WO1994014657A1 - A method for packaging a product for sterilization and a sterilized package manufactured by the method - Google Patents

A method for packaging a product for sterilization and a sterilized package manufactured by the method Download PDF

Info

Publication number
WO1994014657A1
WO1994014657A1 PCT/FI1993/000554 FI9300554W WO9414657A1 WO 1994014657 A1 WO1994014657 A1 WO 1994014657A1 FI 9300554 W FI9300554 W FI 9300554W WO 9414657 A1 WO9414657 A1 WO 9414657A1
Authority
WO
WIPO (PCT)
Prior art keywords
package
product
sterilization
protective gas
irradiation
Prior art date
Application number
PCT/FI1993/000554
Other languages
French (fr)
Inventor
Esa KARHAPÄÄ
Anne MYKKÄNEN
Marja Himottu
Jouko Pirkkanen
Original Assignee
Kolmi-Set Oy
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 Kolmi-Set Oy filed Critical Kolmi-Set Oy
Priority to EP94902785A priority Critical patent/EP0636088A1/en
Priority to DE4396775T priority patent/DE4396775T1/en
Priority to GB9416461A priority patent/GB2278333A/en
Priority to AU57005/94A priority patent/AU5700594A/en
Publication of WO1994014657A1 publication Critical patent/WO1994014657A1/en
Priority to SE9402786A priority patent/SE9402786L/en

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
    • B65B55/08—Sterilising wrappers or receptacles prior to, or during, packaging by irradiation

Definitions

  • the invention relates to a method for packaging a product for sterilization effected by irradiation, wherein the product is enclosed in a substantially gas impermeable package.
  • the invention also relates to a sterilized package manufactured by the method.
  • Sterile packages such as packages for hospital equipment, are often bag-like, airproof, or air per ⁇ meable but bacterium impermeable packages in which the equipment to be packaged is placed before the packages are sealed. Sterilization is effected by irradiating the package by ionizing radiation, such as gamma radiation, ultraviolet light or by some other means.
  • ionizing radiation such as gamma radiation, ultraviolet light or by some other means.
  • the products to be packaged may be surgical textiles, surgical instruments, various tubes, syringes, cannulae, etc.
  • packages of this type when opened, they give off a strong odour. Radiation causes the oxygen within the package to be converted into ozone, which reacts with the molecular chain of the product, which is usually plastic-based, to form bad- smelling compounds, such as acetic acid and butanal. Moreover, an oxidizing environment reduces the mechan- ical strength of the plastic products placed in the packages. This problem has been discussed e.g. in European Patent No. 218 003.
  • the package disclosed in this reference comprises a deoxidizer, such as activated iron oxide, for the elimination of odour.
  • the solution requires, however, a two-layer package: a breathing inner layer and a tight outer layer, between which the deoxidizing - and thus deodorizing - agent is posi ⁇ tioned.
  • the disadvantages of such a package are that it is complicated and that iron oxide must be separately added thereto.
  • the object of the present invention is to provide such a method for sterilizing a package, and a sterilized package manufactured by the method, by means of which the product can be easily and securely packaged for sterilization, and in which the problem of odour caused by radiation in the corresponding known products has been minimized.
