WO2020046207A1 - Procédé et système de test d'intégrité d'emballages coque - Google Patents

Procédé et système de test d'intégrité d'emballages coque Download PDF

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Publication number
WO2020046207A1
WO2020046207A1 PCT/SG2019/050426 SG2019050426W WO2020046207A1 WO 2020046207 A1 WO2020046207 A1 WO 2020046207A1 SG 2019050426 W SG2019050426 W SG 2019050426W WO 2020046207 A1 WO2020046207 A1 WO 2020046207A1
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WO
WIPO (PCT)
Prior art keywords
blister
electrodes
electrode structure
frequency range
pair
Prior art date
Application number
PCT/SG2019/050426
Other languages
English (en)
Inventor
Hari Krishna SALILA VIJAYALAL MOHAN
Voon Yew Aaron THEAN
Suryakanta Nayak
Yida Li
Original Assignee
National University Of Singapore
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 National University Of Singapore filed Critical National University Of Singapore
Publication of WO2020046207A1 publication Critical patent/WO2020046207A1/fr

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01M—TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
    • G01M3/00—Investigating fluid-tightness of structures
    • G01M3/02—Investigating fluid-tightness of structures by using fluid or vacuum
    • G01M3/04—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point
    • G01M3/16—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using electric detection means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2205/00—General identification or selection means
    • A61J2205/60—General identification or selection means using magnetic or electronic identifications, e.g. chips, RFID, electronic tags

