DEVICE, SET, PHARMACEUTICAL PLANT AND METHOD FOR UNPACKING A PLURALITY OF ARTICLES

Disclosed are a device and a method for unpacking a plurality of articles arranged in an elongated package having an upper end and a lower end stacked one on top of the other in an elongated stack.

BACKGROUND

The invention relates to a device for unpacking a plurality of articles, in particular pre-sterilized articles, a set, a pharmaceutical plant, and a method for unpacking a plurality of articles, in particular pre-sterilized articles.

For microbiological monitoring in e.g. a pharmaceutical production machine, Petri dishes and/or swab samples are often used. These are plastic dishes filled with nutrient medium (agar) and fitted with a lid. Petri dishes are used for monitoring the air, and swab samples are used for monitoring surfaces. Petri dishes and swab samples are usually stacked on top of each other in stacks of 10 and packed in three sterile foil bags. The two outer bags are removed step by step when the Petri dishes or the swab samples are transferred from the uncontrolled room into the pharmaceutical production machine.

Before the start of production, the innermost bag is cut open manually, e.g. with scissors, by an operator who uses gloves to access the production machine. The Petri dishes or swab samples can then also be removed manually and placed in a storage magazine, for example. They remain there until they are needed for monitoring.

Before the innermost bag is opened (manually), it is decontaminated in a decontamination process within the production machine so that it is germ-free.

Another option is to manually open the bag containing the Petri dishes or the swab samples in a separate isolator (additional isolator to the pharmaceutical production machine) via glove port in the isolator. Subsequently, the Petri dishes or swab samples can be manually sorted into a magazine, which is then fed into the actual production machine via a sterile beta container or via a connecting door. The magazine can be removed from the container by a handling device and placed in the pharmaceutical production machine.

Here, too, the innermost bag is decontaminated in a decontamination process inside the separate isolator before (manual) opening, so that it is germ-free.

The disadvantage of this is that to open the bag containing the Petri dishes or the swab samples in the production machine, glove port is required for manual unpacking or, in addition to the production machine, a separate isolator with glove port is required.

SUMMARY

It is therefore the task of the invention to provide a device, a set, a pharmaceutical plant and a method, whereby the above disadvantages are eliminated and, in particular, an automated unpacking of the Petri dishes or swab samples is made possible.

This task is solved by a device for unpacking a plurality of articles, in particular pre-sterilized articles, arranged in an elongated package with an upper end and a lower end stacked on top of each other in an elongated stack, within a pharmaceutical plant, in particular within a clean room, in particular within an isolator, according to the invention.

The articles may be Petri dishes or swab samples. The package may be in the form of a bag or a tubular bag package, particularly tubular. The lower end of the package may be formed as a lower flap of the package. The upper end of the package may be formed as an upper flap of the package. The upper end of the package may be a (upper) portion of the package. The lower end of the package may be a (lower) portion of the package.

The device includes at least one lower stop for the articles, onto which the stack of articles in the package can be placed at one or more locations distributed around the circumference of the package. The lower stop may be in the form of a receptacle or receiving plate for receiving the package together with the articles disposed therein. The device may include one or more lower stops.

The device further comprises at least one lower fixing device. The lower fixing device is arranged below the lower stop. The lower stop comprises a passage, in particular a central passage, through which the lower end of the package can extend below the lower stop (when the articles are in contact with the lower stop), so that the lower end of the package can be gripped by the inner fixing device while the articles in the package are resting against the lower stop. The device may include one or more lower fixing devices.

The passage can be in the form of a circumferentially closed opening or partially open, for example to the side. The lower fixing device can be designed to fix (clamp) or grip the lower end of the package, in particular in a clamping manner.

The device further comprises at least one upper fixing device. The upper fixing device is arranged above the upper stop. The upper fixing device is designed for gripping the upper end of the package while the articles in the package are resting against the lower stop. The upper fixing device may be configured to fix (clamp) or grip the upper end of the package, in particular in a clamping manner. The upper fixing device may be formed analogously, in particular identically, to the lower fixing device. The device may comprise one or more upper fixing devices.

The device further comprises at least one cutting device for cutting open (or cutting off) one of the ends (the upper end or the lower end) of the package while the articles in the package are resting against the lower stop. The device may comprise one or more cutting devices.

The cutting device can have at least one horizontally movable knife. The knife can be designed as a linearly movable rolling knife. The knife can also be designed as a straight knife which carries out the cutting process with a rotating or pivoting movement.

The cutting device can be arranged above or below the lower stop. The cutting device can be arranged between the lower stop and the lower fixing device. The cutting device can also be arranged between the lower stop and the upper fixing device.

