Control method for checking the integrity of a flexible package

Abstract

The invention relates to a control method for checking the integrity of a flexible package (1) containing content (2), for example sterilized content. The control method is implemented on a control zone (10) of the package and successively comprises: - suction of the control zone by means of a suction device in order to draw a portion (11) of the package away from the content, creating a space (12) between the portion and the content; - piercing the portion by means of an inlet needle (4) having an internal inlet channel (41) and penetrating into the space; - injecting a gas into the space through the internal inlet channel of the inlet needle, which is connected to a gas injection system (6); then - detecting the presence or absence of an integrity defect (19) in the control zone by means of a detection system.

Description

[0001] DESCRIPTION

[0002] TITLE: Control method for verifying the integrity of flexible packaging

[0003] [Technical field]

[0004] The invention relates to a control method for checking the integrity of a flexible package.

[0005] It relates more specifically to a control process to check the integrity of packaging containing sterilized contents.

[0006] The invention also relates to a control installation implementing said control method.

[0007] The invention finds a favorite, but not limited, application in the medical and pharmaceutical fields.

[0008] [State of the art]

[0009] As is well known in the medical and pharmaceutical fields, medical devices (such as syringes, surgical instruments, vials, etc.) are manufactured and sterilized in cleanrooms. To meet stringent sterilization requirements, these medical devices are also packaged in containers made from flexible materials that prevent the penetration of contaminants, such as bacteria, microbes, or particles, into the packaging. The packaging then rests against the medical device it contains, effectively pressing the packaging against the device. The flexible packaging is made from at least one porous film whose pores allow ambient air to penetrate the packaging, but whose dimensions are such that the penetration of contaminants into the packaging is prohibited.Indeed, the size of the pores of commonly used porous materials creates a barrier for particles with dimensions greater than a limit value approximately equal to 0.5 pm.

[0010] The document US2024 / 0417126A1 proposes a method and associated device for detaching a portion of a package from the sterilized product it contains, so as to facilitate the handling or removal of the sterilized product from the package without risk of damaging it.

[0011] According to Annex 1 of Volume 4 of Eudralex, the compilation of rules and regulations governing medicinal products in the European Union, when materials, equipment, articles, or auxiliary components are sterilized in sealed packages or containers, the packaging must be qualified to minimize the risk of contamination. In other words, the integrity of the packaging must be verified before use for each sterilized item.

[0012] In other words, it is mandatory and imperative to check the packaging to verify that it does not have any defects in integrity.

[0013] In the following description, and unless otherwise indicated, "lack of integrity" means an opening, which may for example have a diameter of about 100 micrometers, capable of allowing both air and contamination to pass into the packaging, and therefore impairing the sterility of the product.

[0014] It is mandatory to verify the integrity of packaging after transport, for example, from a first cleanroom where consumables were manufactured and then packaged, to a second cleanroom where the consumables are to be used. Indeed, if the integrity of the packaging has been compromised during transport, the risk of contamination of the second cleanroom upon arrival is high; contaminants contained within the packaging can spread into the second cleanroom when the packaging is opened and / or through any breaches in the packaging's integrity. US2013 / 0192346A1 proposes a method and associated device for verifying the integrity of porous and non-porous packaging containing sterilized products.

[0015] Nevertheless, there is a constant need to provide control methods for verifying the integrity of packaging that are practical to implement, require little time, and offer a high degree of accuracy in detecting integrity defects. [Summary of the invention]

[0016] The invention addresses this need by providing a control method implemented to verify the integrity of packaging before it enters a cleanroom, ensuring that it does not have any integrity defects that could contaminate the cleanroom. In a given application context, the control method is implemented after the packaging has been transported to verify that the packaging has not been damaged, i.e., that its integrity has not been compromised, during transport.

[0017] Thus, the invention relates to a control method for checking the integrity of packaging containing contents, in particular sterilized contents, and made of at least one flexible material;

[0018] The control process is implemented in a packaging control area and comprises the following successive steps:

[0019] - suction of the control area by means of at least one suction device so as to detach a portion of the packaging from the contents, thus creating a gap between said portion and the contents;

[0020] - a perforation of the portion of the packaging, by means of at least one entry needle which thus penetrates the gap by piercing an area called the perforation zone included in the control zone, said at least one entry needle having an internal entry channel;

[0021] - an injection of a gas at a given inlet pressure inside the gap through the internal inlet channel of at least one inlet needle which is connected to a gas injection system;

[0022] - detection of the presence or absence of an integrity defect in the control area by means of a detection system;

[0023] the control process being remarkable in that it includes prior to drilling, a determination of the presence or absence of an integrity defect in the drilling zone by the detection system; the control process being stopped when an integrity defect in the drilling zone is detected, or continuing with the drilling of the drilling zone otherwise.

[0024] The detection stage advantageously allows the detection of integrity defects that could allow microbes or bacteria, dust, or microscopic particles (such as soil) to enter the packaging.

[0025] In one embodiment, the drilling, injection, and detection steps are implemented with at least one suction device in contact with the control area.

[0026] According to one example, the control process is implemented in a test environment which may correspond to a cleanroom for which the permissible concentration of bacteria, microbes, or particles per volume of air (i.e. cubic meter of air) is higher than for the cleanroom in which the contents will be unpacked.

[0027] Following detection, at least one entry needle is removed from the gap. If necessary, at least one suction device is also removed from the packaging if it was in contact with the control area during the detection step. If the packaging shows no integrity defects, it is then transported from the test environment to the cleanroom where the contents will be unpacked. Otherwise (i.e., if an integrity defect has been detected), the packaging and its contents are discarded. The cleanliness of the test environment ensures that the inside of the packaging is not contaminated once at least one entry needle is removed from the gap. It is ensured that the inside of the packaging cannot be contaminated during its transport from the test environment to the cleanroom where the contents will be unpacked.

[0028] In another example, the test environment could be a negative pressure cleanroom.

[0029] The packaging is a flexible package comprising at least one waterproof flexible film and / or at least one porous flexible film. In one embodiment, the packaging is made from a single flexible material. In another embodiment, the packaging is made from at least two distinct flexible materials, for example, one waterproof and the other porous.

[0030] Hereafter, and unless otherwise indicated, "packaging" means "flexible packaging".

[0031] The at least one suction device may, for example, include a single suction device, or several suction devices (i.e., at least two).

[0032] Since it has an internal entry channel, the at least one entry needle is therefore a hollow needle. The at least one entry needle may, for example, comprise a single entry needle, or several entry needles (i.e., at least two); each of the entry needles having an internal entry channel.

[0033] In one embodiment, a sealing gasket is arranged around at least one inlet needle. When the inlet needle enters the gap, the sealing gasket remains outside the packaging. Following gas injection, the packaging, inflated by the injected gas, compresses the sealing gasket of the inlet needle. This compression prevents any risk of leakage around and near the hole made by the inlet needle.

[0034] In one embodiment, at least one suction device is included in a single piece of equipment. This equipment may, for example, be a gripping device. The internal inlet channel of at least one inlet needle passes through the equipment so that it can be connected to the injection system.

[0035] The inspection process can be implemented so that the integrity of the entire packaging surface is checked. In other words, the inspection area can correspond to the entire packaging surface. If the inspection area covers only a portion of the packaging surface, the process steps can be repeated for another inspection area covering a different portion of the packaging surface. To detect whether the inspection area has an integrity defect, a gas is injected into the gap using at least one entry needle inside the packaging. The gas injection will cause the packaging to inflate. As previously mentioned, an integrity defect is defined as an opening with a diameter large enough to allow air or contamination to pass into or be expelled from the packaging.If the packaging has such an opening, then some of the injected gas will escape through it. In other words, during the detection stage, the presence of an integrity defect is detected if a leak or escape of the injected gas from the packaging is observed / determined, which is characteristic of this integrity defect.

[0036] When at least one flexible material from which the packaging is made is porous, the inspection process advantageously distinguishes, during the detection step, a gas leak through the pores of the packaging from a gas leak through an orifice causing an integrity defect. Physically, the pores are smaller than the orifice causing the integrity defect. This is why the pores allow ambient air to pass through, whereas the orifice can, in addition to ambient air, also allow the passage of contaminating micromolecules or macromolecules. In other words, the inspection area is determined to be free of integrity defects when the injected gas escapes only through the pores of the packaging.

[0037] Directly piercing a portion of the packaging while it is still adhered to the contents presents the risk that at least one entry needle will puncture and thus damage the contents. Suction in the inspection zone prior to piercing, which allows a portion of the packaging to be detached from the contents, effectively prevents this risk. Because a gap is created between the contents and the detached portion of the packaging, the at least one entry needle, when it pierces the portion of the packaging, only enters the gap and does not come into contact with the contents.

[0038] In one embodiment, the packaging is placed on a horizontal support plane during the implementation of the control process.

