WO2018025161A1 - Sample element - Google Patents
Sample element Download PDFInfo
- Publication number
- WO2018025161A1 WO2018025161A1 PCT/IB2017/054656 IB2017054656W WO2018025161A1 WO 2018025161 A1 WO2018025161 A1 WO 2018025161A1 IB 2017054656 W IB2017054656 W IB 2017054656W WO 2018025161 A1 WO2018025161 A1 WO 2018025161A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- resins
- sample element
- resinous material
- element according
- gma
- Prior art date
Links
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
Definitions
- the present invention relates to a sample element.
- the present invention is advantageously applied for the realization of a sample or simulation element suitable for use in the process of controlling and validating production processes, in particular of primary packaging machines in the pharmaceutical sector, the following description being made with explicit reference without losing its generality.
- the purpose of the present invention is therefore to overcome the drawbacks of the known art disclosed above.
- the purpose of the present invention is to provide sample element which has a simple construction, is safe and has high quality and durability.
- Another purpose of the present invention is to provide a sample element with high durability against wear, high compressive strength and high resistance to the great stresses imposed within the primary packaging machines of which production performances must be tested.
- FIG. 2 is a schematic sectional view of a second embodiment of a sample element in question.
- E globally a sample or simulation element is indicated which is able to be supplied and introduced into primary packaging machines, in a preferable but not limited way by the pharmaceutical sector, in order to monitor and test the quality and/or validation of the machines themselves and their production processes.
- the sample element E in the purely indicative examples of Figures 1 and 2, is a vial or similar container used to contain liquid substances in the pharmaceutical sector which is made of a single body C through molding of a resinous material with components resistant to bacterial colonization and specially designed to be fed/cold- pressed and pressurized within a mold of a predefined shape and preferably made of a metal material.
- the cold-fed resinous material gives to the element E high hardness, aesthetic validity, very high polishing quality, high wear resistance, high biocompatible mechanical and thermal performances, and also a previously selected and variable color, in order to permit an easy and quick detection of element E during control phases.
- the cited resinous material may include acrylic resins, including PMMA-based resins, hydrophilic acrylic resins modified with hydroxyl methyl methacrylate, by copolymerization of MMA with hydroxyl methyl methacrylate, vinyl acrylic copolymers (vinyl chloride powder or vinyl acetate, liquid-based MMA), component substances such as dimethyl methacrylate F, Xi, N, N-dimethyl-p-toluidine T, N/A- polymethyl methacrylate, N/A-diethyl phthalate, dibenzoyl peroxide E, Xi.
- acrylic resins including PMMA-based resins, hydrophilic acrylic resins modified with hydroxyl methyl methacrylate, by copolymerization of MMA with hydroxyl methyl methacrylate, vinyl acrylic copolymers (vinyl chloride powder or vinyl acetate, liquid-based MMA), component substances such as dimethyl methacrylate F, Xi, N, N-dimethyl-p-
- the resinous material may include composite resins, including conventional composite resins, micro-filled composite resins (barium glasses, quartz and pyrogenic silica), micro-particulate resin complexes, mixed-filled composite resins.
- composite resins including conventional composite resins, micro-filled composite resins (barium glasses, quartz and pyrogenic silica), micro-particulate resin complexes, mixed-filled composite resins.
- the resinous material may include light-curing resins (BIS- GMA, UDMA and TEGDMA), i.e. either a synthesized chemical compound (BIS- GMA) treated with various diluents, or triethylene glycol dimethacrylate (TEGDMA) or ethylene glycol methacrylate (EGDMA) or di-urethane-di-methacrylate (DUEDMA), or bisphenol-A methcrylate (BIS-GMA), or methyl methacrylate (MMA).
- a synthesized chemical compound TEGDMA
- EGDMA ethylene glycol methacrylate
- DUEDMA di-urethane-di-methacrylate
- MMA methyl methacrylate
- the resinous material may include self-cured resins, synthetic resins, artificial resins with fillers, epoxy resins, polyurethane resins with specific dyes (stabilized methyl methacrylate).
- the element E then has integrated control sensor means S, at different selected points of the element E itself ( Figures 1 and 2), such as resistors, temperature probes, pressure probes, inserts detectable by external analysis systems (such as cameras, metal detectors, X-rays, etc.) or equivalent.
- integrated control sensor means S such as resistors, temperature probes, pressure probes, inserts detectable by external analysis systems (such as cameras, metal detectors, X-rays, etc.) or equivalent.
- the sensors S will therefore be integrated in a single body with the same element E, in order to guarantee technical characteristics and high strength, high wear life, high compressive strength and high resistance to the considerable stresses imposed within the primary packaging machines.
