EP2140245A1

EP2140245A1 - Packaging testing apparatus

Info

Publication number: EP2140245A1
Application number: EP08737242A
Authority: EP
Inventors: Wayne Adrian Kimberlin; Darren Woodcock; Richard Lyster WHEATLY; Philip Rhys EVANS; Colin Scaife
Original assignee: Ethiprint Ltd
Current assignee: Ethiprint Ltd
Priority date: 2007-05-01
Filing date: 2008-05-01
Publication date: 2010-01-06
Also published as: WO2008132519A1; GB0708337D0

Abstract

The invention provides packaging testing apparatus comprising packaging retaining means adapted, in use, to hold an item of packaging to be tested, and means for application to the packaging of mechanical force in accordance with a plurality of predetermined test protocols. The invention also provides a method for testing an item of packaging.

Description

PACKAGING TESTING APPARATUS

The present invention relates to packaging testing apparatus, and to methods for testing packaging. In particular, the invention relates to apparatus and methods for testing the packaging of consumer products, for example pharmaceutical products, and the like.

The growing concern over the accidental ingestion of pharmaceutical products by children under the age of five is leading to wider legislation requiring packaging to comply with standards based on child and adult protocol testing. A child-resistant packaging protocol was developed in America in 1970, and the idea was adopted in the UK in 1975 for certain pharmaceutical products, and similarly in Germany in 1985. Concerns over this issue resulted in the EU Commission introducing Directives 91/410/EEC and 91/442/EEC, requiring child-resistant packaging for retail packs of potentially harmful household products.

At the time of the implementation of these Directives, there was an international standard, ISO 8317, for child-resistant reclosable packages, but no comparable standard for non-reclosable packaging. The Commission mandated CEN (Comite Europeen de Normalisation) to develop a standard to show child-resistant compliance for non-reclosable packaging and a working group was formed to address this issue. Prior to the EU directive, the use of child-resistant packaging was restricted in Germany, Italy, the Netherlands and the UK to the packaging of specified pharmaceutical products. Further legislation was introduced in the UK for potentially harmful household products in 1987 with the The Child Resistant Packaging (Safety) Regulations'. As so few EU member states had experience of child-resistant packaging there was great debate as to how a European-wide standard would be implemented. The conclusion was that there would be two standards, one for potentially hazardous household products, as they tend to be single-use non-reclosable, and a subsequent standard for specified pharmaceutical preparations. The drafting of a standard for a non-reclosable pharmaceutical packaging has been contentious because of the varying views on what constitutes the fail criteria for a multi-dose non-reclosable package. Current methods for testing the safety of such packaging involve giving packs of pills to panels of 30 to 100 or more children who are under the age of five, and observing how many pills they can remove within ten minutes. If 20% of the children are able to remove eight or more pills within the allotted time, the packaging fails and is deemed to be unsafe. Some representatives believe the fail criteria for a packaging should be based on 'access to a specific number of doses' (ie BS 8404 - 'access to 8 or more' as the fail criterion) as tested by a child panel. However, it is clear that the child panel is a subjective test, and is therefore inaccurate and often the results are not repeatable. Therefore, others believe that fail criteria for a packaging should be based upon product toxicity (as in the US protocol) instead of using a child panel. There is therefore no agreement as to how the safety of different packaging should be tested.

It should also be appreciated that while it is important that under fives should not be able to release pharmaceutical pills from the packaging, it is a requirement that the elderly or infirm are able to break open the packaging to release their medication. Accordingly, packaging has to be sufficiently resistant to prevent young children from opening it, but not so strong that the elderly and ill are unable to open it. This trade-off between strength and weakness of the packaging makes it difficult to accurately determine what constitutes a pass or fail for any particular type of packaging.

A further significant problem with known packaging testing methods is that it is not possible to accurately quantify the 'strength' of the packaging itself, and so, to date, it has not been possible to apply a standard numerical test to existing testing methods. As mentioned above, the commonly used method of child panels is subjective. Accordingly, there is a significant need in the art for an apparatus by which accessibility to a packaged product can be quantified. Another problem with the use of child panels is that it increases the risk that the children may actually learn how to open packaging in the home environment. Clearly, this should be avoided at all costs. Another problem with current methods involving the use of child panel testing is that it is extremely expensive. There is therefore a requirement to reduce the costs associated with testing packaging while still meeting all safety legislations.

It is therefore an object of the present invention to overcome or mitigate one or more of the problems of the prior art, whether identified herein or elsewhere, and to produce a commercially available test apparatus and associated methods that minimise or even avoid the reliance on child panel testing, and by which the strength of packaging of consumer products may be tested.

Early on in the development of this invention, the inventors recognised that standards for mechanical testing would be required to supplement forthcoming legislation relating to the testing of packaging. These standards would rely on child and adult panel testing to prove compliance, and would need to involve a one-off test. These standards would call for user companies to establish quality control (QC) procedures to ratify compliance. The establishment of a mechanical test standard would enable this to be achieved and also provide a means for suggesting changes to packaging construction.

The inventors attempted to develop such a standard. However, they found that the diversity of unit dose non-reclosable packaging meant that a more scientific approach was necessary. The inventors of the present invention have therefore attempted to provide the pharmaceutical industry with a means of scientifically monitoring packaging performance for child-resistant/adult-friendly compliance through mechanical testing. They have successfully developed an apparatus and mechanical method by which packaging may be tested in a quantifiable and repeatable manner, and which can be used instead of currently used child panels. A feasibility study was carried out that based on the mechanical testing of non- reclosable pharmaceutical packaging because of the international recognition of this style of packaging. However, the inventors believe that the apparatus that they have developed is not limited to testing solely pharmaceutical packaging, and may be used to test the strength (or weakness) of any type of packaging, for example that which may be used to package or encase any consumer products.

Hence, according to a first aspect of the invention, there is provided packaging testing apparatus comprising packaging retaining means adapted, in use, to hold an item of packaging to be tested, and means for application to the packaging of mechanical force in accordance with a plurality of predetermined test protocols.

The apparatus according to the invention may be used to test the integrity of the item under test, ie to test for defects in that item. The apparatus is of particular usefulness, however, in testing the strength or robustness of the packaging item and in particular for testing for compliance with an established standard or specification. The invention is especially useful in the testing of packaging designs for compliance with standards relating to child-resistance and adult-friendliness.

Advantageously, the test protocols according to which the apparatus of the invention applies mechanical force to the item under test to simulate the actions of a child handling the item, and provide detailed information on the force that is required to break the packaging material. The apparatus provides data through a software algorithm on the strength required for the apparatus to break the packaging. Advantageously, therefore, the apparatus according to the invention may be used to test compliance of the packaging being tested in a repeatable and quantifiable manner. Furthermore, the apparatus enables the packaging to be tested in a one-off test. In addition, the apparatus enables various standards to be generated for different types of packaging, which facilitate changes which may need to be made to packaging design and construction. The apparatus thus provides the packaging industry and those monitoring packaging compliance for child-resistance/adult-friendliness with accurate and scientifically-based data, which has not be possible to date, and therefore renders current child/senior adult testing panels redundant. The apparatus of the invention may be used to test many different types of packaging. However, the apparatus is particularly useful for the testing of blister packs, especially blister packs used for the packaging of pharmaceutical products. The invention may also be useful for the testing of blister packs containing other types of product, eg cosmetics, detergents, toxic substances, adhesives, contact lenses, food, chewing gum, detergents, bleach tablets, watch batteries, pills, or capsules. The apparatus may be used to test packaging containing horticultural products, for example slug pellets or plant feed. The apparatus may be used to test packaging containing veterinary products, such as tablets, for example for horses. Products contained within the packaging which may be tested by the apparatus of the invention may include solids, suspensions, liquids, powders, or gels.

As described above, the apparatus may be used to test blister packs, and the like. A blister pack most commonly comprises a sheet of polymer material that is deformed to create one or more depressions ("pockets"). The products to be packaged are placed (usually individually) in the pockets and a sheet or roll of coated aluminium, or a similar laminate structure, is applied to the base sheet, thereby sealing the pockets. Blister packs are commonly used to package pharmaceuticals, in particular pills, tablets, lozenges and capsules. The invention will be described herein primarily with reference to the testing of blister packs, and references to the edge or plane of the packaging should be understood as referring to such features of a blister pack (which is a substantially planar item). With appropriate modifications, the invention may however be applicable to the testing of numerous other forms of packaging.

Preferably, the apparatus comprises processing means, which controls the force applied to the packaging. The processing means is preferably a computer loaded with software for controlling the apparatus.

As the apparatus of the invention is particularly useful for the testing of an item for compliance with standards relating to child-resistance/adult-friendliness, the test protocols according to which mechanical forces are applied to the item may be designed to simulate the typical actions of a child or senior adult handling such an item. Thus, the test protocols may be designed to simulate actions such as: (i) compressing the packaging (ii) bending of the packaging; (iii) pulling of the packaging; (iv) pushing of the packaging; (v) twisting of the packaging;

(vi) prodding of the packaging, in particular prodding of the lidding closure (eg coated aluminium foil) of a blister, as may lead to puncture of that lidding closure; (vii) picking at the packaging, in particular picking at the edge of the lidding closure of a blister pack; (viii) biting the packaging; and combinations of any of the above actions.

The apparatus comprises packaging retaining means, which is adapted to hold the item of packaging being tested in position while force is applied to the packaging. The packaging retaining means preferably mimics the manner in which the item under test may be grasped by a child or adult. Preferably, a surface of the retaining means which contacts the packaging is resilient or compressible, and is preferably of a non-slip material. For example, the surface of the retaining means which contacts the packaging under test may be made of rubber, or the like. The coefficient of friction between the packaging and the surface which contacts the packaging is preferably between about 0.2 and 1.0, more preferably between about 0.3 and 0.8, and most preferably between about 0.5 and 0.7.

