WO2004104572A1 - Sterility indicating systems - Google Patents

Sterility indicating systems Download PDF

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Publication number
WO2004104572A1
WO2004104572A1 PCT/EP2004/005444 EP2004005444W WO2004104572A1 WO 2004104572 A1 WO2004104572 A1 WO 2004104572A1 EP 2004005444 W EP2004005444 W EP 2004005444W WO 2004104572 A1 WO2004104572 A1 WO 2004104572A1
Authority
WO
WIPO (PCT)
Prior art keywords
sheet material
sterility
reel
desired portion
indicating
Prior art date
Application number
PCT/EP2004/005444
Other languages
French (fr)
Inventor
Andrea Bartoli
Luca Turci
Original Assignee
Sarong Societa'per Azioni
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 Sarong Societa'per Azioni filed Critical Sarong Societa'per Azioni
Priority to EP04739275A priority Critical patent/EP1625392A1/en
Publication of WO2004104572A1 publication Critical patent/WO2004104572A1/en

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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
    • A61L2/26—Accessories or devices or components used for biocidal treatment
    • A61L2/28—Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour

Definitions

  • the present invention relates to sterility indicating systems, particularly sterility indicating systems for sheet material to use to obtain sterile containers.
  • the sheet material that is used to obtain sterile containers in particular heat-formed pharmaceutical containers, must be subjected to a sterilising process that makes it suitable for the before mentioned purpose before it comes into contact with a substance that must be packaged in sterile conditions.
  • the sheet material is wound on reels and is bombarded with gamma rays for a fixed time period that must be sufficient to sterilise the sheet material of the reels.
  • a sterility indicating label is normally applied that is provided with colour-changing characteristics, which in other words changes colour when hit by gamma rays.
  • a further drawback consists of the fact that the labels may be tampered with.
  • One object of the invention is to improve the sterility indicating systems of reels of sheet material.
  • a further object is to provide sterility indicating means that provide greater guarantees of the actual sterility of the sheet material.
  • a yet further object is to provide sterility indicating means that is stably associated with the sheet material.
  • a sterility indicating system comprising a reel of sheet material suitable for being used to obtain sterile containers, characterised in that it comprises sterility indicating means placed on at least one desired portion of a longitudinal extension of such reel of sheet material.
  • the presence of sterility indicating means in a plurality of portions of the longitudinal extension of the reel enables the actual sterility conditions of each section of sheet material provided with the sterility indicating means to be ascertained, in other words enables the effectiveness of the penetration of the gamma rays into the reel to be determined.
  • a method for obtaining a reel of sheet material suitable for being used to obtain sterile containers comprising supplying sterility indicating means, characterised in that said supplying comprises applying said sterility indicating means to a desired portion of said reel.
  • This portion may be continuous, or interrupted, and be located along a section of the longitudinal extension of the sheet material however extended. In this way, reels of sheet material are obtained with which a sterility indicating means is associated in a non-removable manner and which, therefore, may be moved at will without running the risk that the sterility indicating means is separated therefrom.
  • detecting means of print centering as sterility detecting means .
  • a container in particular a container for a product that has to be packaged in sterile conditions, provided with sterility indicating means placed thereupon.
  • a user of the product contained in the container according to the invention may directly establish whether the material that forms the container is sterile or not.
  • Figure 1 is an interrupted front view of a general section of sheet material provided with sterility indicating means
  • Figure 2 is a view like the one in Figure 1, showing a further embodiment of the sterility indicating means
  • Figure 3 is a view like the one in Figure 1, showing another embodiment of the sterility indicating means;
  • Figure 4 is a perspective view of a section of sheet material provided with sterility indicating means according to a yet further embodiment, and of detecting means of the sterility indicating means.
  • Figures 1 to 4 show a first section 1 of sheet material 2 provided with a sterility indicator 3 having different embodiments . This sterility indicator 3 is placed on at least one portion of the sheet material 2.
  • the sterility indicator 3 is made from a colour-changing material, i.e. from a material that changes its colour when it is hit for a sufficient period of time by gamma rays.
  • the sterility indicator 3 enables to determine whether a specific reel or any section of sheet material has been irradiated with gamma rays and can therefore be used to obtain sterile containers. To sterilise the sheet material, it is bombarded with gamma rays whilst it is wound in the form of a reel and, if the sterilising process is effective, a change in the colour of the sterility indicator 3 takes place.
  • sterile a general section of sheet material into which the colour change of the sterility indicator 3 has really taken place.
  • the sheet material To correctly determine the sterility of a general section of sheet material, it is sufficient for the sheet material to be made of a different colour from the colour to which the sterility indicator 3 changes.
  • the sterility indicator 3 is provided on a portion of the sheet material 2 having the shape of an indicating strip 4 that extends along the length of the sheet material 2 parallel to one of its edges. In this way, it is possible to determine the sterility of a section 1 of sheet material 2 taken in any position of the longitudinal extension of the sheet material 2.
  • the sterility indicator 3 shown in Figure 2 is provided on a further portion of the sheet material 2 shaped as a further indicating strip 5 that extends along the length of the sheet material 2, and which is provided with a message 6 that is repeated along the length of the sheet material 2 and which bears the word "STERILE", or an equivalent.
  • the message 6 of the further strip 5 is made in a colour- changing material, so as to be legible only when the material changes colour. Furthermore, the message 6 is legible only in the actually sterile zones of the sheet material 2.
  • the sterility indicator 3 is provided, in the embodiment in Figure 4, in a plurality 7 of distinct indicating portions 8 that alternate in the longitudinal extension of the sheet material 2 and which can be arranged on the sheet material 2 at a desired distance D.
  • these indicating portions 8 can be arranged at a distance that is the same as the print centering distance. In this way, it is possible to use a common photocell 10 that is the same as the one used to check print centering to determine the sterility conditions of the sheet material 2.
  • the sterility indicator 3 is provided on a portion of the sheet material 2 shaped in such a way as to make on the sheet material 2 an ornamental pattern 11 extending both along the length and width of the sheet material 2.
  • the ornamental pattern 11 of the sterility indicator 3 may be appropriately varied in such a way as to produce any desired decorating effect on a container obtained from the sheet material 2.