Definitions

  • the present invention relates broadly to the inspection of the integrity of blister packaging for pharmaceutical tablets, specifically to the non-destructive inspection of the integrity of blister packaging for pharmaceutical tablets.
  • over-the-counter (OTC) drugs and medicines which are mass-produced and packaged at a very high speed, may suffer from defective packaging.
  • Pharmaceutical industries use blister packaging or PTP (press through packaging), for such products requiring unit-dose confinement like tablets, capsules, lozenges, etc. to maintain the high production assembly line throughput.
  • Blister packs confine the products in a cavity and a lidding material seals the cavity, usually with a paper backing or aluminum or film seal.
  • the main advantages of blister packaging include stable and reliable storage condition of the medicine, unit dose and serial packaging; safe, hygienic, portable and convenient packaging; increased shelf life; and tamper evident to counter forgery.
  • Embodiments of the present invention seek to address at least one of the above problems.
  • a method of integrity testing of a blister package comprising the steps of:
  • an electrode structure comprising at least one pair of electrodes
  • a system for integrity testing of a blister package comprising:
  • an electrode structure comprising at least one pair of electrodes
  • a measuring unit configured to measure an electrical property of the blister over a frequency range while the AC bias voltage is varied over the frequency range
  • a processing unit for determining the integrity of the blister package based on the measured electrical property of the blister over the frequency range.
  • Figure 1A shows a schematic representation of cross section of a good blister package unit with tablet in cavity.
  • Figure 1B shows a schematic representation of cross section of a blister package unit with defective lid with tablet in blister.
  • Figure 1C shows a schematic representation of cross section of a blister package unit with defective lid and no product filling.
  • Figure 1D shows a schematic representation of cross section of a blister package unit with no lid and no tablet.
  • Figure 2A shows a schematic representation of the cross-section of a single unit of a blister pack with the two electrodes for testing, according to an example embodiments.
  • Figure 2B shows photographs of circular disk and blister cavity shaped electrode for use in an example embodiment.
  • Figure 3A shows plots of impedance (in Ohms) vs frequency (in Hertz)for four experimental cases according to example embodiments: (I) blister unit with tablet, (II) blister unit with tablet and tampered lid,( III) blister unit with tablet and no lid, and (IV) blister unit with no tablet and no lid.
  • Figure 3B shows plots of phase (in Degrees) vs frequency (in Hertz) for four experimental cases according to example embodiments: (I) blister unit with tablet, (II) blister unit with tablet and tampered lid,( III) blister unit with tablet and no lid, and (IV) blister unit with no tablet and no lid.
  • Figure 3C shows plots of capacitance (in Farads) vs frequency (in Hertz) for four experimental cases according to example embodiments: (I) blister unit with tablet, (II) blister unit with tablet and tampered lid,( III) blister unit with tablet and no lid, and (IV) blister unit with no tablet and no lid.
  • Figure 4A shows a schematic diagram illustrating interdigitated ring electrodes for use in example embodiments.
  • Figure 4B shows schematic diagrams of different possible textured surfaces (pyramids, saw tooth and pores) of electrodes for use in example embodiments.
  • Figure 4C shows a schematic diagram illustrating an array detection set up according to an example embodiment.
  • Figure 4D shows a schematic diagram illustrating cross-section of non-contact detection scheme for blister-package integrity testing according to an example embodiment.
  • Figure 5 shows a flowchart illustrating a method of integrity testing of a blister package, according to an example embodiment.
  • Figure 6 shows a schematic drawings illustrating a system for integrity testing of a blister package, according to an example embodiment.
  • Embodiments of the present invention use a circular disk electrode for the lidding material and a semispherical/cylindrical cavity shaped electrode for the blister to electrically profile and recognize defects in tablet blister packs.
  • the electrode-pair detection setup is connected to a frequency response analyzer in example embodiments, which generates an AC electric field of varying frequencies as the input to the system.
  • the output response is analyzed in the form of an electrical quantity, for example, capacitance
  • the presence of a defect for example, tom seal, leads to air gap/lack of lidding material, which generates a differential capacitance reading when compared to a well-sealed blister unit in a packet
  • Figure 1 shows schematic representations of the cross section of a blister package unit with possible defects: A) good unit with tablet in cavity, B) defective lid (hole) with tablet in cavity, C) defective lid (hole) and no product filling and D) no lid and no tablet.
  • embodiments of the present invention exploring an electrical quantity, which differs with and without a proper sealing. For example, capacitance between a sensing and reference electrode is altered when an external entity perturbs the electric field, or an existing material composition changes. As another example, absence of sealing layer alters the fringing fields between electrodes, which in turn, changes the capacitance.
  • the frequency response analysis using the proposed electrode-pair system can advantageously help in identifying the presence or absence of different types of defects in the seal.
  • the detection setup of two copper electrodes according to example embodiments includes one circular shaped disk electrode connected to the lid and the other electrode shaped to conform to the shape of the blister.
  • An AC electric field from a frequency response analyzer system is applied across the electrode pair serving as sensing and reference electrodes, respectively, according to example embodiments.
  • the output can be monitored electrically in the form of, for example, capacitance according to example embodiments. For instance, the absence of sealing material leads to exposed product/pinhole, which results in decreased capacitance.
  • Monitoring the capacitance change can enable classification of good and defective samples in real-time with high throughput to preferably match the sealing/packaging process throughput. Based on the extent of damage, for example, capacitance fingerprints can be created to quantify the defect.
  • a single frequency analysis can give only limited information in terms of change in an electrical parameter, for example, capacitance, for integrity testing of blister packages without divulging details regarding the type of defect.
  • a wide frequency analysis is used according to example embodiments, which allows complete electrical characterization of the lid-tablet-cavity unit by converting the complex impedance-frequency spectrum into simple circuit elements comprising of resistance (R), capacitance (C) and inductance (L), akin to a Randles circuit model for an electrochemical cell.
