EP4151542A2 - Système de protection d'aiguille de remplissage - Google Patents

Système de protection d'aiguille de remplissage Download PDF

Info

Publication number
EP4151542A2
EP4151542A2 EP22382830.2A EP22382830A EP4151542A2 EP 4151542 A2 EP4151542 A2 EP 4151542A2 EP 22382830 A EP22382830 A EP 22382830A EP 4151542 A2 EP4151542 A2 EP 4151542A2
Authority
EP
European Patent Office
Prior art keywords
filling
needle
filling needle
magnet
protection system
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP22382830.2A
Other languages
German (de)
English (en)
Other versions
EP4151542A3 (fr
Inventor
Miquel Massaguer i Agulló
Mario Gutiérrez Xivillé
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Radial Italica 3000 SL
Original Assignee
Radial Italica 3000 SL
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Radial Italica 3000 SL filed Critical Radial Italica 3000 SL
Publication of EP4151542A2 publication Critical patent/EP4151542A2/fr
Publication of EP4151542A3 publication Critical patent/EP4151542A3/fr
Pending legal-status Critical Current

Links

Images

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B39/00—Nozzles, funnels or guides for introducing articles or materials into containers or wrappers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • B65B3/006—Related operations, e.g. scoring ampoules
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B31/00—Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers
    • B65B31/02—Filling, closing, or filling and closing, containers or wrappers in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas
    • B65B31/025—Filling, closing, or filling and closing, containers or wrappers in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas specially adapted for rigid or semi-rigid containers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
    • B65B55/10—Sterilising wrappers or receptacles prior to, or during, packaging by liquids or gases
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
    • B65B55/10—Sterilising wrappers or receptacles prior to, or during, packaging by liquids or gases
    • B65B55/103—Sterilising flat or tubular webs
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B2210/00—Specific aspects of the packaging machine
    • B65B2210/06—Sterilising or cleaning machinery or conduits
    • B65B2210/08—Cleaning nozzles, funnels or guides through which articles are introduced into containers or wrappers

