
  • the surfactant is a nonionic surfactant, such as nonylphenyl polyethoxy nonionic surfactant, polyoxyethylene sorbitan mono-oleate surfactant, and other water soluble or dispersable U.S.P. grade surfactants.
  • An aqueous choline-containing cleansing agent for use in accordance with the present invention can also include a lower alkanol, having, for example, from 1 to about 3 carbon atoms, the lower alkanol being in the aqueous solution at a concentration of from about 0.1% to about 0.6% by weight.
  • the lower alkanol is methanol.
  • the surface of the medical device to be cleaned is contacted with the choline-containing cleansing agent for a period of from about 1 to about 10 minutes at a temperature of from about 30°C to about 60 ⁇ C.
  • the surface to be cleaned is submerged in the choline solution and agitated during the cleansing treatment. Following the cleansing treatment with the choline solution, the treated surface is vigorously rinsed with water for injection or equal quality water and/or isopropyl alcohol, dried, and then packaged for shipment and subsequent use.
  • EXAMPLE 1 A choline solution including 0.5% by weight choline base, 0.45% by weight methanol, 0.3% by weight nonylphenyl polyethoxy nonionic surfactant and the balance water was evaluated for depyrogenation of materials used in medical device construction. The materials tested were as follows.
  • Duplicate samples of each material were placed in separate Corning tubes for subsequent treatment and ov lu ticn.
  • One set of samples were treated by washing with LAL reagent water at 37°C with agitation for 10 minutes.
  • a second set were exposed to the choline solution under identical conditions.
  • the wash solutions were discarded, and all samples were extracted with LAL reagent water and the extract subjected to LAL testing. The results are shown in
  • the tested choline solution was shown to destroy the LAL reactivity of LPS upon exposure for 30 minutes at 37°C. Specifically, a concentration of LPS of l.Oug/ml was completely inactivated. This concentration is approximately 2,000 times the level which is permissible in medical device extracts (0.05ng.ml) .
  • the tested choline solution was also effective in the depyrogenation of surfaces of all of the materials tested. Furthermore, the tested choline solution left no interfering residues and had no observable effect on any of the tested materials (embrittlenient, discoloration, etc.). The tested choline solution appears to be more effective in depyrogenation of Lyophilization stoppers than hot hydrogen peroxide
  • the tested choline solution has the advantage that it does not appear to chemically attack the stopper material. Vigorous washing with pyrogen-free water was ineffective in removing LPS from all of the surfaces tested. This has important implications with respect to the adequacy of current test procedures for devices as well as for manuf cturing practices. One such implication is that in the case of devices which are
  • pyrogen testing by aqueous extract may not disclose endotoxins which remain adherent to the surfaces of the device and thus may permit exposure.
  • EXAMPLE 2 Heart valves were cleaned with the choline solution tested in Example 1 at 37°C for 30 minutes and thereafter tested for fatty acid residues. No fatty acids were detected on the cleaned heart valves.
  • EXAMPLE 3 Heart valves cleaned in accordance with the procedures set forth in Example 2 were compared to a heart valve cleaned by a conventional vapor degreaser cleaning procedure utilizing Freon, for the presence of surface carbon on the heart valves.
  • the heart valve cleaned by the conventional vapor degreaser cleaning procedure had the highest surface carbon.
  • the present invention provides a particularly effective method for precision cleaning of medical devices without the environmental and regulatory problems of conventional processes utilizing cholorofluorocarbons such as Freon. Since many modifications, variations and changes in detail may be made to the described embodiments, it is intended that all matter in the foregoing description be interpreted as illustrative and not in a limiting sense.

Landscapes

  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Wood Science & Technology (AREA)
  • Organic Chemistry (AREA)
  • Detergent Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

Un dispositif médical est minutieusement nettoyé en étant mis en contact avec un agent nettoyant contenant de la choline, cela permettant d'enlever les pyrogènes dudit dispositif médical.
PCT/US1991/002379 1990-04-12 1991-04-08 Procede de nettoyage minutieux de dispositifs medicaux WO1991016410A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP91507454A JPH05506049A (ja) 1990-04-12 1991-04-08 医療用装置の精密洗浄法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US50781090A 1990-04-12 1990-04-12
US507,810 1990-04-12

Publications (1)

Publication Number Publication Date
WO1991016410A1 true WO1991016410A1 (fr) 1991-10-31

Family

ID=24020233

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1991/002379 WO1991016410A1 (fr) 1990-04-12 1991-04-08 Procede de nettoyage minutieux de dispositifs medicaux

Country Status (5)

Country Link
EP (1) EP0525013A1 (fr)
JP (1) JPH05506049A (fr)
AU (1) AU7659391A (fr)
CA (1) CA2075633A1 (fr)
WO (1) WO1991016410A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012177276A1 (fr) * 2011-06-22 2012-12-27 Colgate-Palmolive Company Compositions de nettoyage à base d'un sel de choline
WO2017058563A1 (fr) * 2015-10-02 2017-04-06 Ethicon, Inc. Procédés et systèmes pour traiter des dispositifs et des fluides médicaux

