EP2291244B1 - Procédé pour introduire un objet dans une chambre propre - Google Patents

Procédé pour introduire un objet dans une chambre propre Download PDF

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Publication number
EP2291244B1
EP2291244B1 EP09766215A EP09766215A EP2291244B1 EP 2291244 B1 EP2291244 B1 EP 2291244B1 EP 09766215 A EP09766215 A EP 09766215A EP 09766215 A EP09766215 A EP 09766215A EP 2291244 B1 EP2291244 B1 EP 2291244B1
Authority
EP
European Patent Office
Prior art keywords
bag
inner liner
inlet
seam
fused
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.)
Not-in-force
Application number
EP09766215A
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German (de)
English (en)
Other versions
EP2291244A1 (fr
Inventor
Viktor Schnyder
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.)
Lugaia STS Sterile Transfer Solutions AG
Original Assignee
Lugaia STS Sterile Transfer Solutions AG
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.)
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Publication date
Application filed by Lugaia STS Sterile Transfer Solutions AG filed Critical Lugaia STS Sterile Transfer Solutions AG
Publication of EP2291244A1 publication Critical patent/EP2291244A1/fr
Application granted granted Critical
Publication of EP2291244B1 publication Critical patent/EP2291244B1/fr
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L1/00—Enclosures; Chambers
    • B01L1/02—Air-pressure chambers; Air-locks therefor
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/08—Ergonomic or safety aspects of handling devices
    • B01L2200/082—Handling hazardous material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/046—Function or devices integrated in the closure
    • B01L2300/047—Additional chamber, reservoir

Definitions

  • the invention relates to a method for introducing at least one article packed and sterilized in a bag into a clean room.
  • the known method is based on the object to inject objects, in particular of medical items in a sterile condition in a clean room.
  • the objects such as syringes
  • the objects are arranged in a container made of plastic, which is open at its top and is covered there with a gas-permeable but germ-proof material.
  • the cover of germ-proof material is sealed with a sealed seam to the container.
  • the so sealed container is repackaged by means of a bag, which in turn is wholly or partly made of the same or a similar material as the cover, and again the container germ-tight, but gas-permeable closes.
  • the container After the objects have been introduced into the container, the container is sealed and the container has been bagged into the bag, the whole is now sterilized in a sterilization chamber. After removal from the sterilization chamber, the packaged items including and also the complete container are sterile. The same applies to the space between the bag and the container. The outer packaging by means of the bag avoids recontamination of the container. The thus packed container with the objects is then brought to its destination. There, the container is removed from the bag and passed through a lock in a sterile clean room.
  • a disadvantage of the known method it is especially the danger of contamination of the surface of the container is given by the required removal of the outer packaging prior to introduction of the container into the clean room.
  • Another disadvantage is also in the relatively complex and time-consuming packaging process.
  • the bag is connected to an inner liner connecting the clean room with an outer space and then opened on a region facing the inner liner, so that closed to the Ausseuraum, hose-like connection between the interior the bag and the inner liner is formed, through which the at least one object in the clean room is transferred.
  • the inner liner is tubular in this case.
  • it can be formed, for example, from an internally and externally weldable and peelable on its inside after welding endless tubular film.
  • the bag is made of a continuous film tube which is weldable on its outside and inside, wherein the inside of the endless film tube is peelable after welding and the bag closed after filling with the at least one object by welding and then the at least one object is sterilized.
  • an inlet of the inner liner around the outside of the bag can be arranged such that the side edge of the inlet comes to lie above a weld seam closing the bag, whereupon the bag is welded to the inlet, so that between its existing weld and the inlet side edge of the inlet at least one continuous new second weld arises, on the one hand connects the inside of the inlet to the outside of the bag and on the other hand at the same point the inside of the bag, whereupon the peelable inside of the bag and dissolved the bag is opened in the direction of the clean room for transferring the at least one article.
  • the bag has an inlet and the inner liner is also formed from a continuous film tube which is closed with a weld, wherein the inlet is arranged so that the edge of the inlet comes to rest above the weld, whereupon the endless film tube is welded to the inlet, so that between the existing weld and the edge of the inlet at least one continuous new second weld arises, on the one hand connects the inside of the inlet to the outside of the continuous film tube and on the other hand at the same point the inside of the continuous film tube, whereupon the peelable inside of the endless film tube (1a) is released and the bag is peeled open and opened in the direction of the clean room for transferring the at least one article.
