US3169906A - Method of sterilizing with alkylene oxide - Google Patents

Method of sterilizing with alkylene oxide Download PDF

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Publication number
US3169906A
US3169906A US152936A US15293661A US3169906A US 3169906 A US3169906 A US 3169906A US 152936 A US152936 A US 152936A US 15293661 A US15293661 A US 15293661A US 3169906 A US3169906 A US 3169906A
Authority
US
United States
Prior art keywords
aerosol
alkylene oxide
sterilizing
room temperature
alkylene
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 - Lifetime
Application number
US152936A
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English (en)
Inventor
Richard M Donchak
Joseph J May
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.)
Warner Chilcott Pharmaceuticals Inc
Original Assignee
Norwich Pharmacal Co
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 Norwich Pharmacal Co filed Critical Norwich Pharmacal Co
Priority to US152936A priority Critical patent/US3169906A/en
Priority to GB41919/62A priority patent/GB989036A/en
Priority to DEN22339A priority patent/DE1287255B/de
Priority to BR144633/62A priority patent/BR6244633D0/pt
Priority to DK490162AA priority patent/DK103089C/da
Priority to AT902162A priority patent/AT255659B/de
Application granted granted Critical
Publication of US3169906A publication Critical patent/US3169906A/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q17/00Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings
    • A61Q17/005Antimicrobial preparations
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L3/00Preservation of foods or foodstuffs, in general, e.g. pasteurising, sterilising, specially adapted for foods or foodstuffs
    • A23L3/34Preservation of foods or foodstuffs, in general, e.g. pasteurising, sterilising, specially adapted for foods or foodstuffs by treatment with chemicals
    • A23L3/3409Preservation of foods or foodstuffs, in general, e.g. pasteurising, sterilising, specially adapted for foods or foodstuffs by treatment with chemicals in the form of gases, e.g. fumigation; Compositions or apparatus therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/49Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A61K8/4973Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with oxygen as the only hetero atom
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/12Aerosols; Foams
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20Gaseous substances, e.g. vapours
    • A61L2/206Ethylene oxide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/22Phase substances, e.g. smokes, aerosols or sprayed or atomised substances

Definitions

  • Another advantage of the present invention is the fact that adequate proportions of alkylene oxide are retained within the pressurized dispenser throughout its use to prevent any contamination of the contents.
  • alkylene oxides useful in this invention are ethylene oxide and propylene oxide, particularly useful, however, is ethylene oxide which compound is considered the more active sterilant.
  • the alkylene oxides are preferably blended with an inert gaseous propellant such as carbon dioxide or nitrogen. Particularly useful, arethe commercially available Freon and Genitron propellants such as monochlorodifluroethane, trichloromonofluromethane and mixtures thereof.
  • the alkylene oxide is mixed with the propellant by introducing 40 to 1000 p.p.m. of alkylene oxide into a charged or liquified' cylinder of said propellant. Then the propellant-alkylene oxide mixture, normally in a liquid state, is introduced into the individual aerosol dispenser containing the topical pharmaceutical preparation and sealed therein under an internal pressure ,pf 15 to 100 p.s.i.g. by conventional means.
  • the alkylene oxide-propellant mixture will effectively sterilize the aerosol preparation in 2 to 60 days, the actual time for any particular preparation will be dependent upon the concentration of alkylene oxide and internal pressure of the aerosol dis- 4 to 5 weeks under normal aerosol Even at minimum concentrations of about 20 p.p.m. complete sterilization can be expected within about 2
  • the following example is illustrative of the present in vention:
  • Example I To determine the effectiveness of minute non-toxic concentrations of ethylene oxide as a sterilant, a topical pharmaceutical preparation having the following formulation was prepared:
  • the aerosol units to be tested were inoculated with spores of Bacillus subtilis. Inoculum 5,625,000 cells/ml. of the above formulation. (Spore count was determined by plate dilution method using heart infusion agar and distilled Water pH 5.7.) Bacillus subtilis spores were selected because of their known resistance to the antimicrobial agentFuracin. After inoculation, the test units were filled with 1.25 oz. avoir. of the above glycol-Furacin solution then the 25% by weight of trichloromonofluromethane was added followed by addition of 25% by weight of the monochlorodifluromethane ethylene oxide mixture.
  • the monochlorodifluroethane-ethylene oxide mixtures were prepared via a pressure burette such that the total concentration in the test units was varied from 500 to 0 p.p.m. The 0 p.p.m. being used as a control. Initial pressure within the test units was 18 p.s.i.g.
  • one 'cc. of the inoculated sample was sprayed into a Millipore filter and washed with one liter of sterile distilledwater. In this way, the Furacin was washed through; the filter leaving B. subtilz's spores on the filter. The filter was transferred to thioglycollate media'and incubated for 72 hours at 37 C. and checked for sterility. The units containing 500; 100 and 50 ppm. ethylene oxide were sterile; the unit containing p.p.m. ethylene oxide was.
  • Example 11 To further illustrate. thepresent invention 115 0 aerosol samples containing Formulation A were prepared under non-sterile commercial packaging conditions by first preparing and filling the sample units with 1.25 oz. avoir.-of the 0.2% Furacin in hexylene glycol-polyethylene glycol base and then introducing the propellant (2, 5 by weight of trichloromonofiuromethane was added followed by addition of 25% by Weight of a monochlorodifluromethane- J ethylene oxide mixture) containing 70 ppm. ethylene oxide, such that the final concentration of ethylene oxide within the aerosol was.35 p.p.'m.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Birds (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Nutrition Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)
US152936A 1961-11-16 1961-11-16 Method of sterilizing with alkylene oxide Expired - Lifetime US3169906A (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
US152936A US3169906A (en) 1961-11-16 1961-11-16 Method of sterilizing with alkylene oxide
GB41919/62A GB989036A (en) 1961-11-16 1962-11-06 Aerosol preparation
DEN22339A DE1287255B (de) 1961-11-16 1962-11-12 Verfahren zur Herstellung von sterilen, nicht toxischen Loesungen
BR144633/62A BR6244633D0 (pt) 1961-11-16 1962-11-13 Processo para preparar solucoes estereis em forma de aerosol
DK490162AA DK103089C (da) 1961-11-16 1962-11-14 Steriliserende, utoxisk opdrivningsmiddel til tilvejebringelse af en aerosol fra en beholder som indeholder et opløst præparat til lokal anvendelse på mennesker.
AT902162A AT255659B (de) 1961-11-16 1962-11-16 Verfahren zur Herstellung steriler, nichttoxischer Aerosollösungen