The fixing device (the lower or the upper one) arranged at the end (the lower or the upper one) of the package opposite the cutting device while the articles in the package are resting against the lower stop is designed as a removal device. The removal device is adapted to pull off (remove) the package opened (cut open) by the cutting device from the stack of articles.

The lower end may be formed as a first end and the upper end may be formed as a second end of the package. The lower fixing device may be formed as a first fixing device and the upper fixing device may be formed as a second fixing device. The lower stop may be formed as a first stop.

The cutting device and the lower fixing device can be arranged below the lower stop, and the upper fixing device designed as a removal device can be arranged above the lower stop. In this way, the lower end (or the lower flap) of the package can be cut open or cut off and the cut open package can be pulled away (or removed) from the articles by means of the removal device in an upward direction, in particular in a direction opposite to the direction of gravity.

It is also conceivable that the cutting device and the upper fixing device can be arranged above the lower stop and the lower fixing device designed as a removal device can be arranged below the lower stop. In this way, the upper end (or the upper flap) of the package can be cut open or cut off and the cut open package can be pulled away downwards from the articles, in particular in the direction of gravity, by means of the removal device.

The placement (positioning) of the package together with the articles contained therein in the pharmaceutical plant, in particular in the clean room, especially in the isolator, can be carried out manually by an operator or automatically by means of a handling device. (e.g. robot arm).

In the present case, the terms such as “downwards”, “lower”, “below” or “upwards”, “upper”, “above” refer to gravity or the direction of gravity. For example, the lower fixing device is arranged below the upper fixing device with respect to the direction of gravity.

A cleanroom in the present sense may be a barrier system, e.g., RABS (Reduced Access Barrier System), an isolator (e.g., aseptic or cytotoxic isolator), or a biosafety cabinet. A cleanroom in this sense may be pressurized to prevent or minimize the risk of contamination intrusion. Alternatively, a cleanroom in this sense can also be operated under negative pressure to prevent the escape of any toxic or otherwise hazardous substances to be handled in the cleanroom.

By means of the device, the package can be removed from the articles received therein without the need for manual intervention by an operator during the unpacking of the articles. The unpacking process can thus be automated. Glove ports in the pharmaceutical equipment and/or an isolator (with glove ports) additional to the pharmaceutical equipment for unpacking the articles can be eliminated.

The device may further comprise a guide. The guide may be arranged laterally of the stack of articles when the articles in the package are resting against the lower stop. The guide may be configured to hold the articles in their stacked arrangement (e.g., as a pile) while the articles in the package rest against the lower stop. The guide may contact the package and/or the articles laterally to hold them in their stacked arrangement while the articles rest against the lower stop.

The guide may comprise a holding device or be designed as a holding device. The holding device can be set up to fix (hold) the articles in the package when they rest against the lower stop, in particular during the removal of the cut open package. The articles can be (firmly) held by means of the holding device so that they remain in their position or location during the removal process of the cut open package, i.e. do not change their position or location.

The guide may comprise at least one shaft with an upper stop (or retaining element). In particular, the guide may comprise three shafts each having an upper stop (or retaining element) for the articles (in particular for the uppermost article of the stack of articles). The upper stop may be formed as a second stop.

The shaft may be arranged in a base plate. The base plate can be a (set-up) base for the entire device. The base plate can be arranged below the lower stop. The shaft may extend through the lower stop. For this purpose, the lower stop may have an opening through which the shaft extends. The lower stop can be coupled to the shaft, in particular rotatably.

The lower stop can be coupled or connected to the base plate by means of the shaft. The lower stop can be connected to the base plate by means of the shaft in such a way that there is a constant distance between the lower stop and the base plate (in particular in the direction of gravity). The lower stop can be arranged parallel to the base plate.

The upper stop can be designed to pivot between a fixing position and a release position.

In the fixing position, the stack of articles can be gripped (held or fixed) between the lower stop and the upper stop. The lower stop limits in particular a downward movement of the articles. The upper stop limits in particular an upward movement of the articles in the fixing position. In particular, the upper stop can be transferred to the fixing position by pivoting the upper stop towards the stack of articles. In the fixing position, the stack of articles may be arranged between the lower stop and the upper stop. In the fixing position, the stack of articles can be form-fitted gripped (held or fixed) between the lower stop and the upper stop.

In the release position, the stack of articles can be released by the upper stop. In the release position, the stack of articles can be inserted into the device from above and removed from the device. In the release position, the upper stop may be arranged such that the stack of articles is in particular not arranged between the lower stop and the upper stop. In particular, the upper stop can be transferred to the release position by pivoting the upper stop away from the stack of articles.