The packaging retaining means may comprise suction means for maintaining the packaging in position during the test. However, preferably the retaining means comprises gripping means adapted to grip the packaging. Preferably, the gripping means is arranged in use to grip a peripheral edge of the packaging. Preferably, the retaining means comprises first and second gripping means, each of which is adapted to grip a different part of the packaging under test. Preferably, in use, the first gripping means is adapted to grip one side of the packaging, and the second gripping means is adapted to grip an opposite side of the packaging. Preferably, the or each gripping means comprises first and second gripping members which contact upper and lower surfaces of the packaging. Preferably, the gripping means is pneumatically controlled to grip the packaging.

In some embodiments of the apparatus the retaining means may itself be adapted to apply a force to the packaging. The force applied to the packaging by the retaining means, and most preferably the gripping means, may be a compression force. By the term "compression force", we mean a force, which is applied to upper and lower surfaces of the packaging by the retaining means. Preferably, the compression force is applied at an angle to the plane of the packaging, and preferably substantially perpendicularly to the plane of the packaging. This axis is referred to herein as the y-axis, which is illustrated as axis D-D in Figure 5.

Preferably, the retaining means is adapted to vary the force applied to the packaging. The pressure applied to the packaging may be between about 0.2 bar and about 11 bar, preferably between about 0.5 bar and about 9 bar, more preferably between about 1 bar and about 7 bar, and most preferably between about 3 bar and about 5 bar. The most preferred pressure that is applied to the packaging by the retaining means is about 5 bar.

Preferably, the apparatus comprises at least one force detection means adapted to detect the force applied to the packaging, and preferably a plurality of force detection means. Preferably, the apparatus comprises a first force detection means adapted to detect the force applied to the packaging by the retaining means, and preferably by the or each gripping means. The force detection means may be a sensor, such as a pressure gauge, by which the pressure of the grip on the packaging may be monitored. It is preferred that the first force detection means comprises a strain gauge or force transducer. Preferably, the first force detection means is adapted to determine the maximum pressure applied to the packaging by the retaining means that the packaging can withstand without breaking. This calculation is referred to as "force feedback", which is described in Example 2. Advantageously, calculation of the force feedback value for the packaging enables precise quantification for the strength of the packaging. This has thus far never been possible, and enables an accurate means for testing the packaging.

The apparatus of the invention is adapted to apply mechanical force to the packaging, and the effect of the force applied thereto is used to test the packaging. The force applied to the packaging may be applied along an axis, as in compression (pushing) force or tension (pulling or stretching) force. Alternatively, or in addition, the apparatus may be adapted to apply a rotational force (bending or folding) to the packaging. The force applied to the packaging preferably has a component that is at an angle to the plane of the packaging. The force may be applied at any angle between 0° and 90° to the plane of the packaging. It will be appreciated that 0° is along the plane of the packaging, and that 90° is perpendicular to the plane of the packaging. The apparatus may be adapted to apply a transverse (ie a sideways) force to the packaging, for example along the packaging's surface.

Preferably, the apparatus comprises packaging probing means. In some embodiments, the probing means may be capable of applying a force in a direction which is substantially parallel to the plane of the packaging, ie along the packaging edge. However, preferably the probing means is adapted to apply a force at an angle to the plane of the packaging, and most preferably a force which is substantially perpendicular to the plane of the packaging. This force is referred to as the downwards force. Preferably, the downwards force applied to the packaging by the probing means is along an axis which is substantially parallel to the force that is applied to the packaging by the retaining means. Hence, the force is applied to the packaging along the y-axis, which is illustrated as axis C-C in Figure 2. Preferably, the probing means applies the downwards force to a central region of the packaging.

Preferably, the probing means comprises a probe, which is adapted to contact the packaging to apply the downwards force thereto. The probe has a diameter of between about 1 mm and 20mm, more preferably between about 5mm and 15mm, and most preferably between about 8mm and 13mm. The inventors have found that the average finger diameter for a child of 5 years of age is about 11 mm. Preferably, the probe comprises a resilient or compressible material, which is preferably non-slip. The probe is preferably made of the same material as the gripping means, preferably having a similar coefficient of friction. For example, the tip of the probe may be made of rubber, or the like.

Preferably, the probing means comprises a first actuation means, which is adapted to urge the probe towards the packaging to apply the downwards force thereto. Preferably, the first actuation means is adapted to urge the probe away from the packaging. Hence, the probe may be urged towards and away from the packaging in a reciprocating manner. The probing means may comprise a second actuation means which is adapted to displace the probe across the surface of the packaging, preferably while applying the downwards force thereto. Hence, in addition to applying the downwards force to the packaging, the probing means is preferably capable of applying a transverse force to the packaging. As shown in Figure 14, the transverse force is applied to the packaging along axis E-E. By combining the downwards and transverse forces, the probe may be drawn over the surface of the packaging in one direction, lifted away from the packaging at the end of the stroke, followed by a reapplication of the probe at the start point of the previous motion, and then repeating. Accordingly, a rotary motion may be performed thereby simulating the action of drawing a child's finger nail over the surface of the packaging in one direction, lifting the finger nail away at the end of the stroke followed by a reapplication of the finger nail at the start point of the previous motion, and so on. Therefore, it will be appreciated that the probing means may simulate the actions of a child pushing and prodding the packaging with their fingers and thumbs, pushing and prodding the packaging with their finger nails, and also peeling the packaging, eg peeling the lidding away from a blister pack to thereby release a product from the packaging. This peeling action could be applied to, but is not restricted to, either the edge of the packaging, or where the prodding action has caused a break in the lidding, or above a blister.

Additionally, in order to satisfy the requirement to demonstrate that the packaging is not only child-resistant, but also that the packaging is suitable for use by adults (ie that an adult may open the packaging), the probing means may also simulate the actions of an adult pushing against the packaging with their thumb.

Preferably, the first actuation means is adapted to vary the downwards force applied by the probe to the packaging. The downwards force applied to the packaging by the probe may be between about 5N and about 200N, but is preferably between about 2ON and about 120N, more preferably between about 4ON and about 100N, and most preferably between about 5ON and about 8ON. The most preferred downwards force that is applied to the packaging by the probing means for a child is about 6ON, and about 73N for an adult.

Preferably, the apparatus comprises a second force detection means adapted to detect the downwards force applied to the packaging by the probing means. It is preferred that the second force detection means comprises a strain gauge or force transducer. The transducer is preferably a linear force transducer. Preferably, data generated by the second force detection means is analysed by the processing means to provide information about the strength of the packaging. Preferably, the second force detection means is adapted to determine the maximum force applied to the packaging by the probing means that the packaging can withstand without breaking, ie "force feedback".

Preferably, the second actuation means is adapted to vary the transverse force applied by the probe to the packaging. The transverse force applied to the packaging by the probe may be between about 10N and about 150N, but is preferably between about 2ON and about 100N, more preferably between about 3ON and about 8ON, and most preferably between about 45N and about 6ON.

Preferably, the apparatus comprises a third force detection means adapted to detect the transverse force applied to the packaging by the probing means as it is drawn thereacross. It is preferred that the third force detection means comprises a strain gauge or force transducer, such as a linear force transducer. Preferably, the third force detection means is adapted to determine the maximum in-line force applied to the packaging by the probing means that the packaging can withstand without breaking, ie force feedback.

The first and second actuation means may comprise one or more motors. For example, the or each motor may be a servo motor.

Preferably, the apparatus comprises packaging bending means for applying a bending force to the packaging. This test is illustrated in Figure 9. By "bending force", we mean a bending or folding moment that is applied to the packaging. The bending force is preferably applied about an axis which is substantially in the plane of the packaging. This is referred to herein as the z-axis, which is illustrated as axis A-A in Figure 2. The bending force applied to the packaging by the bending means is preferably applied along an axis which is substantially perpendicular to the axis along which the force is applied to the packaging by the probing means. The bending means may be capable of bending the packaging at least 30° with respect to the plane of the packaging. Preferably, the bending means is capable of bending the packaging at least 40°, more preferably at least 50°, even more preferably at least 60°, and most preferably at least 70° with respect to the plane of the packaging.

The bending means preferably comprises the second gripping means. Preferably, the bending means comprises actuation means adapted to pivot the second gripping means with respect to the first gripping means, wherein pivoting causes the packaging to bend. The actuation means may be a motor, and preferably a servo motor.

Preferably, the apparatus comprises a fourth force detection means adapted to detect the bending force or torque applied to the packaging by the bending means. It is preferred that the fourth force detection means comprises a strain gauge or force transducer. The transducer is preferably a rotational force transducer. Preferably, data generated by the fourth force detection means is analysed by the processing means to provide information on the strength of the packaging. Preferably, the fourth force detection means is adapted to determine the maximum bending force applied to the packaging by the bending means that the packaging can withstand without breaking, ie "force feedback".

The apparatus may comprise a contact surface which the packaging contacts, and is preferably bent over, when the bending force is applied thereto. Preferably, in use, the contact surface contacts an elongate axis of the packaging, and preferably an inner portion thereof. Preferably, the contact surface is moveable between a first position in which it is in contact with the packaging, and a second position in which it is not in contact with the packaging. The apparatus may comprise a hinge about which the contact surface pivots between the first and second positions. The contact surface may be moved between the first and second positions either manually or mechanically, for example by an actuator. The contact surface may comprise an elongate bar.

