Barrier system with handling device for automated sampling and method for automated sampling

{
  "publication_number": "US2024058967A1",
  "country": "US",
  "kind": "A1",
  "title": "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_excerpt": "For microbiological monitoring in e.g., a pharmaceutical production plant, Petri dishes and contact samples are often used. These are plastic dishes filled with nutrient medium (e.g., agar) and fitted with a lid. Petri dishes are used for monitoring the air, and contact samples are used for monitoring surfaces. In order to enable sampling on surfaces, the contact samples are designed in such a way that the nutrient medium protrudes slightly over the edge of the plastic dish (referred to below as the bottom). The two microbiological samples (Petri dishes and contact samples) differ in size and shape, but both are usually supplied in stacks of 10, triple-sterile and packaged in tubular foil bags. The bags containing the microbiological samples are brought into a pharmaceutical production plant for use, where they are unpacked via glove ports or automated. Finally, they are ready for monitoring, e.g., in a magazine. As part of “good manufacturing practice” in pharmaceutical production plants, contact samples are usually taken after the end of production to pick up any microorganisms (such as fungi or bacteria) that may be present on surfaces and to subsequently hatch them in an incubator.\n\nIn currently known pharmaceutical production plants, this process is carried out manually by the operating personnel after the end of production. In a production plant with a barrier system, for example, which can be designed as an isolator, this is done by an operator who uses glove ports to access the plant. The operator removes an unused contact sample from, e.g., a magazine.",
  "cpc": [
    "B25J 9/1682",
    "B25J 11/005",
    "B25J 15/0028",
    "B25J 21/00",
    "B25J 21/005",
    "B25J 9/1653",
    "C12M 23/50",
    "C12M 33/02",
    "C12M 37/06",
    "C12M 41/00",
    "C12Q 1/24",
    "G01N 1/2806",
    "G01N 2001/028"
  ],
  "ipc": [
    "B25J 11/00",
    "B25J 15/00",
    "B25J 21/00",
    "B25J 9/16"
  ],
  "assignees": [
    "SYNTEGON TECH GMBH"
  ],
  "inventors": [
    "ILGENFRITZ MARKUS",
    "KRAUSS ULRICH",
    "NAGLER STEFAN",
    "STEGMEIER SAMUEL"
  ],
  "filing_date": "2023-07-28",
  "publication_date": "2024-02-22",
  "priority_date": "2022-08-16",
  "application_number": "US-202318361382-A",
  "family_id": "87060449",
  "citations": [
    "US2023029276A1"
  ]
}