Enhanced monitoring method in a drug containers handling line and drug containers handling line thereof

{
  "publication_number": "US11407533B2",
  "country": "US",
  "kind": "B2",
  "title": "Enhanced monitoring method in a drug containers handling line and drug containers handling line thereof",
  "abstract": "A method for reconciliation in a drug filling line includes providing a batch number relating to a predetermined batch of containers to be filled with a drug. Each one of the containers is marked with a unique identifier differentiating and/or identifying each container among others. Each unique identifier is stored and associated with the batch number by a processing and control unit, before starting the filling step of each container. Filled containers are flashed by at least one identifier reader to check correspondence between the batch number being processed and each filled container, in order to validate or reject in real time each container with respect to a predetermined batch being processed by the filling line.",
  "claims": [
    "1. A monitoring method in a drug container handling line comprising the steps of: providing a predetermined batch of containers to be handled along a handling line; providing a batch number relating to the predetermined batch of containers to be handled; providing each one of said containers with a first unique identifier differentiating and/or identifying each container; storing and associating each unique identifier with said batch number by a processing and control unit, before starting a handling step of each container; checking a first weight and scanning one or more of said containers by at least one identifier reader at an inspection station to check correspondence between the batch number being processed and each container to validate or reject in real time each container with respect to a predetermined batch being processed by the drug container handling line; labeling one or more of said containers by applying a second unique identifier differentiating and/or identifying each container, wherein the second unique identifier is inspected by at least one identifier reader; packaging each of said containers at a packaging station; checking a second weight of each of said packaging containers to verify the contents and final weight of each of said packaging containers; and placing each of the verified packaging containers into a storage.",
    "2. The monitoring method in a drug container handling line according to claim 1, wherein, in case of negative check of the correspondence between the batch number and a container, said container is removed from or spaced apart from the drug container handling line.",
    "3. The monitoring method in a drug container handling line according to claim 1, wherein each negative check is communicated, in real time, to the processing and control unit.",
    "4. The monitoring method in a drug container handling line according to claim 1, wherein the steps of scanning containers by at least one identifier reader, validating or rejecting a container are performed in at least two different, spaced apart, spots/stations along the handling line so that intruder containers can immediately be identified when the intruder containers appear, and the spots/stations where containers get stuck are spotted immediately.",
    "5. The monitoring method in a drug container handling line according to claim 1, wherein the steps of scanning containers by at least one identifier reader, validating or rejecting a container are performed in real time and communicated to the processing and control unit, without interrupting the drug handling line.",
    "6. The monitoring method in a drug container handling line according to claim 1, comprising the step of mapping position and the timing of each container along the drug handling line, in correspondence of at least two scanning spots/stations.",
    "7. The monitoring method in a drug container handling line according to claim 1, wherein each unique identifier comprises data relating each container and the drug to be contained therein.",
    "8. The monitoring method in a drug container handling line according to claim 1, wherein said drug container handling line is a drug inspection line, wherein said containers are filled with a drug after being provided with a unique identifier.",
    "9. The method according to claim 1, further comprising the step of embedding the identifier within a wall of a container.",
    "10. The monitoring method according to claim 1, wherein the scanning is performed on all of the containers.",
    "11. The method according to claim 1, wherein the step of scanning containers by at least one identifier reader further comprises the steps of: rotating each container, around a main axis, while scanning each container; scanning each container while rotating each container around said main axis by at least 360 degrees.",
    "12. The method according to claim 11, wherein the scanning is performed by a scanning device scanning an area of the container spaced apart a top or a bottom of the container by a distance of at least one quarter of an overall length of the container, said distance and length being measured along a direction parallel to the main axis.",
    "13. A drug handling line comprising: a processing and control unit, wherein the processing and control unit stores a batch number relating to a predetermined batch of containers to be handled by the handling line; at least one identifier, wherein the at least one identifier is unique for each container and applied to each container, each identifier being stored and associated to a unique container in said processing and control unit; at least one identifier reader placed along the handling line, wherein the at least one identifier reader is configured to read the identifier of each container, wherein the at least one identifier reader is positionable at a plurality of locations within the drug handling line; and a selector configured to perform one of the actions from a group consisting of discarding, rejecting, or blocking a container in case of negative correspondence between the at least one identifier and the batch number relating to the batch being processed in the handling line, wherein the selector is located upstream of a filling station; and a plurality of processing stations, wherein the plurality of processing stations are configured to sterilize and inspect each container by visually scanning each container.",
    "14. The drug handling line according to claim 13, comprising an inspection line having an inspection station.",