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US152936A US3169906A (en) 1961-11-16 1961-11-16 Method of sterilizing with alkylene oxide

Publications (1)

Publication Number Publication Date
US3169906A true US3169906A (en) 1965-02-16

Family

ID=22545078

Family Applications (1)

Application Number Title Priority Date Filing Date
US152936A Expired - Lifetime US3169906A (en) 1961-11-16 1961-11-16 Method of sterilizing with alkylene oxide

Country Status (6)

Country Link
US (1) US3169906A (de)
AT (1) AT255659B (de)
BR (1) BR6244633D0 (de)
DE (1) DE1287255B (de)
DK (1) DK103089C (de)
GB (1) GB989036A (de)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5000918A (en) * 1984-12-10 1991-03-19 Sanitized Verwertungs A.-G. Method of disinfecting petroleum and petroleum products
US5376333A (en) * 1989-07-28 1994-12-27 Alliedsignal, Inc. Ethylene oxide-carrier gas compositions having improved flammability suppressant characteristics

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2296431A1 (fr) * 1974-12-31 1976-07-30 Fabre Sa Pierre Procede de sterilisation a l'aide d'un germicide gazeux
WO1990003807A1 (en) * 1988-10-03 1990-04-19 Allied-Signal Inc. Azeotrope-like compositions of dichlorotrifluoroethane and ethylene oxide
US4976922A (en) * 1989-03-03 1990-12-11 Union Carbide Corporation Sterilization method
US5611210A (en) * 1993-03-05 1997-03-18 Ikon Corporation Fluoroiodocarbon blends as CFC and halon replacements

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2075845A (en) * 1933-05-05 1937-04-06 Liggett & Myers Tobacco Compan Method of sterilizing
US2705696A (en) * 1951-03-30 1955-04-05 American Cyanamid Co Production of antigens
US2891838A (en) * 1957-04-10 1959-06-23 Ben Venue Lab Inc Non-inflammable ethylene oxide sterilant

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2075845A (en) * 1933-05-05 1937-04-06 Liggett & Myers Tobacco Compan Method of sterilizing
US2705696A (en) * 1951-03-30 1955-04-05 American Cyanamid Co Production of antigens
US2891838A (en) * 1957-04-10 1959-06-23 Ben Venue Lab Inc Non-inflammable ethylene oxide sterilant

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5000918A (en) * 1984-12-10 1991-03-19 Sanitized Verwertungs A.-G. Method of disinfecting petroleum and petroleum products
US5376333A (en) * 1989-07-28 1994-12-27 Alliedsignal, Inc. Ethylene oxide-carrier gas compositions having improved flammability suppressant characteristics

Also Published As

Publication number Publication date
GB989036A (en) 1965-04-14
AT255659B (de) 1967-07-10
DK103089C (da) 1965-11-15
DE1287255B (de) 1969-01-16
BR6244633D0 (pt) 1973-05-31

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