  • a further variant of the invention which is characterized in that it can be very efficiently avoided with her contaminations Umzu Italiander objects, provides that a sterilized bag is welded to the inlet of the inner liner, the sterilized bag has a tubular transition foil, the inside not but outside already weldable and connected with its side facing away from the inlet with a bag-shaped sealing film, the bag bottom is within the transition foil and the sack edge connected to the inlet facing away from the side of the transition foil, for example welded, for the sealing film, a plastic is chosen, the good weldable and the bag-shaped sealing film is arranged around the outside of the bag containing the at least one article such that the weld closing this bag comes to lie within the bag, wherein the bag containing the at least one article is welded to the sealing film so that between the existing weld seam of the bag containing the at least one article and the free edge of the sealing film, at least one continuous new weld seam, preferably a double-seam seam, which on the one hand forms
  • the bag can have an inlet, with which a sterilized bag is welded, wherein the sterilized bag has a tubular transitional film, the inside but not already outside and already welded with its side facing away from the inlet with a bag-shaped sealing film is connected, the sack bottom is within the transition foil and the sack edge connected to the inlet side facing away from the transition foil, for example welded, for the sealing film, a plastic is chosen, which is well weldable, and the bag-shaped sealing film around the outside of the inner liner around is arranged so that a weld closing the inner liner comes to lie within the bag, wherein the inner liner is welded to the sealing film, so that between the existing weld innerliner and the free edge of the sealing film at least one continuous new e weld seam preferably double weld arises, on the one hand connects the inside of the sealing film with the outside of the inner liner and on the other hand at the same point the inside of the inner line
  • the bag has a bag-shaped receptacle for a welded end portion of the inner liner, wherein the receptacle is double-walled and made of an externally weldable and internally non-weldable plastic, and two separate from the walls of the receptacle , Areas are bounded, one of which is closed to the bag, and the other area is in communication with the interior of the bag, for refilling the bag contents, the portion of the end portion of the inner liner in the receptacle is arranged so that the weld within the Recording comes to rest, whereupon the recording and the section of the inlet located therein are welded, so that between the edge of the receptacle and the existing weld of the inner liner, a further weld is formed, a Trennaht is set, preferably in the middle of the other weld, so in that after loosening the separating seam between the interior of the bag and the inner liner,
  • the tube-like connection between the bag and the inner liner is interrupted by attaching a weld and then the inner liner is separated from the bag.
  • the inner liner is formed by an endless film tube mounted axially around an inlet of the clean room.
  • a bag 1 may contain, depending on the size of the articles 1 ', a single article 1' or even a large number of articles 1 ', for example of the order of ten thousand.
  • Plastic bags 1 are used, which ensure the sterility of the contents during transport and which are also compatible with an inner liner. Thereafter, these sterilized and packaged items 1 'are transported to a clean room and introduced there.
  • these articles 1 ' can be introduced from the bags 1 sterile into the clean room by means of the inner liner connecting the clean room to the outer space, and thus pass from the interior of the bag 1 into the clean room without further on-site sterilization being necessary is.
  • Fig. 2 is the bag 1 is made of an endless film tube 1 a, which is weldable on its outside and inside.
  • the inside of the endless film tube 1a is peelable after welding and the bag 1 is closed by welding after its filling.
  • Fig.2 and 3 further show the initial situation before the introduction of the objects 1 'in the clean room:
  • the bag 1 is connected to an inner liner 4a connecting the clean room with an outer space and is then opened on a region facing the inner liner 4a, so that an outer space is closed, hose-like connection between the interior of the bag 1 and the inner liner 4a is formed, through which a discharge of the bag can be made in the clean room.
  • the inner liner 4a is thus part of a lock for the clean room or acts as such.
  • the bag 1 faces with a free end, which is closed with a sealing weld 3a in an inlet 2a.
  • the inlet 2a is part of the inner liner 4a and is internally weldable. It is open in this embodiment and therefore may not be sterile.
  • the first weld 3a and the second weld 6a are peeled, ie from the outside detects an operator, the endless tubular film 1a and pulls them apart, wherein the internal welds 3a and 6a aufpeelen.