Preferably, the apparatus comprises means for applying a pulling force and/or a pushing force to the packaging. By "pulling force", we mean a stretching force that is applied to a side of the packaging. By "pushing force", we mean a compression force that is applied to a side of the packaging. Preferably, the pulling and pushing forces are applied to the packaging along the same axis. The pulling force and/or pushing force may be applied along an axis which is substantially parallel to the plane of the packaging. This is referred to herein as the x-axis, which is illustrated as axis B-B in Figure 2. It will be appreciated that the x-axis and z-axis are on the same plane as each other but form an angle of 90° therebetween, and that the y- axis extends perpendicularly with respect to the x- and y-axes. Hence, the pulling force or pushing force that is applied to the packaging is preferably applied along an axis which is substantially perpendicular to the axis along which the force is applied to the packaging by the probing means. The pulling/pushing force is preferably applied along an axis which is orientated about 90° to the axis along which the bending force is applied to the packaging by the bending means.

Preferably, the means for applying the pulling force comprises actuation means which is adapted to move the first gripping means away from the second gripping means, or vice versa, to thereby pull or stretch the packaging. The means for applying the pushing force comprises actuation means adapted to move the first gripping means towards the second gripping means, or vice versa, to thereby push or compress the packaging. The pulling and pushing actions may be in a reciprocating motion, and may be carried out repeatedly. The pulling and/or pushing force applied to the packaging may be between about 1 N and about 6ON. A force of 2N is equivalent to the force that a 2 year old child can apply to packaging, and a force of 52N is equivalent to the force that a 5 year old can apply to packaging. Hence, the apparatus is capable of applying between this range of forces depending on the specific test being carried out on the packaging.

Preferably, the apparatus comprises a fifth force detection means adapted to detect the pulling and/or pushing force applied to the packaging. It is preferred that the fifth force detection means comprises a strain gauge or force transducer. Preferably, the transducer is a linear force transducer. Preferably, data generated by the fifth force detection means is analysed by the processing means to provide information on the strength of the packaging. Preferably, the fifth force detection means is adapted to determine the maximum push or pull force applied to the packaging by the means for applying the pushing/pulling force that the packaging can withstand without breaking, ie "force feedback".

Preferably, the apparatus comprises packaging twisting means which is operable in use to apply a twisting force to the packaging. By "twisting force", we mean a rotational or torsion force that is applied to the packaging. The twisting force may be applied about an axis which is substantially parallel to the plane of the packaging. This is referred to herein as the x-axis, which is illustrated as axis B-B in Figure 2. Hence, it will be appreciated that the twisting force is applied to the packaging about substantially the same axis as the pushing/pulling forces. When a packaging, such as a blister pack, is twisted, it contracts. This contraction of the packaging has an effect on the deflection caused when applying the twist to the packaging. Therefore, it is preferred that the push/pull force is applied to the packaging on the same axis as the twisting force to compensate for the contraction. The twisting means may be capable of twisting the packaging through at least 30°. Preferably, the twisting means is capable of bending the packaging through at least 40°, more preferably at least 50°, even more preferably at least 60°, and most preferably at least 70°.

Preferably, the packaging twisting means comprises at least one actuation means adapted to rotate the first gripping means with respect to the second gripping means or vice versa, wherein said rotation causes the packaging to twist. Preferably, the packaging twisting means comprises first and second actuation means, the first actuation means capable of twisting the first gripping means, and the second actuation means capable of twisting the second gripping means. The torque applied to the packaging may be between about 0.1 Nm and about 10Nm. A torque of 0.5Nm is equivalent to the twisting force that a 2 year old child can apply to packaging, and a torque of 3.68Nm is equivalent to the twisting force that a 5 year old can apply to packaging. Hence, the apparatus may apply forces in this range of forces, depending on the specific test being carried out on the packaging.

Preferably, the apparatus comprises a sixth force detection means adapted to detect the twisting force applied to the packaging. It is preferred that the sixth force detection means comprises a strain gauge or force transducer. The transducer is preferably a rotational force transducer. Preferably, data generated by the sixth force detection means is analysed by the processing means to provide information on the strength of the packaging. Preferably, the sixth force detection means is adapted to determine the maximum twisting force applied to the packaging by the twisting means that the packaging can withstand prior to breaking, ie "force feedback".

Preferably, the apparatus comprises packaging biting means, which is operable to apply a compression force to a corner of the packaging. Preferably, the biting means is pneumatically controlled to apply the compression force to the packaging. The compression force is preferably applied to upper or lower surfaces of the packaging. Preferably, the compression force is applied at the corner of the packaging, along a line disposed at an angle of between about 1° and 90° to the edges of the packaging, more preferably between about 10° and 60°, and most preferably between about 35° and 50° to the edges. As shown in Figure 20, the biting means preferably applies the compression force at a 45° angle across the corner of the packaging, indicated as axis F-F. The biting means may be moveable between a first position in which it engages the packaging and a second position in which it does not engage the packaging.

The force applied to the packaging by the biting means may be between about 1 N and about 100N, but is preferably between about 5N and about 75N, more preferably between about 10N and about 65N, and most preferably between about 4ON and about 6ON. In use, the biting means is preferably configured to apply the compression force to one corner of the packaging, while the retaining means (and preferably a gripping means) applies a pulling force to one side of the packaging, preferably the side that is opposite to the biting means. In so doing, the apparatus resembles a child simultaneously biting and pulling on the packaging.

Preferably, the apparatus comprises a seventh force detection means adapted to detect the biting force applied to the packaging. It is preferred that the seventh force detection means comprises a strain gauge or force transducer. Preferably, data generated by the seventh force detection means is analysed by the processing means to provide information on the strength of the packaging, ie "force feedback".

Hence, in a preferred embodiment, the invention provides a packaging testing apparatus for testing an item of packaging, the apparatus comprising packaging gripping means for gripping packaging, and means for application to the packaging of mechanical force in accordance with a plurality of predetermined test protocols, the means for application to the packaging of mechanical force comprising packaging probing means and/or packaging bending means and/or packaging twisting means and/or means for applying a pulling force and/or a pushing force and/or a biting force to the packaging.

Preferably, the apparatus comprises packaging probing means, packaging bending means, packaging twisting means, and means for applying a pulling force, a pushing force, and a biting force to the packaging. Preferably, the apparatus is adapted to determine force feedback for each force that is applied to the packaging to thereby determine the strength of the packaging. This is enabled by the force detection means associated with the packaging manipulation means.

From the foregoing, it will be appreciated that the apparatus is operable in use to apply various forces to the packaging along and about a number of different axes. Preferably, the apparatus is operable to apply a force to the packaging along or about at least one axis, eg the x-axis, the y-axis or the z-axis. Preferably, the apparatus is operable to apply a force to the packaging along or about at least two axes, eg the x-axis and the y-axis, or the z-axis and the x-axis, or the z-axis and the y-axis. Preferably, the apparatus is operable to apply a force to the packaging along or about at least three axes, eg the x-axis, the y-axis and the z-axis. Preferably, the apparatus is operable to apply a force to the packaging along or about at least four axes, and more preferably along or about at least five axes, even more preferably along or about at least six different axes, and most preferably along or about at least seven axes.

The apparatus of the first aspect has been designed to closely simulate, using the various actuation means and force detection means, actions such as bending, twisting, pushing, pulling, piercing, biting and tearing. This allows the real-time force feedback control of each manipulation against the strength capabilities of children. Preferably, the apparatus is controlled by software run on the processing means, which software controls motion control, preferably data capture, and preferably real-time interpretation of the force feedback data.

In a most preferred embodiment, the apparatus is adapted to carry out at least six manipulations on a packaging to simulate a child's manipulation of the packaging. Preferably, the six manipulations include bending, twisting, pulling, pushing, prodding, biting and squeezing. The inventors have devised various types of tests that can be carried out on a packaging as described in Example 7. The apparatus may be operable to conduct any manipulation test individually on the packaging. For example, tests may be defined as single manipulative activities, for example bending, or twisting, or push out or biting etc, ie just one type of manipulation test may be conducted on the packaging at any one time. However, preferably the apparatus is operable to conduct a plurality of manipulation tests on the packaging. Multi-manipulative tests may be carried out on the packaging for more realistic testing, ie bending and twisting, or pushing and piercing, or tearing and pulling, and so on.

Most preferably, the apparatus is adapted to subject the packaging to a multi- manipulative test, which involves more than one manipulation test, more preferably more than two tests, even more preferably more than three tests, still more preferably more than four tests, yet still more preferably, more than five tests, and most preferably more than six tests. Tests may be carried out either sequentially or simultaneously.

The inventors believe that the apparatus according to the first aspect may be used in a novel method for testing a packaging.

Hence, according to a second aspect of the invention, there is provided a method for testing packaging, the method comprising use of the apparatus of the first aspect.

Preferably, the method comprises applying a force (referred to as a deflection) to the packaging along a chosen axis. Preferably, the method comprises subjecting a packaging under test to a force that does not exceed the strength of an average child, based on published data. Preferably, the method comprises applying a plurality of different forces to the packaging along a plurality of different axes. The forces may be applied simultaneously or sequentially. The method preferably comprises detecting the reaction force (ie the force applied by the packaging in reaction to the deflection force applied thereto) to determine the force feedback. Hence, preferably the method comprises calculation of the force feedback value for the deflection force. Preferably, this force feedback is monitored by the processing means and compared to a standard value or threshold for a given child/senior adult age and sex. Data logging may be recorded at a specified sampling rate and variables may be logged for further analysis. Preferably, the method of the invention is repeated until the packaging breaks or fails. The method preferably comprises comparing the maximum force that a packaging can withstand before breaking with a standard value for a given child/senior adult age and sex (ie force feedback measurement).

