EP3825239B1 - Packaging system for pharmaceutical products, chemical products, biocidal products and the like - Google Patents

Packaging system for pharmaceutical products, chemical products, biocidal products and the like Download PDF

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Publication number
EP3825239B1
EP3825239B1 EP20205514.1A EP20205514A EP3825239B1 EP 3825239 B1 EP3825239 B1 EP 3825239B1 EP 20205514 A EP20205514 A EP 20205514A EP 3825239 B1 EP3825239 B1 EP 3825239B1
Authority
EP
European Patent Office
Prior art keywords
clean room
products
sheet
packaging system
film
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.)
Active
Application number
EP20205514.1A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP3825239A2 (en
EP3825239A3 (en
Inventor
Davide Martelli
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.)
Individual
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Individual
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Filing date
Publication date
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Publication of EP3825239A2 publication Critical patent/EP3825239A2/en
Publication of EP3825239A3 publication Critical patent/EP3825239A3/en
Application granted granted Critical
Publication of EP3825239B1 publication Critical patent/EP3825239B1/en
Active legal-status Critical Current
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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
    • B65B47/00—Apparatus or devices for forming pockets or receptacles in or from sheets, blanks, or webs, comprising essentially a die into which the material is pressed or a folding die through which the material is moved
    • 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
    • B65B9/00—Enclosing successive articles, or quantities of material, e.g. liquids or semiliquids, in flat, folded, or tubular webs of flexible sheet material; Subdividing filled flexible tubes to form packages
    • B65B9/02—Enclosing successive articles, or quantities of material between opposed webs
    • B65B9/04—Enclosing successive articles, or quantities of material between opposed webs one or both webs being formed with pockets for the reception of the articles, or of the quantities of material
    • 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
    • B65B11/00—Wrapping, e.g. partially or wholly enclosing, articles or quantities of material, in strips, sheets or blanks, of flexible material
    • B65B11/50—Enclosing articles, or quantities of material, by disposing contents between two sheets, e.g. pocketed sheets, and securing their opposed free margins
    • B65B11/52—Enclosing articles, or quantities of material, by disposing contents between two sheets, e.g. pocketed sheets, and securing their opposed free margins one sheet being rendered plastic, e.g. by heating, and forced by fluid pressure, e.g. vacuum, into engagement with the other sheet and contents, e.g. skin-, blister-, or bubble- 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
    • 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
    • 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
    • B65B31/021—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 the containers or wrappers being interconnected
    • 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
    • B65B37/00—Supplying or feeding fluent-solid, plastic, or liquid material, or loose masses of small articles, to be packaged
    • B65B37/02—Supplying or feeding fluent-solid, plastic, or liquid material, or loose masses of small articles, to be packaged by gravity flow
    • 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
    • B65B37/00—Supplying or feeding fluent-solid, plastic, or liquid material, or loose masses of small articles, to be packaged
    • B65B37/16—Separating measured quantities from supply
    • 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
    • B65B41/00—Supplying or feeding container-forming sheets or wrapping material
    • B65B41/12—Feeding webs from rolls
    • 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
    • B65B55/027—Packaging in aseptic chambers
    • 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
    • B65B61/00—Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages
    • B65B61/04—Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages for severing webs, or for separating joined packages
    • B65B61/06—Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages for severing webs, or for separating joined packages by cutting