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- Physics & Mathematics (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Compositions Of Macromolecular Compounds (AREA)
- Dental Preparations (AREA)
- Crystals, And After-Treatments Of Crystals (AREA)
- Thyristors (AREA)
Abstract
A sample element (E) comprises a single body (C) made of a resinous material and supporting control sensor means (S) embedded in said body (C).
Description
SAMPLE ELEMENT .
The present invention relates to a sample element.
The present invention is advantageously applied for the realization of a sample or simulation element suitable for use in the process of controlling and validating production processes, in particular of primary packaging machines in the pharmaceutical sector, the following description being made with explicit reference without losing its generality.
In general, it is known to use sample or simulation elements fed into operating machines in order to monitor and test the quality and/or validation performance of the machines themselves and regarding their production processes.
Currently, the realization of such simulations is very complicated and particularly expensive.
In fact, such simulations are made from individual portions in different materials which then must be subsequently assembled, thus rendering the simulations thus produced extremely fragile and delicate.
The purpose of the present invention is therefore to overcome the drawbacks of the known art disclosed above.
In particular, the purpose of the present invention is to provide sample element which has a simple construction, is safe and has high quality and durability.
Another purpose of the present invention is to provide a sample element with high durability against wear, high compressive strength and high resistance to the great stresses imposed within the primary packaging machines of which production performances must be tested.
The structural and functional features of the present invention and its advantages with respect to the known art will become even clearer and evident from
the appended claims, and in particular by an examination of the following description, made with reference to the accompanying schematic drawings, and relating to some preferred but not limitative embodiments of a sample or simulation element, in which: - Figure 1 is a schematic sectional view of a first embodiment of a sample element in question;
- Figure 2 is a schematic sectional view of a second embodiment of a sample element in question.
With reference to the attached figures, with E globally a sample or simulation element is indicated which is able to be supplied and introduced into primary packaging machines, in a preferable but not limited way by the pharmaceutical sector, in order to monitor and test the quality and/or validation of the machines themselves and their production processes.
The sample element E, in the purely indicative examples of Figures 1 and 2, is a vial or similar container used to contain liquid substances in the pharmaceutical sector which is made of a single body C through molding of a resinous material with components resistant to bacterial colonization and specially designed to be fed/cold- pressed and pressurized within a mold of a predefined shape and preferably made of a metal material.
It should be noted that the cold-fed resinous material gives to the element E high hardness, aesthetic validity, very high polishing quality, high wear resistance, high biocompatible mechanical and thermal performances, and also a previously selected and variable color, in order to permit an easy and quick detection of element E during control phases.
The cited resinous material may include acrylic resins, including PMMA-based resins, hydrophilic acrylic resins modified with hydroxyl methyl methacrylate, by copolymerization of MMA with hydroxyl methyl methacrylate, vinyl acrylic copolymers (vinyl chloride powder or vinyl acetate, liquid-based MMA), component substances such as dimethyl methacrylate F, Xi, N, N-dimethyl-p-toluidine T, N/A- polymethyl methacrylate, N/A-diethyl phthalate, dibenzoyl peroxide E, Xi.
As an alternative, the resinous material may include composite resins, including conventional composite resins, micro-filled composite resins (barium glasses, quartz and pyrogenic silica), micro-particulate resin complexes, mixed-filled composite resins.
As an alternative, the resinous material may include light-curing resins (BIS- GMA, UDMA and TEGDMA), i.e. either a synthesized chemical compound (BIS- GMA) treated with various diluents, or triethylene glycol dimethacrylate (TEGDMA) or ethylene glycol methacrylate (EGDMA) or di-urethane-di-methacrylate (DUEDMA), or bisphenol-A methcrylate (BIS-GMA), or methyl methacrylate (MMA).
As an alternative, the resinous material may include self-cured resins, synthetic resins, artificial resins with fillers, epoxy resins, polyurethane resins with specific dyes (stabilized methyl methacrylate).
In addition, as an alternative to the use of cited metallic mould, it is possible to use a currently available 3D printing methodology.
The element E then has integrated control sensor means S, at different selected points of the element E itself (Figures 1 and 2), such as resistors, temperature probes, pressure probes, inserts detectable by external analysis systems (such as cameras, metal detectors, X-rays, etc.) or equivalent.
The sensors S will therefore be integrated in a single body with the same
element E, in order to guarantee technical characteristics and high strength, high wear life, high compressive strength and high resistance to the considerable stresses imposed within the primary packaging machines.
Claims
1. Sample element (E), in particular adapted to be used in control and validation operations of production processes, characterized in that it comprises a single body (C) made of resinous material and supporting embedded in said body (C) sensing control means (S).