Advantageously, the method according to the invention is able to detect when the packaging material has been broken because there is a sharp reduction in force feedback. Using this data, the method may be used to determine whether or not the packaging passes or fails the test.

All of the features described herein (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined with any of the above aspects in any combination, except combinations where at least some of such features and/or steps are mutually exclusive.

For a better understanding of the invention, and to show how embodiments of the same may be carried into effect, reference will now be made to the Examples and accompanying Figures, in which:-

Figure 1 shows a first perspective view of a first embodiment of an apparatus according to the invention for testing packaging of consumer products;

Figure 2 shows a second perspective view of the apparatus shown in Figure 1 ; Figure 3 shows a side view of the apparatus;

Figure 4 shows a plan view of the apparatus;

Figure 5 shows an enlarged view of a gripper assembly of the apparatus;

Figure 6 shows a perspective view of the gripper assembly gripping a blister pack; Figure 7 shows the apparatus of the invention including a computer and power source;

Figure 8 shows a screen print of a software command box which controls the apparatus; Figure 9 shows alignment of a blister pack in the gripper assembly for a Bend Test

(Type i );

Figure 10 shows alignment of a blister pack in the gripper assembly for a Bend

Test (Type 2);

Figure 11 shows alignment of a blister pack in the gripper assembly for a Torsion Test;

Figure 12 shows alignment of a blister pack in the gripper assembly for a Prod

Test;

Figure 13 shows a side view of a second embodiment of the apparatus according to the invention; Figure 14 shows a perspective view from above of a prodder assembly of the apparatus shown in Figure 13;

Figure 15 shows a perspective view from below of the prodder assembly shown in

Figure 14;

Figure 16 shows a plan view the prodder assembly shown in Figure 14; Figure 17 shows a perspective view of the second embodiment of the apparatus showing a bite assembly;

Figure 18 shows an enlarged plan view of a teeth gripper component of the bite assembly in a closed configuration;

Figure 19 shows an enlarged plan view of the teeth gripper component of the bite assembly in an open configuration; and

Figure 20 shows a plan view of the bite assembly engaging a packaging.

Examples

The following examples describe the development and use of an apparatus according to the invention, which is used for testing a pack 54 for a consumer product. The apparatus is particularly useful for testing pharmaceutical packaging, such as a blister pack as shown in Figures 9 to 12, and is described with reference to such a pack 54. Different views of a first embodiment of the apparatus 2 are shown in Figures 1 to 4, and different views of a second embodiment of the apparatus 78 are shown in Figures 13 to 20.

The apparatus 2,78 includes a grip assembly 12 which grips the pack 54 during tests. The grip assembly 12 is shown in detail in the enlarged views of Figure 5 and 6. Figures 7 illustrates the apparatus 2 and associated PC 56 which runs software 58 for controlling and recording data generated by tests carried out on the pack 54, as shown in Figure 8. Once the pack 54 has been inserted into the grip assembly 12, the apparatus 2 applies a range of different forces to the pack 54 by a series of servo motors (ie actuators) to thereby simulate bending, twisting, push-pull, push through, piercing, biting and tearing along a number of different axes of manipulation, as shown in Figures 9 to 12. The apparatus 2 will now be described in detail with reference to the Figures.

Example 1 - Description of the Apparatus

Referring to Figures 1 to 4, there are shown different views of the first embodiment of the apparatus 2. The apparatus 2 consists of a frame assembly 4, which is supported by legs 8, and has two vertical uprights 6, which are held in position by angle supports 10. A blister pack 54 is inserted into a grip assembly 12, which is shown in more detail in Figure 5. The development of the grip assembly 12 is described in Example 3. Referring to Figure 5, the grip assembly 12 consists of two sets of pneumatic grippers 14,15. The surfaces of the grippers 14,15, which contact the pack 54 under test, are covered in rubber and are designed to simulate a child's grip. One side of the pack 54 to be tested is inserted in between one set of grippers 14, and the opposite side of the pack 54 is inserted between the other set of grippers 15. Hence, both sides of the pack 54 are firmly gripped or compressed by the grippers 14,15, along axis D-D, as shown in Figure 5.

Once gripped by grippers 14,15, the pack 54 may then be subjected to a number of different tests. Referring to Figures 1 and 2, grippers 15 are mounted on a bend arm assembly 16, which is pivotally mounted to the frame assembly 4 by spigots 20. As shown in Figure 2, the spigots 20 define axis A-A therebetween, about which the bend arm 16 pivots under the control of a bend arm motor assembly 18. The bend arm motor assembly 18 includes a servo motor 17 and a torque sensor 19. The torque sensor 19 is a force transducer which can measure the strain or torque applied to the pack 54 as it is bent. As the servo motor 17 is actuated by computer 56, it causes the bend arm 16, and hence grippers 15, to pivot around axis A-A in a direction indicated by arrow 'X', as illustrated in Figure 2. Pivoting bend arm 16 and grippers 15 apply a bending force to the pack 54 along axis A-A, thereby causing it to bend with respect to grippers 14. Hence, bending the pack 54 in this manner constitutes a manipulation test applied about a first (A-A) axis. The amount of strain or torque applied to the pack 54 is detected by the torque sensor 19, and sent to the computer 56 for data analysis.

Referring to Figure 4, apparatus 2 includes two brackets 46, which are mounted by hinges 52 on either side of the frame assembly 4. A rigid bar 48 is supported between the two brackets 46. The brackets 46 and bar 48 may be moved away from the pack 54 and bend arm 16 about hinges 52, if desired, to improve access to the grip assembly 12. However, in use, the bar 48 is moved into position so that it provides a surface against which the underside of the pack 54 under test will be urged when the bend arm 16 is pivoted about axis A-A, ie during the bending test. In effect, therefore, the bar 48 provides a bending anvil which defines a fold axis for the pack 54. Although not shown in the Figures, it is envisaged that the rigid bar 48 may be moved linearly towards and away from the pack 54, either manually or by an actuator.

Referring to Figures 1 and 2, the other set of grippers 14, which grip the packaging under test, is mounted on to the end of a "push-pull-twist" assembly 25, which is itself mounted to the frame assembly 4 by inner gimbals 24. One side of each gimbal 24 is rigidly attached to the "push-pull-twist" assembly 25, and the opposite side of each gimbal 24 is provided with an aperture through which a threaded steel rod 26 is received. Each threaded rod 26 extends parallel to the axis of the assembly 25, a first end being rigidly fixed to the front of the frame assembly 4 and a second end being rigidly attached to the rear of the frame assembly 4. The "push-pull-twist" assembly 25 further includes a servo motor 22, and a torque sensor 38, to which the gripper 14 is attached. When actuated by the computer 56, the servo motor 22 causes the assembly 25 including grippers 14 to rotate around axis B-B in a direction indicated by arrow ¹Y', as illustrated in Figure 2. The rotating action first occurs in one direction, and then when it reaches its end point, it rotates in the opposite direction. Hence, rotating the grippers 14 about axis B-B applies a force to the pack 54 such that it bends with respect to the other set of grippers 15. Hence, rotating or twisting the pack 54 in this way is a manipulation test about the second axis (B-B). The amount of strain or torque applied to the pack 54 by the twisting or torsion force provided by the servo motor 22 is detected by the torque sensor 23, and sent to the computer 56 for data analysis.

In addition to the twisting action that may be applied to the pack 54 about axis B-B by the assembly 25, the apparatus 2 is also capable of applying a push-pull force to the pack 54 along axis B-B. The push-pull force is generated by a second servo motor 38 provided at the back of the apparatus 2 as shown in Figure 1. The servo motor 38 is mounted to a cross-beam 32, which extends between opposite sides of the frame assembly 4, and a threaded bar 40 which is connected to the rear of the frame assembly 4. Once actuated by the computer 56, the servo motor 38 causes the whole assembly 25 to move in a first direction along axis B-B towards the pack 54 guided by the parallel threaded rods 26,40, and then in a second, opposite direction away from the pack 54 along axis B-B, as shown in Figure 2. The parallel threaded steel rods 26 extending along each side of the frame assembly 4 control the movement of the assembly 25 and hence grippers 14 along the B-B axis. Movement towards the pack 54 is referred to as a "push", and movement away from the pack 54 is referred to as a "pull". By pushing and pulling the grippers 14 along axis B-B by servo motor 38, pulling and pushing forces are alternately applied to the pack 54, thereby manipulating it with respect to the other set of grippers 15 provided on the bend arm 16. Hence, pulling and pushing the pack 54 in this way is a further manipulation test along the B-B axis.

As shown in the Figures, the assembly 25 includes a strain gauge sensor 28 (ie a linear force transducer; Model No: KAP-S, 100N capacity) and an alignment guide 30. The amount of strain or torque applied to the pack 54 by the pushing and pulling forces provided by the servo motor 38 is detected by the strain gauge 28, and sent to the computer 56 for data analysis. In particular, the apparatus 2 is able to calculate the amount of force feedback, and this is described further in Example 2.

Referring to Figure 2, the cross-beam 32 is fitted with a cross-beam extension 34 which provides additional support for the assembly 25 at the rear of the apparatus 2. A block 36 is attached to the underside of the cross-beam extension 34, which ensures that the push/pull force remains parallel to axis B-B, so as not to deflect the transducer 28 in any other axis of orientation, which could otherwise distort the test results.