Abstract

A sterility indicating system, comprising a reel of sheet material (2) suitable for being used to obtain sterile containers, characterised in that it comprises sterility indicating means (3, 4; 3, 5, 6; 3, 7, 8; 3, 11) applied to at least one desired portion of a longitudinal extension of said reel; a method for obtaining of a reel of sheet material (2) suitable for being used to obtain sterile containers, comprises supplying at least sterility indicating means (3, 4; 3, 5, 6; 3, 7, 8; 3, 11), characterised in that said supplying comprises placing said sterility indicating means (3, 4; 3, 5, 6; 3, 7, 8; 3, 11) on at least one desired portion of said reel of said sheet material (2); the use of print centering means (10) as sterility detecting means; a container, in particular a container of a product that must be packaged in sterile conditions, provided with sterility indicating means (3, 4; 3, 5, 6; 3, 7, 8; 3, 11) placed thereupon.

Description

Indicating Systems
The present invention relates to sterility indicating systems, particularly sterility indicating systems for sheet material to use to obtain sterile containers. The sheet material that is used to obtain sterile containers, in particular heat-formed pharmaceutical containers, must be subjected to a sterilising process that makes it suitable for the before mentioned purpose before it comes into contact with a substance that must be packaged in sterile conditions. For this purpose, the sheet material is wound on reels and is bombarded with gamma rays for a fixed time period that must be sufficient to sterilise the sheet material of the reels. In order to determine the efficacy of the irradiation of a reel with gamma rays, on an external surface of such reels a sterility indicating label is normally applied that is provided with colour-changing characteristics, which in other words changes colour when hit by gamma rays.
When irradiation with gamma rays has terminated, it is deduced from the colour of the label that the reel of sheet material has been subjected to irradiation.
One drawback of prior-art labels is their lack of reliability, which consists of a presumptive evaluation of whether sterilisation has occurred, which is based on the mere control that the colour of the labels has changed in the zones on which they are applied. A further drawback is that such labels may separate from the sheet material on which they are applied, especially during transportation and/or storage of the reels.
If such labels separate from the reels, all indications about the sterility conditions or lack thereof of the reels are lost.
A further drawback consists of the fact that the labels may be tampered with.
One object of the invention is to improve the sterility indicating systems of reels of sheet material.
A further object is to provide sterility indicating means that provide greater guarantees of the actual sterility of the sheet material.
A yet further object is to provide sterility indicating means that is stably associated with the sheet material.
In a first aspect of the invention, there is provided a sterility indicating system, comprising a reel of sheet material suitable for being used to obtain sterile containers, characterised in that it comprises sterility indicating means placed on at least one desired portion of a longitudinal extension of such reel of sheet material.
Owing to this aspect of the invention, it is possible to obtain greater certainty regarding the sterility conditions of a reel of sheet material . In fact, the presence of sterility indicating means in a plurality of portions of the longitudinal extension of the reel enables the actual sterility conditions of each section of sheet material provided with the sterility indicating means to be ascertained, in other words enables the effectiveness of the penetration of the gamma rays into the reel to be determined.
In a second aspect of the invention, there is provided a method for obtaining a reel of sheet material suitable for being used to obtain sterile containers, comprising supplying sterility indicating means, characterised in that said supplying comprises applying said sterility indicating means to a desired portion of said reel.
This portion may be continuous, or interrupted, and be located along a section of the longitudinal extension of the sheet material however extended. In this way, reels of sheet material are obtained with which a sterility indicating means is associated in a non-removable manner and which, therefore, may be moved at will without running the risk that the sterility indicating means is separated therefrom. In a third aspect of the invention, there is provided the use of detecting means of print centering as sterility detecting means .
Owing to this aspect of the invention it is possible to automate the detection of the sterility conditions of a reel of sheet material, thereby avoiding losses of time connected with manual detection, and easily extending this detection along the entire longitudinal extension of the reel, in such a way as to be able to automatically detect the sections of the sheet material that are not sterile for rejecting them. In a fourth aspect of the invention, there is provided a container, in particular a container for a product that has to be packaged in sterile conditions, provided with sterility indicating means placed thereupon.
