EP0636088A1 - 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

Info

Publication number
EP0636088A1
EP0636088A1 EP94902785A EP94902785A EP0636088A1 EP 0636088 A1 EP0636088 A1 EP 0636088A1 EP 94902785 A EP94902785 A EP 94902785A EP 94902785 A EP94902785 A EP 94902785A EP 0636088 A1 EP0636088 A1 EP 0636088A1
Authority
EP
European Patent Office
Prior art keywords
package
product
sterilization
protective gas
irradiation
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.)
Withdrawn
Application number
EP94902785A
Other languages
German (de)
French (fr)
Inventor
Esa KARHAPÄÄ
Anne MYKKÄNEN
Marja Himottu
Jouko Pirkkanen
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.)
KOLMI-SET Oy
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
Publication of EP0636088A1 publication Critical patent/EP0636088A1/en
Withdrawn legal-status Critical Current

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).

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Toxicology (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Food Preservation Except Freezing, Refrigeration, And Drying (AREA)
  • Packages (AREA)

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
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.
EP94902785A 1992-12-23 1993-12-22 A method for packaging a product for sterilization and a sterilized package manufactured by the method Withdrawn EP0636088A1 (en)

Applications Claiming Priority (3)

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
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

Publications (1)

Publication Number Publication Date
EP0636088A1 true EP0636088A1 (en) 1995-02-01

Family

ID=8536457

Family Applications (1)

Application Number Title Priority Date Filing Date
EP94902785A Withdrawn EP0636088A1 (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)

Families Citing this family (10)

* 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
US5577368A (en) * 1995-04-03 1996-11-26 Johnson & Johnson Professional, Inc. Method for improving wear resistance of polymeric bioimplantable components
US5839258A (en) * 1995-11-28 1998-11-24 Mitsubishi Chemical Corporation Storing method for adsorbent particles
SE506058C2 (en) * 1996-02-28 1997-11-03 Tetra Laval Holdings & Finance Ways to sterilize closed packages
FR2782644B1 (en) * 1998-08-27 2001-08-31 Becton Dickinson France PROCESS FOR EXTERNAL DECONTAMINATION OF A PACKAGED OBJECT
GB2387587A (en) * 2002-04-19 2003-10-22 Sca Hygiene Prod Gmbh Gastight package containing a protective gas
FR2848183B1 (en) * 2002-12-10 2006-01-27 Tornier Sa STERILE CONDITIONING METHOD OF A POLYETHYLENE PROTHETIC IMPLANT
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
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

Family Cites Families (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

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9414657A1 *

Also Published As

Publication number Publication date
FI925878A (en) 1994-06-24
GB2278333A (en) 1994-11-30
FI94043B (en) 1995-03-31
FI925878A0 (en) 1992-12-23
GB9416461D0 (en) 1994-10-05
FI94043C (en) 1995-07-10
SE9402786D0 (en) 1994-08-22
WO1994014657A1 (en) 1994-07-07
SE9402786L (en) 1994-08-22
DE4396775T1 (en) 1995-02-23
AU5700594A (en) 1994-07-19

Similar Documents

Publication Publication Date Title
EP0218003B1 (en) Radiation-sterilized, packaged medical device
EP0197217B1 (en) Electron-beam irradiation sterilization process
US4035981A (en) Aseptic packaging
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
CA2150523C (en) Process of sterilization
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
WO2005073091A2 (en) Package of sensitive articles
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
Mehta et al. Organoleptic, chemical and microbiological changes in ultra-high-temperature sterilized milk stored at room temperature
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
JPH07145264A (en) Irradiation sterilization of tightly sealed material
CA1049970A (en) Storage stable package for absorbable polyglycolic acid sutures, and process for preparing same
JP3205939B2 (en) Radiation treatment method for silicone rubber tube
JPH01267130A (en) Method for disinfecting packaging material
JPS6326011B2 (en)

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

AK Designated contracting states

Kind code of ref document: A1

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

17P Request for examination filed

Effective date: 19941214

RBV Designated contracting states (corrected)

Designated state(s): FR

REG Reference to a national code

Ref country code: DE

Ref legal event code: 8566

17Q First examination report despatched

Effective date: 19971216

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 19981209