WO1998016259A1 - A method of sterilizing a package material - Google Patents
A method of sterilizing a package material Download PDFInfo
- Publication number
- WO1998016259A1 WO1998016259A1 PCT/SE1997/001575 SE9701575W WO9816259A1 WO 1998016259 A1 WO1998016259 A1 WO 1998016259A1 SE 9701575 W SE9701575 W SE 9701575W WO 9816259 A1 WO9816259 A1 WO 9816259A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- hydrogen peroxide
- plastic surface
- sterilizing
- container
- gaseous phase
- Prior art date
Links
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
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/20—Gaseous substances, e.g. vapours
- A61L2/208—Hydrogen peroxide
-
- 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
- B65B55/10—Sterilising wrappers or receptacles prior to, or during, packaging by liquids or gases
- B65B55/103—Sterilising flat or tubular webs
-
- 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
- A61L2202/23—Containers, e.g. vials, bottles, syringes, mail
Definitions
- the present invention refers to a method of steril- izing a package material. More precisely the invention refers to a method of sterilizing a package material having a plastic surface by means of hydrogen peroxide in gaseous phase being supplied to the previously heated plastic surface .
- Sterile containers which are ready to be filled can be obtained in various ways.
- One method of sterilization implies that the plastic containers are sealed directly in connection with the manufacturing procedure, e.g. when blow moulded. Due to the collapse of the container at a sub- sequent lowering of the temperature the sealing in this case results in considerable problems.
- the container must therefore be stored at an elevated temperature since the volume of air enclosed in the container will decrease if the temperature is decreased. Such a storage is both cumbersome and costly. In order to avoid this, among other materials hydrogen peroxide is nowadays utilized in a liquid or gaseous phase, the inside of the containers then being sterilized.
- Hydrogen peroxide is a very potent but not especially stable oxidant, and an advantage is that only plain water is formed as by-product. However, the half-life of hydrogen peroxide is very long, and the sterilizing agent has thus to be removed after it has been allowed to exert its effect . Hydrogen peroxide is supposed to exert its antimicrobial activity through its powerful oxidizing effect by acting on components in the cytoplasmic membrane of the microorganisms. In the sterilizing procedure hydrogen peroxide is used as a water solution which is sprayed into a container. When the container is subsequently heated the hydrogen peroxide is gasified and can be ventilated away after having exerted its effect .
- a container is in a first step subjected to hydrogen peroxide in gaseous phase, which is allowed to condensate on the inside of the container.
- a homogeneous coating of hydrogen peroxide is obtained, which completely covers the package material .
- the condensated gas is again gasified and is finally ventilated away.
- a further problem is that with certain plastics in the package material, above all polyester, residues of hydrogen peroxide are obtained which are adsorbed on the inside of the container as a result of spraying, coating or condensation. They can afterwards have a negative influence on the filling material, for example by changing the colour. The authorities have established limit values which must not be exceeded for residues of hydrogen peroxide.
- PET polyethylene terephtalate
- the hydrogen peroxide can be ventilated away, e.g. at the elevated temperature or by sterile air being blown into the container.
- Such a procedure is costly and it would thus be desirable if shorter ventilation times could be used, which would result in a lower cost per container.
- the purpose of the invention is to eliminate or reduce the drawbacks mentioned above which arise during a sterilization by means of hydrogen peroxide according to the state of the art.
- a sterilizing process with a condensation of hydrogen peroxide comprises four phases of different time intervals: a heating phase, a gassing phase, a holding phase, and a ventilation phase.
- the container is heated to a suitable temperature.
- the heating phase is not necessary. However, it reduces the amount of condensate which later on has to be ventilated away.
- gaseous hydrogen peroxide is injected into the previously heated container and over the surface which is to be exposed to the treatment, onto which the gas condensates, and a condensate in the form of droplets is formed.
- the gas used is a mixture of air and a gasified solution of hydrogen peroxide.
