AU603419B2

AU603419B2 - Hermetically sealed package tester

Info

Publication number: AU603419B2
Application number: AU11149/88A
Authority: AU
Inventors: Anthony David Mcintosh Hawes; Melvin Vinton
Original assignee: Analytical Instruments Ltd
Current assignee: Analytical Instruments Ltd
Priority date: 1988-02-01
Filing date: 1988-02-01
Publication date: 1990-11-15
Anticipated expiration: 2008-02-01
Also published as: AU1114988A

Description

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AUSTRALIA

PATENTS ACT 1952 COMPLETE SPECIFICATION Form

(ORIGINAL)

FOR OFFICE USE Short Title: Int. Cl: Application Number: Lodged: rcOTt^AUS the FT71- documer contains the danmts made under Il n 49 and is correct for printing r Complete Specification-Lodged: Accepted: Lapsed: Published: Priority: Related Art: t TO BE COMPLETED BY APPLICANT Name of Applicant: Address of Applicant: ANALYTICAL INSTRUMENTS LIMITED LONDON ROAD

PAMPISFORD

CAMBRIDGE, CB2 4EF

ENGLAND

Actual Inventor: Address for Service: 1C c St 4.

CLEMENT HACK CO., 601 St. Kilda Road, Melbourne, Victoria 3004, Australia.

Complete Specification for the invention entitled: HERMETICALLY SEALED PACKAGE TESTER The following statement is a full description of this invention including the best method of performing it known to me:- 14 4' C C C C'CC C

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DESCRIPTION

HERMETICALLY SEALED PACKAGE TESTER The present invention is concerned with an apparatus and a method of testing hermetically sealed packages, such as pharmaceutical pill packs of the type which have metal foil or metallic laminate in the material of the package.

It is desirable for pharmaceutical pill packs to be hermetically sealed. The current practice is for audit tests to be performed during the packaging process to determine that the packaging has been properly carried out. Such audit tests involve dipping the packs in liquid methylene blue dye and evacuating the system. Any leaking packs fill with 15 dye and are picked out by eye. All packs which are tested are destroyed and the process is also very slow and messy.

It is known to test flexible sealed packages and containers for leaks using the so-called bulge test 20 wherein the container under test is subjected to a partial vacuum and the resulting expansion of the package or container is monitored. In general, leaking packages and containers when subjected to a partial vacuum do not expand at all or only expand slowly and to a lesser extent than non-leaking packages and containers. It is also known to monitor the expansion of the package or container under vacuum by measuring the movement of a flexible portion of the package or container. This measurement has been made by the use of mechanical probes, by electromagnetic and by electrostatic means.

It is an object of the present invention to provide an improved method and apparatus for testing the hermetic integrity of packages, in particular packages of the type which have a metal foil or metallic laminate in the material of the package.

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I CC C C f C 250 -CI C C C C C 30 In accordance with the present invention there is provided apparatus for testing flexible sealed packages of the blister pack type having one side made of an electrically nonconductive plastics material which defines a plurality of individual sealed compartments, or "blisters" which are closed off by a common, flexible, electrically conductive foil or metallic laminate, the apparatus comprising: an evacuable chamber adapted to support a package under test therewithin; a plurality of first fixed electrodes in said chamber positioned so as to lie opposite to respective parts of the foil or metallic laminate corresponding to the individual blisters when a blister pack under test is supported in the chamber; a second fixed electrode in said chamber which, in use, lies on the non-conductive side of the pack whereby a series capacitance arrangement is obtained, with a first capacitance (CF) being effectively formed between said second electrode and said flexible, electrically conductive foil or metallic laminate of the package and a second capacitance (Cp) being effectively formed between the flexible, electrically conductive foil or metallic laminate of the package and said first fixed electrodes, and, a capacitance measuring means having a multiplexing capability enabling sequential monitoring of the capacitance between the respective part of the foil or metallic laminate corresponding to each blister and the respective one of said first fixed electrodes.