The upper stop can be non-rotatably connected (or coupled) to the shaft. The upper stop can be detachably connected to the shaft by means of a screw. The shaft can be designed to be rotatable. The axis of rotation of the shaft or the axis of rotation (pivot axis) of the upper stop can be oriented along the direction of gravity and, in particular, be identical to the central longitudinal axis of the shaft. In particular, the upper stop can be transferred from the release position to the fixing position and vice versa by rotating the shaft.

The upper stop can be designed as a resilient element (e.g. made of plastic). The upper stop may be formed as a resilient sheet (metal sheet). The upper stop can be arranged at a distance from the uppermost object and/or above the uppermost object of the stack of articles when these are resting against the lower stop.

The upper stop may have a beveled portion. The beveled portion of the upper stop may be located above the topmost article of the stack of articles, particularly in the fixing position. Due to the beveled portion, the package can slide more easily along the upper stop during removal by means of the removal device. This can prevent the package from getting stuck and/or tearing during removal by means of the removal device.

The lower fixing device can have two clamping jaws for clamping fixation (gripping) of the lower end of the package. The upper fixing device can have two clamping jaws for clamping fixation (gripping) of the upper end of the package. The cutting device or its knife may be arranged to cut along an edge (or along a surface) of the clamping jaws of the lower or the upper fixing device.

The device may include at least one waste container for receiving the cut open package, the upper end of the package, the lower end of the package, and/or any desiccant bag present in the package. The desiccant bag may either fall into the waste container on its own, for example due to gravity, after the package is removed from the articles. The device may comprise one or more waste containers.

The device may include a handling device (e.g., robotic arm) by means of which the cut open package, the upper end of the package, the lower end of the package, and/or the desiccant bag, if present in the package, may be conveyed into the waste container.

The device may comprise at least one optical detection device for monitoring the position and/or the location of the articles. The optical detection device may comprise a camera or be designed as a camera. The optical detection device can monitor the position and/or the location of the articles, in particular while the articles in the package are resting against the lower stop. This can, for example, detect slippage of the articles and, for example, generate and output an alarm signal (optical and/or acoustic). The device may comprise one or more optical detection devices.

The above task is further solved by a set according to the invention.

The set comprises at least one device as described above and at least one package. The package is in particular a package as described above. The package comprises an elongated stack of stacked articles.

The package may be elongated, in particular tubular. The package can have an upper (protruding) end and a lower (protruding) end. The upper end and/or the lower end of the package may each be designed to be grippable (in particular, to be clampably fixable or graspable) by means of a fixing device.

The package can be in the form of a bag or a tubular bag package, in particular tubular.

With regard to the advantages achievable with the set, reference is made to the explanations on the device in this respect. The measures described in connection with the device and/or those explained below can be used for the further design of the set.

The above task is further solved by a pharmaceutical plant, in particular by a clean room, in particular by an isolator, according to the invention.

The pharmaceutical plant comprises at least one device as described above and at least one set as described above.

With regard to the advantages achievable with the pharmaceutical plant, reference is made to the explanations concerning the device or set in this respect. The measures described in connection with the device or with the set and/or the measures explained below can serve for the further design of the pharmaceutical plant.

The pharmaceutical plant may comprise an ventilation device. The ventilation device may be arranged inside the pharmaceutical plant. It is also conceivable that the ventilation device can be arranged at least partially outside the pharmaceutical plant.

The ventilation device can be designed to generate an air flow, in particular a laminar air flow, which is directed towards the device and in particular in the direction of gravity. In other words, the, in particular laminar, air flow generated by the ventilation device can be directed onto the device from above. In this way, particles that are produced, for example, during the cutting of the package can be blown off the package so that they do not come into contact with the articles.

The above task is further solved by a method for unpacking a plurality of, in particular pre-sterilized, articles arranged in an elongated package with a upper end and a lower end stacked on top of each other in an elongated stack, within a pharmaceutical plant, in particular within a clean room, in particular within an isolator, according to the invention.

The articles may be Petri dishes or swab samples. The package may be in the form of a bag or a tubular bag package, particularly tubular. The lower end of the package may be formed as a lower flap of the package. The upper end of the package may be formed as an upper flap of the package. The upper end of the package may be a (upper) portion of the package. The lower end of the package may be a (lower) portion of the package.

The method includes the steps:

Providing at least one lower stop for the articles onto which the stack of articles in the package can be placed at one or more locations distributed around the circumference of the package.

Placing (Positioning) the stack of articles in the package against the lower stop. This can be done manually or automatically by a handling device, e.g. a robot.