  • the opening or the Aufpeelen can optionally also be achieved by the optionally slightly increased inerting pressure of the article 1 '.
  • the welding between the outside of the endless tubular film 1a and the inlet 2a remains.
  • the innerliner 4a is tightly connected to the bag 1.
  • the counter sand 1 ' is transferred via the inner liner 4a in the clean room.
  • the endless tubular film 1 is preferably separated with a separating weld seam 3b.
  • a separating weld 3b is a weld which, after the welding operation, allows separation of the two parts which abut the weld. The two parts remain welded at the ends facing each other. The transfer process of the article 1 'from the bag 1 in the clean room is thus closed, since the dividing seam, as mentioned, forms an edge weld.
  • the weld seam 3b corresponds to the weld seam 3a in a new cycle.
  • FIGS. 12 and 13 show the next step, in which preferably the inner liner 4a is closed again at its upper end by the free ends of the inlet 2a are welded tight at a fourth point 7.
  • the welded-off (3b ") remainder of the endless tubular film 1 is placed or inserted in the inlet 2a.
  • Fig.14 and 15 show the initial situation for the sterile and contamination-free introduction of objects into a clean room according to the further development of the invention:
  • the inner liner 4b to be filled has a short inlet 2b, which is welded to a special tubular transition foil 5.
  • the transition foil 5 is internally not weldable and externally weldable.
  • the side facing away from the inlet 2b is welded edge-tight with a bag-like sealing foil 6.
  • the sealing film 6 is made of pure PE and good weldability on all sides.
  • the inner liner 4b is tightly welded to the transition foil 5 and can be gas or gamma sterilized. The entire package can thus be delivered, for example, in sterile packaging and placed on site (e.g., in the clean room) in the facility.
  • FIGS. 16 and 17 show how the bag 1 is inserted with a section in the special inlet structure consisting of transition foil 5 and sealing film 6 and welded to the inlet formed as a bag 7:
  • the endless tubular film 1a and the bag 1 is in the bag-shaped recess of the sealing film 6 to filling inner liner 4b inserted.
  • the outer sides of the sealing film 6 thus touch the outer sides of the endless tubular film 1a of the bag 1.
  • the outer side in this case is the side which comes into contact with the environment. From the point of view of the bag 7, however, it is rather an inner side due to the bag formation of the sealing film 6.
  • the external side always speaks in the above sense.
  • Fig.18 and 19 now show the process in which the nested endless tubular film 1a of the bag 1 and the sealing film 6 are welded: - With a welder (not shown, because conventional per se), the endless tubular film 1a and the sealing film are welded together, so that two tight welds 8a , 8b arise between the endless film tube 1a and the bag 7. In this process, the endless tubular film 1a is also welded together. During the welding process, a separating seam 9 is set between the welding seams 8a and 8b. This separates the non-sterile part in the form of a token 10. The welding and separation is done from the outside through the transition foil 5 through. Since the inner layer is not weldable, there is no connection of the inside of the transition foil 5 with the inside of the sealing foil 6 or with the endless tubular foil 1a.
  • FIGS. 20 and 21 show the process of separation of the token 10: The token falls down into the inner liner 4b and is taken from the clean room side.
  • Fig.22 and 23rd show the process of peeling, in which the endless tubular film 1a and with it the sealing film 16 is opened.
  • the innerliner 4b is tightly connected to the bag 1. In this state, the inner liner 4b is filled or emptied sterile.
  • the introduction of the articles 1 'into the clean room can be both a horizontal and a vertical conveying process.
  • a horizontal sluice is realized because it can be used to ensure better protection against contamination.
  • the separating seam 3b would correspond with its edge welding to the weld seam 3a on the endless tubular film 1.
  • Fig. 26 - 28 show a further variant of the inventive method.
  • the bag 1 has a bag-shaped receptacle 12 for an end section 13 of the inner liner 4c which is closed with a welded seam 11.
  • the receptacle 12 is double-walled and made of an externally weldable and internally non-weldable plastic.
  • two separate regions 12a, 12b are delimited, one of which is closed to the bag 1 and the other is in communication with the interior of the bag 1.