  • the method accord ⁇ ing to the invention is characterized in that the product is placed in the package, the package is de- aerated and filled with a protective gas, whereafter the package is sealed for sterilization by irradiation.
  • the invention has the advantages that, in addi ⁇ tion to being odourless, the package is uncomplicated, and the different steps of manufacture can be rapidly taken.
  • the same nozzle can be used both for removing air and for adding a protective gas.
  • the package may be a simple plastic package, wherefore it is also inexpens ⁇ ive.
  • Figures 5 to 8 show gas chromatograms of the contents of packages according to the invention and those of reference packages.
  • a sterile package according to the invention containing a product (e.g. a surgical gown) to be sterilized, is manufactured by disposing a product 1 in a plastic package 2 ( Figure 1 ), whereafter the package is deaerated e.g. by a vacuum pump (not shown) through a hose 3 ( Figure 2).
  • a protective gas such as nitrogen or carbon dioxide, is then added to the package 2 ( Figure 3) .
  • the package is sealed and sterilized by gamma radiation ( Figure 4), whereafter it is ready for use.
  • Table 1 shows results based on sensory evalua ⁇ tion of odour (scale from 0 to 3 ) .
  • Sample A is a gamma sterilized package without a protective gas
  • sample B is a corresponding package where the protective gas is nitrogen
  • sample C is a corresponding package where the protective gas is carbon dioxide.
  • most of the assessors 1-7 sense that the odour of sample A is strong (average ca 1.8), whereas the odour of samples B and C is typically hardly dis ⁇ cernible (average ca 1 ) .
  • the oxygen is typically hardly dis ⁇ cernible
  • Figure 5 shows a gas chromatogram of a package which contains air and which has not been irradiated. It can be seen that various compounds are present only in relatively low contents.
  • Figure 6 shows the effect of irradiation when the package containing air (cf. Figure 5) is irradiated by gamma radiation. From the gas chromatogram it can be seen that, in addition to the increase in the amount of the compounds already present, two new compounds are formed in considerable amounts.
  • butanal and acetic acid which are both known to have a very strong odour. Butanal and acetic acid are probably formed as a result of the reactions of ozone with the plastic materials in the package due to gamma radiation. Reactive ozone reacts with plastic polymers, causing oxidation reactions, whereby bad-smelling com- pounds, for example, are produced.
  • Figures 7 and 8 show gas chromatograms of cor ⁇ responding packages which have first been deaerated in accordance with the invention and then filled with a protective gas: nitrogen ( Figure 7) or carbon dioxide ( Figure 8) . It can be seen that the butanal and acetic acid peaks have disappeared completely or almost com ⁇ pletely. Thus it seems that the sensed lack of odour or the considerable decrease in it is a result of the fact that in packages filled with a protective gas there are hardly any signs of two compounds with a strong odour - butanal and acetic acid - which are present in an irradiated package containing air ( Figure 6).