[0039] In another embodiment, the suction of the inspection zone also serves to suspend the packaging. The packaging is suspended when the following steps are successively carried out: perforation of the portion of the packaging, injection of gas into the packaging, and detection of the presence or absence of a defect in integrity. In such an embodiment, the entire surface of the packaging can advantageously be inspected during a single implementation of the successive steps of the inspection process.

[0040] The suction device, the gas injection system, and the detection system can, for example, be automatically controlled by separate control units or by a single control unit to respectively implement the suction of the inspection area, the injection of the inlet gas into the gap created within the packaging, and the detection of the presence or absence of the integrity defect. Similarly, a control unit can control the movement of the needle from an initial position, outside the packaging and without contact with it, to a final position allowing it to pierce the detached portion of the packaging and penetrate the gap. Alternatively, and advantageously, the inspection process can be fully automated and thus require no human intervention.The control unit(s) may include a processor configured to execute a program comprising a list of instructions relating to the control of at least one suction device, and / or at least one inlet needle, and / or the injection system and / or the detection system so as to implement steps of the control process.

[0041] As described later, one advantage of the control process is that an integrity defect can be detected by a plurality of methods that can be considered independently of each other; or combined (i.e., implemented simultaneously or successively) for increased detection.

[0042] The drilling area is included in the control area; and the suction of the control area by means of at least one suction device to detach the portion of the packaging from the contents is implemented in the drilling area.

[0043] When a sealing gasket is arranged around at least one entry needle, the compression of the sealing gasket by the packaging occurs at a surface of the packaging included in the drilling area.

[0044] The packaging and its contents are discarded when a defect in integrity is detected in the drilling area.

[0045] Advantageously, when an integrity defect is determined in the perforation zone, the perforation, gas injection, and integrity defect detection steps in the inspection zone are not implemented; hence a significant time saving in the implementation of the inspection process when considering packaging for which an integrity defect can be detected simply by inspecting the perforation zone. The determination of an integrity defect in the perforation zone can take place after the inspection zone has been vacuum-sealed; or prior to it (hence an even more significant time saving in the implementation of the inspection process if an integrity defect is detected in the inspection zone).

[0046] When at least one entry needle comprises multiple entry needles, either the multiple entry needles pierce the portion of the packaging in a common perforation zone (for example, if the multiple entry needles are spatially close), or they pierce the portion of the packaging separately in their own perforation zones. In the second case, each of the multiple perforation zones is inspected to verify whether or not it has an integrity defect.

[0047] According to one embodiment of the invention, the determination of the integrity defect in the drilling zone comprises:

[0048] - an optical inspection of the drilling area by an image acquisition device included in the detection system, which provides data representative of the optical appearance of the drilling area, for example, pixels in an image; - an image processing analysis performed by the detection system of the data previously provided by the image acquisition device; and

[0049] The integrity defect in the drilling zone is detected when at least one of the data has a value of an image processing parameter that does not conform to a threshold of said image processing parameter.

[0050] According to one embodiment of the invention, the determination of the integrity defect in the drilling zone comprises:

[0051] - the generation of waves at a given emission frequency within a range of ultrasonic frequencies and a direction of said waves on the drilling area, by an external transmitting system included in the detection system; - the reception, by an external receiving system included in the detection system, at a reception frequency, of the waves when they are reflected by the drilling area, and

[0052] The integrity defect in the drilling zone is detected when the receiving frequency is not within a predefined frequency range based on the transmitting frequency.

[0053] The frequency range is defined within the ultrasound frequency band.

[0054] The detection system applies image processing algorithms designed by a person in the field of expertise, based on available knowledge in the field of image processing, and which are adapted to the challenges of the analysis, for the analysis of data.

[0055] The image processing parameter can be chosen from at least: hue, color intensity, saturation, brightness, contrast.

[0056] Thus, image processing analysis can, for example, correspond to a greyscale analysis of an image of the packaging surface including the perforation area, with:

[0057] - each pixel of the image which is, in a known way, coded by an integer value between 0 and 255 representing a level of light intensity, and

[0058] - the threshold which is defined as an integer representing a low light intensity;

[0059] such that an integrity defect in the drilling area is determined when the value of a pixel in the image is less than this threshold value.

[0060] The image processing parameter threshold is defined so as to distinguish in the control area, when the flexible packaging is made from a porous material, a pore of the packaging from an integrity defect.

[0061] The determination of an integrity defect in the drilling area can also be done by optical inspection with the naked eye when the diameter of the orifice is large enough to make observation of said orifice possible by an operator (for example when the orifice has a diameter greater than or equal to 1 millimeter).

[0062] According to one feature of the invention, at least one flexible material of the packaging is a non-woven, fibrous synthetic material, containing, for example, polyethylene fibers.

[0063] In other words, in one embodiment, the packaging can be made entirely or partly of Tyvek®.

[0064] According to one embodiment of the invention, the packaging comprises a single pouch which contains the contents; the control zone corresponds to a surface of the single pouch; and during the suction of the control zone, a portion of the single pouch is detached from the contents, creating a gap between the portion of the single pouch and the contents.

[0065] According to one embodiment of the invention, the packaging comprises an outer pouch and an inner pouch such that the inner pouch contains the contents and the outer pouch contains the inner pouch; the control zone corresponds to a surface of the outer pouch; and during suction of the control zone, a portion of the outer pouch is detached from the inner pouch, creating a gap between the portion of the outer pouch and the inner pouch. According to one embodiment of the invention, the at least one suction device comprises at least one suction cup, such that suction of the control zone is achieved by pressing at least one suction cup against the control zone and moving at least one suction cup away from the contents.

[0066] In other words, the suction created by the control zone to detach a portion of the packaging from the contents is achieved through a vacuum grip provided by at least one suction cup. It is the difference between the vacuum created inside the suction cup and atmospheric pressure that allows the suction cup to adhere to the control zone.

[0067] In one embodiment, the distance of at least one suction cup from the contents allows the packaging to be suspended.

[0068] In one embodiment, at least one suction device comprises several suction devices, each comprising at least one suction cup.

[0069] In one embodiment, at least one suction device comprises a single suction device comprising several suction cups.

[0070] In a particular embodiment, at least one entry needle comprises an entry needle, and at least one suction device comprises a single suction device with two suction cups. The entry needle and the suction device are included in the same equipment and are arranged such that the entry needle is positioned between the two suction cups (for example, equidistant from each of them). The entry needle thus pierces a portion of the packaging lifted by the two suction cups.

[0071] In one embodiment of the invention, the control method comprises, following the injection of the gas:

[0072] - another perforation of the portion of the packaging by means of an exit needle which penetrates the gap, which exit needle having an internal exit channel,

[0073] - a measurement in the spacing of an internal pressure by a pressure sensor included in the detection system and connected to the internal outlet channel of the outlet needle;

[0074] such that, prior to detection, the presence of an integrity defect in the control area is determined when a pressure differential, determined from the internal pressure and an external pressure prevailing outside the packaging, is greater than a predefined pressure differential threshold.

[0075] By "external pressure prevailing outside the packaging", atmospheric pressure is meant. The measurement of internal pressure can be carried out with the packaging placed on a horizontal support plane, or suspended above a horizontal support plane.

[0076] A pressure differential greater than the predefined pressure differential threshold means that a significant pressure drop occurs in the packaging gap due to gas leakage characteristic of the integrity defect.

[0077] When at least one flexible material is a porous material, the definition of the differential pressure threshold takes into account the escape of the gas injected through the pores of the flexible material.

[0078] Similar to the at least one entry needle, a sealing gasket is placed around the exit needle. When the packaging is inflated, it compresses the sealing gasket of the exit needle, thus preventing any risk of leakage around and near the hole pierced by the exit needle.

[0079] As explained previously, the openings in the packaging that cause integrity defects can have varying diameters. Depending on this diameter, these openings can allow contaminants of varying sizes to enter or be expelled from the packaging. The following are distinguished:

[0080] - openings, referred to hereafter as primary openings, with a diameter of several hundred micrometers (or even close to a millimeter), capable of allowing contaminants such as heavy dust and soil particles to pass into the packaging; and

[0081] - openings, referred to in the rest of the description as second openings, with a diameter close to one hundred micrometers, which allow only finer contaminants (in other words, smaller in size) such as dust suspended in the ambient air, bacteria, microbes, and viruses to pass into the packaging.

[0082] The detection step described above allows for the detection of the presence or absence of first and second orifices within the control zone. Detecting second orifices can be time-consuming depending on their size.

