BARRIER SYSTEM WITH HANDLING DEVICE FOR AUTOMATED SAMPLING AND METHOD FOR AUTOMATED SAMPLING

Abstract

A barrier system of a production plant, in particular a pharmaceutical production plant, with a closed or separate area in which a sterile environment is provided, wherein a handling device for automated sampling with a contact sample is arranged in the closed or separate area, as well as methods for automated sampling.

Claims

1. Barrier system (10), in particular isolator (10), of a, in particular pharmaceutical, production plant (12), having a closed or separate region (14) in which a sterile environment (16) is provided, characterized in that in the closed or separate region (14), a handling device (20) and a contact sample holder (22) are arranged, wherein the contact sample holder (22) is configured to provide at least one contact sample (24), and wherein the handling device (20) is configured to automatically remove, open and automatically perform sampling on a surface section (42) in the closed or separated area (14) in a reproducible manner.

2. Barrier system (10) according to claim 1, characterized in that said handling device (20) is configured to directly grip said contact sample (24) during sampling.

3. Barrier system (10) according to claim 1, characterized in that the handling device (20) is configured to feed the contact sample (24) to a sample carrier (40) after removal and to move the sample carrier (40) during sampling.

4. Barrier system (10) according to claim 1, characterized in that the handling device (20) comprises a gripper (36) with two gripper jaws (38) which are movable towards and away from each other, in particular wherein the gripper (36) is arranged on a gripper member (34) of the handling device (20) which is pivotable by at least 90, in particular by 180, in particular by 360.

5. Barrier system (10) according to claim 3, characterized in that the contact sample holder (22) comprises a holder (23) for the sample carrier (40).

6. Barrier system (10) according to claim 1, characterized in that the contact sample holder (22) is configured to receive a plurality of contact samples (24) and the contact samples (24) can be arranged horizontally in the contact sample holder (22).

7. Barrier system (10) according to claim 1, characterized in that it comprises a detection device (46) configured to detect an identification feature (48) of the contact sample (24), and in particular to associate the identified contact sample (24) with the time and/or location of a sampling.

8. Barrier system (10) according to claim 7, characterized in that the detection device (46) comprises a bar code reader, a DataMatrixCode reader, a plain text code reader or RFID reader, which is configured to read a corresponding code or an information on a contact sample (24) or a data carrier, on the contact sample (24), in particular a RFID chip.

9. Barrier system (10) according to claim 7, characterized in that the detection device (46) is configured to detect the location and/or the time of a sample extraction, in particular wherein the barrier system (10) comprises a data processing system (54) which is configured to associate the location and/or the time of the sample extraction in a data record with the identification feature (48) of the contact sample (24).

10. Barrier system (10) according to claim 1, characterized in that the barrier system (10) is designed to be glove-port-free.

11. Method for automated sampling in a closed or separate area (14) of a barrier system (10), in particular isolator (10), of a, in particular pharmaceutical, production plant (12), wherein a sterile environment (16) is provided in the closed or separate area (14), characterized in that at least one handling device (20) is arranged in the closed or separate area (14), a contact sample (24) is provided in the closed or separated area (14), and the handling device (20) grasps the provided contact sample (24), opens it and carries out sampling on a surface section (42), which is arranged in particular on a static or movable element, in the closed or separated area (14).

12. Method according to claim 11, characterized in that the handling device (20), after the grasp, places the contact sample (24) on a sample carrier (40), which holds the contact sample (24), in particular in a force-locking and/or form-locking manner, opens the contact sample (24), and, for sampling, grips the sample carrier (40) and moves the sample carrier (40) with the contact sample (24) held thereon to a surface section (42) in the closed or separated area (14) and carries out the sampling.

13. Method according to claim 11, characterized in that during sampling the handling device (20) orients the contact sample (24) or the sample carrier (40) with the contact sample (24) held thereon in such a way that a sample surface (31) of the contact sample (24) is aligned parallel to the surface (43) of the sampled surface section (42) and is pressed against the latter, in particular with defined pressure and for a defined duration.

14. Method according to claim 11, characterized in that the handling device (20) closes the contact sample (24) after sampling.

15. Method according to claim 11, characterized in that the handling device (20) feeds the contact sample (24) to a detection device (46) before or after sampling, and the detection device (46) detects an identification feature of the contact sample (24), in particular wherein the identification feature (48) is assigned to a sampling, in particular to its time and/or location.

16. Method according to claim 11, characterized in that the handling device (20) removes the contact sample (24) from a contact sample holder (22) before sampling and/or feeds it to a contact sample holder (22) after sampling.