Abstract

The invention relates to a method for packaging a product for sterilization effected by irradiation and a sterilized package, wherein the product (1) is enclosed in a substantially gas impermeable package (2). The invention is characterized in that the product (1) is placed in the package (2), the package is deaerated and filled with a protective gas, whereafter the package is sealed for sterilization by irradiation.

Description

A method for packaging a product for sterilization and a sterilized package manufactured by the method
The invention relates to a method for packaging a product for sterilization effected by irradiation, wherein the product is enclosed in a substantially gas impermeable package. The invention also relates to a sterilized package manufactured by the method.
Sterile packages, such as packages for hospital equipment, are often bag-like, airproof, or air per¬ meable but bacterium impermeable packages in which the equipment to be packaged is placed before the packages are sealed. Sterilization is effected by irradiating the package by ionizing radiation, such as gamma radiation, ultraviolet light or by some other means. The products to be packaged may be surgical textiles, surgical instruments, various tubes, syringes, cannulae, etc.
The problem with packages of this type is that when opened, they give off a strong odour. Radiation causes the oxygen within the package to be converted into ozone, which reacts with the molecular chain of the product, which is usually plastic-based, to form bad- smelling compounds, such as acetic acid and butanal. Moreover, an oxidizing environment reduces the mechan- ical strength of the plastic products placed in the packages. This problem has been discussed e.g. in European Patent No. 218 003. The package disclosed in this reference comprises a deoxidizer, such as activated iron oxide, for the elimination of odour. The solution requires, however, a two-layer package: a breathing inner layer and a tight outer layer, between which the deoxidizing - and thus deodorizing - agent is posi¬ tioned. The disadvantages of such a package are that it is complicated and that iron oxide must be separately added thereto. The object of the present invention is to provide such a method for sterilizing a package, and a sterilized package manufactured by the method, by means of which the product can be easily and securely packaged for sterilization, and in which the problem of odour caused by radiation in the corresponding known products has been minimized. To achieve this, the method accord¬ ing to the invention is characterized in that the product is placed in the package, the package is de- aerated and filled with a protective gas, whereafter the package is sealed for sterilization by irradiation.
The invention has the advantages that, in addi¬ tion to being odourless, the package is uncomplicated, and the different steps of manufacture can be rapidly taken. The same nozzle can be used both for removing air and for adding a protective gas. The package may be a simple plastic package, wherefore it is also inexpens¬ ive.
The other preferred embodiments of the method according to the invention and the package according to the invention are characterized by what is disclosed in the appended claims. In the following, the invention will be described in greater detail with reference to the accompanying drawings, in which Figures 1 to 4 show the package of the inven¬ tion during the different steps of manufacture,
Figures 5 to 8 show gas chromatograms of the contents of packages according to the invention and those of reference packages. A sterile package according to the invention, containing a product (e.g. a surgical gown) to be sterilized, is manufactured by disposing a product 1 in a plastic package 2 (Figure 1 ), whereafter the package is deaerated e.g. by a vacuum pump (not shown) through a hose 3 (Figure 2). A protective gas, such as nitrogen or carbon dioxide, is then added to the package 2 (Figure 3) . The package is sealed and sterilized by gamma radiation (Figure 4), whereafter it is ready for use.
Practical experiments have shown that when the packaging method of the invention is used, the unpleas¬ ant odour which a package sterilized by irradiation emits when opened almost completely disappears.
Table 1 shows results based on sensory evalua¬ tion of odour (scale from 0 to 3 ) . Sample A is a gamma sterilized package without a protective gas, sample B is a corresponding package where the protective gas is nitrogen, and sample C is a corresponding package where the protective gas is carbon dioxide. As appears from the table, most of the assessors 1-7 sense that the odour of sample A is strong (average ca 1.8), whereas the odour of samples B and C is typically hardly dis¬ cernible (average ca 1 ) . In samples B and C the oxygen
Figure imgf000005_0001
TABLE 1 content of the packages was below 1%, in sample A it was the normal oxygen content of air (21%). Depending e.g. on the size of the product to be sterilized, a suitable oxygen content in the package is estimated to be 0.5 to 5%.
The reason for the lack of odour or the con¬ siderable decrease in it has been studied at the University of JyvSskylS by gas chromatography and mass spectrometer measurements (Figures 5 to 8) . Figure 5 shows a gas chromatogram of a package which contains air and which has not been irradiated. It can be seen that various compounds are present only in relatively low contents. Figure 6 shows the effect of irradiation when the package containing air (cf. Figure 5) is irradiated by gamma radiation. From the gas chromatogram it can be seen that, in addition to the increase in the amount of the compounds already present, two new compounds are formed in considerable amounts. These compounds are butanal and acetic acid, which are both known to have a very strong odour. Butanal and acetic acid are probably formed as a result of the reactions of ozone with the plastic materials in the package due to gamma radiation. Reactive ozone reacts with plastic polymers, causing oxidation reactions, whereby bad-smelling com- pounds, for example, are produced.
Figures 7 and 8 show gas chromatograms of cor¬ responding packages which have first been deaerated in accordance with the invention and then filled with a protective gas: nitrogen (Figure 7) or carbon dioxide (Figure 8) . It can be seen that the butanal and acetic acid peaks have disappeared completely or almost com¬ pletely. Thus it seems that the sensed lack of odour or the considerable decrease in it is a result of the fact that in packages filled with a protective gas there are hardly any signs of two compounds with a strong odour - butanal and acetic acid - which are present in an irradiated package containing air (Figure 6). In addi¬ tion to the above-mentioned protective gases, it is also possible to use other gases for the same purpose. On account of the insignificant formation of ozone or the lack of it during irradiation (cf. EP 218 003), which is due to the low content of oxygen, the pungent odour emitted by known packages (sample A in table I) has been eliminated in the packages manu- factured according to the invention (samples B and C in table I).
It will be clear to one skilled in the art that the different embodiments of the invention are not restricted to the examples described above but can be modified within the scope of the appended claims.