[0083] Measuring the internal pressure with the pressure sensor and comparing it to the minimum internal pressure threshold determines whether or not the first perforations are present in the inspection area. This internal pressure measurement and subsequent comparison are quick and easy to perform, saving time during the inspection process when the package being inspected has an integrity defect caused by a first perforation. In such cases, the package and its contents are discarded. Otherwise, the inspection process continues with the detection step described earlier to identify the presence of an integrity defect caused by a second, smaller perforation within the inspection area.

[0084] According to one embodiment of the invention, the internal inlet channel of at least one inlet needle comprises a closure system configured to vary between an open configuration and a closed configuration such as:

[0085] - during gas injection, the obturator system adopts its open configuration and allows the gas to flow into the internal inlet channel of at least one inlet needle and then penetrate into the gap; and

[0086] - following the injection of the gas, the sealing system adopts its closed configuration, thus preventing the gas from flowing downstream of the sealing system and from penetrating inside the gap;

[0087] in which a pressure sensor is included in the detection system and is connected to the internal inlet channel of at least one inlet needle, downstream of the obturating system;

[0088] in which the control process includes, once the sealing system is in its closed configuration, a measurement of an internal pressure by the pressure sensor;

[0089] such that prior to detection, the presence of an integrity defect in the control area is determined when the internal pressure drops below a minimum internal pressure threshold in a time interval less than a predetermined pressure drop duration.

[0090] More specifically, the determined integrity defect is caused by a first orifice.

[0091] Measuring the internal pressure allows us to deduce a pressure drop value. Internal pressure can be measured with the package placed on a horizontal support surface, or suspended above a horizontal support surface.

[0092] The integrity defect in the control zone caused by the first orifice is detected:

[0093] - when the measured internal pressure value falls below a minimum internal pressure threshold, indicating a sudden drop in pressure due to the leakage of injected gas through the integrity defect; and

[0094] - that this sudden drop in pressure is observed for a time interval less than a predetermined pressure drop duration. In one embodiment, the pressure drop duration is defined by the operator implementing the control process.

[0095] In another embodiment, where at least one flexible material is a porous material, the determined pressure drop time corresponds to the time required for the internal pressure measured in a conforming package, i.e. one which does not include an integrity defect, to decrease below the minimum internal pressure threshold.

[0096] The shut-off system can, for example, be a valve. Switching the shut-off system between its open and closed positions can be controlled by a control unit. This control unit may or may not be the same as the one controlling the injection system.

[0097] When at least one entry needle comprises multiple entry needles, each of the internal entry channels of the multiple entry needles includes an obturator system.

[0098] In a particular embodiment, the test environment comprises a first test area and a second test area such as:

[0099] - in the first test area are implemented suction, drilling, gas injection, and optional determination of the presence or absence in the control area of ​​an integrity defect caused by a first orifice according to one of the embodiments presented above;

[0100] - in the second test area the detection step described at the beginning of the section is implemented to detect the presence or absence in the control area of ​​an integrity defect caused by a second orifice.

[0101] Contaminants can be expelled from the packaging during gas injection into the gap. Therefore, during the injection, the packaging is exposed in this first test zone to a laminar flow that channels and then removes any potentially expelled contaminants from said first test zone.

[0102] In this particular embodiment, once it has been verified that the control zone does not contain any integrity defect caused by a first orifice, the package being inspected is transported from the first test zone to the second test zone, with at least one entry needle remaining within the gap and at least one suction device in contact with the control zone, i.e., with the portion of the package. According to an embodiment of the invention, wherein the gas comprises a chemical compound, and in which the detection comprises measuring a quantity of the chemical compound outside the package, by means of a dedicated sensor included in the detection system; and the integrity defect in the control zone is detected when the measured quantity of the chemical compound exceeds a predefined chemical compound quantity threshold.

[0103] The threshold quantity of chemical compound corresponds to the quantity of this chemical compound that the ambient air should conventionally contain (this quantity may possibly be zero).

[0104] If the dedicated sensor measures a quantity of the chemical compound outside the packaging that is greater than this threshold value, then a leak of the injected gas outside the packaging, characteristic of an integrity defect, is detected.

[0105] In one embodiment, the injected gas is an ionized gas, and the chemical compound in question is ozone. In other words, in this embodiment, an integrity defect is detected if the amount of ozone measured outside the packaging exceeds a threshold.

[0106] According to one embodiment of the invention, the detection includes a measurement of a sound frequency by an external acoustic system comprising at least one external acoustic sensor placed outside the packaging, which external acoustic system being included in the detection system; and the integrity defect is detected when the sound frequency is within a predefined and given frequency range in the ultrasonic band.

[0107] In other words, the leak of injected gas characteristic of the integrity defect is detected by the noise / sound it emits, which is within a predefined frequency range given in the ultrasound band.

[0108] When at least one flexible material of the packaging is a porous material, this frequency range is distinct from the characteristic frequencies of sounds emitted by air entering or leaving the packaging through the pores.

[0109] According to one embodiment of the invention, the detection comprises: - a generation of waves at a given emission frequency within a range of ultrasonic frequencies and a direction of said waves on the control zone, by an external transmitter system included in the detection system; - a reception by an external receiver system included in the detection system, at a reception frequency, of the waves when they are reflected by the control zone, and the integrity defect in the control zone is detected when the reception frequency is not within a predefined frequency range depending on the emission frequency.

[0110] The presence or absence of an integrity defect in the control zone is detected by the Doppler effect, in other words, by the echo emitted by the transmitting system and received by the receiving system. If the received frequency is not within the frequency range defined according to the transmitted frequency, then this means that the latter has been altered by the gas leak characteristic of the integrity defect (waves are accelerated when propagating near the gas leak).

[0111] When at least one flexible material of the packaging is a porous material, this frequency range is distinguished from the characteristic frequencies of gas escaping from the packaging through its pores.

[0112] According to a preferred embodiment of the invention, the detection comprises a measurement of a heat loss representative of a gas escape, outside and near the control zone, by at least one calorimetric flow sensor which is included in the detection system; and

[0113] The integrity defect in the control zone is detected when the measured heat loss is greater than a predefined heat loss threshold.

[0114] In this embodiment, the leakage (i.e., the escape) of gas from the packaging characteristic of the integrity defect is detected by a loss of calorie (i.e., a heat loss) that it induces in the ambient air and which is greater than the predefined heat loss threshold, which heat loss is measured by at least one calorimetric flow sensor located at a distance from the control area enabling a heat loss caused by an integrity defect to be distinguished from a heat loss caused by the passage of air or gas through the pores of the packaging when the latter is made from at least one flexible porous material.

[0115] The threshold for calorie loss is also defined in such a way as to allow for such a distinction.

[0116] In one variant, the minimum calorimetric flow sensor comprises a single calorimetric flow sensor.

[0117] In another embodiment, the at least one calorimetric flow sensor comprises several calorimetric flow sensors, the number of which is proportional to the surface area of ​​the control zone, such that each of the several sensors is associated with a distinct portion of the surface area of ​​the control zone to measure a heat loss relative to that portion, thus increasing the accuracy of the detection step. According to one embodiment of the invention, the gas is injected at a given inlet temperature by the gas injection system, and the detection comprises a temperature measurement outside and near the control zone by means of a temperature sensor that is included in the detection system; and the integrity defect is detected when the measured temperature is not within a predefined temperature range that is at least a function of the inlet temperature.

[0118] In this embodiment, the leak of gas characteristic of the integrity defect is detected if a rise or fall in temperature is observed near the packaging. A rise or fall in temperature is observed depending on whether the inlet temperature of the injected gas is higher or lower than the ambient temperature. A rise or fall in temperature is observed when the measured temperature is not within a predefined temperature range.

[0119] This temperature range makes it possible to distinguish a temperature variation (rise or fall) caused by a lack of integrity from a temperature variation caused by the escape of gas through the pores of the packaging when it is made from at least one porous flexible material.

[0120] According to one embodiment of the invention, the gas is injected at a given inlet temperature by the gas injection system, and wherein the detection comprises:

[0121] - a thermographic control of the control area by an acquisition device which is included in the detection system, which acquisition device delivers a thermal image representative of the control area;

[0122] - an image processing analysis, performed by the detection system, of the thermal image of the control zone; and

[0123] The integrity defect in the control area is detected when at least one of the data relating to the thermal image, for example a pixel, has a value of an image processing parameter that does not conform to a threshold of said image processing parameter.

[0124] As stated above, when the control zone has an integrity defect, the gas leak causes a rise or fall in temperature near the integrity defect depending on whether the inlet temperature of the injected gas is higher or lower than the ambient temperature.

[0125] The threshold of the image processing parameter (for example relating to a color of the pixels) is defined so as to detect, from the data relating to the thermal image of the control area delivered by the acquisition device (which is a thermal camera), this temperature variation.

[0126] The treatment parameter threshold is defined so as to distinguish a gas leak outside the packaging caused by an integrity defect from a gas leak through the pores of the packaging when the latter is made from at least one porous flexible material.