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4647911B2 (ja) * 2001-12-26 2011-03-09 日本メジフィジックス株式会社 エンドトキシン除去用組成物及び除去方法

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1573208A (en) * 1975-11-26 1980-08-20 Tokyo Shibaura Electric Ltd Surface treating agent adapted for intermediate products of a semiconductor device
US4339340A (en) * 1975-11-26 1982-07-13 Tokyo Shibaura Electric Co., Ltd. Surface-treating agent adapted for intermediate products of a semiconductor device
US4592856A (en) * 1983-11-14 1986-06-03 Shin-Etsu Chemical Co., Ltd. Liquid detergent composition
US4686002A (en) * 1986-07-18 1987-08-11 Syntex (U.S.A.) Inc. Stabilized choline base solutions

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1573208A (en) * 1975-11-26 1980-08-20 Tokyo Shibaura Electric Ltd Surface treating agent adapted for intermediate products of a semiconductor device
US4339340A (en) * 1975-11-26 1982-07-13 Tokyo Shibaura Electric Co., Ltd. Surface-treating agent adapted for intermediate products of a semiconductor device
US4592856A (en) * 1983-11-14 1986-06-03 Shin-Etsu Chemical Co., Ltd. Liquid detergent composition
US4686002A (en) * 1986-07-18 1987-08-11 Syntex (U.S.A.) Inc. Stabilized choline base solutions

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012177276A1 (fr) * 2011-06-22 2012-12-27 Colgate-Palmolive Company Compositions de nettoyage à base d'un sel de choline
US8901061B2 (en) 2011-06-22 2014-12-02 Colgate-Palmolive Company Choline salt cleaning compositions
WO2017058563A1 (fr) * 2015-10-02 2017-04-06 Ethicon, Inc. Procédés et systèmes pour traiter des dispositifs et des fluides médicaux
CN108136062A (zh) * 2015-10-02 2018-06-08 伊西康公司 用于处理医疗装置和流体的方法和系统

Also Published As

Publication number Publication date
JPH05506049A (ja) 1993-09-02
AU7659391A (en) 1991-11-11
EP0525013A1 (fr) 1993-02-03
CA2075633A1 (fr) 1991-10-13

Similar Documents

Publication Publication Date Title
JP3058656B2 (ja) コンタクトレンズ用液剤組成物及びそれを用いたコンタクトレンズの洗浄若しくは保存方法
JP4484514B2 (ja) 酸化剤ベースの処方物を用いるプリオンに感染した物質で汚染された表面の汚染除去
DK166590B1 (da) Anvendelse af ethoxylerede fedtaminer som oploesningsformidlere
US20100006121A1 (en) Plasma cleaning method
JPH09512586A (ja) 外科用器具用洗浄剤
JP2009543904A (ja) 低発泡性洗浄剤
JP2005292849A (ja) コンタクトレンズを洗浄および消毒するための炭水化物組成物および方法
AU703790B2 (en) A process for cleaning and disinfecting sensitive medical instruments
CN108676629A (zh) 去血渍清洗剂及其制备方法
RU2370283C2 (ru) Машинная дезинфекция предметов
US10669513B2 (en) Compositions and methods for handling potential prion contamination
US5110367A (en) Method for precision cleaning of medical devices
WO1991016410A1 (fr) Procede de nettoyage minutieux de dispositifs medicaux
US8142714B2 (en) Cleaning and disinfection of surgical and medical instruments and appliances
JP3986440B2 (ja) 酵素前処理を用いる乳製品加工パイプラインの洗浄方法
JP2009544813A (ja) 水溶性バリヤーフィルム絶縁保護被覆組成物および医療器具の表面を清浄化するための方法
Hoover et al. Cleaning challenges: Can extended soil dry times be reversed?
Polonini et al. Development of a standardized procedure for cleaning glass apparatus in analytical laboratories
US9045718B2 (en) Residue cleaning composition and method
CN111321418B (zh) 一种高效重油污清洗剂及其制备方法以及重油污清洗方法
Buhl et al. Durability and stability of antimicrobial coated surfaces
JP3861166B2 (ja) 酵素含有洗浄剤組成物
WO2015009926A1 (fr) Composition de prétraitement, composition de nettoyage de résidus, et procédé d'utilisation
JP3825812B2 (ja) 固体表面の処理剤
AU2013205960A1 (en) Improved Hygiene System

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AU CA JP

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): AT BE CH DE DK ES FR GB GR IT LU NL SE

WWE Wipo information: entry into national phase

Ref document number: 1991907649

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 2075633

Country of ref document: CA

WWP Wipo information: published in national office

Ref document number: 1991907649

Country of ref document: EP

WWR Wipo information: refused in national office

Ref document number: 1991907649

Country of ref document: EP

WWW Wipo information: withdrawn in national office

Ref document number: 1991907649

Country of ref document: EP