Claims

Claims
1. A method for packaging a product for steril¬ ization effected by irradiation, wherein the product (1) is enclosed in a substantially gas impermeable package (2), c h a r a c t e r i z e d in that the product (1) is placed in the package (2), the package is deaerated and filled with a protective gas, whereafter the package is sealed for sterilization by irradiation.
2. A method according to claim 1, c h a r a c ¬ t e r i z e d in that the protective gas is nitrogen.
3. A method according to claim 1, c h a r a c ¬ t e r i z e d in that the protective gas is carbon dioxide.
4. A method according to claim 1, 2 or 3, c h a r a c t e r i z e d in that the package is de¬ aerated in such a manner that the amount of residual oxygen does not exceed 1% of the amount of gas contained in the package after the addition of the protective gas.
5. A substantially gas impermeable package (2) sterilized by irradiation, c h a r a c t e r i z e d in that it comprises a package containing a product (1), the package (2) being substantially deaerated and filled with a protective gas for sterilization by irradiation.
6. A package according to claim 4, c h a r ¬ a c t e r i z e d in that the protective gas contained in the package is nitrogen.
7. A package according to claim 4, c h a r ¬ a c t e r i z e d in that the protective gas contained in the package is carbon dioxide.
PCT/FI1993/000554 1992-12-23 1993-12-22 A method for packaging a product for sterilization and a sterilized package manufactured by the method WO1994014657A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
EP94902785A EP0636088A1 (en) 1992-12-23 1993-12-22 A method for packaging a product for sterilization and a sterilized package manufactured by the method
DE4396775T DE4396775T1 (en) 1992-12-23 1993-12-22 Method of accomplishing sterile packaging and sterile packaging
GB9416461A GB2278333A (en) 1992-12-23 1993-12-22 A method for packaging a product for sterilization and a sterilized package manufactured by the method
AU57005/94A AU5700594A (en) 1992-12-23 1993-12-22 A method for packaging a product for sterilization and a sterilized package manufactured by the method
SE9402786A SE9402786L (en) 1992-12-23 1994-08-22 Method of providing a sterile package and sterile package

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FI925878A FI94043C (en) 1992-12-23 1992-12-23 Method for providing an odorless and sterile package and a sterilizable product package obtained by the method
FI925878 1992-12-23

Publications (1)

Publication Number Publication Date
WO1994014657A1 true WO1994014657A1 (en) 1994-07-07

Family

ID=8536457

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/FI1993/000554 WO1994014657A1 (en) 1992-12-23 1993-12-22 A method for packaging a product for sterilization and a sterilized package manufactured by the method

Country Status (7)

