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1. WO2020109195 - MANUFACTURING A FLEXIBLE CONTAINER

Publication Number WO/2020/109195
Publication Date 04.06.2020
International Application No. PCT/EP2019/082342
International Filing Date 25.11.2019
IPC
A61J 1/10 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
1Containers specially adapted for medical or pharmaceutical purposes
05for collecting, storing or administering blood, plasma or medical fluids
10Bag-type containers
A61J 1/14 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
1Containers specially adapted for medical or pharmaceutical purposes
05for collecting, storing or administering blood, plasma or medical fluids
14Details; Accessories therefor
A61J 1/20 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
1Containers specially adapted for medical or pharmaceutical purposes
05for collecting, storing or administering blood, plasma or medical fluids
14Details; Accessories therefor
20Arrangements for transferring fluids, e.g. from vial to syringe
A61J 1/06 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
1Containers specially adapted for medical or pharmaceutical purposes
05for collecting, storing or administering blood, plasma or medical fluids
06Ampoules or cartridges
CPC
A61J 1/067
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
1Containers specially adapted for medical or pharmaceutical purposes
05for collecting, storing or administering blood, plasma or medical fluids
06Ampoules or carpules
067Flexible ampoules, the contents of which are expelled by squeezing
A61J 1/10
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
1Containers specially adapted for medical or pharmaceutical purposes
05for collecting, storing or administering blood, plasma or medical fluids
10Bag-type containers
A61J 1/1468
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
1Containers specially adapted for medical or pharmaceutical purposes
05for collecting, storing or administering blood, plasma or medical fluids
14Details ; , e.g. provisions for hanging or shape retaining means; Accessories therefor ; , e.g. inlet or outlet ports, filters or caps
1468Containers characterised by specific material properties
A61J 1/1475
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
1Containers specially adapted for medical or pharmaceutical purposes
05for collecting, storing or administering blood, plasma or medical fluids
14Details ; , e.g. provisions for hanging or shape retaining means; Accessories therefor ; , e.g. inlet or outlet ports, filters or caps
1475Inlet or outlet ports
A61J 1/2024
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
1Containers specially adapted for medical or pharmaceutical purposes
05for collecting, storing or administering blood, plasma or medical fluids
14Details ; , e.g. provisions for hanging or shape retaining means; Accessories therefor ; , e.g. inlet or outlet ports, filters or caps
20Arrangements for transferring ; or mixing; fluids, e.g. from vial to syringe
2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
202Separating means
2024having peelable seals
A61J 1/2093
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
1Containers specially adapted for medical or pharmaceutical purposes
05for collecting, storing or administering blood, plasma or medical fluids
14Details ; , e.g. provisions for hanging or shape retaining means; Accessories therefor ; , e.g. inlet or outlet ports, filters or caps
20Arrangements for transferring ; or mixing; fluids, e.g. from vial to syringe
2093Containers having several compartments for products to be mixed
Applicants
  • F. HOFFMANN-LA ROCHE AG [CH]/[CH] (AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BE, BF, BG, BH, BJ, BN, BR, BW, BY, BZ, CA, CF, CG, CH, CI, CL, CM, CN, CO, CR, CU, CY, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, FR, GA, GB, GD, GE, GH, GM, GN, GQ, GR, GT, GW, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KE, KG, KH, KM, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LT, LU, LV, LY, MA, MC, MD, ME, MG, MK, ML, MN, MR, MT, MW, MX, MY, MZ, NA, NE, NG, NI, NL, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SI, SK, SL, SM, SN, ST, SV, SY, SZ, TD, TG, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, UZ, VC, VN, ZA, ZM, ZW)
  • HOFFMANN-LA ROCHE INC. [US]/[US] (US)
Inventors
  • LEMA MARTINEZ, Carmen
  • LUEMKEMANN, Joerg
  • WERK, Tobias
  • ZUMSTEIN, Thomas
  • KULLMANN, Daniel
Agents
  • LATSCHA, Silvan
Priority Data
18208318.826.11.2018EP
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) MANUFACTURING A FLEXIBLE CONTAINER
(FR) FABRICATION D'UN CONTENANT SOUPLE
Abstract
(EN)
A method of manufacturing a flexible container (1) housing a drug substance, comprises: forming a first compartment (11) of the container (1) out of a flexible sheet-like material, filling a liquid (2) into the first compartment (11) of the container (1), sealing the first compartment (11), forming a second compartment (12) of the container (1) out of the flexible sheet-like material, filling a dry drug formulation (3) into the second compartment (12), and sealing the second compartment (12). The method further involves lyophilizing the drug formulation inside a tubular cartridge such that the dry drug formulation (3) is generated and held in the tubular cartridge, wherein filling the dry drug formulation (3) into the second compartment (12) comprises: introducing the tubular cartridge holding the dry drug formulation (3) through an opening of the second compartment (12) of the container (1) such that an open end of the tubular cartridge is positioned distant from the opening of the second compartment (12), providing the dry drug formulation (3) out of the open end of the tubular cartridge into the second compartment (12), and withdrawing the tubular cartridge out of the opening of the second compartment (12) of the container (1). The first compartment (11) is separated from the second compartment (12) by a frangible seal (14) which opens when the first compartment (11) is compressed.
(FR)
Un procédé de fabrication d'un contenant souple (1) recevant une substance médicamenteuse comprend : la formation d'un premier compartiment (11) du contenant (1) à partir d'un matériau stratiforme souple, le remplissage d'un liquide (2) dans le premier compartiment (11) du contenant (1), le scellage du premier compartiment (11), la formation d'un second compartiment (12) du contenant (1) à partir du matériau stratiforme souple, le remplissage avec une formulation de médicament sec (3) du second compartiment (12), et le scellage du second compartiment (12). Le procédé comprend en outre la lyophilisation de la formulation de médicament à l'intérieur d'une cartouche tubulaire de telle sorte que la formulation de médicament sec (3) est générée et conservée dans la cartouche tubulaire, le remplissage de la formulation de médicament sec (3) dans le second compartiment (12) comprend : l'introduction de la cartouche tubulaire contenant la formulation de médicament sèche (3) à travers une ouverture du second compartiment (12) du contenant (1) de telle sorte qu'une extrémité ouverte de la cartouche tubulaire est positionnée à distance de l'ouverture du second compartiment (12), la fourniture de la formulation de médicament sec (3) hors de l'extrémité ouverte de la cartouche tubulaire dans le second compartiment (12), et le retrait de la cartouche tubulaire hors de l'ouverture du second compartiment (12) du contenant. Le premier compartiment (11) est séparé du second compartiment (12) par un joint cassable (14) qui s'ouvre lorsque le premier compartiment (11) est comprimé.
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