[0127] For the analysis of image processing of data relating to the thermal image of the control area, the detection system applies thermal image processing algorithms designed by the person in the field of the art from the knowledge available in the field of image processing, and which are adapted to the challenges of the analysis.

[0128] According to one embodiment of the invention, the detection comprises: - an optical inspection of the control zone by an image acquisition device included in the detection system, which delivers data representative of an optical appearance of the control zone, for example, pixels of an image; - an image processing analysis, performed by the detection system, of the data previously delivered by the image acquisition device; and

[0129] The integrity defect in the control area is detected when at least one of the data has a value for an image processing parameter that does not conform to a threshold of said image processing parameter.

[0130] Image processing analysis allows for the localization of any integrity defect within the control area. In other words, the location of the integrity defect is determined when the image processing parameter applied to the image-associated data does not meet the threshold of that image processing parameter.

[0131] The image processing parameter threshold is defined so as to distinguish in the control area, when the flexible packaging is made from a porous material, a pore of the packaging from an integrity defect.

[0132] The detection system applies image processing algorithms designed by a person in the field of expertise, based on available knowledge in the field of image processing, and which are adapted to the challenges of the analysis, for the analysis of data.

[0133] According to one embodiment of the invention, the image processing parameter is at least selected from: a hue, a color intensity, a saturation, a brightness, a contrast. The invention also relates to a control installation for checking the integrity of packaging containing contents, in particular sterilized contents, and made of at least one flexible material with at least one waterproof film and / or at least one porous film;

[0134] said control installation being configured to implement the control process as previously described, comprising:

[0135] - at least one suction device for suction of the control area and detaching a portion of the packaging from the contents;

[0136] - at least one entry needle with an internal entry channel;

[0137] - a gas injection system connected to the internal inlet channel of at least one inlet needle; and

[0138] - a detection system to detect the presence or absence of an integrity defect in said control area.

[0139] The control installation is installed in the previously described test environment.

[0140] The control system can, for example, be semi-automatic or fully automated.

[0141] When the control area of ​​the controlled package does not correspond to the entire surface of the package, and the control process steps must be iterated for at least one other control area, the control installation may include a handling device to manipulate the package (for example, to turn it over) so that the control process steps are applied to that at least one other control area.

[0142] In one embodiment, the manipulation device is a robotic arm.

[0143] In one embodiment, the robotic arm includes a gripper, which gripper includes at least one entry needle and at least one suction device. In one example, the gripper includes a suction device comprising two suction cups, and an entry needle whose internal entry channel passes through the gripper so as to be able to be connected to the injection system. In this embodiment:

[0144] - During suction, the gripper approaches the packaging so that the two suction cups of the suction device press against the control area, then moves away from the packaging so as to detach the portion of the packaging and create the spacing; then - during piercing, the entry needle of the gripper pierces the piercing area with the suction cups still pressed against the control area.

[0145] In one embodiment, the injection of the gas and / or the detection of the presence of an integrity defect are implemented with at least one suction device interacting with the control area (for example, with at least one suction cup pressed against the control area).

[0146] In the particular embodiment in which the test environment includes the first test area and the second test area, the robotic arm is designed so that its gripper can access both test areas so that: - at least suction, drilling, injection, and optionally the detection of an integrity defect in the control area caused by a first orifice are implemented in the first test area;

[0147] - the detection of an integrity defect caused by a second orifice is implemented in the second test area.

[0148] In other words, in this particular embodiment, the robotic arm ensures the movement of the control package from the first test area to the second test area; with at least one entry needle (respectively at least one suction device) that includes the gripper inside the gap (respectively interacting with the control area).

[0149] Advantageously, the control installation can be inserted / integrated into a control line.

[0150] As an example, a conveyor line can transport the packages to be inspected to the environment and the inspection facility. In the particular embodiment comprising the first test area and the second test area, the conveyor line can, for example, direct the packages to be inspected towards the first test area.

[0151] In another example, once no integrity defect has been detected in a package, the inspected package can be conveyed via another conveyor line to the cleanroom where the contents will be unpacked. In the embodiment involving the robotic arm equipped with the gripper, the gripper can access the other conveyor line. Thus, after the detection step, the robotic arm positions itself above the other conveyor line and releases the package (in other words, at least one entry needle is removed from the gap and at least one suction device no longer interacts with the inspection area).

[0152] [Brief description of the figures] Other features and advantages of the present invention will become apparent from the following detailed description of a non-limiting example of implementation, made with reference to the accompanying figures in which:

[0153] [Fig 1] illustrates flowcharts of the control process of the invention according to two embodiments (Figure 1-a and Figure 1-b);

[0154] [Fig 2] is a schematic view illustrating the suction step of the control area of ​​the packaging in an embodiment in which at least one suction device is a single suction device comprising a suction cup;

[0155] [Fig 3] is a schematic view illustrating a package when it includes one bag (a) or two bags (b), the package being shown before implementation of the control process (left figures) and following the injection of the gas (right figures);

[0156] [Fig 4] is a schematic view of a test environment in which the control process is implemented according to one embodiment;

[0157] [Fig 5] is a schematic view related to the test environment of Figure 2, and which illustrates the suction step of the control area of ​​the packaging in an embodiment in which equipment, corresponding to the gripper of a robotic arm shaped to handle the packages to be controlled, includes: a suction device comprising two suction cups, and an entry needle positioned between the two suction cups;

[0158] [Fig 6] is a schematic view illustrating an optional internal pressure measurement in the spacing before implementation of the detection step according to the embodiment of Figure 1-a;

[0159] [Fig 7] is a schematic view illustrating an optional measurement of internal pressure in the spacing before implementation of the detection step according to the embodiment of Figure 1-b;

[0160] [Fig 8] is a schematic view illustrating the detection step of the control process according to a first embodiment;

[0161] [Fig 9] is a schematic view illustrating the detection step of the control process according to a second embodiment.

[0162] [Detailed description of one or more embodiments of the invention]

[0163] The inspection method 100 of the invention is illustrated below with several figures. To improve the clarity of the figures, some elements of the invention are either not shown or are shown but not to scale. Several embodiments of the inspection method 100 are described below. These different embodiments are not exhaustive, are not mutually exclusive, and may be combined.

[0164] The control method 100 of the invention makes it possible to check the integrity of a package 1 containing a sterilized content 2. In other words, the control method 100 makes it possible to check whether the package 1 has an integrity defect 19 that would compromise the sterility of the content 2.

[0165] The packaging 1 is made of at least one flexible material and comprises at least one airtight film and / or at least one porous film made of a porous material that provides permeability for air molecules and a barrier to particles with dimensions exceeding a limit value substantially equal to 0.5 pm. In one embodiment of the invention, the packaging 1 is made of a non-woven, fibrous synthetic material containing polyethylene fibers (also known as Tyvek®).

[0166] As previously stated, an integrity defect 19 is understood to mean an opening, which may, for example, have a diameter of approximately 100 micrometers, capable of allowing both air and contaminants to pass into the packaging 1 or to be expelled from it. This integrity defect 19 differs from the pores of a porous material, which, due to their size, only allow air to pass through (in other words, the pores do not allow contaminating macromolecules or micromolecules to pass through).

[0167] The description goes on to state that integrity defects 19 can be caused by:

[0168] - first orifices having a diameter of several hundred micrometers (and therefore being close to a millimeter) and which can allow contaminating agents such as heavy dust, soil particles to pass into packaging 1; and - second orifices having diameters smaller than those of the first orifices, and close to one hundred micrometers, allowing contaminating agents of smaller dimensions such as bacteria, microbes, viruses, or dust suspended in the ambient air to pass into packaging 1.

[0169] The control process 100 is implemented in particular to check the integrity of a package 1 before it enters a clean room where the sterilized contents 2 will be unpacked for use; so that said clean room is not contaminated in the event that the package 1 has a defect in integrity. The control process 100 is applied to an area called the control zone 10 of the package 1 corresponding to all or part of its surface, the aim being to detect whether or not a defect in integrity 19 is present in this control zone 10.

[0170] With reference to Figures 1 to 3, the method for controlling the invention, following a start-up step E0 during which it is started, comprises at least the following successive steps:

[0171] - a suction El of the control zone 10 by means of at least one suction device 3 so as to detach a portion 11 of the packaging 1 from the contents 2, thus creating a gap 12 between said portion 11 and the contents 2;

[0172] - a drilling E2 of the portion 11 of the packaging 1, by means of at least one entry needle 4 which thus penetrates the gap 12, said at least one entry needle 4 having an internal entry channel 41;

[0173] - an injection E3 of a gas at a given inlet pressure inside the gap 12 through the internal inlet channel 41 of at least one inlet needle 4 which is connected to a gas injection system 6;

[0174] - an E4 detection of the presence or absence of an integrity defect 19 in the control zone 10 by means of a detection system (not illustrated).