17. Method for automated sampling in a closed or separate area (14) of a barrier system (10), in particular isolator (10), of a production plant (12), in particular a pharmaceutical production plant (12), wherein a sterile environment (16) is provided in the closed or separate area (14), characterized in that at least two handling devices (20) are arranged in the closed or separate area (14), a contact sample (24) is provided in the closed or separate area, and wherein the method comprises the following steps: one of the handling devices (20) grasps the provided contact sample (24), one of the handling devices (20) opens the provided contact sample (24), one of the handling devices (20) performs sampling with the contact sample (24) on a surface portion (42) in the closed or separated area (14), wherein the method optionally comprises one or more of the following steps: closing the contact sample (24) after the sampling, placing the contact sample (24) after the grasp on a sample carrier (40) which holds the contact sample (24), in particular in a force-locking and/or form-locking manner, gripping the sample carrier (40) for sampling and moving the sample carrier (40) with the contact sample (24) held thereon to a surface section (42) in the closed or separated area (14) and subsequently carrying out the sampling, wherein each of the handling devices (20) carries out at least one of the steps of the method.

18. Method according to claim 11, characterized in that after a first production interval a first sampling is performed with first sampling parameters and that after a second production interval a second sampling is performed with second sampling parameters, wherein the first and second sampling parameters comprise at least one, in particular several, identical sampling parameters, in particular wherein the sampling parameters are identical, in particular wherein the sampling parameters comprise one or more of the following parameters: sample contact pressure, sample contact duration, sampling location.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0058] The invention is explained in more detail below with reference to the accompanying figures. They show:

[0059] FIG. 1 a schematically illustrated production plant with a closed or separated area;

[0060] FIG. 2 a contact sample in a sectional view;

[0061] FIG. 3 a handling device in a perspective view;

[0062] FIG. 4 another perspective view of the handling device with a sample carrier;

[0063] FIG. 5 the handling device with a contact sample holder in a further perspective view;

[0064] FIG. 6 the handling device in a further perspective view;

[0065] FIG. 7 a side view of the handling device during sampling;

[0066] FIG. 8 a perspective view of the handling device during sampling;

[0067] FIG. 9 a contact sample on a sample carrier;

[0068] FIG. 10 a sample carrier with a contact sample; and

[0069] FIG. 11 a schematically illustrated production plant with a closed or separate area in which two handling devices are arranged that can carry out sampling based on the division of work.

DETAILED DESCRIPTION

[0070] FIG. 1 shows a pharmaceutical production plant 12 with a barrier system 10 comprising a closed or separated area 14. The barrier system 10 is designed as an isolator 10. A sterile environment 16 is provided in the closed or separated area 14 of the isolator 10.

[0071] Within the enclosed or separated area 14 is a handling device 20 and a contact sample holder 22. The contact sample holder 22 is configured to provide at least one contact sample 24 as illustrated in FIG. 2. In the present embodiment, the shown contact sample holder 22 is configured to receive a plurality of contact samples 24, and the contact samples 24 are horizontally arrangeable in the contact sample holder 22. As shown in detail in FIG. 2, the contact sample 24 includes a bottom 26 and a lid 28. A nutrient medium 30, typically agar, is disposed on the bottom 26 and closed by the lid 28. An identification feature 48 is further disposed on the bottom 26, which may be, for example, a QR code (data matrix code, or bar code, or information in a RFID chip). The identification feature 48 is typically located on the outer jacket surface of the bottom 26. The lid 28 is removable so as to expose a sample surface 31 of the contact sample 24 or nutrient medium 30.

[0072] The handling device 20 is configured to remove the provided contact sample 24 from the contact sample holder 22, to open it and to perform a sampling on a surface section 42 in the closed or separated area 14. The surface section 42 to be sampled is thereby arranged on a sample location 50, which is configured to enable reproducible sampling.

[0073] The handling device 20 is designed to be able to directly grip the contact sample 24 during sampling. For this purpose, the handling device 20 has a gripper 36 with gripper jaws 38, as can be seen clearly in FIG. 3. The gripper 36 is arranged on a 3600 pivotable gripper member 34 of the handling device 20. The handling device 20 has a plurality of pivotally interconnected members 32 to allow the gripper to move freely in space.

[0074] As shown in FIG. 5, the contact sample holder 22 may include a holder 23 for a sample carrier 40. Although the handling device 20 can directly grasp the contact sample 24 via the gripper 36, it can also use the sample carrier 40 for sampling.