It will be appreciated that the twist axis and the push-pull axis are both mounted along the same axis B-B. When a blister pack 54 is under test, there is a certain amount of shrinkage or contraction due to the twisting force applied thereto. Therefore, it is considered important for the twist test and the push/pull test to be conducted on the same axis, ie B-B.

In addition to the bending force that may be applied to the pack 54 about axis A-A, the twisting force that may be applied about axis B-B, and the push-pull forces that may be applied along axis B-B, the apparatus 2 is also capable of applying a pushing or prodding force to the packaging along a third axis, axis C-C, which is shown in Figure 2 by a prodding assembly. Development of the prodding assembly is described in Example 4.

Referring to Figure 2, the apparatus 2 includes a horizontal cross-bar 33 extending between the two uprights 6 at the front of the apparatus 2. Extending downwardly from the cross-bar 33 there is provided a probe 42, which is moved under the power of a servo motor 44. When actuated by the computer 56, the servo motor 44 applies a force to the probe 42 such that it moves in a first direction along axis C-C towards the pack 54, and then in a second, opposite direction away from the pack 54 along axis C-C. A physical stop 50 extends transversely out of the cross- beam 33 and is provided to ensure that the probe 42 does not extend too far along axis C-C when traveling in either direction. Prodding or poking the pack 54 with the probe 42 is a further manipulation test along a third (C-C) axis. As shown in the Figures, the apparatus 2 includes a strain gauge sensor 28, which is used to measure the amount of strain or torque applied to the pack 54 by the prodding force provided by the motor 44 to the probe 42. Strain data is detected by the strain gauge 28, and sent to the computer 56 for data analysis.

In summary, the first embodiment of the apparatus 2 includes a series of servo motors 17, 25, 38, 44, each of which apply forces to the pack 54 held in the grippers 14,15. The apparatus 2 further includes sensors or force transducers 19, 23, 28, which measure the various manipulation forces that are applied to the pack 54 along or about the various axes.

With reference to Figures 2 and 5, the pneumatic grippers 14,15 apply varying compression forces along axis D-D, which extends perpendicular to the plane of the pack 54. The probe 42 applies a downwards force on to the centre of the packaging along axis C-C, which is parallel to axis D-D. Motor 38 applies either a push force or a pull force to the side of the pack 54 along axis B-B, which is orientated at 90° with respect to axis D-D. Also, motor 25 applies a twisting force to the packaging about axis B-B. Finally, motor 17 applies a bending force to the packaging about axis A-A, which is on the same plane as axis B-B, but is orientated at 90° with respect to axis B-B.

Example 2 - Force Feedback Development

A review of child panel test videos was carried out to define the cycling frequency and displacement of the various servo motors in order to replicate children's actions. A cycling frequency of 2Hz and a displacement of 25mm or 180° were selected, as shown in Table 1. Table 1 - Specifications of the axes

The various force sensors (ie transducers) that were used in the apparatus 2 are produced by AST (Angewandte System Technik, Marschnerstrasse 26, 01307, Dresden, Germany). The sensors were connected through a signal conditioning unit to the PC 56 via a card sold under the trade name NetX, which enabled highspeed real-time capture of the data from all four channels of sensors.

The servo motors 17, 25, 38, 44 that were used in the apparatus 2 were rotary stepper motors each fitted with a 5:1 gearbox, and were produced by Total Motion Solutions, 12 Grosvenor Court, Wheel House Road, Rougeley, Staffordshire, WS15 1 LH, United Kingdom. These motors were used for the bend and twist axes and enabled the specified torque and 2Hz requirements to be met adequately. The pull and prod axes used stepper motors with lead screws. The motion and sensing system along the various axes were assembled together with the control systems, bench-tested and then integrated into the final apparatus 2.

The provision of the sensors made it possible to calculate force feedback for each manipulation force that is applied to the pack 54. Force feedback may be calculated as follows. The apparatus 2 applies a given deflection (ie a force) to the pack 54 in any of the four axes (ie twist (B-B), bend (A-A), pull/push (B-B), or prod (C-C)). Using the various force transducers 19, 23, 28, the reaction force (ie the force applied by the pack 54 in reaction to the force applied thereto) is fed back to the computer 56. This force feedback measurement is logged and compared to the threshold force for a certain child's age and sex (data available from the DTI - ie the figures shown in Table 1). Should the force feedback exceed the threshold for a given child's age and sex, then the direction of the movement of the given servo motor is reversed. This is repeated on all axes to determine force feedback values along each axis. Hence, once the force feedback value has been determined for a given manipulation test on a given axis for a given packaging, it is possible to calculate the maximum force that the pack 54 can withstand without breaking, and thereby determine the strength of the pack 54 being tested.

Example 3 - Gripper development

Referring to Figure 5, the development of the grippers 14,15 for the apparatus 2, which manipulate the packaging along axis D-D, involved two design concepts intended to resemble children's fingers. The first was intended to resemble gripping between the thumb and the forefinger, and the second was intended to resemble the tips of the fingers against the palm of the hand. Pneumatic grippers 14,15 were therefore designed and manufactured based upon the action of moving the fingertips to the palm of the hand. The components of the grippers 14,15 that mimic the fingertips and palm were manufactured using silicone rubber supported on a steel core, which were thought to simulate skin and bone, respectively. The dimension of the fingertips was 11 mm, the average finger diameter for a 5 year old child. The pneumatic control included a double-acting cylinder (not shown) with a five-way control valve and a regulator, which regulated air pressure to control the grip force driving the grippers 14,15. The grippers 14,15 were calibrated in a mechanical test machine in two modes: (i) a grip-closure load; and (ii) a pull-out load. The results (not shown) demonstrated that the pneumatically controlled grips 14,15 could be controlled with varying grip force along axis D-D, and closely resembled the friction provided by a child's fingers.

Example 4 - Probe Development

The probe 42, which manipulated the packaging along axis C-C, was developed to simulate the following actions used by children to open packaging, ie (i) pushing and prodding with fingers (referred to as a soft action); (ii) pushing and prodding with finger nails (referred to as a sharp action); and (iii) peeling. As with the development of the grippers 14,15, the probe 42 was designed with a diameter of 11mm, which is the average finger diameter for a 5 year old child. The probe tip was manufactured using silicone rubber to resemble the skin on a child's finger. Bench tests were carried out which demonstrated that, under low forces, the probe 42 'massaged' the packaging 54 in a similar manner to that observed at child panel testing. Under higher forces, the probe 42 was able to push a tablet from out of the pack 54. Hence, the inventors were satisfied that the probe 42 closely resembled the various "prodding" actions conducted by a child trying to open packaging.

Example 5 - Use of the apparatus

Children's actions when playing with various types of packaging have been studied by review of video recordings of child test panels. Children's strength capabilities have been taken from DTI Strength Handbooks and also the results of the inventors' study. The apparatus 2 has therefore been designed to closely simulate bending, twisting, push-pull, push through, piercing and tearing actions.

This allows the real-time force feedback control of each manipulation against the actual strength capabilities of children. The apparatus 2 is controlled by software, which controls motion control, real-time interpretation of the force feedback information, and data capture.

The inventors have devised various types of tests that can be carried out on a pack 54, as described in Example 6. For example, tests can be defined as single manipulative tests, such as bending, or twisting, or push out, or push, or pull, etc.

Hence, a single type of manipulation test can be conducted on the pack 54.

However, more frequently, packaging under test is subjected to multi-manipulative tests for more complex and more realistic testing, ie simultaneous bending and twisting, or simultaneous pushing and piercing, or simultaneous tearing and pulling, and so on. Ideally, packaging is subjected to a full multi-manipulative test, which involves subjection to every available test either sequentially, or simultaneously.

Each test specifies a start position, a target position, force thresholds, a number of repetitions and the cycle time for each axis of manipulation. The apparatus 2 attempts to move from the start position to the target position within a defined cycle time. A repetition is completed once either the target position has been reached (a "pass") or a force threshold exceeded, in which case the packaging will break (a "fail"). Data logging is recorded at the specified sampling rate for further analysis. Force feedback analysis is carried out for each force or manipulation applied to the packaging on each axis.

Example 6 - Test Protocol (1 )

This example presents a Test Protocol for the apparatus 2 for testing a blister pack 54. The aim of the Test Protocol was to determine the conditions for various packaging manipulation tests that attempt to replicate the results obtained from child panel testing. The results from each test provided data: (i) as part of the apparatus' proof of principle; and (ii) towards the generation of a test standard for child-resistant compliant blister packs.

Apparatus set-up The apparatus 2 was set up as shown in Figure 7, and mains power was applied to both to the apparatus 2 and the PC 56. A safety screen surrounding the apparatus 2 was opened, after which the grippers 14,15 were then opened by the pneumatic cylinder. The operator then inserted a blister pack 54 in the grippers 14,15 as shown in Figure 6 in preparation for the various different tests, as illustrated in Figures 9 to 12.

Test samples

The blister packs 54 that were tested are shown in Figures 9 to 12, and were filled with coated placebo tablets having the following dimensions: (i) diameter 11.2mm, height 5.6mm and radius 13mm, and (ii) diameter 6mm, thickness 3.3mm.

Example 7 - Test Protocol (2)

The purpose of the Test Protocol was to define the type and number of manipulations (bending, twisting, pushing, pulling, prodding etc) required by the apparatus 2 to open or "fail" the pack 54 to the same extent as a child. A draft test Protocol was produced, which defined the apparatus 2 set-up for various tests, the samples to be tested, the test procedure for each mode, and analysis of test results. Test samples were based on two tablet sizes, ie 6mm and 11 mm diameter, three lidding materials, two base materials, and one strip material. The materials were: 35gsm glassine paper/9 μm soft tempered Aluminium - 859-e; 30 μm hard tempered Aluminium with pyramid embossing - 912-e; 25 μm soft tempered Aluminium - 749-e; Cold forming foil 25 μm OPA/45 μm Soft Tempered Aluminium/60 μm PVC- cff; 250 μm opaque PVC.