In this way, a user of the product contained in the container according to the invention may directly establish whether the material that forms the container is sterile or not.
The invention may be better understood and implemented with reference to the attached drawings that illustrate some exemplifying non-limiting embodiments thereof, in which: Figure 1 is an interrupted front view of a general section of sheet material provided with sterility indicating means;
Figure 2 is a view like the one in Figure 1, showing a further embodiment of the sterility indicating means;
Figure 3 is a view like the one in Figure 1, showing another embodiment of the sterility indicating means; Figure 4 is a perspective view of a section of sheet material provided with sterility indicating means according to a yet further embodiment, and of detecting means of the sterility indicating means. Figures 1 to 4 show a first section 1 of sheet material 2 provided with a sterility indicator 3 having different embodiments . This sterility indicator 3 is placed on at least one portion of the sheet material 2.
The sterility indicator 3 is made from a colour-changing material, i.e. from a material that changes its colour when it is hit for a sufficient period of time by gamma rays.
Different materials are known in the prior art that have the above said colour-changing characteristics if they are subjected to gamma rays, these materials being also suitable for being associated with a sheet material. The sterility indicator 3 enables to determine whether a specific reel or any section of sheet material has been irradiated with gamma rays and can therefore be used to obtain sterile containers. To sterilise the sheet material, it is bombarded with gamma rays whilst it is wound in the form of a reel and, if the sterilising process is effective, a change in the colour of the sterility indicator 3 takes place.
For this reason, may be considered to be sterile a general section of sheet material into which the colour change of the sterility indicator 3 has really taken place.
To correctly determine the sterility of a general section of sheet material, it is sufficient for the sheet material to be made of a different colour from the colour to which the sterility indicator 3 changes. In the embodiment shown in Figure 1, the sterility indicator 3 is provided on a portion of the sheet material 2 having the shape of an indicating strip 4 that extends along the length of the sheet material 2 parallel to one of its edges. In this way, it is possible to determine the sterility of a section 1 of sheet material 2 taken in any position of the longitudinal extension of the sheet material 2.
The sterility indicator 3 shown in Figure 2 is provided on a further portion of the sheet material 2 shaped as a further indicating strip 5 that extends along the length of the sheet material 2, and which is provided with a message 6 that is repeated along the length of the sheet material 2 and which bears the word "STERILE", or an equivalent.
The message 6 of the further strip 5 is made in a colour- changing material, so as to be legible only when the material changes colour. Furthermore, the message 6 is legible only in the actually sterile zones of the sheet material 2.
In this way, it is possible to facilitate the analysis of a reel of sheet material 2 for determining its effective sterility.
In this way, it is further possible for a user of the products contained in a container made from the sheet material 2, to directly realize if the material that makes up the container is sterile or not.
The sterility indicator 3 is provided, in the embodiment in Figure 4, in a plurality 7 of distinct indicating portions 8 that alternate in the longitudinal extension of the sheet material 2 and which can be arranged on the sheet material 2 at a desired distance D.
In particular, these indicating portions 8 can be arranged at a distance that is the same as the print centering distance. In this way, it is possible to use a common photocell 10 that is the same as the one used to check print centering to determine the sterility conditions of the sheet material 2. With reference to Figure 4, the sterility indicator 3 is provided on a portion of the sheet material 2 shaped in such a way as to make on the sheet material 2 an ornamental pattern 11 extending both along the length and width of the sheet material 2.
In this way, it is possible to check the sterility of the sheet material 2, also in its width, in such a way as to eliminate any doubts about the homogeneity of sterilisation of the sheet material 2.
The ornamental pattern 11 of the sterility indicator 3 may be appropriately varied in such a way as to produce any desired decorating effect on a container obtained from the sheet material 2.