Definitions

  • the present invention relates to a packaging system for pharmaceutical products, chemical products, biocidal products and the like.
  • Some types of products in the pharmaceutical sector (but also some biocidal products and even, in general, several types of chemical products) need to be packaged separately for the purpose of preventing contamination phenomena.
  • a packing machine according to preamble of claim 1 is also known from DE 10340876 B3 .
  • Blister packs are sheets (generally made of polymeric or metallic or composite material) provided with a plurality of receptacles distributed on their surface; each receptacle is designed to accommodate an individual element (pastille, pill, tablet, generic solid block); the sheet of receptacles is covered with a closing sheet that also hermetically closes each receptacle and its contents (i.e. the pastille, pill, tablet and/or the generic solid block).
  • the packaging operations must be carried out in a protected and segregated environment known, in the sector, as a "clean room".
  • any malfunction of the machines located inside the clean room implies shutting down production and discarding the production queue.
  • the aim of the present invention is to solve the abovementioned drawbacks, by providing a packaging system for pharmaceutical products, chemical products, biocidal products and the like that makes it possible to reduce the costs of providing, installing and maintaining the respective clean room.
  • an object of the invention is to provide a packaging system for pharmaceutical products, chemical products, biocidal products and the like that facilitates the operations of ordinary and extraordinary maintenance of the machines that constitute it.
  • Another object of the invention is to provide a packaging system for pharmaceutical products, chemical products, biocidal products and the like that minimizes the effects of a machine shutdown caused by a malfunction.
  • Another object of the invention is to provide a packaging system for pharmaceutical products, chemical products, biocidal products and the like that makes it possible to preserve and use the production queue, when a malfunction occurs.
  • Another object of the present invention is to provide a packaging system for pharmaceutical products, chemical products, biocidal products and the like that is low cost, easily and practically implemented and safe in use.
  • the reference numeral 1 generally designates a packaging system for pharmaceutical products, chemical products, biocidal products and the like.
  • the packaging system 1 comprises a forming station 2 for a continuous sheet provided with a plurality of receptacles.
  • the station 2 comprises a spool on which a ribbon 4 is gathered which is entrained toward an operating area where it is subjected to deformation (through the application of thermal and/or mechanical stresses and/or combinations thereof) in order to provide a plurality of distributed receptacles and form the continuous sheet provided with receptacles.
  • the system 1 further comprises an assembly 5 for depositing pre-dosed rations of pharmaceutical products, chemical products, biocidal products and the like into each receptacle of the sheet.
  • the deposition of the rations i.e. capsules, pastilles, tablets, pills and other discrete elements and/or powders of any form and/or granulometry
  • the deposition of the rations can be achieved solely by falling (gravity) or by using methods that are more precise and complex (for example through means for picking and placing, in use in the sector).
  • the system 1 further comprises an apparatus 6 for coupling a film on a surface of the sheet 3 in order to close the receptacles.
  • a cutting unit 7 Downstream of the system 1 there is a cutting unit 7 for cutting the stratified combination 8 constituted by the sheet 7 closed by the respective film so as to contain and segregate the rations in the receptacles.
  • the cutting operations executed by the unit 7 will be such as to generate individual packages (blister packs) that have specific predefined and standardized formats.
  • the assembly 5 (designed to deposit the pre-dosed rations of pharmaceutical products, chemical products, biocidal products and the like into each receptacle) and the apparatus 6 (which carries out the coupling of the film on a surface of the sheet in order to close the receptacles) are contained inside a clean room 9 with a controlled atmosphere.
  • the system 1 advantageously entails the cutting unit 7 which faces toward and is proximate to the clean room 9, but outside it.
  • Such architecture of the system 1 is particularly advantageous and innovative because it makes it possible to execute all the necessary operations to handle pharmaceutical products, chemical products, biocidal products and the like inside the clean room 9 (therefore isolating these products from the outside environment with consequent elimination of all risks of contamination thereof and of intoxication of the operators responsible for conducting and controlling the system), while minimizing the dimensions of the clean room 9 itself, since the cutting unit 7 will be located outside the chamber 9.
  • the forming station 2 and the cutting unit 7 are located inside the clean room 9 and therefore the clean room must have a volume that is sufficient to accommodate them.
  • the arrangement of the unit 7 outside the clean room 9 reduces the probability of having to intervene for maintenance operations inside the clean room 9 itself.
  • the clean room 9 accommodates the assembly 5 for depositing pre-dosed rations of pharmaceutical products, chemical products, biocidal products and the like and the apparatus for coupling the film 6 for closing and also the forming station 2, thus reducing the risk that the portion of the system in which the malfunction occurs could be inside the clean room 9.
  • the cutting unit 7 is certainly the portion of the system that requires the most frequent maintenance, since the cutting means can be subject to wear and tear and therefore these means need to be replaced and/or restored.
  • an internal pressure is established in the chamber 9 which is greater than the pressure of the outside environment, in order to prevent the entry of contaminants at the point of entry of the sheet 3.
  • It comprises at least one passage opening 11 for the exit of the sheet 3a closed by the film.
  • the atmosphere inside the clean room 9 will be positively maintained at a pressure greater than that of the outside environment in order to prevent the entry of contaminants at the point of exit of the closed sheet 3a.
  • upstream of the cutting unit 7 a spool can be installed for winding the closed sheet 3a.
  • the cutting unit 7 will profitably comprise, downstream, at least one container 12 for collecting processing waste, such as defective packages (blister packs), offcuts and the like.
  • the unit 7 will further comprise, at its exit, means for transferring the correctly manufactured packages (blister packs) of predefined format to further work machines that are adapted for storage or for secondary packaging or for other operating steps.
  • the clean room 9 will positively have an internal volume that is appreciably smaller than that provided in traditional systems and substantially linked to the encumbrances of the group constituted by the forming station 2, by the assembly for deposition 5 and by the apparatus for coupling 6: keeping the cutting unit 7 outside will therefore make it possible to carry out operations to maintain it without contaminating anything inside the clean room 9.
  • the clean room 9 can have an internal volume that is much smaller than in traditional systems and substantially linked to the encumbrances of the group constituted by the assembly 5 for deposition and by the apparatus 6 for coupling.
  • the forming station 2 for a continuous sheet provided with a plurality of receptacles can conveniently be accommodated inside a second room 13 with a controlled atmosphere, which is separate from the clean room 9.
  • the second room 13 can also circulate purified air similar to the clean room 9 and in this case the advantage of subdividing the various parts of the system 1 into two similar (but smaller) chambers lies in the possibility of carrying out targeted maintenance interventions, excluding the possibility of contaminating all parts of the system 1. Furthermore the rooms of small dimensions have generally lower production and installation costs, not least due to the greater ease of transporting smaller components that precedes their installation.
  • the second room 13 can have a less rigorous control of the atmosphere with respect to the control maintained in the clean room 9 and this will determine a further reduction in the running costs with respect to traditional systems.
  • the assembly 5 for depositing pre-dosed rations of pharmaceutical products, chemical products, biocidal products and the like can advantageously comprise an upper hopper 14 for the temporary accommodation of a plurality of rations (to be inserted subsequently into the receptacles) and a distribution and dispensing element 15, which is provided with means for delivering at least one block inside a respective receptacle.
  • the clean room 9 and the second room 13 with a controlled atmosphere can profitably comprise a respective forced ventilation circuit for establishing a laminar air flow directed from the top of the room 9, 13 to the floor thereof, so as to ensure that no deposits of dust and/or contamination can occur.
  • the arrangement of the format cutting unit 7 for the packages further makes it possible to arrange the boxing machines (for the secondary packaging) downstream of the system 1, without it being necessary to also install these in an area with a controlled atmosphere, as happens in some implementation solutions in the background art.
  • the present invention solves the abovementioned problems, by providing a packaging system 1 for pharmaceutical products, chemical products, biocidal products and the like that makes it possible to reduce the costs of providing, installing and maintaining the related clean room 9.
  • the system 1 according to the invention in any case ensures that levels of safety against contamination of the products being packaged and levels of protection of staff from risk of intoxication are kept at least analogous to (and potentially much higher than) those of the traditional systems.
  • system 1 facilitates the operations of ordinary and extraordinary maintenance of the machines that constitute it.
  • the system 1 minimizes the effects of machine shutdowns caused by a malfunction.
  • the system 1 makes it possible to preserve and use the production queue, when a malfunction occurs.
  • the system 1 according to the invention therefore makes it possible to reduce the packaging operations inside the clean room 9 (in a protected atmosphere) to those strictly necessary for the protection of the product, by separating the operations to the point where the operations in direct contact with the product to be packaged can be isolated. In this manner the clean room 9 is optimized for just the operations necessary and the portion of the system 1 to be enclosed in a protective atmosphere is shorter than in traditional systems.
  • the passage between the clean room 9 and the non-aseptic room i.e. where the cutting unit 7 is located
  • the passage between the clean room 9 and the non-aseptic room is better controlled and controllable because it is simpler to manage a continuous closed sheet 3a than it is to manage a plurality of individual packages (blister packs) that are laterally adjacent and aligned.
  • blister packs individual packages
  • the present invention makes it possible to provide a packaging system 1 that is easily and practically implemented and which is low-cost: the characteristics highlighted make the assembly 1 according to the invention an innovation that is certain to be safe in use.
  • the materials employed, as well as the dimensions, may be any according to requirements and to the state of the art.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Packages (AREA)
  • Containers And Plastic Fillers For Packaging (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
EP20205514.1A 2019-11-21 2020-11-03 Packaging system for pharmaceutical products, chemical products, biocidal products and the like Active EP3825239B1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IT102019000021762A IT201900021762A1 (it) 2019-11-21 2019-11-21 Impianto di confezionamento per prodotti farmaceutici, prodotti chimici, biocidi e simili

