# US 11,027,862 B2 · Cold blow-fill-seal packaging system and process > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,027,862 B2 - Document ID: US11027862B2 - Status: Granted - Kind: B2 - Application number: 14/746,159 - Filed: 2015-06-22 - Published: 2015-12-24 - Granted: 2021-06-08 - Earliest claimed: 2014-06-23 - Assignees: Woodstock Sterile Solutions, Inc. - Applicants: Woodstock Sterile Solutions, Inc. - Inventors: Waiken K. Wong - Web page: https://patentgrep.com/patent/US11027862B2 ## CPC - B65B 3/022: {Making containers by moulding of a thermoplastic material} - B29C 49/04: Extrusion blow-moulding - B65B 3/003: {Filling medical containers such as ampoules, vials, syringes or the like} - B65B 3/10: by application of pressure to material (by screw-type feeders B65B3/08) - B29C 49/42802: {a closure or a sealing foil to the article or pincing the opening} - B29C 49/42808: {Filling the article} - B65B 3/04: Methods of, or means for, filling the material into the containers or receptacles - B65B 2039/009: {Multiple outlets} - B65B 2220/16: Packaging contents into primary and secondary packaging - 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) - B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00) ## Abstract A method and system for cold blow-fill-seal packaging of a product. The method and system are directed to maintaining a relatively cold temperature of the product to be packaged during the flow-fill-seal process. This accomplished via the use of one or more of, for example, a heat-exchanger in the system, insulated flow lines and steps taken during the procedure to maintain the temperature of the product below a certain level. ## Claims ### Claim 1 A method for blow-fill-seal packaging in a blow-fill-seal machine of a heat sensitive product that is subject to denaturing and/or precipitation in the event that the product becomes too warm, said method comprising steps of: forming a container to provide a formed container in a mold of the blow-fill-seal machine; cooling the formed container to a container temperature between 60° C. to 80° C., said cooling step consisting of waiting a duration of from more than one second to about 5 seconds from when the container is formed, filling the formed container with the product after the cooling step, and wherein the container is at a temperature between 60° C. to 80° C. at the start of the filling step and the product employed in the filling step has a temperature between about 0° C. to about 20° C. and immediately after filling the formed container, has a temperature no greater than 40° C.; and sealing the container; wherein the blow-fill-seal (BFS) packaging is a packaging in which in a sterile and pyrogen-free state, formation of a container by blowing an extruded resin, filling of a product in the formed container and sealing of the container are carried out by means of a single mold. ### Claim 2 (depends on 1) The method of claim 1, wherein the product is passed through a heat-exchanger prior to said filling step. ### Claim 3 (depends on 2) The method of claim 2, wherein the heat exchanger is a counter-current heat exchanger. ### Claim 4 (depends on 1) The method of claim 1, wherein the waiting step has a duration of from about 2 to about 5 seconds from when the container is formed. ### Claim 5 (depends on 1) The method of claim 1, wherein the product, immediately after filling the formed container, has a temperature of about 40° C. ### Claim 6 (depends on 1) The method of claim 1, wherein the product, immediately after filling the formed container, has a temperature of less than about 40° C. ### Claim 7 (depends on 1) The method of claim 1, wherein the product, immediately after filling the formed container, has a temperature of less than about 38° C. ### Claim 8 (depends on 1) The method of claim 1, wherein the product, immediately after filling the formed container, has a temperature of less than about 36° C. ### Claim 9 (depends on 1) The method of claim 1, wherein a resin melt parison used to form the container is extruded at a temperature of between about 160° C. to 180° C. ### Claim 10 (depends on 9) The method of claim 9, wherein a flash formed when the mold closes around the parison is at a temperature between about 120° C. to 140° C. ### Claim 11 A system for cold blow-fill-seal packaging of a heat sensitive product that is subject to denaturing and/or precipitation in the event that the product becomes too warm, said system comprising: a holding tank for holding the heat sensitive product that is subject to denaturing and/or precipitation in the event that the product becomes too warm; and a blow-fill-seal machine adapted to: (a) form a container in a mold of the blow fill seal machine to provide a formed container in the mold; (b) cool the formed container in the mold to a temperature between 60° C. to 80° C., by a cooling step consisting of waiting for more than one second to about five seconds once the container is formed, and (c) fill the heat sensitive product into the formed container having the temperature between 60° C. to 80° C. in the mold after cooling the formed container to the temperature between 60° C. to 80° C., and wherein the product, immediately after filling has a temperature no greater than 40° C.; and (d) seal the container; wherein the blow-fill-seal (BFS) machine is a machine in which in a sterile and pyrogen-free state, formation of the container by blowing an extruded resin, filling of the product in the formed container and sealing of the container are carried out by means of a single mold. ### Claim 12 (depends on 11) The system of claim 11, further comprising a buffer tank located between the holding tank and the blow-fill-seal machine and fluidly connected to the flow line. ### Claim 13 (depends on 11) The system of claim 11, wherein the heat exchanger is a counter-flow heat exchanger. ### Claim 14 (depends on 11) The system of claim 11, wherein the flow line is insulated.