Definitions

  • the present invention falls within the pharmaceutical product production sector, more specifically to the field of pharmaceutical product production by means of filling vials using needles or nozzles, and more specifically to the field of sanitising and sterilising the needles or nozzles used for filling vials of pharmaceutical products.
  • These systems comprise a nozzle or needle, connected by pipes to a reactor, in which the pharmaceutical product is stored, dispensing it into the vials or ampoules by means of the aforementioned nozzles or needles, which are aligned and introduced inside the same, enabling the correct filling.
  • sterilisation is carried out by means of an autoclave, which is nothing more than a pressure vessel, with air-tight closure, carrying out sterilisation with steam, such that pharmaceutical materials and instruments are sanitised.
  • document CN210915250U belongs to the state of the art, in which a filling unit for moving vehicles is described, with a liquid filling operation platform, where the moving vehicle comprises a body, with a pump, a rolling assembly and a positioning assembly for the rolling assembly, arranged in the lower portion of the body; and a drug injection assembly, comprising a needle support and a lifting mechanism arranged on the platform of the pump unit.
  • the support of the needle comprises a support connection part and a needle mounting seat, which extends outside the platform of the pump unit, as well as a cleaning sleeve for the needles of the filling machine, with an opening and a sealing platform that act as a centring collar.
  • Document CN203625000 also belongs to the state of the art, in which a cleaning and sterilisation method for filling needles is described, wherein an internal filling needle, with a sleeve, which is inserted into an external filling needle, which comprises an access port.
  • an outer filling cavity which is formed between the inner wall of the outer filling needle and the outer wall of the inner filling needle.
  • cleaning and sterilisation can be carried out when a cleaning and sterilisation source is introduced into the inner filling needle and the outer filling chamber, since the outer needle comprises an open end in the lower portion.
  • the filling needle protection system that the invention proposes is thus configured as a notable novelty within its field of application, since according to its implementation and in an exhaustive manner, the indicated objectives are satisfactorily achieved, with the characterising details that make it possible and that differentiate them conveniently included in the final claims that accompany this description.
  • the present invention proposes a filling needle protection system that allows its use during the sterilisation phase of the needles, by means of the use of an autoclave or the like, its handling for assembly in the vial filling machine, and the subsequent removal of said protection system, for the use of the needle in vial filling methods.
  • the filling needle protection system comprises at least one filling needle, a centring device for the needle, and a protector of the same.
  • the centring device of the needle is used to mount it on a fork of the filling machine that is part of the vial filling process, and is made of stainless steel, such as for example Duplex 2205, with which it is intended to avoid corrosion that may occur during sterilisation of the assembly by means of autoclave.
  • the protector of the needle comprises at least one protective tube, a housing that is used to house a magnet, and a centring element.
  • the protective tube is made of stainless steel, preferably of the 300 series, and specifically AISI 316L; and comprises an open end, such that the accumulation of moisture due to condensation that occurs during the sterilisation process by means of autoclaving is prevented.
  • This element is configured to cover, at least partially, the outside of the filling needle, achieving its protection in the mounting method of the same in the fork of the filling machine, once it has been sterilised by using the autoclave.
  • the housing for the magnet is arranged at the end opposite the open end of the protective tube, and houses a magnet that is used to make the removable connection of the protective tube with respect to the centring device of the needle.
  • the magnet is made of a material resistant to high temperatures, and comprises a force of attraction sufficient to achieve the aforementioned objective.
  • Both the magnet and its housing are covered by a sealing element, which prevents the entry of moisture during the sterilisation process by means of autoclave, such that the durability thereof is not affected.
  • centring element is arranged adjacent or substantially adjacent to the housing of the magnet, and are configured to maintain the mounting of the protector of the needle when the needle is mounted on the fork of the filling machine.
  • the protection system can be easily removed, allowing the use of the needle in the production steps of filling the vials.
  • the present invention proposes a filling needle protection system, configured to be installed on a filling needle 1, which is mounted in a filling machine 3; and that comprises at least one centring device 2 of the filling needle 1, which is used to assemble the filling needle 1 in the filling machine 3.
  • a protector of the filling needle 1 which in turn comprises a protective tube 4 with an open end 5; a housing 6, located at the end opposite the open end 5 of the protective tube 4, which house a magnet 7 therein; and an extension element 8, located adjacent or substantially adjacent to the housing 6.
  • the magnet 7 is configured to carry out the removable joint between the protective tube 4 and the centring device 3 of the filling needle, by means of applying the magnetic retention force.
  • extension element 8 is configured to enable the mounting of the needle protector on the filling needle 1, when the filling needle 1 is installed in the filling machine 3.
  • the protection system may remain installed at any time, both during the installation and fastening of the filling needle 1 in the filling machine 3, due to the extension element 8; and during the sterilisation step by means of autoclave or the like, due to the fact that the open end of the protective tube 4 prevents moisture from accumulating due to the condensation produced in the aforementioned sterilisation step of the assembly.
  • the housing 6 and/or the magnet 7 are covered by a sealing element 9, which prevents the entry of any type of moisture that could affect the operation and/or durability of the magnet 7.
  • the magnet 7 is made of a material resistant to high temperatures, close to 250 °C, and comprises an attraction force greater than 500 grams, such that it is sufficient to maintain the protector of the filling needle 1 in its working position, during the sterilisation and assembly phases of the filling needle 1 in the filling machine 3.
  • the needle protector is made of stainless steel, specifically 300 series stainless steel, such as AISI 316L.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
EP22382830.2A 2021-09-15 2022-09-07 Système de protection d'aiguille de remplissage Pending EP4151542A3 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
ES202130859A ES2936385B2 (es) 2021-09-15 2021-09-15 Sistema de proteccion de agujas de llenado

Publications (2)

Publication Number Publication Date
EP4151542A2 true EP4151542A2 (fr) 2023-03-22
EP4151542A3 EP4151542A3 (fr) 2023-08-16

Family

ID=85223279

Family Applications (1)

Application Number Title Priority Date Filing Date
EP22382830.2A Pending EP4151542A3 (fr) 2021-09-15 2022-09-07 Système de protection d'aiguille de remplissage

Country Status (2)

