WO2018025161A1 - Sample element - Google Patents

Sample element Download PDF

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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
Application number
PCT/IB2017/054656
Other languages
French (fr)
Inventor
Stefano COLLISELLI
Original Assignee
Colliselli Stefano
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 Colliselli Stefano filed Critical Colliselli Stefano
Priority to EP17780203.0A priority Critical patent/EP3494377A1/en
Publication of WO2018025161A1 publication Critical patent/WO2018025161A1/en

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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic 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.
PCT/IB2017/054656 2016-08-04 2017-07-31 Sample element WO2018025161A1 (en)

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)

* Cited by examiner, † Cited by third party
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)

* Cited by examiner, † Cited by third party
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

Patent Citations (4)

* Cited by examiner, † Cited by third party
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)

* Cited by examiner, † Cited by third party
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 *

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Publication number Publication date
EP3494377A1 (en) 2019-06-12
IT201600082156A1 (en) 2018-02-04

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