Country Link
EP (1) EP0636088A1 (en)
AU (1) AU5700594A (en)
DE (1) DE4396775T1 (en)
FI (1) FI94043C (en)
GB (1) GB2278333A (en)
SE (1) SE9402786L (en)
WO (1) WO1994014657A1 (en)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5540033A (en) * 1994-01-10 1996-07-30 Cambrex Hydrogels Integrated Manufacturing process for hydrogels
WO1997031826A1 (en) * 1996-02-28 1997-09-04 Tetra Laval Holdings & Finance S.A. Method for sterilizing closed containers
US5839258A (en) * 1995-11-28 1998-11-24 Mitsubishi Chemical Corporation Storing method for adsorbent particles
FR2782644A1 (en) * 1998-08-27 2000-03-03 Becton Dickinson France PROCESS FOR EXTERNAL DECONTAMINATION OF A PACKAGED OBJECT
FR2848183A1 (en) * 2002-12-10 2004-06-11 Tornier Sa Sterile packaging procedure for polyethylene prosthetic implant consists of vacuum sachet in gas-impermeable envelope filled with inert gas and sealed
CN102582867A (en) * 2011-01-18 2012-07-18 紫罗兰家纺科技股份有限公司 Asepsis and nutrient adding technology for home textiles and clothing
CN102580125A (en) * 2011-01-18 2012-07-18 紫罗兰家纺科技股份有限公司 Double-sterilization and nutrient addition vacuum packaging technology for home textiles and dress products
CN102582866A (en) * 2011-01-18 2012-07-18 紫罗兰家纺科技股份有限公司 Two-time sterilization, aseptic production and nutrient adding technology for home textiles and clothing

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5577368A (en) * 1995-04-03 1996-11-26 Johnson & Johnson Professional, Inc. Method for improving wear resistance of polymeric bioimplantable components
GB2387587A (en) * 2002-04-19 2003-10-22 Sca Hygiene Prod Gmbh Gastight package containing a protective gas

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3483005A (en) * 1966-10-31 1969-12-09 Swift & Co Irradiation with co2 under pressure
US4112124A (en) * 1971-04-26 1978-09-05 Drisan Packaging Ltd. Food packaging system and method
US5014494A (en) * 1988-09-27 1991-05-14 Sherwood Medical Company Method of sterilizing medical articles

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3483005A (en) * 1966-10-31 1969-12-09 Swift & Co Irradiation with co2 under pressure
US4112124A (en) * 1971-04-26 1978-09-05 Drisan Packaging Ltd. Food packaging system and method
US5014494A (en) * 1988-09-27 1991-05-14 Sherwood Medical Company Method of sterilizing medical articles

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5540033A (en) * 1994-01-10 1996-07-30 Cambrex Hydrogels Integrated Manufacturing process for hydrogels
US5839258A (en) * 1995-11-28 1998-11-24 Mitsubishi Chemical Corporation Storing method for adsorbent particles
CZ296774B6 (en) * 1996-02-28 2006-06-14 Tetra Laval Holdings & Finance S. A. Method for sterilizing closed container
WO1997031826A1 (en) * 1996-02-28 1997-09-04 Tetra Laval Holdings & Finance S.A. Method for sterilizing closed containers
AU724202B2 (en) * 1996-02-28 2000-09-14 Tetra Laval Holdings & Finance Sa Method for sterilizing closed containers
FR2782644A1 (en) * 1998-08-27 2000-03-03 Becton Dickinson France PROCESS FOR EXTERNAL DECONTAMINATION OF A PACKAGED OBJECT
WO2000012388A1 (en) * 1998-08-27 2000-03-09 Becton Dickinson France Method for external decontamination of a packaged object
FR2848183A1 (en) * 2002-12-10 2004-06-11 Tornier Sa Sterile packaging procedure for polyethylene prosthetic implant consists of vacuum sachet in gas-impermeable envelope filled with inert gas and sealed
EP1428757A1 (en) * 2002-12-10 2004-06-16 Tornier Method for sterile packaging a prosthetic implant made of polyethylene
US7364694B2 (en) 2002-12-10 2008-04-29 Tornier Process for the sterile packaging of a polyethylene prosthetic implant
CN102582867A (en) * 2011-01-18 2012-07-18 紫罗兰家纺科技股份有限公司 Asepsis and nutrient adding technology for home textiles and clothing
CN102580125A (en) * 2011-01-18 2012-07-18 紫罗兰家纺科技股份有限公司 Double-sterilization and nutrient addition vacuum packaging technology for home textiles and dress products
CN102582866A (en) * 2011-01-18 2012-07-18 紫罗兰家纺科技股份有限公司 Two-time sterilization, aseptic production and nutrient adding technology for home textiles and clothing

