EP3624860A1

EP3624860A1 - Method and apparatus for sterilizing an article by means of a pulsed light source

Info

Publication number: EP3624860A1
Application number: EP18725736.5A
Authority: EP
Inventors: Mirko EBELING
Original assignee: Ebetech GmbH
Current assignee: Ebetech GmbH
Priority date: 2017-05-18
Filing date: 2018-05-07
Publication date: 2020-03-25
Also published as: DE102017004752A1; WO2018210445A1; US20210154341A1

Abstract

The invention relates to a method and an apparatus for sterilizing an article for a pharmaceutical or cosmetic application in a decontaminated environment, wherein the article is transported from a first region (11) into a second region (12) through a lock (16) and, after the sterilization has been carried out, said article is transported on into a third region (13) through a further lock (17) for further handling. The invention is characterized in that the article is completely irradiated from all sides by pulsed light in the second region (12) for sterilization purposes.

Description

Method and device for sterilizing an object by means of a pulsed light source

description

The invention relates to a method for sterilizing an article for a pharmaceutical or cosmetic application according to the preamble of claim 1. Furthermore, the invention relates to a device for sterilizing an article for a pharmaceutical or cosmetic application according to the preamble of claim 8.

In the manufacture of pharmaceutical and cosmetic products, the highest demands are placed on the cleanliness and sterility not only of the articles used, such as, for example, packaging, containers, syringes, vials and the like, but also on the means for handling the articles. Even the smallest amount of microorganisms and / or germs, which has deposited, for example, in a syringe for pharmaceutical use, can lead to serious damage to health. The same applies to the infestation of a packaging for such items by germs. For example, contamination of a package or the like may result in contamination of the packaged article due to cross-contamination.

Methods and techniques and devices for sterilizing pharmaceutical and cosmetic articles are known in which the articles are exposed to, for example, a gas such as hydrogen peroxide. By "flushing" the objects with hydrogen peroxide at least a majority of all germs can be killed, however, the expense of building a hydrogen peroxide atmosphere in a treatment chamber and venting the chamber in which the sterilization

CONFIRMATION COPY takes place, very time and cost intensive. In addition, areas where the objects are held by a holding means during sterilization or stand areas are not lapped by the gas. Furthermore, it is known to irradiate objects to be sterilized with an e-beam. The object is specifically exposed to electrons, which kill germs by their ionizing effect. However, since the safety outlay for operating such a device is very high in this method, this method of sterilization is also particularly complicated and expensive.

Based on this, the object of the invention is to provide a method and a device for sterilizing an article, by means of which an article can be sterilized in a particularly simple and favorable manner.

A method for achieving this object comprises the measures of claim 1. Accordingly, it is provided for sterilizing an article, in particular a tub, for a pharmaceutical or cosmetic application in a decontaminated environment, to transport the object from a first area to a second area in which the sterilization takes place. In a third area, a further manufacturing process, such as, for example, feeding the article, can be carried out by further means. The different areas are separated by locks. In the second region, the article for sterilization is irradiated completely from all sides by light, or pulsed electromagnetic waves from a source of light or radiation, whereby the article in the second region is automatically gripped by a robot arm at least once, by the robot arm is aligned and set down again at least once relative to the light source for irradiation and the object is gripped by the robot arm several times at different positions, aligned relative to the light source and set down again until the object has been completely exposed to light from the light source and after irradiation and a settling of the object by a robot arm and before re-grasping the object or another object of the robot arm are also sterilized by the light source. The fact that the object is irradiated from all sides, forms no shadow in which germs could survive. By using a light source which preferably emits light of the visible spectral optical range, no increased security measures are required for the use of this light source. The application of light to the object, in particular of the visible optical spectral range, is also particularly simple and fast, since it is not first necessary to produce a predetermined concentration of a gas in the second region. By using the pulsed light or the pulsed electromagnetic radiation for sterilization can thus be realized a particularly simple and inexpensive way of sterilizing an object. After the article has first been gripped by the robotic arm and variously oriented relative to the light source for irradiation, the article is dropped off again to be gripped again at a different position, so that the areas where the article previously grasped by the robot arm were able to be charged with light. In this way, the article can be fully exposed to light for sterilization. Therefore, there are no areas where germs can survive.