[0175] The E4 detection step enables the detection of integrity defects 19 caused by first orifices and second orifices.

[0176] In the following description, it is considered that the at least one suction device 3 comprises a single suction device 3, and that the at least one entry needle 6 comprises a single entry needle 4.

[0177] The entry needle 4 has two ends, with one of the two ends, called the first end, intended to pierce the portion 11 of the packaging 1 to enter the gap, and the other of the two ends, called the second end, connected to the gas injection system 6.

[0178] In the following description, and unless otherwise stated, when it is indicated that the entry needle enters packaging 1 and / or is located in gap 12, it is understood that it is the first end of the entry needle that enters gap 1 and / or is located in gap 12.

[0179] In the embodiments described below, the suction device 3 includes at least one suction cup 31, for example a single suction cup as illustrated in Figure 2. Thus, the suction El of the control zone 10 is achieved by pressing the suction cup 31 against the control zone 10 and moving the suction cup 31 away from the contents 2. In other words, the suction El of the control zone 10 to detach a portion 11 of the packaging 1 from the contents 2 is achieved by means of a vacuum grip provided by the suction cup 31.

[0180] The packaging 1 can, in an alternative embodiment, be placed on a horizontal support plane 9 during the implementation of steps El, E2, E3, E4 of the control process 100. In this case, during the suction El, the portion 11 of the packaging 1 is detached from the contents 2 with the lower part of the packaging 1 placed on the support plane 9.

[0181] In another variant, the suction El of the inspection zone 10 can, for example, also be used to suspend the package 1 (above a horizontal support plane 9, from the ground). The package 1 remains suspended while steps E2, E3, and E4 are carried out successively. In such an embodiment, the entire surface of the package 1 can advantageously be inspected during a single execution of steps El, E2, E3, and E4 of the inspection process 100.

[0182] Directly piercing a portion 11 of the packaging 1 while it is still adhered to the contents 2 would present the risk that the entry needle 4 would pierce the contents 2 and thus damage it. The suction El of the control zone 10 before piercing E2, which allows the portion 11 of the packaging 1 to be detached from the contents 2, advantageously prevents this risk, as the entry needle 4 only enters the gap 12 and does not come into contact with the contents 2.

[0183] With reference to Figure 3-a, in one variant, the package 1 comprises a single sachet 13 which contains the contents 2; the control zone 10 then corresponds to a surface of the single sachet 13; and during the suction El of the control zone 10, a portion 11 of the single sachet 13 is detached from the contents 2, creating a gap between the portion 11 of the single sachet 13 and the contents 2. In this variant, the portion 11 of the single sachet 13 therefore corresponds to the portion 11 of the package 1 described so far.

[0184] Referring to Figure 3-b, in another variant, the package 1 comprises an outer pouch 14 and an inner pouch 15 such that the inner pouch 15 contains the contents 2 and the outer pouch 14 contains the inner pouch 15. The control zone 10 corresponds to a surface of the outer pouch 14, and during the suction E1 of the control zone 10, a portion 11 of the outer pouch 14 is detached from the inner pouch 15, creating a gap 12 between the portion 11 of the outer pouch 14 and the inner pouch 15. In this other variant, the portion 11 of the outer pouch 14 therefore corresponds to the portion 11 of the package 1 described so far; and the needle, after perforation E2, enters the gap 12 between the outer pouch 14 and the inner pouch 15 without coming into contact with the inner pouch 15.During the E2 piercing, the entry needle 4 is moved from an initial position (in which it is outside the package 1 and not in contact with it) to a final position for which it has pierced the portion 11 of the package 1 and penetrated inside the gap 12. The entry needle 4 pierces the package 1 in an area called the piercing zone 16 which comprises the portion 11 detached from the package 1.

[0185] Note that the drilling zone 16 is included in the control zone 10; and the suction El of the control zone 10 by the suction device 3 to detach the portion 11 of the packaging 1 from the contents 2 is implemented in the drilling zone 16.

[0186] The gas injection E3 into the gap is used to implement the detection step E4. The gas injection E3 will cause the package 1 to inflate (as illustrated in Figure 3). If the package 1 has an integrity defect 19, then a quantity of the injected gas will escape through it from the package 1. In other words, during the detection step E4, the presence of an integrity defect 19 is detected, in particular, if a leak / escape of the injected gas from the package 1, characteristic of this integrity defect 19, is observed / determined.

[0187] A sealing gasket (not shown) is positioned around the inlet needle 4. When the inlet needle 4 enters the gap, the sealing gasket remains outside the packaging 1. Following the injection E3 of gas, the packaging 1, inflated by the injected gas, compresses the sealing gasket of the inlet needle 4. This compression prevents any risk of leakage around and near the hole drilled by the inlet needle 4. The compression of the sealing gasket by the packaging 1 occurs at a surface of the packaging 1 located within the drilling area 16.

[0188] The drilling steps E2, injection E3, and detection E4 can, as described below, be implemented with at least one suction device in contact with the control area 10.

[0189] At the end of the detection step E4, the entry needle 4 is removed from the gap 12 and the suction device 3 ceases to be in contact with the package 1 (in other words, the suction cup 31 is no longer pressed against the inspection area 10). When the package 1 has an integrity defect 19, it is, along with its contents 2, discarded. Otherwise, the package 1, if it does not have an integrity defect 19, is transported to a cleanroom where the contents will be unpacked. During this transport, it is ensured that the inside of the package 1 cannot be contaminated by contaminants. As illustrated in Figure 1, the inspection process includes, prior to the piercing E2, a determination step Eli, by the detection system, of the presence or absence of an integrity defect 19 in the piercing area 16.Advantageously, when an integrity defect 19 is determined during the determination step Eli in the perforation zone 16 of the package 1 being inspected, the inspection process 100, for said package 1, is stopped during a stop step E9. In other words, steps E2, E3, E4 are not implemented, resulting in a significant time saving in the implementation of the inspection process 100 for the inspection of this package 1.

[0190] In different embodiments, the Eli step can be implemented with the packaging 1 placed on a support plane 9, or suspended above a support plane 9.

[0191] The Eli determination step can be implemented in a variant before the El suction, or, as illustrated in Figure 1, after it.

[0192] Referring to Figure 1, the inspection process 100 may optionally include, following gas injection E3 and prior to detection E4, a determination of the presence or absence of integrity defects 19 in the inspection zone 10 caused solely by first orifices. Following this optional determination, if the package 1 exhibits an integrity defect 19 caused by a first orifice, it is discarded. The stop step E9 is then implemented to halt the inspection process 100. Otherwise, the inspection process 100 continues with detection E4 to determine whether the package 1 exhibits an integrity defect 19 caused by a second orifice.

[0193] This optional determination saves time in the implementation of the control process 100, as it is faster than detection E4. Indeed, the optional determination is dedicated to determining the presence or absence of first orifices in the control zone 10; whereas detection E4 is implemented to detect the presence or absence in the control zone 10 of both types of orifice, knowing that the second orifices have smaller dimensions than the first orifices (hence a longer implementation time for the detection step E4 to verify and be certain that the control zone 10 does not contain a second orifice).

[0194] In various embodiments, this optional determination of an integrity defect 19 caused by a first opening in the inspection zone 10 can be carried out with the package 1 placed on a support 9, or suspended above a support 9. The inspection procedure 100 is carried out by an inspection system designed to be installed in a test environment 200, which may be a cleanroom in which the permissible concentration of bacteria, microbes, or particles per volume of air is higher than that of the cleanroom in which the contents will be unpacked. The degree of cleanliness of the test environment 200 ensures that the inside of the package 1 is not contaminated: once the entry needle 4 is removed from the gap 12; and during the transport of the package 1 from the test environment 200 to the cleanroom where the contents 2 will be unpacked.This test environment 200 can, for example, correspond to a negative pressure cleanroom.

[0195] At a minimum, the control installation includes the suction device 3, the inlet needle 4, the gas injection system 6, and the detection system.

[0196] The control installation can be configured to implement control procedure 100 automatically, without requiring human intervention. For example, the control installation may include at least one control unit configured to control at least: the suction device 3, or the inlet needle 4, or the gas injection system 6, or the detection system. This at least one control unit may, for example, include a processor to execute a program containing a list of instructions for controlling one or more of the aforementioned equipment to implement, at a minimum, steps E1, E2, E3, and E4 of control procedure 100.

[0197] The control installation is also designed to be easily understood / integrated into a production line.

[0198] In an embodiment illustrated by means of Figure 4 and Figure 5, the packages 1 are conveyed to the test environment 200 by means of a conveyor line Cl.