Gripping (fixing), in particular clamping (gripping), the lower end of the package.

Grasping (fixing), in particular clamping (gripping), the upper end of the package.

Cutting open the package, especially cutting off the lower end or the upper end of the package.

Pulling off (removing or taking out) the cut open package from the stack of articles.

The cut open package can be pulled upwards or downwards along the direction of gravity. In other words, the cut open package can be pulled off in the direction of gravity or against the direction of gravity.

The method may further comprise the steps of:

Provide at least one upper stop for the articles.

Gripping (or holding) the stack of articles between the lower stop and the upper stop while pulling the cut open package from the stack of articles.

The method may further comprise the step of:

Decontaminating the package (from the outside), in particular by means of hydrogen peroxide (H2O2). This decontamination step can be carried out temporally, in particular, before the lower end of the package is gripped, before the upper end of the package is gripped and/or before the package is cut open.

The position and/or the location of the articles, in particular during the removal of the cut open package from the stack of articles, can be monitored. This can be implemented in particular by means of at least one optical detection device, in particular by means of at least one camera.

The method may further comprise the step of:

Placing (positioning) the cut open package, the lower end of the package, the upper end of the package and/or any desiccant bag present in the package, in particular by means of a handling device, into at least one waste container.

A device as described above, a set as described above, or a pharmaceutical plant as described above may be used to perform the method.

With regard to the advantages achievable with the method, reference is made to the explanations relating thereto concerning the device, the set or the pharmaceutical plant. The measures described in connection with the device, the set or the pharmaceutical plant and/or the measures still explained below can serve to further design the method.

DETAILED DESCRIPTION

In the following description and in the figures, the corresponding components and elements have the same reference signs. For the sake of clarity, not all reference signs are shown in all figures.

FIG.1shows a perspective view of a plurality of articles12in a package14. In the present case, the package14is designed as a tubular bag package and has an upper end16and a lower end18. The upper end16is formed as an upper flap17projecting upwardly from the tubular package14. The lower end18is formed as a lower flap19projecting downwardly from the tubular package14.

In the present case, the articles12are ten Petri dishes13stacked on top of each other in a pile and arranged in the package14in a pre-sterilized state.

The terms “downward”, “lower”, “below” and “upward”, “upper”, “above” refer to gravity and the direction of gravity15. The direction of gravity15is indicated by an arrow inFIGS.1to4.

FIG.2shows a perspective view of a device10andFIG.3shows a side view of the device10according toFIG.2.

The device10has a base plate11, which is used to set up the device10. Three shafts34are arranged on the base plate11, which extend vertically upwards from the base plate11. The three shafts34are configured to rotate about their respective central longitudinal axes. In other words, the three shafts34are each rotatably coupled (connected) to the base plate11.

The device10has a lower stop20for the articles12. The lower stop20is designed in the present case in the form of a receiving plate21. The lower stop20is arranged above the base plate11.

In the present case, the three shafts34are each rotatably coupled (connected) to the lower stop20. In other words, the three shafts34can each be rotated relative to the lower stop20. The three shafts34extend through the lower stop20. The lower stop20has an opening23(i.e. three openings23) for this purpose.

The lower stop20may be coupled (connected) to the base plate11by means of the three shafts34. The three shafts34can be rotatably mounted in the lower stop20. This can be implemented in particular by means of bearings (not shown) arranged in the openings23. The lower stop20can be firmly connected to the base plate11via at least one fixing element (not shown).

The three shafts34can extend through the lower stop20such that they do not contact the lower stop20. For this purpose, the openings23can each have a diameter that is larger than the diameter of each of the three shafts34.

In the presently illustrated state, the stack of articles12in the package14is placed on the lower stop20. The lower stop20has a central passage24, which in the present case is in the form of a through opening. The lower end18of the package14extends through the passage24to below the lower stop20.

The device has a lower fixing device22. The lower fixing device22is arranged below the lower stop20. The lower fixing device22is designed for fixing the lower end18of the package14, which protrudes from the passage24to below the lower stop20. The lower fixing device22has two clamping jaws38for this purpose. The lower end18of the package14can thus be fixed or gripped below the lower stop20by means of the two clamping jaws38of the lower fixing device22by means of clamping.

The device10further comprises an upper fixing device26for gripping the upper end16of the package14. For the sake of a better overview, the upper fixing device26is not shown inFIG.2and is only schematically indicated inFIG.3.

The upper fixing device26is disposed above the lower stop20. The upper fixing device26is designed to fix the upper end16of the package14while the articles12in the package14rest against the lower stop20. For this purpose, the upper fixing device26has two clamping jaws38, which are not shown inFIG.2and are only schematically indicated inFIG.3. The upper end16of the package14can thus be fixed or gripped (above the lower stop20) by means of the two clamping jaws38of the upper fixing device26by means of clamping.