In some cases, the measurement of capacitance under vacuum conditiohs can be compared to the measured capacitance under atmospheric conditions, a predetermined increase of capacitance being indicative of an acceptable package seal._ ~-rnm

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9 t C C 4TC C t 00 0 0 00 a 0 0 0 00 00 o 00 -3- 1n other cases, where the spacing between the various components is preset, a meaningful test can be made by absolute measurement of the capacitance under vacuum conditions alone.

Measurement of capacitance is conveniently made using a capacitance bridge.

The invention is described further hereinafter, by way of example only, with reference to the accompanying drawings, in which:- Fig. 1 is a diagrammatic sectional view through one embodiment of an apparatus in accordance with the present invention for testing a hermetically sealed package; Fig. 2 is a diagrammatic plan view on A-A in Fig.

15 1; and Fig. 3 is a circuit diagram illustrating the electrical part of the apparatus.

The embodiment which is illustrated and described hereinafter is concerned with testing the hermeticity 20 of so-called blister packs for foil-packed pills in which each pill is held in its own sealed "blister".

As illustrated in Fig. 1, a blister pack 10 to be tested comprises an electrically non-conductive body 12 formed with a plurality of recesses 14 in each of which is disposed a respective pill (not shown). The surface of the body 12 containing the recesses 14 is covered by a thin layer 16 of metal foil which is sealed to the latter surface so as to separate the recesses into separate, hermetically sealed compartments, each of which contains a pill.

As shown in Fig. 1, the blister pack 10 is laid in a nest 18 which is made of an electrically conductive material and which contains a plurality of recesses 19 into which the pill-containing compartment of the blister pack 10 extend. The nest 18 is itself located within a chamber 20 defined in a metal container 22, a 0090, el A r 1

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0 It 00, 0 a 0* to 00 04 0 00 0 00 0 00 00 0 00 -4the height of the nest 18 in the chamber 20 being determined by electrically conductive, adjustable packing members 24. The chamber can be closed in an air-tight manner by means of a lid 26 and an O-ring seal 28.

The lid 26 acts as an electrode support for a multiplicity of flat electrodes 30 arranged on an electronic printed circuit board 32 adjacent the individual compartments of the blister pack. The individual electrodes 30 are connected by leads 34 to the fixed contacts of a rotary switch S whose movable contact can selectively connect the electrodes 30 to one fixed terminal 38. A second fixed terminal 40 is connected by a lead 42 to the metal container 22 and thence, via the height adjusters 24, to the nest 18.

It will be appreciated that, by virtue of this arrangement, there is formed a multiplicity of pairs of series capacitors, the first capacitor Cp in each pair being established by the capacitance between a respective one of the electrodes 30 and the opposed portion of the metal foil 16 and the second capacitor in that pair being established by the capacitance between the foil 16 and the nest 18. Thus, there is a separate pair of series capacitors for each of the individual electrodes 30, the metal foil backing 16 of the blister pack acting as a second electrode forming a capacitative link to the electrodes 30 on the printed circuit 32.

For the purposes of measurement, it is convenient 30 to place the series capacitors in a capacitance bridge 31, as illustrated in Fig. 3. Since the capacitance of the second capacitor is the same for each series pair, it has been shown by a single capacitor CF in Fig. 3. The first capacitors Cp corresponding to each of the individual electrodes 30 can be connected selectively into the arm DE of the bridge by the

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4 i 7 Ii -i 0 0 0 0 000 00 000 0 00*0013 multi-way multiflexing switch S. The other arms of the bridge BE, BC and CD contain fixed capacitors

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1 respectively. An alternating supply voltage is applied to the points BD of the bridge and the points CE are connected to a detector circuit, indicated schematically by an amplifier 46. The capacitance Cp, formed between the individual electrodes 30 and the pill pack foil can thereby be measured in turn by taking a separate measurement for each position of the switch S.

In performing a test, the pack 10 is placed in the nest 18 and the lid 26 is closed. Each capacitance Cp is measured in turn and memorised in a memory 48. A vacuum is then applied to the chamber 20 for a short 15 time by means of a pressure control device 43, such as a vacuum pump, and by way of a duct 44 and the capacitances Cp are all measured again. In the event that any particular blister is properly sealed, the portion of the foil 16 covering that blister will bulge outwardly somewhat in the direction of the adjacent electrode 30 such that the measured capacitance CP at that electrode 30 will increase.