[0075] The handling device 20 is appropriately configured to feed the contact sample 24 to the sample carrier 40 after removal from the contact sample holder 22 (see FIGS. 5 and 6), and to move the sample carrier 40 during sampling (see FIGS. 7 and 8). The sample carrier will be explained in further detail below.

[0076] The barrier system 10 includes a detection device 46 configured to detect an identification feature 48 of the contact sample 24. The detection device 46 typically includes or is a bar code reader or a DataMatrixCode reader. Accordingly, the identification feature 48 may be a corresponding code (bar code or DataMatrixCode) on a contact sample 24. The contact sample 24 may also include a RFID chip having the identification feature 48, such that the identification feature 48 is provided as information on the RFID chip in a readable manner.

[0077] The detection device 46 is connected to a data processing system 54 via a data link 56, which may be wired or wireless. The data processing system 54 may associate the identified contact sample 24 (recognized by its identification feature 48) with the time and/or location of a respective sampling, for example, storing it as a corresponding data record. The detection area 52 of the detection device 46 may include the range of movement of the handling device 20, or the contact sample 24 may be moved into the detection area 52 of the detection device 46 with its identification feature 48.

[0078] Since the steps required for sampling are automated in the production plant 12, the barrier system 10 can be designed to be glove-port-free.

[0079] According to the invention, there is also a method for automated sampling in the closed or separated area 14 of the barrier system 10. Here, as in the production plant 12 according to the invention, at least one handling device 20 is arranged in the closed or separated area 14. In the closed or separated area 14, the method involves providing the contact sample 24, and the handling device 20 grasps (FIG. 6) the provided contact sample 24, opens it by removing the lid 28 of the contact sample 24, and performs a sampling on a surface portion 42 in the closed or separated area 14.

[0080] In FIG. 7, the sampling is shown, whereby the contact sample 24 has been placed on the sample carrier 40 by means of the handling device 20.

[0081] The sample carrier 40 holds the contact sample 24 in a force-locking (variant FIGS. 4 to 8) and/or form-locking (variant FIGS. 9 and 10) manner. The form-locking is achieved via several fastening fingers 44, which are shown in FIGS. 9 and 10. The fastening fingers 44 are arranged evenly distributed in the circumferential direction around a contact surface 45. The contact surface 45 is designed in such a way that the contact sample 24 can be placed flat thereon. The contact sample 24 can be held in a force-locking manner via a suction opening 58 or an adhesive surface 60, which can be formed, for example, as a microstructured polymer film. The suction opening 58 is connected to a connection 64 for a vacuum supply via a pressure line that runs in the sample carrier 40.

[0082] The handling device 20 opens the contact sample 24, which is held on the sample carrier 40. For sampling, it grasps the sample carrier 40 and moves the sample carrier 40 with the contact sample 24 held on it to the surface section 42 in the closed or separated area 14 and performs sampling by pressing the nutrient medium against a surface 43 of the sampled surface section 42.

[0083] During the sampling, the handling device 20 orients the contact sample 24 or the sample carrier 40 with the contact sample 24 held on it in such a way that a sample surface 31 of the contact sample 24 is aligned parallel to the surface 43 of the sampled surface section 42 and is pressed against it, in particular with defined pressure and for a defined duration.

[0084] After the sampling, the handling device 20 reseals the contact sample 24 by placing the lid on it.

[0085] The handling device 20 feeds the contact sample 24 to the detection device 46 before or after sampling, and the detection device 46 detects the identification feature 48 (see FIG. 9) of the contact sample 24. After sampling and detection of the identification feature 48, the handling device 20 feeds the contact sample 24 back to the contact sample holder 22.

[0086] FIG. 11 illustrates a barrier system 10 with two handling devices 20. The handling devices 20 operate alternately and perform different steps required for sampling. The first of the two handling devices 20 grasps the provided contact sample 24. The second of the two handling devices 20 opens the provided contact sample 24, i.e. removes its lid 28 the first handling device 20 places the contact sample 24 on a sample carrier 40, the second handling device 20 grips the sample carrier 40 and performs sampling with the contact sample 24 on the surface section 42 in the closed or separated area 14. After sampling, the first handling device 20 reseals the contact sample 24 by placing the lid 28 on it. Thereafter, the second handling device 20 places the contact sample 24 back into the contact sample holder 22. The individual steps can also be performed by the respective other handling device 20, but each of the handling devices 20 performs at least one of the steps of the method. This relates to the process variant according to the invention with two handling devices.