[0199] In this embodiment, the control installation includes a robotic arm 9 configured to handle, in an automated manner, the packages 1. More specifically, the end of the robotic arm is provided with a gripper 91, on one face of which are arranged the entry needle 4 and the suction device 3, which includes two suction cups 31.

[0200] As illustrated in Figure 5, the gripper 91 has a lumen through which the internal inlet channel 41 of the inlet needle 4 passes so that:

[0201] - a part of the inlet needle 4, including the first end, exits through a first face of the gripper 91 on which are arranged the two suction cups 31 of the suction device 3, with for example and as illustrated the first end of the needle positioned between the two suction cups and equidistant from each of them; - that the second end of the inlet needle 4 is accessible from a second face of the gripper opposite to the first face in order to connect for example an injection pipe 61 for a fluidic connection between the internal inlet channel 41 of the inlet needle 4 and the gas injection system 6 (so that the gas can flow into the internal inlet channel 41).

[0202] In this embodiment, the test environment 200 comprises a first test area ZI and a second test area Z2 such as:

[0203] - Steps E1, E2, E3, and optionally the determination of integrity defects 19 caused by initial orifices, are implemented in the first test zone ZI; and

[0204] - the detection step E4, for the detection of integrity defects 19 caused by the second orifices, is implemented in the second test zone Z2.

[0205] The Eli determination step can, for example, also be implemented in the first test zone Zl.

[0206] In Figure 4, the package 1 to be checked is conveyed to the first test area Zl by the conveyor line Cl.

[0207] Once the package 1 is in the test zone Z1, the robotic arm 9 moves to bring its gripper 91 closer to the package 1 until the suction cups 31 come into contact with the control zone 10 (more precisely, and as mentioned above, the drilling zone 16). During the suction El, the gripper 91 moves away from the contents 2 of the package 1 so as to detach the portion 11 from the package 1.

[0208] During drilling E2, while the two suction cups 31 lift the portion 11 of the package 1 with the entry needle 4 which is moved from its initial position to its final position so that it pierces the portion 11 of the package 1 between the two suction cups 31, and enters the gap 12.

[0209] During the optional determination of the presence or absence of an integrity defect 19 caused by a first orifice in the control zone 10, the suction cups 31 remain pressed against the control zone 10 and the entry needle 4 remains positioned in the gap.

[0210] The injection E3 of gas into the gap 12 can cause the expulsion of contaminants from the package 1. Therefore, in the first test zone Z1, the package 1 is subjected to a laminar flow that channels and then removes from said first test zone any contaminants potentially expelled from the package 1. When no integrity defect 19 caused by a first orifice is detected, the robotic arm is configured to transport the package 1 from the first test zone Z1 to the second test zone Z2 to inspect the control zone 10 according to the detection E4. The robotic arm 9 transports the package 1 between the two test zones with the suction cups 31 still pressed against the control zone 10 and the first end of the inlet needle 4 in the gap 12.

[0211] Following detection E4, package 1, when it does not contain an integrity defect 19 caused by a second orifice, is transported by the robotic arm to another conveyor line C2. When the gripper 91 is positioned above the other conveyor line C2, the gripper 91 releases package 1, i.e. the entry needle 4 returns to its initial position and therefore exits the gap 12, and the suction cups 31 no longer come into contact with the control zone 10. Package 1 is then conveyed by the other conveyor line C2 to the clean room in which the contents 2 will be unpacked.

[0212] When an integrity defect 19 in the drilling area 16 (respectively in the control area 10) is detected following the Eli step, or when it is determined following the optional determination that the package 1 under inspection has an integrity defect 19 caused by a first hole, the robotic arm 9 can for example be configured to move the package 1 to a scrap area (not shown) a includes the test environment 200 and release the package 1 in this scrap area.

[0213] In one embodiment, the determination Eli of the integrity defect 19 in the drilling zone 16 includes:

[0214] - an optical control of the drilling area 16 by an image acquisition device (such as a camera) which is included in the detection system, and which delivers data representative of an optical appearance of the drilling area 16, for example pixels of an image;

[0215] - an image processing analysis performed by the detection system on data previously delivered by the image acquisition device; and

[0216] The integrity defect 19 in the drilling area 16 is detected when at least one of the data has a value of an image processing parameter that does not conform to a threshold of said image processing parameter.

[0217] The detection system applies image processing algorithms designed by a person in the field of expertise, based on available knowledge in the field of image processing, and adapted to the challenges of the analysis, for data analysis. The image processing parameter can be chosen from at least: a hue, a color intensity, a saturation, a brightness, a contrast.

[0218] The image processing parameter threshold is defined so as to distinguish in the control area 10, when the package 1 is made from a porous material, a pore of the package 1 from an integrity defect 19.

[0219] In the event that the orifice causing the integrity defect has a sufficiently large diameter, it may be possible to detect it with the naked eye.

[0220] In one embodiment, the determination Eli of the integrity defect 19 in the drilling zone 16 includes:

[0221] - the generation of waves at a given emission frequency within a range of ultrasonic frequencies and a direction of said waves on the drilling zone 16, by an external transmitting system included in the detection system; - the reception, by an external receiving system included in the detection system, at a reception frequency, of the waves when they are reflected by the drilling zone 16, and

[0222] The integrity defect 19 in the drilling zone 16 is detected when the reception frequency is not within a frequency range, within the ultrasonic band, predefined according to the emission frequency.

[0223] A first embodiment for the optional determination in the control zone 10 of the presence or absence of an integrity defect 19 caused by a first orifice is illustrated with reference to Figure 1-a and Figure 6. In Figure 6, the package 1 is assumed to be placed on a horizontal support plane 9. For clarity and readability, the suction cups 31 are not shown, and the inlet needle is connected directly to the injection system 6.

[0224] In this embodiment, the optional determination includes: - another drilling E31 of the portion 11 of the packaging 1 by means of an exit needle 5 which penetrates the gap 12, which exit needle 5 having an internal exit channel 51;

[0225] - a measurement E32 of an internal pressure in the gap 12 by a pressure sensor 7 included in the detection system and connected to the internal outlet channel 51 of the outlet needle 5; and

[0226] - a comparison E33 between a pressure differential, determined from the internal pressure and an external pressure prevailing outside the package 1 (i.e. atmospheric pressure), and a predefined pressure differential threshold.

[0227] Similar to the inlet needle 4, a sealing gasket is arranged around the outlet needle so that the inflated packaging 1, once the outlet needle 5 is inserted into the gap, compresses the sealing gasket of the outlet needle 5, thus preventing any risk of leakage around and near the hole pierced by the outlet needle 5.

[0228] When the determined pressure differential exceeds the predefined pressure threshold, it is determined that the inspection zone 10 of the package 1 has an integrity defect 19 caused by a first orifice. A pressure differential exceeding the pressure differential threshold implies that a significant pressure drop occurs in the gap of the package 1 due to the leakage of the gas characteristic of the integrity defect 19.

[0229] In one embodiment, with reference to Figure 1-a and Figure 7, the internal inlet channel 41 of the inlet needle 4 includes a shut-off system 8 (for example, a valve) configured to vary between an open and a closed configuration. In Figure 7, the packaging 1 is shown to be placed on a horizontal support plane 9. For clarity and readability, the suction cups 31 are not shown and the inlet needle is connected directly to the injection system 6. During the injection E3, the obturator system 8 adopts its open configuration to allow the gas to flow into the internal inlet channel 41 of the inlet needle 4, and then enter the gap 12. The internal inlet channel 41 of the inlet needle 4 is also connected, downstream of the obturator system, to a pressure sensor 7 included in the detection system.Following the injection of gas E3, the control process 100 includes a switchover E34 during which the sealing system 8 adopts its closing configuration.

[0230] Following the E34 switchover, the optional determination in the control zone 10 of the presence or absence of an integrity defect 19 caused by a first orifice includes:

[0231] - a measurement E35 by the pressure sensor 7, once the sealing system 8 is in its closed configuration, of an internal pressure in the gap 12 from which a pressure drop in the gap 12 can be deduced;

[0232] - an E36 analysis of the pressure drop in the 12 gap.

[0233] The presence of an integrity defect 19 in the control zone 10 is detected when:

[0234] - when the measured internal pressure value falls below a predefined minimum internal pressure threshold, indicating a sudden drop in pressure due to the leakage of injected gas through the integrity defect 19; and

[0235] - that this sudden drop in pressure is observed for a time interval less than a predefined pressure drop duration. In one variant, the pressure drop duration is defined by the operator implementing the control process 100. For example, the internal pressure must not fall below the minimum internal pressure threshold in a time interval of 3 seconds.

[0236] In another embodiment, when the packaging 1 is made from at least one flexible porous material, the determined pressure drop time corresponds to the time required for the internal pressure measured in a compliant packaging 1, i.e., one that does not contain any integrity defects, to decrease below the minimum internal pressure threshold.