Preferably, it is further provided that the object in the second area at least once automatically gripped by a robot arm, is aligned by the robot arm for irradiation depending on the shape of the object several times relative to the light source and set down again. After the article has been transported through the sluice from the first region to the second region, the article is fully automatically gripped by a robotic arm and aligned relative to the light source, which is located inside or outside the second region, so that the article is as complete as possible Light is applied. After the first irradiation of the object by the light source or by the radiation, the object is reoriented by a robotic arm so that previously lying in the shadow areas of the object can also be reached by a further irradiation. After completion of the irradiation, the object is again deposited by the robot. Because in the As a rule, the same objects are always irradiated, the robot arm can fully automate the sterilization of the object in interaction with the light source. In the event that another object is to be sterilized, the robotic arm can be reprogrammed in a known manner to provide light to this object to a sufficient extent.

A further advantageous embodiment of the present invention can provide that the object is irradiated by the light source in dependence on application and contamination of the object with light pulses of different rate, pulse duration, intensity, energy and / or repetition rate. For example, it may be provided that pharmaceutical products are subjected to a higher intensity, pulse duration, energy or repetition rate of the light pulses than articles for a cosmetic application. Likewise, it is conceivable that products which can react sensitively to light or electromagnetic radiation themselves are exposed to a lower intensity of light. In these cases, it is conceivable that the pulse duration or rate may be increased to ensure that at least a majority of all germs have been hit. For particularly heavily contaminated or contaminated articles, special treatment by light may also be envisaged. The values for these properties of the light pulse are manually adjustable or are automatically selected by a control unit when detecting the object. By this automated adjustment of the quality or quantity of irradiation, a sufficient irradiation of the objects can be ensured.

Furthermore, it can be inventively provided that after irradiation and settling of the article by a robot arm and before re-grasping the article or another object gripping means of the robot arm are also sterilized by the light source. For gripping the object, the robot arm on gripping means, which may be formed, for example, as a gripper, suction cups or electromagnets. Before grasping an object and the gripping surfaces of this gripping means by the Light source subjected to the sterilizing light, so that no germs can fix here. By sterilizing the gripping means thus cross contamination between the robot arm and the objects is avoided. The exposure of the gripping means to the light can be done depending on the type of gripping means. Thus, for example, the gripping means from different directions can be acted upon by appropriate alignment of the robot arm with the light.

Furthermore, it can be provided that a pressure gradient, in particular a pressure cascade, is established between the various areas through the locks. Through this pressure cascade, it can be ensured that no contamination is sucked into the area in which the sterilization takes place. By maintaining an overpressure in the second area over the other areas, all foreign matter can be forced out of the second area. The second region may be, for example, an insulator which is decontaminated after completion of sterilization of a batch of articles, for example with hydrogen peroxide. To check whether a sufficient decontamination has taken place, for example, bioindicators can be supplied to the second area, which detect a residual contamination. Furthermore, to check the quality of the electromagnetic radiation or of the light at a regular distance, a bioindicator, which is exposed to germs, can be exposed to the light. By observing the development of the irradiated germs, it can be determined whether the light source still has enough power to kill the germs.

In particular, the present invention may provide that the articles are tubs for receiving glass containers. The tubs are unpacked in the first area, sterilized in the second area, preferably an insulator, and after being unpacked in a third area, the glass containers are subjected to an agent for pharmaceutical or cosmetic use. The tubs can be tray or carton-type objects whose opening is closed by, for example, a foil. However, it is also conceivable that any other Articles for pharmaceutical or cosmetic use are sterilized by the described method.

An apparatus for solving the above-mentioned problem has the features of claim 8. Accordingly, a device for sterilizing an article for a pharmaceutical or cosmetic application is provided with a decontaminated chamber, with sluices for introducing and discharging the article into and out of the chamber and with a transport means for transporting the article into and out of the chamber. In this case, the chamber is associated with a light or radiation source for pulsed light or pulsed electromagnetic waves, which is designed for sterilizing and complete irradiation of the object. Due to the pulsed light, all germs on the object can be killed. Due to the irradiation from all sides, there are no shadows on the irradiation where the germs could survive. As a result of this irradiation of the objects with light, complete sterilization of the objects can thus be achieved in a simple and favorable manner. Preferably, the present invention may provide that a robotic arm is positioned in the chamber for gripping the article, orienting the article relative to the light source, and depositing the article, wherein the sample is repeatedly graspable, alignable, and in the chamber for complete irradiation is deductible. The robot arm is controlled by a control device. Depending on the type and shape of the object, as well as the position of the light source and the type of light source, the robot arm can be programmed in such a way that the entire object can be sterilized by the light. The robotic arm may have a plurality of axes to accomplish any movement necessary to align the article relative to the light source. The robotic arm also meets all the requirements for working in a sterile environment. The light source can be placed either in the chamber for sterilization or outside the chamber. In the event that the light source is placed outside the chamber, a transparent window pane should be used, 0

7 which absorbs the light to sterilize the object only to a small extent.