  • such a wide range frequency analysis advantageously provides sufficient inputs for machine learning to create electrical templates to classify and quantify defects according to example embodimens.
  • a highly complex mixture such as capsules with fluid contents like multi-vitamin capsules
  • Copper was used for the construction of metal electrodes according to example embodiments, by way of example, not limitation.
  • a circular disk shaped electrode 200 and a hollow cavity electrode 202 conforming to the blister’s 204 shape sandwiching the lid 206-blister 204 interface of an individual blister unit from a blister package formed the testing set up according to an example embodiments.
  • the blister package used for testing (Dazit 5 MG Tablet, SUN pharmaceuticals) has a blister 204 made of an insulating material and a metallic film lid 206.
  • the testing was done over a frequency (f) range from 100 Hz to 1 MHz at an AC bias voltage of 1 V to get impedance (Z), capacitance (C) and Phase (0) using a E4980AL LCR meter as the frequency response analyser 208 connected to the electrode pair 200, 202.
  • the electrodes 200, 202 are provided with respective plastic supports 2010, 212.
  • Both the electrodes 200, 202 are in contact with the blister packet while testing according to this example embodiment.
  • the electrical field strength and penetration depth is lower.
  • any air gap (lack of material) arising due to defects reduces electrical field lines through the blister package reflected via capacitance instantaneously during integrity testing according to this example embodiment.
  • the electrodes 200, 202 touch the blister package to allow the short-range electric field lines to penetrate the blister package
  • the lid 206-blister 204 interface is preferably sandwiched between the electrodes 200, 202. It is noted that at higher RF frequencies, the electrical field strength is stronger with greater penetration depth allowing package scanning from a distance without the need to touch the blister packs, according to different example embodiments.
  • the experiments were done using the electrode pair 200, 202 for the following cases listed below:
  • the use of the above mentioned electrode -pair system according to example embodiments allows defect identification on both the lidding and cavity side, but can be limited to a specific blister shape, and operates in contact mode and is configured for high sensitivity measurement when dealing with highly non-conductive packages.
  • extended design considerations and possible integration of sensors data with a data analytics tool are provided according to modified example embodiments.
  • an electrode design comprising of interdigitated ring electrodes 400, 402 can help to encompass different blister unit sizes.
  • using a textured electrode surface for one or both of the electrodes of the/each pair of electrodes such as pores- 404, saw tooth- 406 and/or pyramid- 408 textured can help in producing a highly concentrated and strong electric field, which can drastically increase the sensitivity of the detection when there is a defect.
  • Such electrode -pair systems can be operated either as a single sensor, which electrically profiles each blister unit moving on a conveyor system, or as a sensor array 410 as shown in Figure 4C according to an example embodiment that simultaneously records electrical signatures from different locations and identifies the location of defects based on the differential readings.
  • the sensor array 410 detects blister unit 1 to be good as indicated at numeral 412, while blister unit 2 is detected as compromised, here a missing lid portion exposing the tablet as indicated at numeral 414 in Figure 4C.
  • the sensor array 410 (or a single sensor in different embodiments) will cross both well-sealed and defective sites; thus measuring the electrical quantity at each scan point over the whole package to give electrical signatures for the package.
  • electrode systems according to example embodiments can adventurously identify the type of defects (no seal, seal tom, no product, etc.), defect location and quantify defects (size of pinholes, amount of product, etc.) by comparing against control standards (well-sealed blister packages).
  • the exposed seal portion(s) will give a differential capacitance compared to well-sealed areas and the numbering of the electrodes in the array 410 will reveal the location of defects.
  • the RF ranges from few kHz to GHz.
  • the electrodes used in the example embodiment described above are compatible with the LCR meter allowing contact mode of operation with the lid-blister interface sandwiched between the electrodes.
  • impedance analysis at frequencies greater than 1 MHz is involved, which is possible using high frequency operating systems like impedance analyzer and network analyzer.
  • Such high frequencies > 1 MHz
  • delivering such high frequency signals to the package under test without transmission loss, signal attenuation and electromagnetic interference can be a challenge.
  • a RF measurement system (network analyzer and impedance analyzer) compatible electrode design is used in such modified embodiments.
  • using a RF compatible electrode array to obtain impedance signatures across the blister unit according to such modified example embodiments generates a stronger electrical field that can advantageously provide an in-depth blister unit impedance profile to study and classify defects both in contact and in non-contact mode.
  • Embodiments of the present invention can advantageously allow examination of different types of blister packages and their contents (conductive and insulating) for characterizing defective seals, poor inner coatings, lack of product filling, product leak, etc., preferably in a non-contact mode.
  • Systems according to example embodiments can generate a massive dataset due to multipoint scanning/multiple electrodes. These electrical fingerprints preferably serve as input patterns for machine learning systems to quantitatively and qualitatively identify and classify defects.
  • FIG. 5 shows a flowchart 500 illustrating a method of integrity testing of a blister package, according to an example embodiment.
  • an electrode structure comprising at least one pair of electrodes is provided.
  • a blister of the blister package is disposed relative to the electrode structure such that the blister is subjectable to an electric field resulting from the application of an AC bias voltage to the electrode structure.
  • the AC bias voltage is applied to the electrode structure.
  • an electrical property of the blister is measured over a frequency range while the AC bias voltage is varied over the frequency range.
  • the integrity of the blister package is determined based on the measured electrical property of the blister over the frequency range.
  • the electrical property may comprise one or more of a group consisting of capacitance, resistance, phase and impedance.
  • the integrity of the blister package may be determined based on identifying a hole in a seal lid of the blister, absence of a content intended for the blister, and/or absence of the seal lid based on the measured electrical property of the seal portion over the frequency range.
  • Disposing the blister of the blister package relative to the electrode structure may comprise sandwiching the blister between the electrodes of the pair of electrodes.