Eight different variants of pack 54 were used for testing the apparatus 2. In order to define the number of cycles for each manipulation test, there were two stages to each test procedure. Stage 1 defined the number of cycles needed to achieve the same result as the child panel test in single cycle steps, and Stage 2 tested up to 25 blister packs of each type. The test procedure will now be described below.

Test procedure

(a) Bend Test (Type 1 )

This test involves bending the pack 54 over the bending anvil 48 about axis A-A.

As shown in Figure 9, the packaging is placed into the grippers 14,15 of the apparatus 2, and the bending anvil 48 is aligned along the mid-line of the centre row of tablets in the pack 54, ie row 3 beneath the blister. The apparatus 2 is set up with the test parameters as shown in "Bend (Type 1 )" of Table 2.

Table 2 - Test machine set-up conditions

The start position for the test is when the pack 54 is in the horizontal configuration, ie 0°. When the test is initiated, grippers 15 bend the pack 54 over the bending anvil 47 until it reaches the stop position at an angle of 65° below the horizontal. The bending force of 4Nm is applied a total of 6 times (ie 6 repetitions) until one or both of the blisters fail. If the pack 54 fails, no further tests are carried out. However, if the pack 54 passes this test, the apparatus is reconfigured so that the pack 54 is bent over the anvil 48 to an angle of 70°, and the test is repeated six times. If the pack 54 passes this test, the apparatus is reconfigured so that the pack 54 is bent over the anvil 48 to an angle of 75°, and the test is repeated six times. The bend tests are carried out as above using 25 blister packs of each material to be tested. The test type and sample number is written on the test blister pack 54. The test data is saved using filenames defining test type, pack type, materials code no, and sample number. A note is made of the number of test repetitions needed to cause failure of an individual blister, and the position on the pack 54. On completion of each individual test, the blister pack 54 is retained for subsequent examination and analysis. If the packaging passes Bend Test (Type 1 ), it is then subjected to Bend Test (Type 2).

(b) Bend Test (Type 2)

This test involves pushing and pulling the pack 54 along axis B-B. The pack 54 is placed into the apparatus 2, as shown in Figure 10, and the apparatus 2 tests the parameters as shown in "Bend (Type 2)" in Table 2. The start position for the test is when the pack 54 is fully extended and not pulled or pulled by the grippers 14, ie 0mm. When the test is initiated, the grippers 14 are moved 20mm towards the packaging along axis B-B, thereby applying a pushing force thereto, causing the pack 54 to bend. Once the grippers 14 reach the end position (ie 20mm), the direction of movement is reversed, and a pulling force is then applied along axis B- B. The test is run at the "0-20mm" setting with a bending force of 52Nm, and six repetitions are carried out. If the pack 54 passes the six repetitions, the pack 54 is realigned in the grippers 14,15 to the "0-21 mm" setting, in which the end position is 21 mm away from the start position. Hence, the pack 54 is subjected to a more rigorous bending force. The pack 54 is tested 6 times, and if it passes, it is reconfigured to the "0-22mm" setting, and the test is run again for six repetitions. If the pack 54 fails the Bend Test (Type 2), no further tests are carried out. However, if the pack 54 passes the Bend Test (Type 2), it is subjected to the Torsion Test.

(c) Torsion (ie twist) Test This test involves twisting the pack 54 along axis B-B. The packaging is placed into the apparatus 2, as shown in Figure 11 , and the apparatus 2 tests the parameters as shown in "Torsion" in Table 2. The start position for the test is when the pack 54 is in the horizontal untwisted configuration, ie 0°. When the test is initiated, grippers 15 twist the pack 54 until it reaches the stop position at an angle of 60°. The test is run with a force of 7Nm, and then repeated for six repetitions or cycles. Two further Torsion Tests may be carried out in which the pack 54 is twisted up to 70° and then up to 80° from the untwisted start position. If the pack 54 fails the Torsion Test, no further tests are carried out. However, if the pack 54 passes the Torsion Test, it is subjected to the Prod Test.

(d) Prod Test

This test involves prodding the pack 54 along axis C-C. The packaging is placed into the apparatus 2, as shown in Figure 12, and the apparatus 2 tests the parameters as shown in "Prod" in Table 2. The start position for the test is when the prodder 42 just contacts the surface of the pack 54, 0mm. The test is run by prodding with a force of 6ON, and moving the prodder 10mm towards the pack 54. The cycle is repeated for 6 cycles. If the pack 54 fails the Prod, no further tests are required.

Conclusion

The Prod Test is the last test that is carried out on the packaging using the first embodiment of the apparatus 2, and the inventors have found that the various tests described in the Protocol closely resemble a child attempting to open a packaging.

Example 8

Following on from their findings discussed in Examples 1 to 7, the inventors modified the apparatus 2 so that it could conduct other manipulation tests on the pack 54 in addition to the twist (axis B-B), bend (axis A-A), push (axis B-B), pull (axis B-B), and prod (axis C-C) tests. The second embodiment of the apparatus 78 is shown in Figure 13 in which the prodder 42, force transducer 28, stop 50 and prodder servo motor 44 of the first embodiment of the apparatus 2, have been replaced with a more advanced prodder assembly 80. The assembly 80 is capable of performing several manipulations or tests on the pack 54, ie (i) a "prod" test (axis C-C), (ii) a "puncture and peel" test, and (iii) a "puncture and edge pick" test. The second embodiment 78 also includes a bite assembly 82, which is provided to simulate the actions of a child biting the pack 54, ie a "bite" test.

Furthermore, the second embodiment of the apparatus 78 includes an additional servo motor 23 and sensor 22 which enables the gripper 15 to be twisted, these components being positioned along axis B-B but on the opposite side of the pack 54. Hence, both sets of grippers 14,15 can be twisted along axis B-B. Furthermore, it is possible to twist and bend the packaging simultaneously, if desired.

Referring to Figures 14 to 16, there are shown various views of the prodder assembly 80. The prodder assembly 80 includes a prodder 67 and associated components, which are supported on a moveable platform 108. The platform 108 is mounted by bearings on a slide 74, which is rigidly fixed to a base plate 65 under the control of an actuator 66. The actuator 66 is mounted on the base plate 65 by two struts 100. The actuator 66 includes a body 101 , and two rods 102 which are attached to an extendible side plate 104. The plate 104 of the actuator 66 abuts a corresponding plate 106 which is attached by the platform 108 to an end bracket 72. The end bracket 72 is connected to an elongate frame 73 which supports the prodder 67 and its associated components. A pivot arm 60 extends away from one end of the elongate frame 73, and two further actuators 62,64 are attached to the pivot arm 60 by means of a mating plate 61. The actuators 62, 64 sandwich a load cell 63, which is provided to measure the force that is applied to the prodder 67 by actuators 62,64. The prodder 67 is attached to actuator 64, which urges the prodder 67 towards and away from the pack 54. The alignment of the prodder 67 with a pack 54 is controlled by a guide block 68, which is attached to an adjuster 70 and a fine adjustment slide 71 , which is connected to the bracket 72. A further load cell 69 is provided between the guide block 68 and the adjuster 70, and measures the movement force that is applied to the prodder 67 by actuator 66.

The first manipulation carried out by the prodder assembly 80 is the "Prod" Test, which involves aligning the prodder 67 above a pocket 83 on the pack 54 in which a pill or capsule may be contained. In use, the actuator 62 urges the assembly comprising the load cell 63, actuator 64 and prodder 67 down onto the pack 54 with the pockets 83 facing upwards. When the load cell 63 senses that the prodder 67 is in contact with the pocket 83, the downward motion is halted. Actuator 64 then extends thereby pushing the prodder 67 against the pocket 83. Again, the load cell 63 monitors the force exerted by the prodder 67 against the pocket 83. The forces exerted on the pocket 83 can be varied using the software 58 and, depending on the test selected, can simulate either a child force or an adult force. A puncture test may be performed in the same manner as above, but from the opposite side of the pack 54. Each of these Prod tests are carried out along the C-C axis, as shown in Figure 14.

Another function of the prodder assembly 80 is the "puncture and peel" test. This involves drawing the prodder 67 along the foil side of the pack 54 (ie the opposite side to the pockets 83) while pushing down against the foil. With reference to Figure 14, upon actuation of actuator 66, the two rods 102 extend the side plate 104 away from the body 101 (to the left of the Figure). This action causes the plate 106 and the assembly carried by platform 108 to be urged to the right of the Figure. Hence, as actuator 66 extends, the assembly on bracket 72 and thus the prodder 67, are moved away from the centre of the pack 54 along axis E-E. Actuator 62 brings the assembly comprising the load cell 63, actuator 64 and prodder 67 down onto the pack 54 along axis C-C. When the load cell 63 senses the prodder 67 is in contact with the pack 54, actuator 64 extends until the required downward force is applied to the pack 54, as monitored by load cell 63. Actuator 66 then retracts, thereby pulling the entire assembly on bracket 72 along the slide 74 and the pack 54 back along axis E-E. The force applied along the surface of the pack 54 is monitored by the load cell 69. At the end of the stroke, or when the required force is reached, actuator 62 is retracted moving the prodder 67 away from the pack 54, and actuator 66 is then extended returning the prodder 67 back to its original position. This motion is repeated until either the test is complete, or the foil on the pack 54 splits or fails.