  • the end portion 13 of the inner liner 4c is arranged in the receptacle 12 so that the weld seam 11 comes to lie within the receptacle 12, whereupon the receptacle 12 and the portion 13 of the inner liner 4c therein are welded, so that between the edge the receptacle 12 and the existing weld seam 11 of the inner liner 4c, a further weld seam 11 a is formed. Then a dividing seam can be set to separate the weld seam 11 a.
  • the space 13a is formed by the bottom of the receptacle 12 and an inner side wall 12b 'of the bag 12 closed portion 12b and a separated side wall portion 12a "of an inner side wall 12a' of the bag (1) open area 12a.
  • the receptacle 12 and the inner liner 4c become a tubular one due to the region 12a of the receptacle 12 which is in communication with the interior of the bag 1 Connection for transferring the at least one object formed in the clean room.
  • the hose-like connection between the bag 1 and the inner liner 4c is interrupted by attaching a separating weld seam and a separation of the inner liner 4c from the bag can be made.
  • Fig. 29 shows a lock 14 for a clean room 15, to Verdanblidung the invention.
  • the lock 14 has an inlet opening 14a for transferring the article 1 'into the clean room 15.
  • the inlet opening 14a is penetrated by the inner liner 4c, which connects the clean room 15 with an outer space 16.
  • welding means are provided to connect the inner liner 4c to the bag 1.
  • the inner liner 4c formed from an endless tubular film is completely closed towards the outer space 16 before the transfer process. Wide, the inner liner 4c is axially supported around the inlet opening 14a in a chamber 14b annularly arranged around the inlet opening 14a of the clean room 15.
  • the inner liner is mirrored at its end portion located in the outer space 16 by attaching the weld seam 11 a by means of both sides of an imaginary extension of the axis of the inlet opening 14, per se conventional and therefore not shown welding equipment.
  • inner liner 4a, 4b, 4c and bag 1 are such that the bag 1 on a connecting wall for the inner liner 4a, 4b, 4c as the The innerliner 4a, 4b, 4c described above and shown in the figures is designed, wherein the inner liner 4a, 4b, 4c may be formed at its edge as the bag 1 described above.
  • Essential to the invention here is merely that bag 1 and inner liner 4a, 4b, 4c are compatible with each other.

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  • Health & Medical Sciences (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bag Frames (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Claims (11)

  1. Procédé pour introduire au moins un objet (1') emballé dans un sachet (1) et stérilisé dans une salle blanche (15), caractérisé en ce qu'on relie le sachet (1) à un liner intérieur (4a, 4b, 4c) reliant la salle blanche (15) à un espace extérieur (16), suite à quoi, on l'ouvre dans une zone faisant face au liner intérieur (4a, 4b, 4c), de sorte à créer une liaison de type tubulaire fermée sur l'espace extérieur (16) entre l'intérieur du sachet (1) et le liner intérieur (4a, 4b, 4c), à travers laquelle on transfère l'au moins un objet (1') dans la salle blanche (15).
  2. Procédé selon la revendication 1, caractérisé en ce qu'on fabrique le sachet (1) dans un film tubulaire continu, qui est soudable sur sa face extérieure et sa face intérieure, après un soudage, la face intérieure du film tubulaire continue (1a) étant pelable et après remplissage avec l'au moins un objet, le sachet étant fermé par soudage, suite à quoi, l'au moins un objet étant stérilisé.
  3. Procédé pour introduire au moins un objet (1') emballé dans un sachet (1) dans une salle blanche (15), caractérisé en ce qu'on relie par soudage le sachet (1) à un liner intérieur (4a, 4b, 4c) reliant la salle blanche (15) à un espace extérieur (16), suite à quoi, on l'ouvre dans une zone faisant face au liner intérieur (4a, 4b, 4c), de sorte à créer une liaison de type tubulaire, fermée sur l'espace extérieur (16) entre l'intérieur du sachet (1) et le liner intérieur (4a, 4b, 4c), à travers laquelle on transfère l'au moins un objet (1') dans la salle blanche (15), le sachet (1) étant fabriqué dans un film tubulaire continu, qui est soudable sur sa face extérieure et sa face intérieure, après un soudage, la face intérieure du film tubulaire continue (1a) étant pelable et après remplissage avec l'au moins un objet, le sachet étant fermé par soudage, suite à quoi, l'au moins un objet étant stérilisé.