Thus, a measured increase of capacitance is indicative of a properly sealed blister. A minimum capacitance change can be set on a comparator 50 and compared with a preselected reference R below which the pack is rejected by a reject/accept detector 52.

It is advantageous to include a thin gasket 66 (see Fig. 2) (for example of neoprene) to ensure correct spacing of the pack 10 away from the electrodes 30. With the gaskets 66 in place it is possible to set an absolute capacitance level which must be exceeded before the pack is accepted. This removes the necessity of memorising individual capacitances in many circumstances.

-6- V If very small leaks are present, then the pack will swell on first applying the vacuum but will slowly relax as the air is lost from inside the pack.

It is possible to detect such small leaks by the use of a device 54 which detects the rate of change of the detected signal from the amplifier 46 and hence the rate of change of capacitance in the circuit, which is indicative of the leak rate. The two measures of capacitance and rate of change of capacitance can be.

employed to find both large and small leaks in the pack.

other types of foil packs can be tested by the same technique but with different types of evacuation chamber and electrode arrangements. For example, if it is convenient to make direct electrical contact to g the foil itself, then the other capacitance CF is eliminated and one is just measuring the increase of capacitance of a capacitor when the spacing between 9 its two electrodes is reduced.

The method is particularly suitable for TO pharmaceutical packs and food packs, but is adaptable to all hermetically sealed conductive packs.

Some pill packs, by virtue of their manner of formation, have raised foils which would show little or no movement under vacuum if simply subjected to the aforegoing technique. In this case, the pressure controlling device of Fig.l is arranged initially to provide a positive pressure to the pill pack via the duct 44 before then subjecting the pill pack-*to vacuum as before. This positive pressure application forces the foil over the blisters into a depressed state before the vacuum caus.-. a raised state. The test is then otherwise the same as before.

Furthermore, in the case of packs with only small leaks, the test time can be reduced by appl,-ing ramp functions of pressure and/or vacuum change rather than simply a sudden on/off change.

The present invention thus provides a fast, nondestructive method of testing hermetically sealed packs which enables the packs to be used after testing (if successful). The speed of testing available by the method allows testing of 100% of the product and 1o not just a representative sample as hitherto.

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Claims

2. Apparatus according to claim 1, wherein said further fixed electrode is in the form of an electrically conductive nest providing a plurality of depressions for receiving respective ones of the "blisters" of said package during a test.
3. Apparatus according to claim 2, wherein said nest is positioned in the chamber on electrically conductive packing members of adjustable height. I 4 C 0 0 0 0 0 oooooe o 0 0 Oo 00 o o 0000 0 0~00 O 00 00 0 'JO 00 0 QJOO
4. Apparatus according to any one of claims 1, 2 or 3, wherein said plurality of electrodes are carried by a printed circuit board which forms part of a removable lid of the chamber. Apparatus according to any one of claims 1 to 4, including means for subjecting the chamber to a positive pressure, prior to being subjected to a vacuum.
6. Apparatus according to any one of claims 1 to including a comparator means for comparing the measured capacitance under vacuum conditions with a reference level in order to distinguish acceptable packages from packages to be rejected.
7. Apparatus according to any one of claims 1 to 6, including means for detecting the rate of change of capacitance under vacuum conditions.
8. Apparatus according to any one of claims 1 to 7, wherein said means for selectively evacuating the chamber is adapted to reduce the pressure applied to the chamber by a ramp function of vacuum.
9. Apparatus according to any one of claims 1 to 7, wherein said means for selectively evacuating the chamber is adapted to reduce the pressure applied to the chamber abruptly.
10. Apparatus for testing flexible sealed packages of the blister pack type, substantially as hereinbef ore described with reference to and as illustrated in the accompanying drawings. 00 00 0 4 0 0 Dated this 3rd day of July, 1990 ANALYTICAL IM9TRUMENTS LIMITED By Its Patent Attorneys: GRIFFITH HACK CO. Fellows Institute of Patent Attorneys of Australia. T j 1. 'i