- the solution of hydrogen peroxide is supplied as a commercial grade which consists of about 65 % water and about 35 % hydrogen peroxide. However, other concentrations can of course be used in dependence of other parameters .
- the condensate is allowed to exhibit its effect, and during the ventilation phase the container is ventilated, the condensate again being transformed into gaseous phase and removed from the container.
- hot air is used which has been prefil- tered and sterilized by means of filtration.
- the method according to the invention implies briefly that the containers are sterilized with gasified hydrogen peroxide, the containers first being heated to a temperature which is higher than the dew point of the gas used. The containers are then blown to dryness with hot sterile air.
- the containers are thus for a certain period of time exposed to gaseous hydrogen peroxide of a specific temperature, dew point and flow rate. Apart from the hydrogen peroxide concentration these parameters are important in order to achieve an effective killing.
- the dew point is the temperature the gaseous hydrogen peroxide must be cooled to in order to obtain a condensation, a water solution of hydrogen peroxide being separated. This temperature is dependent on the hydrogen peroxide content in the gas .
- the dew point is adjusted to be used in an existing sterilizing equipment . Preliminary experiments have shown that the amount of residual hydrogen peroxide per unit area varied after contact with different types of package material.
- PET bottles were inoculated with spores of Bacillus subtilis NCA 7252, and after the respective sterilization treatment the results were statistically evaluated with a conventional procedure (based on the method with "Most Probable Number") which is well known to the man skilled in the art .
- a gassing phase of 3 sec was used with gaseous hydrogen peroxide, the gas having a temperature of 90 °C, a dew point of 65 °C, and a flow rate of 40 kg/h.
- the length of the holding phase was 1 sec .
- Those containers which should be subjected to gassing/condensation were during the heating phase heated to 50-55 °C, and the containers were ventilated for 10 sec with sterile air of 70 °C having a flow rate of 40 kg/h.
- the ventilation time was adjusted in such a way that all visible condensate had evaporated.
- Those containers which had been subjected to gassing alone according to the invention were during the heating phase subjected to a temperature of 70-80 °C, and during the ventilation phase the containers were fluxed for 2 sec with sterile air of 80 °C at a flow rate of 60 kg/h.
- the results indicated that a sufficient killing effect was achieved in the form of a logarithmic reduction of at least log 5 (10 5 ) with both sterilizing methods.
- Example 2 Comparison between evolved residual amounts.
- the sterilization method according to the invention is preferably intended to be used for sterilizing containers which are ready to be filled and/or for a package material having a plastic surface which can comprise a polyester, e.g. polyethylene terephtalate .
- the method is not limited to containers which are ready to be filled.
- a container is sterilized as a "preform", i.e. before it - for example by means of blow moulding - has obtained its final form which has a difficult geometry from a sterilizing point of view.
- the package material in the form of a sheet or a web can thus in the same way as a container which is ready to be filled be subjected to the above mentioned four phases, heating phase, gassing phase, holding phase, and ventilation phase, the sterilization being effected by means of the method according to the invention.
- the package material may well be treated continuously.