  4. Procédé selon la revendication 2 ou 3, caractérisé en ce que pour l'introduction de l'au moins un objet (1') dans la salle blanche (15), on dispose une entrée (2a) du liner intérieur (4a) autour de la face extérieure du sachet (1) de sorte que le bord côté sachet de l'entrée (2a) vienne se placer au-dessus d'une soudure (3a) fermant le sachet (1), suite à quoi, on soude le sachet (1) sur l'entrée (2a), de sorte à créer entre sa soudure (3a) existante et le bord côté entrée de l'entrée (2) au moins une nouvelle, deuxième soudure continue (6a), qui d'une part relie la face intérieure de l'entrée (2a) avec la face extérieure du sachet (1) et d'autre part, au même endroit, relie la face intérieure du sachet (1), suite à quoi, on détache la face intérieure pelable du sachet (1) et on ouvre le sachet (1) en direction de la salle blanche (15) pour transvaser l'au moins un objet.
  5. Procédé selon la revendication 2 ou 3, caractérisé en ce que le sachet (1) comporte une entrée (2a) et en ce que le liner intérieur est également formé d'un film tubulaire continu (1a) qui est fermé par une soudure (3a), l'entrée (2a) étant disposée de sorte que le bord de l'entrée (2a) vienne se placer au-dessus de la soudure (3a), suite à quoi, on soude le film tubulaire continu (1a) sur l'entrée (2a), de sorte à créer entre la soudure existante (3a) et le bord de l'entrée (2) au moins une nouvelle, deuxième soudure continue (6a), qui d'une part relie la face intérieure de l'entrée (2a) à la face extérieure du film tubulaire continu (1a) et d'autre part relie au même endroit la face intérieure du film tabulaire continu (1a), suite à quoi, on détache la face intérieure pelable du film tubulaire continu (1a) et on pèle le sachet (1) et on l'ouvre en direction de la salle blanche (15) pour transvaser l'au moins un objet.
  6. Procédé selon la revendication 2 ou 3, caractérisé en ce qu'on soude un sac (7) stérilisé sur une entrée (2b) du liner intérieur (4b), le sac (7) stérilisé comportant un film tubulaire de transition (5) qui n'est pas soudable à l'intérieur, mais toutefois à l'extérieur et qui par sa face opposée à l'entrée (2b) est relié à un film d'étanchéité (6) en forme de sac, dont le fond de sac se situe à l'intérieur du film de transition (5) et dont le bord de sac est relié, par exemple soudé sur la face du film de transition (5) qui est opposée à l'entrée (2b), alors que pour le film d'étanchéité (6), on choisit une matière plastique qui est facilement soudable et le film d'étanchéité (6) en forme de sac étant disposé autour de la face extérieure du sachet (1) contenant au moins un objet, de sorte que la soudure (3a) fermant ledit sachet (1) vienne se placer à l'intérieur du sac, le sachet (1) contenant au moins un objet étant soudé avec le film d'étanchéité (6), de sorte à créer entre la soudure (3a) existante fermant le sachet (1) contenant au moins un objet et le bord libre du film d'étanchéité (6) au moins une nouvelle soudure continue (8), de préférence une double soudure (8a, 8b), qui relie d'une part la face intérieure du film d'étanchéité (6) avec la face extérieure du sachet (1) contenant au moins un objet et d'autre part, au même endroit la face intérieure du sachet (1) contenant au moins un objet, pendant ce processus de soudage, au centre de la soudure (8), de préférence entre les doubles soudures (8a, 8b) soit placée une soudure de sectionnement (9), de sorte à sectionner la partie faisant face au liner intérieur du sachet (21) contenant l'objet sous la forme d'un jeton (10) renfermant de la matière, conjointement au film d'étanchéité (6) qui l'entoure, suite à quoi, on détache la face intérieure pelable du sachet (1) contenant au moins un objet sur son deuxième endroit soudé (8a), de telle sorte que l'au moins un objet (1') puisse être transféré dans la salle blanche (15).