2. Sample element according to claim 1 , characterized in that said resinous material is defined by acrylic resins, such as PMMA based resins, hydrophilic acrylic resins modified with idrossimetilmetacrillato, by copolymerization of MMA with idrossimetilmetacrillato, vinyl-acrylic copolymers (powder- vinyl chloride or vinyl acetate; liquid-based MMA), components substances such as metacrilatodimetile F; Xi, N, N-dimethyl-p-toluidine T, polymethylmethacrylate N / a, phthalate diethyl N / a, dibenzoyl peroxide E, Xi.
3. Sample element according to claim 1 , characterized in that said resinous material is defined by composite resins, among which conventional composite resins, composite resins with micro filled (barium glass, quartz and fumed silica), complex with resinous microparticles, resins composite mixed with filler.
4. Sample element according to claim 1 , characterized in that said resinous material is defined by light-curing resins (BIS-GMA, UDMA and TEGDMA), or a synthesized chemical compound (BIS-GMA) treated with various diluents, or TEGDMA or EGDMA, or DUEDMA, or of bisphenol a methacrylate (BIS-GMA), or methyl methacrylate (MMA).
5. Sample element according to claim 1 , characterized in that said resinous material is defined by self-curing resins, synthetic resins, artificial resins with fillers, epoxy resins, polyurethane resins, with specific dyes (methyl methacrylate stabilized).
6. Sample element according to one or more of claims 1 to 5, characterized in that
said body (C) is realized by cold and pressurized forming of said resinous material into a metal mold.
7. Sample element according to one or more of claims 1 to 5, characterized in that said body (C) is realized by a 3D printing of said resinous material.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP17780203.0A EP3494377A1 (en) | 2016-08-04 | 2017-07-31 | Sample element |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
IT102016000082156A IT201600082156A1 (en) | 2016-08-04 | 2016-08-04 | ELEMENT CHAMPION OF CONTROL OF A PRODUCTION PROCESS. |
ITUA2016A005834 | 2016-08-04 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2018025161A1 true WO2018025161A1 (en) | 2018-02-08 |
Family
ID=57708681
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/IB2017/054656 WO2018025161A1 (en) | 2016-08-04 | 2017-07-31 | Sample element |
Country Status (3)
Country | Link |
---|---|
EP (1) | EP3494377A1 (en) |
IT (1) | IT201600082156A1 (en) |
WO (1) | WO2018025161A1 (en) |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH0587526U (en) * | 1991-06-14 | 1993-11-26 | スタンレー電気株式会社 | Coupler integrated sensor |
DE102011084686A1 (en) * | 2011-05-19 | 2012-11-22 | Mitsubishi Electric Corp. | temperature sensor |
JP5359549B2 (en) * | 2008-05-30 | 2013-12-04 | 新日鐵住金株式会社 | Method of grasping raw material charging status and operating method of blast furnace in bell-less blast furnace |
WO2015129291A1 (en) * | 2014-02-26 | 2015-09-03 | 学校法人 関西大学 | Method for producing piezoelectric polymer |
Family Cites Families (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP3862770B2 (en) * | 1995-09-07 | 2006-12-27 | 日立化成工業株式会社 | Method for producing metal-clad laminate |
-
2016
- 2016-08-04 IT IT102016000082156A patent/IT201600082156A1/en unknown
-
2017
- 2017-07-31 EP EP17780203.0A patent/EP3494377A1/en not_active Ceased
- 2017-07-31 WO PCT/IB2017/054656 patent/WO2018025161A1/en unknown
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH0587526U (en) * | 1991-06-14 | 1993-11-26 | スタンレー電気株式会社 | Coupler integrated sensor |
JP5359549B2 (en) * | 2008-05-30 | 2013-12-04 | 新日鐵住金株式会社 | Method of grasping raw material charging status and operating method of blast furnace in bell-less blast furnace |
DE102011084686A1 (en) * | 2011-05-19 | 2012-11-22 | Mitsubishi Electric Corp. | temperature sensor |
WO2015129291A1 (en) * | 2014-02-26 | 2015-09-03 | 学校法人 関西大学 | Method for producing piezoelectric polymer |
Non-Patent Citations (1)
Title |
---|
SIMON J. LEIGH ET AL: "A Simple, Low-Cost Conductive Composite Material for 3D Printing of Electronic Sensors", PLOS ONE, vol. 7, no. 11, 21 November 2012 (2012-11-21), pages e49365, XP055088994, DOI: 10.1371/journal.pone.0049365 * |
Also Published As
Publication number | Publication date |
---|---|
EP3494377A1 (en) | 2019-06-12 |
IT201600082156A1 (en) | 2018-02-04 |
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