Abstract
Description
Claims
Priority Applications (9)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE69735012T DE69735012T2 (en) | 1996-10-14 | 1997-09-19 | METHOD FOR STERILIZING A PACKAGING MATERIAL |
JP10518239A JP2001502277A (en) | 1996-10-14 | 1997-09-19 | How to sterilize packaging materials |
NZ334621A NZ334621A (en) | 1996-10-14 | 1997-09-19 | Sterilization of a plastic package material using hydrogen peroxide in a gaseous phase |
BR9712234-3A BR9712234A (en) | 1996-10-14 | 1997-09-19 | Process of sterilizing a plastic surface with hydrogen peroxide in the gas phase. |
US09/284,050 US6682696B1 (en) | 1996-10-14 | 1997-09-19 | Method of sterilizing a package material |
EP97909776A EP1021210B1 (en) | 1996-10-14 | 1997-09-19 | A method of sterilizing a package material |
CA002266079A CA2266079C (en) | 1996-10-14 | 1997-09-19 | A method of sterilizing a package material |
AU47300/97A AU719367B2 (en) | 1996-10-14 | 1997-09-19 | A method of sterilizing a package material |
AT97909776T ATE314098T1 (en) | 1996-10-14 | 1997-09-19 | METHOD FOR STERILIZING A PACKAGING MATERIAL |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
SE9603735-3 | 1996-10-14 | ||
SE9603735A SE507994C2 (en) | 1996-10-14 | 1996-10-14 | Ways of sterilizing packaging material |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1998016259A1 true WO1998016259A1 (en) | 1998-04-23 |
Family
ID=20404223
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/SE1997/001575 WO1998016259A1 (en) | 1996-10-14 | 1997-09-19 | A method of sterilizing a package material |
Country Status (15)
Country | Link |
---|---|
US (1) | US6682696B1 (en) |
EP (1) | EP1021210B1 (en) |
JP (1) | JP2001502277A (en) |
CN (2) | CN1145498C (en) |
AT (1) | ATE314098T1 (en) |
AU (1) | AU719367B2 (en) |
BR (1) | BR9712234A (en) |
CA (1) | CA2266079C (en) |
DE (1) | DE69735012T2 (en) |
DK (1) | DK1021210T3 (en) |
ES (1) | ES2255102T3 (en) |
ID (1) | ID21220A (en) |
NZ (1) | NZ334621A (en) |
SE (1) | SE507994C2 (en) |
WO (1) | WO1998016259A1 (en) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1999051497A1 (en) * | 1998-04-07 | 1999-10-14 | Tetra Laval Holdings & Finance Sa | Method and apparatus for producing a sterile packaging container |
JP2003512260A (en) * | 1999-10-15 | 2003-04-02 | ゲーエーアー フィンナー ゲゼルシャフト ミット ベシュレンクテル ハフツング | How to sterilize PET bottles |
WO2003093113A1 (en) * | 2002-05-03 | 2003-11-13 | Tetra Laval Holdings & Finance Sa | Method and packaging machine for producing sealed packages of pourable food products from precut blanks of sheet packaging material |
WO2013008426A1 (en) * | 2011-07-08 | 2013-01-17 | 四国化工機株式会社 | Method for sterilizing packaging container using dilute hydrogen peroxide-containing gas |
Families Citing this family (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6808681B2 (en) * | 1996-10-14 | 2004-10-26 | Tetra Laval Holdings & Finance Sa | Method of sterilizing a package material |
DE10114758B4 (en) * | 2001-03-20 | 2013-01-31 | Ptm Packaging Tools Machinery Pte. Ltd. | Method for sterilizing containers |
SE524496C2 (en) * | 2002-12-13 | 2004-08-17 | Tetra Laval Holdings & Finance | Control of sterilizing device |
PL1598274T3 (en) * | 2004-05-21 | 2008-02-29 | Deutsche Sisi Werke Betr Gmbh | Apparatus and method for filling flexible foil bags |