  • the pair of electrodes may comprise a disk-shaped electrode and a cavity shaped electrode. Sandwiching the blister between the electrodes of the pair of electrodes may comprise receiving the blister within the cavity of the cavity shaped electrode.
  • the disk-shaped electrode and a cavity shaped electrode may be circular.
  • the frequency range may comprise from about 100 Hz to 1 MHz.
  • the blister may be disposed at the same side of the electrodes of the pair of electrodes.
  • the pair of electrodes may comprise two plate electrodes.
  • the blister of the blister package may be disposed relative to the electrode structure such that the blister is subjectable to an fringing electric field resulting from the application of an AC bias voltage to the two plate electrodes.
  • the frequency range may comprises the radio frequency range, for example from about 3 KHz to 300 GHz.
  • a surface of at least one of the pair of electrodes may be textured.
  • the surface of the at least one of the electrodes may be pyramid textured, saw tooth textured, or pore textured.
  • the electrode structure may comprise an array of pairs of electrodes.
  • Disposing the blister of the blister package relative to the electrode structure may comprise conveying the blister package past the electrode structure or vice versa.
  • FIG. 6 shows a schematic drawings illustrating a system 600 for integrity testing of a blister package, according to an example embodiment.
  • the system 600 comprises an electrode structure 602 comprising at least one pair of electrodes 604, 606, a source 608 for application of an AC bias voltage to the electrode structure 602 such that a blister of the blister package disposed relative to the electrode structure is subjectable to an electric field, a measuring unit 610 configured to measure an electrical property of the blister over a frequency range while the AC bias voltage is varied over the frequency range, and a processing unit 612 for determining the integrity of the blister package based on the measured electrical property of the blister over the frequency range.
  • the electrical property may comprises one or more of a group consisting of capacitance, resistance, phase and impedance.
  • the processing unit 612 may be configured to determine the integrity of the blister package based on identifying a hole in a seal lid of the blister, absence of a content intended for the blister, and/or absence of the seal lid based on the measured electrical property of the seal portion over the frequency range.
  • the electrode structure 602 may be configured for sandwiching the blister between the electrodes of the pair of electrodes 604, 606.
  • the pair of electrodes 604, 606 may comprise a disk-shaped electrode and a cavity shaped electrode.
  • the cavity of the cavity shaped electrode may be configured for receiving the blister.
  • the disk- shaped electrode and the cavity shaped electrode may be circular.
  • the frequency range may comprise from about 100 Hz to 1 MHz.
  • the electrode structure 602 may be configured for disposing at the same side of the blister.
  • the pair of electrodes 604, 606 may comprise two plate electrodes.
  • the electrode structure 602 may be configured such that the blister is subjectable to an fringing electric field resulting from the application of an AC bias voltage to the two plate electrodes.
  • the frequency range may comprise the radio frequency range, for example from about 3 KHz to 300 GHz.
  • a surface of at least one of the pair of electrodes 604, 606 may be textured.
  • the surface of the at least one of the electrodes is pyramid textured, saw tooth textured, or pore textured.
  • the electrode structure may comprise an array of pairs of electrodes.
  • the system may comprising a conveyer unit 614 for conveying the blister package past the electrode structure or vice versa.
  • One or more of the source 608, the measurement unit 608, and the processing unit 610 may be implemented in a single device 616.
  • Embodiments of the present invention can have one or more of the following features and associated benefits/advantages:
  • Industrial applications of example embodiment of the present invention include, but are not limited to the environment of pharmaceutical drug manufacturers filling blister packets and sealing at high speed. During this process, there is a high probability for improper sealing, lack of product filling, tom lid material etc., which leads to poor sample quality. Moreover, existing methods for leak testing for such blister packs are highly dependent on cavity and lidding material, the nature of product, suffer from low throughput and are destructive to both package and product. Furthermore, it generates huge financial loss in terms of package reject and waste disposal.
  • the approach can detect tampered/poor seals for different type/quantity of product as well as cavity/seal material.
  • the approach can identify and locate defective seals at a rapid rate in-line, thereby increasing the throughput during packaging and reducing wastage.
  • the approach can recognize poorly sealed contents non-destructively, thus allowing re-packaging and no product wastage.
  • Computer-readable media in which such formatted data and/or instructions may be embodied include, but are not limited to, non volatile storage media in various forms (e.g., optical, magnetic or semiconductor storage media) and carrier waves that may be used to transfer such formatted data and/or instructions through wireless, optical, or wired signaling media or any combination thereof.
  • Examples of transfers of such formatted data and/or instructions by carrier waves include, but are not limited to, transfers (uploads, downloads, e-mail, etc.) over the internet and/or other computer networks via one or more data transfer protocols (e.g., HTTP, FTP, SMTP, etc.).
  • data transfer protocols e.g., HTTP, FTP, SMTP, etc.
  • a processing entity e.g., one or more processors
  • aspects of the systems and methods described herein such as the source for applying the AC bias to the electrode structure, the measuring unit configured to measure an electrical property of the blister over a frequency range while the AC bias voltage is varied over the frequency range, and/or the processing unit for determining the integrity of the blister package may be implemented as functionality programmed into any of a variety of circuitry, including programmable logic devices (PLDs), such as field programmable gate arrays (FPGAs), programmable array logic (PAF) devices, electrically programmable logic and memory devices and standard cell-based devices, as well as application specific integrated circuits (ASICs).
  • PLDs programmable logic devices
  • FPGAs field programmable gate arrays
  • PAF programmable array logic
  • ASICs application specific integrated circuits
  • microcontrollers with memory such as electronically erasable programmable read only memory (EEPROM)
  • EEPROM electronically erasable programmable read only memory
  • aspects of the system may be embodied in microprocessors having software -based circuit emulation, discrete logic (sequential and combinatorial), custom devices, fuzzy (neural) logic, quantum devices, and hybrids of any of the above device types.
  • MOSFET metal-oxide semiconductor field-effect transistor
  • CMOS complementary metal- oxide semiconductor
  • ECL emitter-coupled logic
  • polymer technologies e.g., silicon-conjugated polymer and metal-conjugated polymer- metal structures
  • mixed analog and digital etc.