The device10has a cutting device28for cutting the lower end18of the package14while the articles12in the package14are resting against the lower stop20. In the present case, the cutting device28is designed for cutting off the lower flap19of the package14while the articles12in the package14are resting against the lower stop20. Accordingly, the cutting device28is arranged between the first fixing device22and the lower stop20.

The cutting device28has a knife29movable perpendicularly to the direction of gravity15(i.e. horizontally). The cutting device28or the knife29of the cutting device28is designed and arranged in such a way that the knife29slides along the upper edge or a surface of the two clamping jaws38of the lower fixing devices22during a cutting process. In this way, the cutting effect can be optimized or enhanced.

The upper fixing device26is designed as a removal device30. For reasons of a better overview, the removal device30is not shown inFIG.2and is only schematically indicated inFIG.3. The removal device30is designed to pull the package14, which has been opened (cut open) by means of the cutting device28, upwards (against the direction of gravity15) from the stack of articles12. For this purpose, the removal device30is designed to be movable relative to the lower stop20, in particular along the direction of gravity15.

The three shafts34extend upwardly from the base plate11through the lower stop20to above the stack of articles12. The three shafts34form a guide32for the stack of articles12when they rest on the lower stop20. The three shafts34can be used in particular to prevent lateral slippage (i.e. transverse to the direction of gravity15).

Each of the three shafts34has an upper stop36at its end opposite the base plate11. The three upper stops36are each (detachably) connected to the respective shaft34by means of a screw37. The shafts34are designed to be rotatable about their respective central longitudinal axis. By rotating the respective shaft34, the respective upper stop36can be pivoted transversely to the direction of gravity15(i.e. within a horizontal plane).

This allows the upper three stops36to be pivoted to a release position, in which the stack of articles12in the package14can be placed along the guide32onto the lower stop20. In the release position, the top three stops36are directed away from the stack of articles12.

The upper three stops36can be pivoted to a fixing position. The fixing position is shown inFIGS.2and3. In the fixing position, the three upper stops36are directed toward the stack of articles12. In the fixing position, the lower stop20, the three upper stops36and the three shafts34form a form-fit for the stack of articles12. The stack of articles12is held (fixed) between the lower stop20and the three upper stops36by means of the lower stop20and the three upper stops36when these are arranged in the fixing position.

The three shafts34are all the same length, such that the three upper stops36are disposed at the same height (within the same horizontal plane). In the present case, the three upper stops36are spaced from the uppermost article12of the stack of articles12in the package14. As the package14is removed upwardly, the package14slides between the topmost article12of the stack of articles12and the three upper stops36due to the distance between the topmost article12of the stack of articles12and the three upper stops36.

The three upper stops36each include a beveled portion39that is positioned above the uppermost article12of the stack of articles12in the package14when in the fixing position. The beveled portions39of the three upper stops36facilitate upward sliding of the package14during removal of the package14.

Thus, the package14cut open below the lower stop20by means of the cutting device28can be pulled off (removed) upwardly from the stack of articles12by means of the removal device30. In doing so, the three upper stops36prevent the articles12from being pulled along with the removed package14and lifted off the stack of articles12, for example. In other words, the three upper stops36hold the stack of articles12in place on the lower stop20.

The device10has a waste container40. For sake of a better overview, the waste container40is not shown inFIG.2and is only schematically indicated inFIG.3. The waste container40may serve to receive the cut open package14, the lower end18of the package14and/or any desiccant bag (not shown) present in the package14.

The device10further has an optical detection device42, which in the present case is in the form of a camera43. For sake of a better overview, the detection device42or the camera43is not shown inFIG.2and is only indicated schematically inFIG.3.

By means of the optical detection device42, the position or location of the stack of articles12can be monitored or controlled, particularly when they are resting against the lower stop20.

FIG.4shows a schematic side view of a pharmaceutical plant44.

The pharmaceutical plant44includes the device10disposed within the pharmaceutical plant44. The pharmaceutical plant44includes an ventilation device46disposed above the device10. In the present embodiment, the ventilation device46is disposed within the pharmaceutical plant44.

The ventilation device46is arranged to generate a laminar air flow48. The laminar air flow48is schematically indicated by arrows inFIG.4. The air flow48is thus directed along the direction of gravity15and towards the device10.

The air flow48can blow off particles that may be generated during the cutting of the package14. In this way, particles that may be generated during the cutting of the package14can be prevented from coming into contact with the articles12and thus contaminating them.