    "15. The drug handling line according to claim 13, comprising at least one drug filling station to fill said containers with drug, wherein at least one identifier reader is placed upstream the filling station of the containers, in order to check identifier correspondence of empty containers before being filled with drug.",
    "16. The drug handling line according to claim 13, comprising at least two spaced apart identifier readers, along different stations of the filling line, able to read the identifiers placed on each container, wherein said identifier readers are operatively connected with said processing and control unit.",
    "17. The drug handling line according to claim 13, wherein the at least one identifier reader is positionable downstream of the selector and upstream of the filling station.",
    "18. The drug handling line according to claim 13, further comprising an inspection station downstream of the filling station, a labeling station downstream of the inspection station, and a packaging station downstream of the labeling station, wherein the at least one identifier reader is positionable upstream of the inspection station and downstream of the filling station, wherein the at least one identifier reader is positionable upstream of the labeling station and downstream of the inspection station, wherein the at least one identifier reader is positionable downstream of the packaging station.",
    "19. A method for reconciliation in a drug inspection line comprising the step of: providing a predetermined batch of containers to be handled along a handling line; providing a batch number relating to the predetermined batch of containers to be handled; providing each one of said containers with a unique identifier differentiating and/or identifying each container; sterilizing each of said containers and filling each of said sterilized containers with a drug, at a filling station within the handling line, after each of said sterilized containers is provided with a unique identifier; storing and associating each unique identifier with said batch number by a processing and control unit, before starting a handling step of each container; and scanning and weighing one or more filled sterilized containers with at least one identifier reader at an inspection station, so as to check the correspondence between the batch number being processed and filled container, in order to perform reconciliation, by validating or rejecting in real time each container with respect to a predetermined batch being processed by the drug inspection line.",
    "20. The method according to claim 19, wherein the scanning is performed on all of the containers.",
    "21. A method for reconciliation in a drug filling line comprising the step of: providing a batch number relating to a predetermined batch of containers to be handled; providing each one of said containers with a unique identifier differentiating and/or identifying each container; sterilizing each of said containers and filling each of said sterilized containers with a drug, at a filling station within the drug filling line, after each of said sterilized containers is provided with a unique identifier; storing and associating each unique identifier with said batch number by a processing and control unit, before starting a handling step of each sterilized container; and scanning each of said sterilized containers by using at least one identifier reader, before each of said sterilized containers are filled with a drug, to reconcile the batch number being processed and the unique identifier of each empty sterilized container by validating or rejecting in real time each sterilized container with respect to the predetermined batch of sterilized containers being processed by the drug filling line.",
    "22. The method according to claim 21, wherein the identifier is selected from a group consisting of a tag, a RFID, a 1D barcode, a 2D barcode, a QR code, an ink jet printing, a laser printing, a laser tattooing, or an engraving."
  ],
  "description_excerpt": "This application is a National Stage Application of PCT/IB2018/054507, filed 19 Jun. 2018, which claims the benefit of Serial No. 102017000068513, filed 20 Jun. 2017 in Italy, and which applications are incorporated herein by reference. To the extent appropriate, a claim of priority is made to each of the above-disclosed applications.\n\nThe present invention relates to an enhanced monitoring method in a drug containers handling line and a drug containers handling line thereof.\n\nIn particular, safety of patients taking medicines is a non negotiable aspect of the pharma industry today.\n\nWhen the safety of some drugs is under concern, in relation e.g. to quality issues of the manufactured products, pharma companies make recalls of part of their products.\n\nRecalls of products are usually selective, corresponding to a given period of manufacturing during which a quality issue has been identified a posteriori.\n\nOne nightmare of the pharma industry is to recall only part of the problem=to leave in the market drugs that may still cause adverse effects.\n\nRecalls are made by lot numbers, i.e. in reference to the packaging numbers, because they are the objects facing the end user (the person who is taking the drug).\n\nInside these packagings, there is a drug formulation, which comes from a given*batch*=a large volume of stock (powder or solution) drug, that is fragmented and dispensed or assembled in pill or container format to be used by the patient.\n\nIn order to eliminate the possibility for an incomplete recall, pharma companies are imposing a one to one correspondence between batch numbers and lot numbers.",
  "cpc": [
    "B65B 3/003",
    "A61J 1/00",
    "A61J 2205/10",
    "A61J 2205/60",
    "B65C 9/46",
    "B65G 2203/0216",
    "B65G 43/10",
    "B65G 47/26",
    "G05B 19/4183",
    "G05B 19/4189",
    "G05B 2219/31432",
    "Y02P 90/02",
    "Y02P 90/80"
  ],
  "ipc": [
    "A61J 1/00",
    "B65B 3/00",
    "B65B 57/00",
    "B65C 9/46",
    "B65G 43/10",
    "B65G 47/26",
    "G05B 19/418"
  ],
  "assignees": [
    "Nuova Ompi SRL"
  ],
  "inventors": [
    "Christophe Bureau",
    "Tod URQUHART",
    "Pierre-Emmanuel LETEURTRE"
  ],
  "filing_date": "2018-06-19",
  "publication_date": "2022-08-09",
  "grant_date": "2022-08-09",
  "priority_date": "2017-06-20",
  "application_number": "US-201816624134-A",
  "family_id": "60813889",
  "cited_by_count": 0,
  "citations": [
    "JPS6130366A",
    "JPH06246518A",
    "WO2001063368A2",
    "WO2003038738A1",
    "US20040123567A1",
    "JP2005257493A",
    "US7636044B1",
    "JP2007011658A",
    "JP2007260295A",
    "US20080121537A1",
    "US20140373969A1",
    "US20120153031A1",
    "WO2011108225A1",
    "US8328082B1",
    "US9033006B2",
    "US20180025185A1",
    "WO2013079409A1",
    "US20140330429A1",
    "WO2013111329A1",
    "JP2013156105A",
    "US20160110519A1"
  ]
}