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  • Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Investigating Or Analyzing Materials By The Use Of Electric Means (AREA)

Abstract

Cette invention concerne un procédé et un système de test d'intégrité d'emballages coque. Le procédé comprend les étapes consistant à : fournir une structure d'électrodes comprenant au moins une paire d'électrodes ; positionner une coque de l'emballage coque par rapport à la structure d'électrodes de telle sorte que la coque puisse être soumise à un champ électrique résultant de l'application d'une tension alternative de polarisation à la structure d'électrodes ; appliquer la tension alternative de polarisation à la structure d'électrodes ; mesurer une propriété électrique de la coque sur une plage de fréquences tandis que la tension alternative de polarisation est modifiée sur la plage de fréquences ; et déterminer l'intégrité de l'emballage coque sur la base de la propriété électrique mesurée de la coque sur la plage de fréquences.
PCT/SG2019/050426 2018-08-31 2019-08-28 Procédé et système de test d'intégrité d'emballages coque WO2020046207A1 (fr)

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SG10201807480R 2018-08-31
SG10201807480R 2018-08-31

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4922181A (en) * 1987-08-06 1990-05-01 Laetus Systems Limited Apparatus for monitoring the dielectric constant of an article
WO2007148361A1 (fr) * 2006-06-21 2007-12-27 Federighi Federigo Système pour tester l'intégrité de récipients fermés fabriqués en un matériau non conducteur
JP2012103079A (ja) * 2010-11-09 2012-05-31 Hiroshima Univ 高粘度液状食品気泡混入の非破壊検査方法
US20140247062A1 (en) * 2012-12-06 2014-09-04 Boehringer Ingelheim International Gmbh Device and method to measure the permeation rate of a packaging
US8922226B2 (en) * 2006-08-28 2014-12-30 Detection Systems Pty Ltd Production line detection apparatus and method
US20160322971A1 (en) * 2012-10-19 2016-11-03 Microchip Technology Germany Gmbh Ii & Co. Kg Electrode Design For Electric Field Measurement System

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4922181A (en) * 1987-08-06 1990-05-01 Laetus Systems Limited Apparatus for monitoring the dielectric constant of an article
WO2007148361A1 (fr) * 2006-06-21 2007-12-27 Federighi Federigo Système pour tester l'intégrité de récipients fermés fabriqués en un matériau non conducteur
US8922226B2 (en) * 2006-08-28 2014-12-30 Detection Systems Pty Ltd Production line detection apparatus and method
JP2012103079A (ja) * 2010-11-09 2012-05-31 Hiroshima Univ 高粘度液状食品気泡混入の非破壊検査方法
US20160322971A1 (en) * 2012-10-19 2016-11-03 Microchip Technology Germany Gmbh Ii & Co. Kg Electrode Design For Electric Field Measurement System
US20140247062A1 (en) * 2012-12-06 2014-09-04 Boehringer Ingelheim International Gmbh Device and method to measure the permeation rate of a packaging

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