Another function of the assembly 80 is the "edge pick" test. This function requires the prodder 67 to be drawn towards the edge of the pack 54, for example on the edge where the packaging batch number is embossed. The pack 54 is placed in the grippers 14,15 with the embossed edge facing outwards. The assembly 80 is aligned with the edge of the pack 54 such that the prodder 67 is able to move between, and parallel to, the forwardly facing edges of each gripper 14,15. The actuator 66 is extended so that the prodder 67 is moved past the edge of the pack 54. Actuator 62 is then extended so that the prodder 67 is in line with the edge of the pack 54, and then actuator 66 is retracted pulling the prodder 67 towards the centre of the pack 54 from the edge. The force applied is monitored by the load cell 69. At the end of the stroke, or if the required force is reached, actuator 62 is retracted thereby moving the prodder 67 away from the surface of the pack 54. Actuator 66 is then extended moving the prodder 67 back to its original position. This motion is repeated until either the test is complete, or the foil on the pack 54 splits or fails allowing a child to gain entry to a pocket 83. It will therefore be appreciated that the prodder assembly 80 enables not only the simple downwards force to be applied to the pack 54 along axis C-C (ie the Prod Test (d), as described in Example 7), but also enables transverse movement across the plane of the packaging along axis E-E.

Referring to Figures 17 to 20, there are shown the various components of the bite assembly 82 of the second embodiment of the apparatus 78. As shown in Figure 17, the bite assembly 82 includes an arm 90 which carries a teeth gripper 92. The arm 90 is moveable between a horizontal orientation (ie parallel with the plane of the pack 54) and an orientation that is about 70° above the horizontal. The gripper 92 includes two teeth elements 94,96 which move about pivots 98 under pneumatic control between a closed configuration (as shown in Figure 18) and an open configuration (as shown in Figure 19). The end 100 of each teeth element 94,96 is shaped to resemble the teeth of a child. The teeth elements 94 and 96 are modelled on those defined in provisional European Standard prEN1400, which is used for testing children's milk bottle teats.

In use, the grippers 15 are first disengaged from the pack 54, and then moved to allow the bite assembly 82 to be moved into position. For example, in one embodiment of the apparatus 78, the assembly consisting of the servo motor 23 and sensor 22 for twisting grippers 15 is mounted on a frame 120 is rigidly fixed at 70° to arm 90 which carries the teeth gripper 92. The frame 120 and its associated components can be pivoted downwardly about hinge 93 away from the plane of the pack 54 to about 70° below the horizontal. By lowering the frame 120, the arm 90 carrying the teeth gripper 92 is automatically lowered down into a horizontal plane parallel with the pack 54. The teeth gripper 92 is then moved into position across one corner of the packaging at an angle (e) of 45°, and the teeth elements 94,96 are then closed onto the packaging along axis F-F, as shown in Figure 20. The pack 54 is thus gripped on one side by gripper 14, and on the other side by the teeth elements 94,96. The gripper 14 is then withdrawn using the assembly containing elements 30, 34 and 36. This action simulates holding the corner of the pack 54 between the front teeth (ie by gripper 92) and then pulling the pack away (ie by gripper 14) in an attempt to open the pack 54.

Example 9

The inventors wished to assess the reliability of the second embodiment of the apparatus 78 for testing packaging, such as a blister pack. Table 3 summarises the various forces applied to packaging by the apparatus 78 along the different axes.

Table 3 - S ecifications of the axes for the second embodiment of the a aratus

In addition to the tests described in Example 7, ie (a) Bend Test (Type 1 ), (b) Bend Test (Type 2), (c) Torsion Test, and (d) Prod Test, the second embodiment of the apparatus 78 is also capable of carrying out (e) a Prod Test 2 (adult) Test, (f) an Edge Pick Test, (g) a Puncture and Peel Test, and (h) a Bite Test. Hence, in order to test a pack 54, the various tests described in Example 7 are first carried out. Using the second embodiment of the apparatus 78, the Torsion Test may be carried out by twisting opposite sides of the pack 54 (eg 30°) instead of twisting only one side of the packaging (eg 60°). If the pack 54 passes each of these tests, the following tests are then conducted.

(e) Prod Test 2 (adult)

This test involves prodding the pack 54 along axis C-C. The pack 54 is placed into the grippers 14,15 of the apparatus as shown in Figure 12, and the apparatus 78 is set up with the test parameters as shown in "Prod Test 2 (adult)" of Table 4.

Table 4 - Set-up conditions for the second embodiment of the apparatus

Once the apparatus 78 is set up, the prodder 67 of the prodding assembly 80 is urged down onto the pack 54 with a force of 73N. The test is carried out for six repetitions until the pack 54 fails. If the pack 54 fails, no further tests are carried out. A pocket 83 is considered to have failed a test if the prodder 67 is able to access the contents of the blister pack 54. However, if the pack 54 passes the Prod Test 2 (adult), the Edge Pick Test is then conducted.

(f) Edge Pick Test

This test involves first prodding the pack 54 along axis C-C (with a force of 60N), and then pulling the prodder transversely across the plane of the pack 54 along axis E-E (with a force of 52N). The pack 54 is placed into the apparatus 78, and the apparatus 78 tests the parameters as shown in "Pick" in Table 4. The test is run, and then repeated for six cycles until the target pass/fail value is achieved. If the pack 54 fails the Edge Pick Test, no further tests are carried out. A pocket 83 is considered to have failed the test if the foil is fractured or split sufficiently to allow a child access to the contents of the blister pack. However, if the pack 54 passes the Edge Pick Test, it is then subjected to the Puncture and Peel Test.

(g) Puncture and Peel Test This test involves first prodding the pack 54 along axis C-C (with a force of 40N), and then urging the prodder transversely across the plane of the pack 54 along axis E-E (with a force of 52N). The pack 54 is placed into the apparatus 78, and the apparatus 78 tests the parameters as shown in "Puncture and Peel" in Table 4. The test is run, and then repeated for six cycles until the target pass/fail value is achieved. If the pack 54 fails the Puncture and Peel Test, no further tests are carried out. A pocket 83 is considered to have failed the test if the foil is split to allow a child access to the contents of the blister pack. However, if the pack 54 passes the Puncture and Peel Test, it is then subjected to the Bite Test. (h) Bite Test

This test involves first biting down on the pack 54 along axis F-F (with a force of 50N) with teeth gripper 92, and then pulling the other side of the pack 54 with gripper 14 along axis B-B (with a force of 52N). The pack 54 is placed into the apparatus 78, and the apparatus 78 tests the parameters as shown in "Bite" in Table 4. The test is run, and then repeated for six cycles until the target pass/fail value is achieved. If the pack 54 fails the Bite Test, no further tests are carried out. A pocket 83 is considered to have failed the test if the foil is fractured or split to allow a child access to the contents of the blister pack. The Bite Test is the last test conducted by the apparatus 78.

Summary

The overall object of the invention was to produce a packaging testing apparatus that minimizes or even avoids the reliance on child panel testing. The successful development of a mechanical testing apparatus and associated testing method will provide industry, and those monitoring package compliance for child- resistance/adult-friendly, with accurate and scientifically-based data. The inventors have determined that the embodiments of the apparatus 2,78 according to the invention enable:- (a) a correlation between the forces that can be exerted by a child to those of the apparatus 2,78 to produce a predictive force algorithm; (b) the replication of a child's movement and forces when manipulating blister packs 54, using a minimum of two axes, incorporating force feed-back and unique software control; (c) the measurement the push-out, puncture, bite and tear forces of blister packs 54 to an accuracy of +/- 5%; and

(d) the statistical validation of the apparatus 2, 78 and method through the use of child panel testing.

Further advantages of the apparatus 2,78 reside in the fact that it is able to test a range of packaging formats and product sizes.

Claims

1. Packaging testing apparatus comprising packaging retaining means adapted, in use, to hold an item of packaging to be tested, and means for application to the packaging of mechanical force in accordance with a plurality of predetermined test protocols.

2. Packaging test apparatus according to Claim 1 , wherein the apparatus is used to test blister packs, and the like.

3. Packaging test apparatus according to either Claim 1 or Claim 2, wherein the apparatus comprises processing means, which controls the force applied to the packaging.

4. Packaging test apparatus according to any preceding claim, wherein the test protocols are designed to simulate actions such as:

(i) compressing the packaging

(ii) bending of the packaging;

(iii) pulling of the packaging;

(iv) pushing of the packaging; (v) twisting of the packaging;

(vi) prodding of the packaging, in particular prodding of the lidding closure of a blister, as may lead to puncture of that lidding closure;

(vii) picking at the packaging, in particular picking at the edge of the lidding closure of a blister pack; (viii) biting the packaging; and combinations of any of the above actions.

5. Packaging test apparatus according to any preceding claim, wherein the force applied to the packaging is applied along an axis, as in compression (pushing) force or tension (pulling or stretching) force.

6. Packaging test apparatus according to any preceding claim, wherein the apparatus is adapted to apply a rotational force (bending or folding) to the packaging.

7. Packaging test apparatus according to any preceding claim, wherein the force applied to the packaging is applied at any angle between 0° and 90° to the plane of the packaging.

8. Packaging test apparatus according to any preceding claim, wherein the apparatus is adapted to apply a transverse (sideways) force to the packaging.

9. Packaging test apparatus according to any preceding claim, wherein the apparatus comprises at least one force detection means adapted to detect the force applied to the packaging.

10. Packaging test apparatus according to Claim 9, wherein the or each force detection means is a strain gauge, or a linear or rotational force transducer.