CN101306726B (en) * | 2007-05-18 | 2011-05-18 | 上海斯开龙包装有限公司 | Sterile filling and packaging machine |
US9448213B2 (en) * | 2013-05-13 | 2016-09-20 | Saban Ventures Pty Limited | Residual sterilant test method |
US11286074B2 (en) * | 2016-09-27 | 2022-03-29 | Orihiro Engineering Co., Ltd. | Aseptic filling and packaging apparatus, and method of aseptically filling plastic film package bag with material |
US11305029B2 (en) * | 2017-02-20 | 2022-04-19 | Dai Nippon Printing Co., Ltd. | Gasifier for sterilizer and cleaning method of gasifier for sterilizer |
IL311121A (en) | 2017-03-27 | 2024-04-01 | Regeneron Pharma | Sterilisation method |
WO2021197928A1 (en) * | 2020-04-03 | 2021-10-07 | Tetra Laval Holdings & Finance S.A. | A packaging machine comprising a disinfection/sterilization station, disinfection/sterilization station and method for disinfection/sterilizing in a packaging machine |
CN112451708A (en) * | 2020-10-30 | 2021-03-09 | 江苏新美星包装机械股份有限公司 | Bottle cap sterilization method |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
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US4797255A (en) * | 1986-03-24 | 1989-01-10 | Snow Brand Milk Products Co., Ltd. | Sterilization method and apparatus therefor |
EP0384535A2 (en) * | 1989-02-22 | 1990-08-29 | Shikoku Kakoki Co., Ltd. | Apparatus for supplying hydrogen peroxide for sterilization |
EP0481361A1 (en) * | 1990-10-13 | 1992-04-22 | Fmc Corporation | Sterilising apparatus |
Family Cites Families (22)
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US3891779A (en) * | 1970-07-08 | 1975-06-24 | Rosini Donald A | Aseptic packaging of foods |
US3893832A (en) * | 1973-11-01 | 1975-07-08 | Mead Corp | Sterile fluid system |
US4169123A (en) * | 1975-12-11 | 1979-09-25 | Moore-Perk Corporation | Hydrogen peroxide vapor sterilization method |
SE401913B (en) * | 1976-10-07 | 1978-06-05 | Tetra Pak Int | DEVICE FOR STERILIZING A PACKAGING MATERIAL PATH |
US4396582A (en) * | 1980-03-31 | 1983-08-02 | Dai Nippon Insatsu Kabushiki Kaisha | Method and apparatus for sterilizing food packages or the like |
US4512951A (en) * | 1980-12-30 | 1985-04-23 | American Sterilizer Company | Hydrogen peroxide liquid film sterilization method |
DE3125430A1 (en) * | 1981-06-27 | 1983-01-20 | Hick & Co Gmbh, 4901 Hiddenhausen | METHOD AND DEVICE FOR STERILIZING CUP-SHAPED CONTAINERS |
DE3235476C2 (en) * | 1981-11-14 | 1986-09-11 | Jagenberg AG, 4000 Düsseldorf | Method and device for disinfecting packaging material, in particular packaging containers |
JPH0651834B2 (en) * | 1984-03-30 | 1994-07-06 | 大日本印刷株式会社 | Heat sealable food packaging materials |
US4756882A (en) * | 1985-06-21 | 1988-07-12 | Surgikos Inc. | Hydrogen peroxide plasma sterilization system |
US4731222A (en) * | 1986-02-06 | 1988-03-15 | Innovative Medical Technologies | Automated liquid sterilization system |
SE459083B (en) * | 1987-10-09 | 1989-06-05 | Roby Teknik Ab | DEVICE FOR GAS STERILIZATION OF A CURRENT PACKAGING MATERIAL RANGE |
JPH0356221A (en) * | 1989-07-26 | 1991-03-11 | Dainippon Printing Co Ltd | Sterilizing method for packaging material |
JPH05131018A (en) * | 1991-11-11 | 1993-05-28 | Terumo Corp | Bag connection body and manufacture thereof |
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-
1996
- 1996-10-14 SE SE9603735A patent/SE507994C2/en unknown
-
1997
- 1997-09-19 NZ NZ334621A patent/NZ334621A/en not_active IP Right Cessation