Also Published As

Publication number Publication date
AU5700594A (en) 1994-07-19
FI925878A0 (en) 1992-12-23
GB9416461D0 (en) 1994-10-05
GB2278333A (en) 1994-11-30
FI94043C (en) 1995-07-10
DE4396775T1 (en) 1995-02-23
SE9402786D0 (en) 1994-08-22
FI94043B (en) 1995-03-31
EP0636088A1 (en) 1995-02-01
FI925878A (en) 1994-06-24
SE9402786L (en) 1994-08-22

Similar Documents

Publication Publication Date Title
EP0218003B1 (en) Radiation-sterilized, packaged medical device
CA1039640A (en) Aseptic packaging
EP0197217B1 (en) Electron-beam irradiation sterilization process
EP1094847B1 (en) A method for disinfecting and sterilizing microbial contaminated materials
EP0759873B1 (en) A PROCESS FOR STERILISATION BY $g(g)-RADIATION AND BY THE USE OF AN OXYGEN ABSORBER, A CONTAINER AND A MEDICAL ARTICLE STERILISED BY THE PROCESS
EP0685399B1 (en) Process of sterilization
US20050268573A1 (en) Package of sensitive articles
US4998400A (en) Medical fluid-filled plastic container and methods of making same
EP0636088A1 (en) A method for packaging a product for sterilization and a sterilized package manufactured by the method
CA2256517A1 (en) Catheter package
ES2105402T3 (en) ELECTRON ACCELERATOR TO STERILIZE A PACKAGING MATERIAL IN AN ASEPTIC PACKING MACHINE.
CA2173279A1 (en) Method for improving wear resistance of polymeric bioimplantable components
KR940014089A (en) Packaging for reducing odor and strength loss due to irradiation of polyolefin based products and its reduction method
JP4102077B2 (en) Use of hydrogen peroxide plasma sterilization method for mild sterilization of temperature sensitive products
JP2876320B2 (en) Radiation sterilization method for medical equipment
US5241803A (en) Ozone sterilization method and product
Chuaqui-Offermanns Food packaging materials and radiation processing of food: a brief review
JPH0889561A (en) Sterilizing method for plastics-containing articles by irradiation with radioactive ray or electron beam
US3738811A (en) Residual alkylating agent detector and method therefor
CA1049970A (en) Storage stable package for absorbable polyglycolic acid sutures, and process for preparing same
Boyd E-beam sterilizes the industry
JPH01267130A (en) Method for disinfecting packaging material
Shaw Toxicological considerations in the selection of flexible packaging materials for foodstuffs
JPH0410826B2 (en)
JPH01226528A (en) Sterilization of packaging material

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AT AU BB BG BR BY CA CH CZ DE DK ES FI GB HU JP KP KR KZ LK LU LV MG MN MW NL NO NZ PL PT RO RU SD SE SK UA US UZ VN

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): AT BE CH DE DK ES FR GB GR IE IT LU MC NL PT SE BF BJ CF CG CI CM GA GN ML MR NE SN TD TG

WWE Wipo information: entry into national phase

Ref document number: 94027869

Country of ref document: SE

WWP Wipo information: published in national office

Ref document number: 94027869

Country of ref document: SE

121 Ep: the epo has been informed by wipo that ep was designated in this application
WWE Wipo information: entry into national phase

Ref document number: 1994902785

Country of ref document: EP

WWP Wipo information: published in national office

Ref document number: 1994902785

Country of ref document: EP

RET De translation (de og part 6b)

Ref document number: 4396775

Country of ref document: DE

Date of ref document: 19950223

WWE Wipo information: entry into national phase

Ref document number: 4396775

Country of ref document: DE

NENP Non-entry into the national phase

Ref country code: CA

WWW Wipo information: withdrawn in national office

Ref document number: 1994902785

Country of ref document: EP