Claims

1. Sterility indicating system, comprising a reel of sheet material (2) suitable for being used to obtain sterile containers, characterised in that it comprises sterility indicating means (3, 4; 3, 5, 6; 3, 7, 8; 3, 11) placed on at least one desired portion of a longitudinal extension of said reel.
2. Sterility indicating system according to claim 1, wherein said at least one desired portion extends along said longitudinal extension of said reel, in such a way as to substantially occupy it over all its length.
3. Sterility indicating system according to claim 1, or 2, wherein said at least one desired portion is shaped in such a way as to define strip means (4, 5) substantially extending along the entire length of said longitudinal extension of said reel of said sheet material (2).
4. Sterility indicating system according to any one of claims 1 to 3, wherein said at least one desired portion further comprises further strip means (5) substantially extending along the entire length of said longitudinal extension of said reel, in a zone of said sheet material (2) distinct from a further zone of said sheet material (2) wherein said strip means (4) extends.
5. Sterility indicating system according to any one of claims 1 to 4, wherein said at least one desired portion is further provided with indicating messages (6) .
6. Sterility indicating system according to any one of claims 1 to 5, wherein said at least one desired portion is shaped in such a way as to define a plurality (7) of distinct portions (8), suitably spaced along said longitudinal extension of said reel.
7. Sterility indicating system according to claim 6, wherein said distinct portions (8) of said at least one desired portion are spaced at a distance (D) corresponding to a print centering distance of said sheet material (2).
8. Sterility indicating system according to any one of claims 1 to 7, wherein said at least one desired portion further comprises a significant section extending in a transverse direction in relation with said longitudinal extension.
9. Sterility indicating system according to any one of claims 1 to 8, wherein said at least one desired portion is shaped in such a way as to define a decorative pattern (11) on said sheet material (2).
10. Sterility indicating system according to any one of claims 1 to 9, wherein said indicating means (3, 4; 3, 5,
6; 3, 7, 8; 3, 11) comprises label means applicable to said at least one desired portion of said sheet material (2) .
11. Sterility indicating system according to any one of claims 1 to 10, wherein said indicating means (3, 4; 3, 5, 6; 3, 7, 8; 3, 11) comprises indicators printable on said sheet material (2).
12. Sterility indicating system according to any one of claims 1 to 11 and further comprising detecting means (10) arranged to detect a colouring of said indicating means (3, 4; 3, 5, 6; 3, 7, 8; 3, 11) .
13. Method for obtaining a reel of sheet material (2) suitable for being used to obtain sterile containers, comprising supplying sterility indicating means (3, 4; 3, 5, 6; 3, 7, 8; 3, 11) characterised in that said supplying comprises placing said sterility indicating means (3, 4; 3, 5, 6; 3, 7, 8; 3, 11) on at least one desired portion of a longitudinal extension of said reel of said sheet material (2) .
14. Method for obtaining a reel of sheet material (2) according to claim 13, wherein said placing comprises printing said sterility indicating means (3, 4; 3, 5, 6; 3, 7, 8; 3, 11) on said at least one desired portion of said reel of said sheet material (2).
15. Method for obtaining a reel of sheet material (2) according to claim 13, wherein said placing comprises applying said sterility indicating means (3, 4; 3, 5, 6; 3, 7, 8; 3, 11) to said at least one desired portion of said reel of said sheet material (2).
16. Method according to any one of claims 13 to 15, and further comprising further placing indicator strip means (5) on said at least one portion of said sheet material (2).
17. Method according to any one of claims 13 to 16, wherein said placing comprises defining indicating message means (6) on said at least one portion of said sheet material (2) .
18. Method according to any one of claims 13 to 17, wherein said placing comprises defining on said sheet material (2) an ornamental pattern (11).
19. Use of print centering detecting means (10) as sterility detecting means.
20. Container, in particular a container of a product that has to be packaged in sterile conditions, provided with sterility indicating means (3, 4; 3, 5, 6; 3, 7, 8; 3, 11) placed thereupon.
PCT/EP2004/005444 2003-05-22 2004-05-20 Sterility indicating systems WO2004104572A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP04739275A EP1625392A1 (en) 2003-05-22 2004-05-20 Sterility indicating systems