- 1997-09-19 EP EP97909776A patent/EP1021210B1/en not_active Revoked
- 1997-09-19 AT AT97909776T patent/ATE314098T1/en active
- 1997-09-19 JP JP10518239A patent/JP2001502277A/en active Pending
- 1997-09-19 DE DE69735012T patent/DE69735012T2/en not_active Revoked
- 1997-09-19 CA CA002266079A patent/CA2266079C/en not_active Expired - Fee Related
- 1997-09-19 CN CNB971988218A patent/CN1145498C/en not_active Ceased
- 1997-09-19 ES ES97909776T patent/ES2255102T3/en not_active Expired - Lifetime
- 1997-09-19 US US09/284,050 patent/US6682696B1/en not_active Expired - Fee Related
- 1997-09-19 ID IDW990185A patent/ID21220A/en unknown
- 1997-09-19 AU AU47300/97A patent/AU719367B2/en not_active Ceased
- 1997-09-19 CN CNB2004100058719A patent/CN100415303C/en not_active Ceased
- 1997-09-19 WO PCT/SE1997/001575 patent/WO1998016259A1/en active IP Right Grant
- 1997-09-19 BR BR9712234-3A patent/BR9712234A/en not_active IP Right Cessation
- 1997-09-19 DK DK97909776T patent/DK1021210T3/en active
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4797255A (en) * | 1986-03-24 | 1989-01-10 | Snow Brand Milk Products Co., Ltd. | Sterilization method and apparatus therefor |
EP0384535A2 (en) * | 1989-02-22 | 1990-08-29 | Shikoku Kakoki Co., Ltd. | Apparatus for supplying hydrogen peroxide for sterilization |
EP0481361A1 (en) * | 1990-10-13 | 1992-04-22 | Fmc Corporation | Sterilising apparatus |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1999051497A1 (en) * | 1998-04-07 | 1999-10-14 | Tetra Laval Holdings & Finance Sa | Method and apparatus for producing a sterile packaging container |
US6692684B1 (en) | 1998-04-07 | 2004-02-17 | Tetra Laval Holdings & Finance S.A. | Method and apparatus for producing a sterile packaging container |
JP2003512260A (en) * | 1999-10-15 | 2003-04-02 | ゲーエーアー フィンナー ゲゼルシャフト ミット ベシュレンクテル ハフツング | How to sterilize PET bottles |
WO2003093113A1 (en) * | 2002-05-03 | 2003-11-13 | Tetra Laval Holdings & Finance Sa | Method and packaging machine for producing sealed packages of pourable food products from precut blanks of sheet packaging material |
US7444796B2 (en) | 2002-05-03 | 2008-11-04 | Tetra Laval Holdings & Finance S.A. | Method and packaging machine for producing sealed packages of pourable food products from precut blanks of sheet packaging material |
WO2013008426A1 (en) * | 2011-07-08 | 2013-01-17 | 四国化工機株式会社 | Method for sterilizing packaging container using dilute hydrogen peroxide-containing gas |
Also Published As
Publication number | Publication date |
---|---|
US6682696B1 (en) | 2004-01-27 |
CA2266079C (en) | 2003-08-12 |
SE507994C2 (en) | 1998-08-10 |
DE69735012T2 (en) | 2006-07-13 |
DE69735012D1 (en) | 2006-02-02 |
EP1021210A1 (en) | 2000-07-26 |
CA2266079A1 (en) | 1998-04-23 |
CN100415303C (en) | 2008-09-03 |
AU4730097A (en) | 1998-05-11 |
NZ334621A (en) | 2000-09-29 |
SE9603735L (en) | 1998-04-15 |
ATE314098T1 (en) | 2006-01-15 |
DK1021210T3 (en) | 2006-05-15 |
SE9603735D0 (en) | 1996-10-14 |
CN1519033A (en) | 2004-08-11 |
ID21220A (en) | 1999-05-06 |
EP1021210B1 (en) | 2005-12-28 |
ES2255102T3 (en) | 2006-06-16 |
BR9712234A (en) | 1999-08-31 |
JP2001502277A (en) | 2001-02-20 |
CN1233190A (en) | 1999-10-27 |
AU719367B2 (en) | 2000-05-04 |
CN1145498C (en) | 2004-04-14 |
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