[0237] Several methods for E4 detection are described below. These different methods can be considered independently of each other; however, they can also be combined for greater accuracy in detecting E4 of an integrity defect 19. In these figures, E4 detection is implemented with the package 1 placed on a horizontal support 9. For clarity and readability, the suction cups 31 are not shown, and the inlet needle is connected directly to the injection system 6.

[0238] A majority of the methods described allow the detection of an integrity defect 19 in the control zone 10 when a leak (in other words, an escape) is detected from the packaging 1, through the orifice that caused the integrity defect 19, of the gas injected during step E3. For these methods, the conditions for detecting the presence of an integrity defect 19 allow, when the packaging 1 is made from at least one porous material, for distinguishing a gas leak through the pores of the packaging 1 from a gas leak caused by an integrity defect 19.

[0239] In one embodiment, similarly to the determination Eli of an integrity defect 19 in the drilling zone 16, the detection E4 of an integrity defect 19 in the inspection zone 10 can be done by:

[0240] - an optical control of the control zone 10 by an image acquisition device included in the detection system, and delivering data representative of an optical appearance of the control zone 10;

[0241] - an image processing analysis, performed by the detection system, of the data previously delivered by the image acquisition device;

[0242] The integrity defect 19 in the control zone 10 is detected (more precisely, located in the control zone 10) when at least one of the data points has a value for an image processing parameter, chosen from at least those mentioned previously, that does not conform to a threshold of said image processing parameter. In one embodiment, the gas is injected into the gap 12 at a given inlet temperature by the gas injection system 6. The detection E4 then includes:

[0243] - a thermographic control of the control zone 10 by an acquisition device (such as an infrared camera) which is included in the detection system, which acquisition device delivers a thermal image representative of the control zone 10;

[0244] - an image processing analysis, performed by the detection system, of the thermal image of the control zone 10; and

[0245] The integrity defect 19 in the control zone 10 is detected when at least one of the data relating to the thermal image has a value of an image processing parameter that does not conform to a threshold of said image processing parameter.

[0246] When the control zone 10 contains an integrity defect 19, the gas leak causes a rise or fall in temperature (i.e., a heat loss or gain) near the integrity defect 19, depending on whether the inlet temperature of the injected gas is higher or lower than the ambient temperature. The threshold of the image processing parameter (for example, related to a pixel color) is defined so as to detect this temperature variation from the thermal image data of the control zone 10 delivered by the acquisition device (which is a thermal camera).

[0247] For the analysis of image processing of data relating to the thermal image of control zone 10, the detection system applies thermal image processing algorithms designed by a person skilled in the art based on available knowledge in the field of image processing, and which are adapted to the challenges of the analysis.

[0248] In one embodiment, the gas injected into the gap 12 contains a chemical compound, and detection E4 comprises measuring the quantity of the chemical compound outside the packaging 1, using a dedicated sensor included in the detection system. The integrity defect 19 is detected when the measured quantity of the chemical compound exceeds a predefined chemical compound quantity threshold.

[0249] The chemical compound quantity threshold corresponds to the amount of this chemical compound that ambient air should conventionally contain (this amount may even be zero). If the dedicated sensor measures an amount of the chemical compound outside the packaging 1 that exceeds this threshold value, then a leak of the injected gas, characteristic of the integrity defect 19, is detected.

[0250] The injected gas may, for example, correspond to an ionized gas, and the integrity defect 19 is detected when, outside and near the control zone 10, an amount of ozone is measured that exceeds a threshold of the amount of ozone that the ambient air must contain.

[0251] Other methods for detecting E4 the presence or absence of an integrity defect 19 in the control zone 10 may consist of sound frequency measurements.

[0252] In one embodiment, detection E4 includes measuring a sound frequency using an external acoustic system (e.g., a microphone) comprising at least one external acoustic sensor located outside the package 1, which external acoustic system being included in the detection system; and the integrity defect 19 in the control zone 10 is detected when the sound frequency falls within a predefined and specified frequency range in the ultrasonic band. In other words, the leak of injected gas characteristic of the integrity defect 19 is detected by the noise / sound it emits.

[0253] In one embodiment, detection E4 includes:

[0254] - the generation of waves at a given emission frequency within a range of ultrasonic frequencies and a direction of said waves on the control zone 10, by an external transmitting system included in the detection system; - the reception, by an external receiving system included in the detection system, at a reception frequency, of the waves when they are reflected by the control zone 10, and

[0255] Integrity fault 19 in control zone 10 is detected when the receive frequency is not within a predefined frequency range based on the transmit frequency.

[0256] In this embodiment, the presence or absence of an integrity defect 19 in the control zone 10 is detected by the Doppler effect, that is, by the echo emitted by the transmitting system and received by the receiving system. If the received frequency is not within the frequency range defined according to the transmitted frequency, then this means that the latter has been modified by the gas leak characteristic of the integrity defect 19 (waves are accelerated when they propagate near the gas leak).

[0257] Other methods for detecting E4 an integrity defect 19 in the control zone 10 may consist of temperature measurements. In a preferred embodiment, illustrated in Figure 8, the detection includes measuring a heat loss representative of gas leakage, outside and near the control zone 10, by a calorimetric flow sensor 71 which is included in the detection system; and the integrity defect 19 in the control zone 10 is detected when the measured heat loss exceeds a predefined heat loss threshold. In this embodiment, the gas leak characteristic of the integrity defect 19 is detected by a heat loss it induces in the ambient air, which exceeds the predefined heat loss threshold.

[0258] The heat flow sensor 71 is positioned at a distance from the control zone 10 that allows for differentiation between heat loss caused by an integrity defect 19 and heat loss caused by the passage of air or gas through the pores of the packaging 1 when the latter is made from at least one porous, flexible material. The heat loss threshold value is also defined to allow for this distinction.

[0259] In an unillustrated variant, several calorimetric flow sensors 71 are configured to detect the presence or absence of an integrity defect 19 in the control zone 10, so as to increase the accuracy of detection E4. The number of calorimetric flow sensors 71 is proportional to the surface area of ​​the control zone 10; and each of the several calorimetric flow sensors 71 is configured to measure a heat loss at a distinct portion of the control zone 10.

[0260] In one embodiment, illustrated in Figure 9, the gas is injected at a gas inlet temperature by the gas injection system 6, and detection E4 includes measuring a temperature outside and near the control zone 10 by means of a temperature sensor 72 (for example, a thermal resistance) which is included in the detection system; and the integrity defect 19 is detected when the measured temperature is not within a predefined temperature range that is at least a function of the inlet temperature. The gas leak characteristic of the integrity defect 19 is therefore detected if a rise or fall in temperature is observed near the packaging 1. A rise or fall in temperature is observed depending on whether the inlet temperature of the injected gas is higher or lower than the ambient temperature.

[0261] Following the detection of the presence or absence of an integrity defect 19 in the control zone 10:

[0262] - either the stop step E9 is implemented to stop the control process 100 when an integrity defect 19 has been detected in the control area 10, or when the integrity of the entire surface of the packaging 1 has been verified;

[0263] - either, when the control zone 10 does not correspond to the whole surface of the packaging 1, at least one other control zone 10 is considered and, for this at least one other control zone 10, the minimum steps E1, E2, E3 and E4 of the control process 100 are iterated.

[0264] When the control area 10 of the controlled package 1 does not correspond to the whole surface of the package 1, and the steps El, E2, E3, E4 of the control process 100 must be iterated for at least one other control area 10, the control installation may for example include a handling device (such as a robotic arm) to handle the package 1 (for example to turn it over) so that the steps El, E2, E3, E4 are applied to this at least one other control area 10.

[0265] The invention positively addresses the need for a 100% reliable control method for verifying the integrity of a flexible package containing sterilized contents which:

[0266] - meets the requirements of Annex 1 of Volume 4 of Eudralex;

[0267] - is practical to implement;

[0268] - is not very time-consuming to check if packaging 1 has an integrity defect 19;

[0269] - during the packaging inspection 1, does not damage or contaminate the sterilized contents;

[0270] - presents a high degree of accuracy in the detection of an integrity defect 19; - allows the implementation of a plurality of different methods (based as described on measurements of pressure, temperature, sound frequencies, etc.) which may or may not be combined together so as to detect with an increased degree of accuracy an integrity defect 19.

[0271] A final advantage of the control process is that it can be easily integrated into a production line.

[0272] Although the present invention has been described with reference to specific embodiments, it is evident that modifications and changes can be made to these examples without departing from the general scope of the invention as defined by the claims. In particular, individual features of the various embodiments illustrated / mentioned can be combined in additional embodiments. Therefore, the description and drawings should be considered in an illustrative rather than restrictive sense. It is also evident that all the features described with reference to the control method are transferable, alone or in combination, to the control installation; and vice versa.