For gripping the object, the robot arm is assigned an effector or a gripping means, which can be designed as a gripper, as a suction cup or as a magnet.

After the article, after possibly several irradiation cycles, is deposited by the robot arm, the article can be discharged through a transport, preferably a conveyor belt, through the lock and fed to another chamber. It is also conceivable that after completion of the irradiation, the lock is opened and the object is placed by the robot arm directly into the subsequent chamber. Preferably, the present invention can also provide that the object can be irradiated by the light source as a function of application and contamination of the object with light pulses of different rate, pulse duration, intensity, energy and / or repetition rate. The quality and the quantity of light or radiation can be adjusted by the control device. The choice of the various parameters for the light can be adjusted manually at the control device or automated by the control device.

A preferred embodiment of the invention will be explained in more detail with reference to the drawing. These show:

Fig. 1 is a perspective view of a device for sterilizing a

2, a further perspective view of the device according to FIG. 1, a view of the device according to FIG. 1, FIG.

Fig. 4 is a sectional view through the device according to FIGS. 1, and Fig. 5 is a view of the device according to FIG. 1 without housing.

For sterilizing articles for a pharmaceutical or cosmetic application, the same are passed through a device 10 and subjected to pulsed light according to the invention.

In the embodiments illustrated in FIGS. 1 to 4, the device 10 for sterilizing objects consists of a first region 11, a second region 12 and a third region 13 (FIG. 4). These three areas 11, 12, 13 can each be designed as closed chambers. For example, it is provided that the second chamber is designed as an insulator, which can be decontaminated by appropriate cycles. While the first region 11 and the second region 12 each have a conveyor belt 14, a tray 15 is centrally provided in the second region 12 for at least short-term storage of the article. Between the first region 11 and the second region 12 as well as between the second region 12 and the third region 13, a lock 16, 17 is provided, which hermetically separate the second region 12 from the first region 11 and the third region 13.

According to the invention, a robot arm 23 is assigned to the middle region 12. With this robot arm 23 of the object to be sterilized is manageable. Furthermore, the second area 12 is associated with a light or radiation source, not shown. This light source may be arranged either in the region 12 or outside the region 12. In the case where the light source is arranged outside the second region 12, the source is arranged on a door 18 to the second region 12 in such a way that the light resp The electromagnetic waves of the light source can radiate through a window 19 in the inner region of the second region 12. In this case, the window 19 has a high transmission rate for the light or the corresponding electromagnetic radiation of the light source. Both the robot arm 23 and the light source can be controlled by a control device. The control can be done manually by an input device 20 or automated by the controller. Furthermore, the device 10 has additional means for ventilating the various areas 11, 12, 13, as well as two further locks 21, 22 for feeding the first area 11 or for dispensing the object from the third area 13 The device shown in FIG. 1 is housed in a compact, box-like frame with a housing 24. However, it is also conceivable that the device 10 is integrated in a further system or consists of zusammenflanschbaren items. For sterilizing the article, not shown, this is supplied through a lock 21 to the first region 11. There, the still packaged item can be unpacked, for example. In the following, the lock 16 opens and the robot arm 23 removes the object from the first area 11, in order to then align it relative to the light source for the irradiation. After the pulse-like irradiation has taken place, the orientation of the object relative to the light source can be changed by the robot arm 23, so that also previously shaded area of the object can be exposed to the light. Once in this way the entire surface of the article has been irradiated, the article can be placed on the tray 15 and the gripping means of the robot arm 23 are also sterilized by the light source. The then sterilized gripping means of the robot arm 23 then again grasp the object, namely at positions which have already been sterilized by the application of light. Subsequently, the areas are then sterilized by the light source, where previously the gripping means of the robot arm 23 have set. In the next step, the lock 17 is opened to the third area 13, whereupon the robot arm 23 deposits the object on the conveyor belt 14 in the third area 13. In order to prevent contamination of the second area 12 during the inflow and outflow, an overpressure prevails in this second area 12 in relation to the areas 11 and 13, so that air from the second area 12 in FIG the areas 1 1 and 13 is pressed and contamination is prevented. After the sterilized article has been deposited in the third region 13, the lock 17 closes and the article is ready for a further process step.