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT000150A ITMO20030150A1 (en) 2003-05-22 2003-05-22 SHEET MATERIAL STERILITY INDICATOR SYSTEM
ITMO2003A000150 2003-05-22

Publications (1)

Publication Number Publication Date
WO2004104572A1 true WO2004104572A1 (en) 2004-12-02

Family

ID=30012750

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2004/005444 WO2004104572A1 (en) 2003-05-22 2004-05-20 Sterility indicating systems

Country Status (3)

Country Link
EP (1) EP1625392A1 (en)
IT (1) ITMO20030150A1 (en)
WO (1) WO2004104572A1 (en)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3078182A (en) * 1960-09-09 1963-02-19 Shuford Mills Inc Color-changing pressure-sensitive adhesive indicator tapes
US3627469A (en) 1970-04-27 1971-12-14 Kendall & Co Exposure and sterilization indicators comprising substituted pyridines quinolines and/or isoquinolines
US4898762A (en) 1988-07-01 1990-02-06 Minnesota Mining And Manufacturing Company Easy tear sterilization indicator tape
US5182212A (en) * 1991-01-31 1993-01-26 Oscar Mayer Foods Corporation Time temperature indicator with distinct end point

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2090574A (en) * 1981-01-02 1982-07-14 Ellison E A & Co Ltd Packaging of a sterile article

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3078182A (en) * 1960-09-09 1963-02-19 Shuford Mills Inc Color-changing pressure-sensitive adhesive indicator tapes
US3627469A (en) 1970-04-27 1971-12-14 Kendall & Co Exposure and sterilization indicators comprising substituted pyridines quinolines and/or isoquinolines
US4898762A (en) 1988-07-01 1990-02-06 Minnesota Mining And Manufacturing Company Easy tear sterilization indicator tape
US5182212A (en) * 1991-01-31 1993-01-26 Oscar Mayer Foods Corporation Time temperature indicator with distinct end point

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP1625392A1

Also Published As

Publication number Publication date
ITMO20030150A1 (en) 2004-11-23
ITMO20030150A0 (en) 2003-05-22
EP1625392A1 (en) 2006-02-15

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