Country Link
EP (1) EP4151542A3 (fr)
ES (1) ES2936385B2 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN203625000U (zh) 2013-10-31 2014-06-04 楚天科技股份有限公司 灌装组件、灌装装置以及清洗灭菌装置
CN210915250U (zh) 2019-08-29 2020-07-03 上海良系制药装备经营设计有限公司 灌装单元移动车及液体灌装操作平台

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3477192A (en) * 1967-03-02 1969-11-11 American Cyanamid Co Container filling process
JP4858687B2 (ja) * 2006-04-05 2012-01-18 東洋製罐株式会社 充填装置の洗浄・殺菌方法及びその装置
US10684303B2 (en) * 2011-07-22 2020-06-16 Vanrx Pharmasystems Inc. Method for protecting and unprotecting the fluid path in a controlled environment enclosure
US10781002B2 (en) * 2013-08-16 2020-09-22 Vanrx Pharmasystems Inc. Method, device and system for filling pharmaceutical containers
GB2535982A (en) * 2015-02-13 2016-09-07 Nerudia Ltd System and apparatus
IL267822B2 (en) * 2017-01-06 2023-09-01 Univ Boston Infusion system and its components

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN203625000U (zh) 2013-10-31 2014-06-04 楚天科技股份有限公司 灌装组件、灌装装置以及清洗灭菌装置
CN210915250U (zh) 2019-08-29 2020-07-03 上海良系制药装备经营设计有限公司 灌装单元移动车及液体灌装操作平台

Also Published As

Publication number Publication date
ES2936385B2 (es) 2024-03-05
ES2936385A1 (es) 2023-03-16
EP4151542A3 (fr) 2023-08-16

Similar Documents

Publication Publication Date Title
US5207983A (en) Method of terminal steam sterilization
AU2006289069B2 (en) Syringe designed to be pre-filled then sterilized by steam autoclaving
US10684303B2 (en) Method for protecting and unprotecting the fluid path in a controlled environment enclosure
US8308472B2 (en) Device for the production and/or handling of a highly pure object
CA2712263C (fr) Conteneur de transfert pour recipients pharmaceutiques
JP2008001430A (ja) 無菌製品のフラスコ用の栓及び無菌計量充填における当該栓の使用
US9588022B2 (en) Sampling device
US10067151B2 (en) Method for protecting and unprotecting the fluid path in a controlled environment enclosure
US20200262609A1 (en) Pre-sterilizable carrier system
NZ201610A (en) Filling containers asceptically
EP4151542A2 (fr) Système de protection d'aiguille de remplissage
EP0072699B1 (fr) Méthode et système pour remplissage stérile de réceptacles avec un fluide
JP4744663B2 (ja) 容器とアイソレーターの間で殺菌した製品を移送する方法および装置
US20230234734A1 (en) System and method for dispensing a liquid in a closed chamber
KR20170076726A (ko) 주사기 및 주사기 제조 방법
WO2013106845A1 (fr) Cartouche de fluide pré-remplie et procédés de remplissage
US10377519B2 (en) Installation for aseptic filling of a receptacle
EP0673261A1 (fr) Procedes de production de dispositifs preremplis d'administration de liquides sans contamination externe ni interne
CA2852185C (fr) Ensemble adaptateur et procede de fourniture d'un sterilisant a un systeme d'emballage pour le nettoyage et le remplissage d'emballages
CA3179225C (fr) Methode de sterilisation d'un dispositif medical
CN116583305A (zh) 用于在高压釜灭菌设施中保持密封传输袋的工具
JP2005034420A (ja) 管の無菌接続方法
KR20220160658A (ko) 의료용 시린지 배럴 및 그의 포장체

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION HAS BEEN PUBLISHED

AK Designated contracting states

Kind code of ref document: A2

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

PUAL Search report despatched

Free format text: ORIGINAL CODE: 0009013

AK Designated contracting states

Kind code of ref document: A3

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

RIC1 Information provided on ipc code assigned before grant

Ipc: B65B 31/02 20060101ALN20230712BHEP

Ipc: B65B 3/00 20060101ALN20230712BHEP

Ipc: B65B 55/10 20060101ALI20230712BHEP

Ipc: B65B 39/00 20060101AFI20230712BHEP

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE

17P Request for examination filed

Effective date: 20240209

RBV Designated contracting states (corrected)

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR