# US 12,179,163 B2 · Safety device for a single-use mixing or storage system > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,179,163 B2 - Document ID: US12179163B2 - Status: Granted - Kind: B2 - Application number: 18/174,988 - Filed: 2023-02-27 - Published: 2023-06-29 - Granted: 2024-12-31 - Earliest claimed: 2020-08-28 - Assignees: Sartorius Stedim Biotech GmbH - Applicants: Sartorius Stedim Biotech GmbH - Inventors: Thomas Dreher; Alexandre Espachs Barroso; Michael Gohs; Alexander Halt; Bjoern Nickel - Web page: https://patentgrep.com/patent/US12179163B2 ## CPC - B01F 35/2113: {Pressure} - B65B 3/003: {Filling medical containers such as ampoules, vials, syringes or the like} - B01F 35/2202: {Controlling the mixing process by feed-back, i.e. a measured parameter of the mixture is measured, compared with the set-value and the feed values are corrected} - B01F 35/2211: {Amount of delivered fluid during a period} - B65B 3/26: Methods or devices for controlling the quantity of the material fed or filled - B65B 57/005: {Safety-devices (B65B57/18 takes precedence)} - B65B 57/145: {for fluent material} - B65B 57/18: causing operation of audible or visible alarm signals - G01L 11/02: by optical means - B01F 2101/22: Mixing of ingredients for pharmaceutical or medical compositions - F17C 5/00: Methods or apparatus for filling containers with liquefied, solidified, or compressed gases under pressures (adding propellants to aerosol containers B65B31/00) - F17C 2203/0685: flexible - F17C 2250/043: Pressure - F17C 2250/0636: Flow or movement of content - B01F: MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING (mixing paints B44D3/06) - B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00) - G01L: MEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE (weighing G01G) - F17C: VESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES (storing fluids in natural or artificial cavities or chambers in the earth B65G5/00; construction or assembling of bulk storage containers employing civil-engineering techniques E04H7/00; variable-capacity gas-holders F17B; liquefaction or refrigeration machines, plants, or systems F25) ## Abstract A safety device for a single-use mixing or storage system (10), especially for use in a biopharmaceutical process, includes a flexible bag (12) made from a film material and a support structure (14) receiving and supporting the bag (12) in several directions. The support structure (14) allows an expansion of the bag (12) in an expansion direction. The safety device further includes a detection unit (20) adapted to detect an expansion of the bag (12) in the expansion direction, and a control unit (28) connected to the detection unit (20) and adapted to initiate a safety measure in response to the expansion of the bag (12) in the expansion direction that exceeds a given threshold. ## Claims ### Claim 1 A safety device for a single-use mixing or storage system for use in a biopharmaceutical process, the safety device comprising: a flexible bag made from a film material, a support structure configured to receive the bag and support the bag in plural directions, wherein the support structure is a container surrounding the bag on all sides except on a top side of the bag, and allows an expansion of the bag in at least one expansion direction including on the top side of the bag, a detection unit adapted to detect the expansion of the bag in the expansion direction, and a control unit connected to the detection unit and adapted to initiate a safety measure in response to a detection of the expansion of the bag in the expansion direction on the top side of the bag that exceeds a given threshold signifying an overfilling of the bag, wherein the detection unit includes a sensor element arranged to come into contact with the bag only during a latter portion of the expansion, when the bag expands so that the sensor element is translated or rotated away from the support structure by the expansion of the bag in the expansion direction on the top side of the bag, and wherein the sensor element includes a pivotable lever. ### Claim 2 (depends on 1) The safety device according to claim 1, wherein the detection unit further includes a trigger element emitting a trigger signal to the control unit in response to the expansion of the bag in the expansion direction exceeding the threshold. ### Claim 3 (depends on 2) The safety device according to claim 2, wherein the trigger element includes a photoelectric sensor. ### Claim 4 (depends on 1) The safety device according to claim 1, wherein the detection unit further includes a trigger element physically performing a switching operation in response to the expansion of the bag in the expansion direction exceeding the threshold. ### Claim 5 (depends on 4) The safety device according to claim 4, wherein the trigger element includes a contact switch. ### Claim 6 (depends on 1) The safety device according to claim 1, wherein the pivotable lever is mounted to the support structure by a mechanical bearing. ### Claim 7 (depends on 5) The safety device according to claim 5, wherein the trigger element includes an angle sensor. ### Claim 8 (depends on 1) The safety device according to claim 1, wherein the control unit is connected to a filling component configured to control a fluid transfer into the bag. ### Claim 9 (depends on 8) The safety device according to claim 8, wherein the filling component comprises a pump configured to control the fluid transfer into the bag. ### Claim 10 (depends on 1) The safety device according to claim 1, wherein the control unit is connected to an alarm system to initiate an audible or visual alarm as the safety measure. ### Claim 11 (depends on 1) A method for increasing safe operation of a single-use mixing or storage system as claimed in claim 1 in a biopharmaceutical process, comprising: providing the single-use mixing or storage system comprising the flexible bag made from the firm material; placing the bag into the support structure of the safety device; filling the bag with a liquid medium; detecting an overfilling expansion of the bag in the expansion direction on the top side of the bag with the detection unit, wherein the sensor element comes into or is in contact with the bag when the bag expands so that the sensor element is translated or rotated away from the support structure by the expansion of the bag in the expansion direction; and initiating the safety measure in response to the detection of the overfilling expansion of the bag in the expansion direction that exceeds the given threshold.