Publications (3)

Publication Number Publication Date
EP3825239A2 EP3825239A2 (en) 2021-05-26
EP3825239A3 EP3825239A3 (en) 2021-07-21
EP3825239B1 true EP3825239B1 (en) 2024-08-28

Family

ID=69904000

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20205514.1A Active EP3825239B1 (en) 2019-11-21 2020-11-03 Packaging system for pharmaceutical products, chemical products, biocidal products and the like

Country Status (5)

Country Link
EP (1) EP3825239B1 (pl)
CN (1) CN112824234A (pl)
ES (1) ES3004513T3 (pl)
IT (1) IT201900021762A1 (pl)
PL (1) PL3825239T3 (pl)

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE423517B (sv) * 1972-08-11 1982-05-10 Tetra Pak Dev Sett att under aseptiska betingelser forpacka sterilt fyllgods i behallare
DE19505197A1 (de) * 1995-02-16 1996-09-05 Hassia Verpackung Ag Aseptisch arbeitende FFS-Maschine
DE10340876B3 (de) * 2003-09-04 2005-02-03 Robert Bosch Gmbh Vorrichtung zum Formen, Füllen und Verschließen von Behältern
JP6254055B2 (ja) * 2014-08-25 2017-12-27 Ckd株式会社 Ｐｔｐ包装機
CN204642272U (zh) * 2014-12-29 2015-09-16 杭州圣合医疗器械成套有限公司 单链硬塑包装机
JP6235684B1 (ja) * 2016-11-29 2017-11-22 Ckd株式会社 検査装置及びｐｔｐ包装機
IT201700094800A1 (it) * 2017-08-21 2019-02-21 Lameplast Spa Impianto per la produzione di contenitori, particolarmente contenitori per prodotti medicali, farmaceutici, cosmetici, alimentari o simili

Also Published As

Publication number Publication date
IT201900021762A1 (it) 2021-05-21
PL3825239T3 (pl) 2025-01-07
EP3825239A2 (en) 2021-05-26
ES3004513T3 (en) 2025-03-12
EP3825239A3 (en) 2021-07-21
CN112824234A (zh) 2021-05-21

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