Claims

DEMANDS 1. Control method (100) for checking the integrity of a package (1) containing a content (2), in particular a sterilized content (2), and made of at least one flexible material; the control process (100) being implemented on a control area (10) of the packaging (1) and comprising the following successive steps: - a suction (El) of the control zone (10) by means of at least one suction device (3) so as to detach a portion (11) of the packaging (1) from the contents (2), thus creating a gap (12) between said portion (11) and the contents (2); - a drilling (E2) of the portion (11) of the packaging (1), by means of at least one entry needle (4) which thus penetrates the gap (12) by drilling an area called drilling zone (16) included in the control zone (10), said at least one entry needle (4) having an internal entry channel (41); - an injection (E3) of a gas at a given inlet pressure inside the gap (12) through the internal inlet channel (41) of at least one inlet needle (4) which is connected to a gas injection system (6); - a detection (E4) of the presence or absence of an integrity defect (19) in the control area (10) by means of a detection system; the control process (100) being characterized in that it includes, prior to drilling (E2), a determination (Eli) of the presence or absence of an integrity defect (19) in the drilling zone (16) by the detection system; the control process (100) being stopped when an integrity defect (19) in the drilling zone (16) is detected, or continuing with the drilling (E2) of the drilling zone (16) otherwise.

2. Control method (100) according to claim 1, wherein the determination of the integrity defect (19) in the drilling zone (16) comprises: - an optical control of the drilling zone (16) by an image acquisition device which is included in the detection system, and which delivers data representative of an optical appearance of the drilling zone (16), for example pixels of an image; - an image processing analysis performed by the detection system on data previously delivered by the image acquisition device; and The integrity defect (19) in the drilling zone (16) is detected when at least one of the data points has a value for an image processing parameter that does not conform to a threshold of said image processing parameter.

3. Inspection method (100) according to claim 1 or 2, wherein the determination of the integrity defect (19) in the drilling zone (16) comprises: - generating waves at a given emission frequency within a range of ultrasonic frequencies and a direction of said waves on the drilling zone (16), by an external emitting system included in the detection system; - receiving, by an external receiving system included in the detection system, at a reception frequency, the waves when they are reflected by the drilling zone (10), and The integrity defect (19) in the drilling zone (16) is detected when the receiving frequency is not within a predefined frequency range depending on the transmitting frequency.

4. Control method (100) according to any one of the preceding claims, wherein at least one flexible material of the packaging (1) is a synthetic non-woven and fibrous material, containing for example polyethylene fibers.

5. Control method (100) according to any one of the preceding claims, wherein the packaging (1) comprises a single bag (13) which contains the contents (2); in which the control zone (10) corresponds to a surface of the single bag (13); and in which, during the suction of the control zone (10), a portion (11) of the single bag (13) is detached from the content (2), creating a gap (12) between the portion (11) of the single bag (13) and the content (2).

6. Control method (100) according to any one of claims 1 to 4, wherein the packaging (2) comprises an outer bag (14) and an inner bag (15) such that the inner bag (15) contains the contents (2) and the outer bag (14) contains the inner bag (15); in which the control zone (10) corresponds to a surface of the outer pouch (14); and in which, during the suction (El) of the control zone (10), a portion (11) of the outer pouch (14) is detached from the inner pouch (15), creating a gap (12) between the portion (ll) of the outer pouch (14) and the inner pouch (15).

7. Control method (100) according to any one of the preceding claims, wherein at least one suction device (3) comprises at least one suction cup (31), such that the suction (El) of the control area (10) is operated by placing at least one suction cup (31) on the control area (10) and moving at least one suction cup (31) away from the contents (2).

8. Control method (100) according to any one of the preceding claims, wherein said control method (100) comprises, following the injection (E3) of the gas: - another perforation (E31) of the portion (11) of the packaging (1) by means of an exit needle (5) which penetrates the gap (12), which exit needle (5) having an internal exit channel (51), - a measurement (E32) in the spacing (12) of an internal pressure by a pressure sensor (7) included in the detection system and connected to the internal outlet channel (51) of the outlet needle (5); such that, prior to detection (E4), the presence of an integrity defect (19) in the control area (10) is determined when a pressure differential, determined from the internal pressure and an external pressure prevailing outside the packaging (1), is greater than a predefined pressure differential threshold.

9. A control method (100) according to any one of claims 1 to 7, wherein the internal inlet channel (41) of at least one inlet needle (4) comprises a closing system (8) configured to vary between an open configuration and a closed configuration such that: - during the injection (E3) of the gas, the obturator system (8) adopts its open configuration and allows the gas to flow into the internal inlet channel (41) of at least one inlet needle (1) and then enter the gap (12), and - following the injection (E3) of the gas, the sealing system (8) adopts its closed configuration, thus preventing the gas from flowing downstream of the sealing system (8) and from entering the gap (12); in which a pressure sensor (7) is included in the detection system and is connected to the internal inlet channel (41) of at least one inlet needle (4) downstream of the obturating system; in which the control method (100) includes, once the sealing system (8) is in its closed configuration, a measurement (E35) of an internal pressure by the pressure sensor (7); such that, prior to detection (E4), the presence of an integrity defect (19) in the control zone (10) is determined when the internal pressure decreases below a predefined minimum internal pressure threshold in a time interval less than a predefined pressure drop time.

10. Inspection control method (100) according to any one of the preceding claims, wherein the gas comprises a chemical compound, and wherein detection (E4) comprises measuring a quantity of the chemical compound outside the packaging (1), by means of a dedicated sensor included in the detection system; and the integrity defect (19) in the control zone (10) is detected when the measured quantity of the chemical compound is greater than a predefined chemical compound quantity threshold.

11. Control method (100) according to any one of the preceding claims, wherein the detection (E4) comprises a measurement of a sound frequency by an external acoustic system comprising at least one external acoustic sensor placed outside the packaging, which external acoustic system being included in the detection system; and the integrity defect (19) is detected when the sound frequency is within a predefined and given frequency range in the ultrasonic band.

12. A control method (100) according to any one of the preceding claims, wherein the detection (E4) comprises: - the generation of waves at a given emission frequency within a range of ultrasonic frequencies and a direction of said waves on the control zone (10), by an external transmitting system included in the detection system; - the reception by an external receiving system included in the detection system, at a reception frequency, of the waves when they are reflected by the control zone (10), and The integrity defect (19) in the control zone (10) is detected when the receive frequency is not within a predefined frequency range depending on the transmit frequency.

13. A control method (100) according to any one of the preceding claims, wherein the detection (E4) comprises a measurement of a heat loss representative of a gas escape, outside and near the control area (10), by at least one calorimetric flow sensor (71) which is included in the detection system; and The integrity defect (19) in the control zone (10) is detected when the measured heat loss is greater than a predefined heat loss threshold.

14. Control method (100) according to any one of the preceding claims, wherein the gas is injected at a given inlet temperature by the gas injection system (6), and the detection (E4) comprises a measurement of a temperature outside and near the control zone (10) by means of a temperature sensor (72) which is included in the detection system; and the integrity defect (19) is detected when the measured temperature is not within a predefined temperature range which is at least a function of the inlet temperature.

15. Control method (100) according to any one of the preceding claims, wherein the gas is injected at a given inlet temperature by the gas injection system (6), and wherein the detection (E4) comprises: - a thermographic control of the control area by an acquisition device which is included in the detection system, which acquisition device delivers a thermal image representative of the control area (10); - an image processing analysis, performed by the detection system, of the thermal image of the control zone (10); and The integrity defect (19) in the control area is detected when at least one of the data relating to the thermal image, for example a pixel, has a value of an image processing parameter that does not conform to a threshold of said image processing parameter.

16. A control method (100) according to any one of the preceding claims, wherein the detection (E4) comprises: - an optical control of the control area by an image acquisition device which is included in the detection system, and which delivers data representative of an optical appearance of the control area (10), for example pixels of an image; - an image processing analysis, performed by the detection system, of the data previously delivered by the image acquisition device; and The integrity defect (19) in the control area (10) is detected when at least one of the data has a value of an image processing parameter that does not conform to a threshold of said image processing parameter.

17. Control method (100) according to claim 15 or 16, wherein the image processing parameter is at least selected from: a hue, a color intensity, a saturation, a brightness, a contrast.

18. Control installation for checking the integrity of a package (1) containing a content (2), in particular a sterilized content (2), and made of at least one flexible material; said control installation being configured to implement the control method (100) according to any one of the preceding claims comprising: - at least one suction device (3) for suction (El) of the control area (10) and detaching a portion (11) of the packaging (1) of the contents (2); - at least one entry needle (4) having an internal entry channel (41); - a gas injection system (6) connected to the internal inlet channel (41) of at least one inlet needle (4); and - a detection system to detect the presence or absence of an integrity defect (19) in said control area (10).

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