11. Packaging test apparatus according to either Claim 9 or Claim 10, wherein the or each force detection means is adapted to determine the maximum force that the packaging can withstand without breaking.

12. Packaging test apparatus according to any preceding claim, wherein a surface of the retaining means which contacts the packaging is resilient or compressible.

13. Packaging test apparatus according to any preceding claim, wherein the packaging retaining means comprises gripping means adapted to grip the packaging.

14. Packaging test apparatus according to Claim 13, wherein the gripping means is arranged, in use, to grip a peripheral edge of the packaging.

15. Packaging test apparatus according to any preceding claim, wherein the retaining means comprises first and second gripping means, each of which is adapted to grip a different part of the packaging under test.

16. Packaging test apparatus according to Claim 15 wherein, in use, the first gripping means is adapted to grip one side of the packaging, and the second gripping means is adapted to grip an opposite side of the packaging.

17. Packaging test apparatus according to either Claim 15 or Claim 16, wherein the or each gripping means comprises first and second gripping members which contact upper and lower surfaces of the packaging.

18. Packaging test apparatus according to any preceding claim, wherein the retaining means is adapted to apply a compression force to the packaging.

19. Packaging test apparatus according to Claim 18, wherein the pressure applied to the packaging by the retaining means is between about 0.2 bar and about 11 bar, preferably between about 3 bar and about 5 bar.

20. Packaging test apparatus according to either Claim 18 or Claim 19, wherein the apparatus comprises a first force detection means adapted to detect the force applied to the packaging by the retaining means.

21. Packaging test apparatus according to any preceding claim, wherein the apparatus comprises packaging probing means.

22. Packaging test apparatus according to Claim 21 , wherein the probing means is capable of applying a force in a direction which is substantially parallel to the plane of the packaging, ie along the packaging edge.

23. Packaging test apparatus according to either Claim 21 or Claim 22, wherein the probing means is adapted to apply a force at an angle to the plane of the packaging.

24. Packaging test apparatus according to Claim 23, wherein the probing means is adapted to apply a force which is substantially perpendicular to the plane of the packaging (ie a downwards force).

25. Packaging test apparatus according to Claim 24, wherein the downwards force applied to the packaging by the probing means is along an axis which is substantially parallel to the force that is applied to the packaging by the retaining means.

26. Packaging test apparatus according to either Claim 24 or Claim 25, wherein the probing means comprises a probe, which is adapted to contact the packaging to apply the downwards force thereto.

27. Packaging test apparatus according to Claim 26, wherein the probe has a diameter of between about 1 mm and 20mm, preferably between about 8mm and 13mm.

28. Packaging test apparatus according to either Claim 26 or Claim 27, wherein the probing means comprises a first actuation means, which is adapted to urge the probe towards the packaging to apply the downwards force thereto.

29. Packaging test apparatus according to any one of Claims 24-28, wherein the downwards force applied to the packaging is between about 5N and about 200N, preferably between about 5ON and about 8ON.

30. Packaging test apparatus according to any one of Claims 24-29, wherein the apparatus comprises a second force detection means adapted to detect the downwards force applied to the packaging by the probing means.

31. Packaging test apparatus according to any one of Claims 28-30, wherein the first actuation means is adapted to urge the probe away from the packaging.

32. Packaging test apparatus according to any one of Claims 28-31 , wherein the probing means comprises a second actuation means which is adapted to displace the probe across the surface of the packaging while applying the downwards force thereto.

33. Packaging test apparatus according to any one of Claims 21-32, wherein the probing means is capable of applying a transverse force to the packaging.

34. Packaging test apparatus according to Claim 33, wherein the transverse force applied to the packaging is between about 1ON and about 150N, preferably between about 45N and about 6ON.

35. Packaging test apparatus according to either Claim 33 or Claim 34, wherein the apparatus comprises a third force detection means adapted to detect the transverse force applied to the packaging by the probing means as it is drawn thereacross.

36. Packaging test apparatus according to any preceding claim, wherein the apparatus comprises packaging bending means for applying a bending force to the packaging.

37. Packaging test apparatus according to Claim 36, wherein the bending force is applied about an axis which is substantially in the plane of the packaging.

38. Packaging test apparatus according to either Claim 36 or Claim 37, wherein the bending force applied to the packaging by the bending means is applied along an axis which is substantially perpendicular to the axis along which the force is applied to the packaging by the probing means.

39. Packaging test apparatus according to any one of Claims 36-38, wherein the bending means is capable of bending the packaging at least 30° with respect to the plane of the packaging, preferably at least 50° with respect to the plane of the packaging.

40. Packaging test apparatus according to one of Claims 36-39, wherein the bending means comprises actuation means adapted to pivot the second gripping means with respect to the first gripping means, wherein pivoting causes the packaging to bend.

41. Packaging test apparatus according to any one of Claims 36-40, wherein the apparatus comprises a fourth force detection means adapted to detect the bending force or torque applied to the packaging by the bending means.

42. Packaging test apparatus according to any one of Claims 36-41 , wherein the apparatus comprises a contact surface which the packaging contacts, and is bent over, when the bending force is applied thereto.

43. Packaging test apparatus according to Claim 42, wherein the contact surface is moveable between a first position in which it is in contact with the packaging, and a second position in which it is not in contact with the packaging.

44. Packaging test apparatus according to either Claim 42 or Claim 43, wherein the contact surface comprises an elongate bar.

45. Packaging test apparatus according to any preceding claim, wherein the apparatus comprises means for applying a pulling force and/or a pushing force to the packaging.

46. Packaging test apparatus according to Claim 45, wherein the pulling and pushing forces are applied to the packaging along the same axis.

47. Packaging test apparatus according to either Claim 45 or Claim 46, wherein the pulling force and/or pushing force is applied along an axis which is substantially parallel to the plane of the packaging.

48. Packaging test apparatus according to any one of Claims 45-47, wherein the pulling force or pushing force is applied to the packaging along an axis which is substantially perpendicular to the axis along which the force is applied to the packaging by the probing means, and/or wherein the pulling/pushing force is applied along an axis which is orientated about 90° to the axis along which the bending force is applied to the packaging by the bending means.

49. Packaging test apparatus according to any one of Claims 45-48, wherein the means for applying the pulling force comprises actuation means which is adapted to move the first gripping means away from the second gripping means, or vice versa, to thereby pull or stretch the packaging.

50. Packaging test apparatus according to any one of Claims 45-49, wherein the means for applying the pushing force comprises actuation means adapted to move the first gripping means towards the second gripping means, or vice versa, to thereby push or compress the packaging.

51. Packaging test apparatus according to any one of Claims 45-50, wherein the pulling and/or pushing force applied to the packaging is between about 1 N and about 6ON.

52. Packaging test apparatus according to any one of Claims 45-51 , wherein the apparatus comprises a fifth force detection means adapted to detect the pulling and/or pushing force applied to the packaging.

53. Packaging test apparatus according to any preceding claim, wherein the apparatus comprises packaging twisting means which is operable, in use, to apply a twisting force to the packaging.

54. Packaging test apparatus according to Claim 53, wherein the twisting force is applied about an axis which is substantially parallel to the plane of the packaging.

55. Packaging test apparatus according to either Claim 53 or Claim 54, wherein the twisting force is applied to the packaging about substantially the same axis as the pushing/pulling forces.

56. Packaging test apparatus according to any one of Claims 53-55, wherein the twisting means is capable of twisting the packaging through at least 30°, preferably at least 50°.

57. Packaging test apparatus according to any one of Claims 53-56, wherein the packaging twisting means comprises at least one actuation means adapted to rotate the first gripping means with respect to the second gripping means or vice versa, wherein said rotation causes the packaging to twist.

58. Packaging test apparatus according to any one of Claims 53-57, wherein the packaging twisting means comprises first and second actuation means, the first actuation means capable of twisting the first gripping means, and the second actuation means capable of twisting the second gripping means.

59. Packaging test apparatus according to any one of Claims 53-58, wherein the torque applied to the packaging is between about 0.1 Nm and about 10Nm.

60. Packaging test apparatus according to any one of Claims 53-59, wherein the apparatus comprises a sixth force detection means adapted to detect the twisting force applied to the packaging.

61. Packaging test apparatus according to any preceding claim, wherein the apparatus comprises packaging biting means, which is operable to apply a compression force to a corner of the packaging.

62. Packaging test apparatus according to Claim 61 , wherein the compression force is applied to upper or lower surfaces of the packaging.

63. Packaging test apparatus according to either Claim 61 or Claim 62, wherein the compression force is applied at the corner of the packaging, along a line disposed at an angle of between about 1 ° and 90° to the edges of the packaging, preferably between about 10° and 60° to the edges.

64. Packaging test apparatus according to any one of Claims 61-63, wherein the force applied to the packaging by the biting means is between about 1 N and about 100N, preferably between about 4ON and about 6ON.

65. Packaging test apparatus according to any one of Claims 61-64, wherein, in use, the biting means is configured to apply the compression force to one corner of the packaging, while the retaining means applies a pulling force to one side of the packaging.

66. Packaging test apparatus according to any one of Claims 61-65, wherein the apparatus comprises a seventh force detection means adapted to detect the compression force applied to the packaging.

67. Packaging test apparatus according to any preceding claim, wherein the apparatus is operable to apply a force to the packaging along or about at least two axes, preferably along or about at least three axes.

68. Packaging test apparatus according to any preceding claim, wherein the apparatus is adapted to subject the packaging to more than one manipulation test, which tests are carried out either sequentially or simultaneously.

69. A method for testing packaging, the method comprising use of the apparatus according to any one of Claims 1-68.