In Fig. 5, the device for illustrative purposes without housing 24 is shown. The robot arm 23, which is arranged in the second region 12, or in the middle chamber, has gripped by means of its gripping means a tube 25 for receiving further objects and directs this relative to the light source, not shown. Due to the plurality of axes of the robot arm 23, the same can be moved in all necessary positions relative to the light source. Further tubs 25 are located on the conveyor belts 14 in the areas 11 and 13 and on the shelf 15. At regular intervals, the second area 12, or the insulator, by decontamination with, for example, hydrogen peroxide decontaminated. To check the degree of contamination or decontamination, a bioindicator can be supplied to the second area 12. Similarly, at regular intervals, the radiant power of the light source should be checked by means of a bio-indicator.

It is expressly understood that the present invention is not limited to the embodiment shown in the drawings. Rather, it is envisaged that the invention can also be realized by other embodiments.

***** LIST OF REFERENCE NUMBERS

10 device

11 first area

12 second area

13 third area

14 conveyor belt

15 storage

16 locks

17 lock

18 door

19 windows

20 input device

21 lock

22 lock

23 robotic arm

24 housing

25 tub

Claims

claims

A method of sterilizing an article, particularly a tub (25), for a pharmaceutical or cosmetic application in a decontaminated environment, the article being transported through a sluice (16) from a first region (11) to a second region (12) is and after sterilization for further handling by a further lock (17) in a third area (13) is further transported, characterized in that the object in the second area (12) for sterilization completely from all sides with pulsed light or electromagnetic Waves of a light source or radiation source is irradiated, wherein the object in the second region (12) at least once automatically grabbed by a robot arm (23), is aligned by the robot arm (23) for irradiation at least once relative to the light source and discontinued and the The subject of the robot arm (23) seized several times at different positions is aligned relative to the light source and set down again, until the object has been completely exposed to the light or electromagnetic waves of the light source and wherein after irradiation and settling of the object by the robot arm (23) and before re-grasping the object or another object of the robot arm (23) are also sterilized by the light source.

A method of sterilizing an article according to claim 1, characterized in that the article in the second region (12) is automatically gripped at least once by a robotic arm (23) from the robotic arm (23) for irradiation depending on the shape of the article repeatedly aligned relative to the light source and set down again.

A method of sterilizing an article according to claim 2, characterized in that the article is received from the robot arm (23). seized several times at different positions, is aligned relative to the light source and lowered again, until the object has been completely exposed to the light of the visible optical spectral range of the light source.

4. Method for sterilizing an article according to one of the preceding claims, characterized in that the object is irradiated by the light source in dependence on application and contamination of the article with light pulses of different rate, pulse duration, intensity, energy and / or repetition rate.

5. A method for sterilizing an article according to any one of the preceding claims, characterized in that after irradiation and settling of the article by the robot arm (23) and before re-grasping the article or another object gripping means of the robot arm (23) also by the light source can be sterilized.

6. A method for sterilizing an article according to one of the preceding claims, characterized in that between the various areas through the locks (16, 17), a pressure gradient, in particular a pressure cascade is constructed.

A method of sterilizing an article according to any one of the preceding claims, characterized in that the articles are tubs (25) for accommodating glass containers which unpacks the tubs (25) in the first region (1 1) the second area (12), preferably an insulator, sterilized and wherein the automatically unpacked glass containers are applied in a third area (13) with a means for pharmaceutical or cosmetic application.

8. Device (10) for sterilizing an article for a pharmaceutical or cosmetic application with a decontaminated chamber, with locks (16, 17) for introducing and discharging the article in or out of the chamber and with a means of transport for Transporting the object in and out of the chamber, characterized in that the chamber is assigned a light source for pulsed light or for pulsed electromagnetic waves for sterilizing and complete irradiation of the object from all sides.

An apparatus (10) for sterilizing an article according to claim 8, characterized in that a robotic arm (23) is positioned in the chamber for gripping the article, orienting the article relative to the light source and depositing the article, the sample being in the chamber is repeatedly graspable, alignable and settable for complete irradiation.

10. An apparatus (10) for sterilizing an article according to claim 8 or 9, characterized in that the object can be irradiated by the light source in dependence on application and contamination of the article with light pulses of different rate, pulse duration, intensity, energy and / or repetition rate.