  7. Procédé selon la revendication 2 ou 3, caractérisé en ce que le sachet (1) comporte une entrée (2b) sur laquelle on soude un sac stérilisé (7), le sac stérilisé (7) comportant un film de transition (5) tubulaire, qui n'est pas soudable à l'intérieur mais toutefois à l'extérieur et qui par sa face opposée à l'entrée (2b) est relié à un film d'étanchéité (6) en forme de sac, dont le fond de sac se situe à l'intérieur du film de transition (5) et dont le bord de sac est relié, par exemple soudé avec la face du film de transition (5) qui est opposée à l'entrée (2b), pour le film (6), une matière plastique facilement soudable étant choisie, et le film d'étanchéité en forme de sac (6) étant soudé autour de la face extérieure du liner intérieur (4b), de sorte qu'une soudure (3a) fermant le liner intérieur (4b) vienne se placer à l'intérieur du sac, alors qu'on soude le liner intérieur (4b) sur le film d'étanchéité (6) de sorte à créer entre la soudure (3a) existante du liner intérieur (4b) et le bord libre du film d'étanchéité (6) au moins une nouvelle soudure (8) continue, de préférence une double soudure (8a, 8b), qui d'une part relie la face intérieure du film d'étanchéité (6) avec la face extérieure du liner intérieur (4b) et d'autre part, au même endroit, la face intérieure du liner intérieur (4b), pendant ce processus de soudage, une soudure de sectionnement (9) étant placée au centre de la soudure (8), de préférence entre les doubles soudures (8a, 8b), de sorte que la partie du liner intérieur (4b) faisant face au sachet (1) soit sectionnée sous la forme d'un jeton (10) renfermant une matière, conjointement au film d'étanchéité (6) qui l'entoure, suite à quoi, on détache la face intérieure pelable du liner intérieur (4b) sur son deuxième endroit soudé (8a), de sorte à permettre de transférer l'au moins un objet (1') dans la salle blanche (15), après pelage du sachet (1).
  8. Procédé selon la revendication 1, caractérisé en ce que le sachet (1) comporte un logement (12) en forme de sac pour une partie d'extrémité (13) du liner intérieur (4c) qui est fermée par une soudure (11), le logement (12) étant réalisé à double paroi et dans une matière plastique soudable à l'extérieur, mais non soudable à l'intérieur (12), et par les parois du logement étant délimitées deux zones (12a, 12b) séparées l'une de l'autre, dont une zone (12b) est fermée par rapport au sachet (1) et l'autre zone (12a) est en liaison avec l'intérieur du sachet (1), pour le transvasement du contenu du sachet, la partie d'extrémité (13) du liner intérieur (4c) étant disposée dans le logement (12) de sorte que la soudure (11) vienne se placer à l'intérieur du logement (12), suite à quoi, on soude le logement (12) et la partie (13) du liner intérieur (4c) qui se trouve dedans, de sorte à créer entre le bord du logement (12) et la soudure (11) déjà existante du liner intérieur (4c) une soudure supplémentaire (11a), suite à quoi, on sectionne la soudure supplémentaire (11a), de sorte à ce qu'une partie (13') du liner intérieur (4c) contenant la soudure (11) de la partie d'extrémité (13) fermée du liner intérieur (4c) soit sectionnée et soit contenue dans un espace (13a) formé par le fond du logement (12) et une paroi latérale intérieure (12b') de la zone (12b) fermée par rapport au sachet (1) et par une partie de paroi latérale sectionnée (12 a") d'une paroi latérale intérieure (12a') de la zone (12a) ouverte par rapport au sachet (1), la zone (12a) du logement (12) qui est en liaison avec l'intérieur du sachet (1) et le liner intérieur (4c) formant une liaison tubulaire pour transvaser l'au moins un objet dans la salle blanche, de préférence, après le transvasement de l'au moins un objet (1') dans la salle blanche (15), la liaison en forme de tube entre le sachet (1) et le liner intérieur (4c) étant interrompue par application d'une soudure et il étant procédé à un sectionnement du liner intérieur (4c) du sachet.
  9. Procédé selon l'une quelconque des revendications 1 à 8, caractérisé en ce que le liner intérieur (4a, 4b, 4c) est formé par un film tubulaire continu placé en direction axiale autour d'une entrée de la salle blanche.
  10. Procédé pour introduire au moins un objet (1') emballé dans un sachet (1) et stérilisé dans une salle blanche (15), caractérisé en ce qu'on relie par soudage le sachet (1) à un liner intérieur (4a, 4b, 4c) reliant la salle blanche (15) à un espace extérieur (16), suite à quoi, on l'ouvre sur une zone faisant face au liner intérieur (4a, 4b, 4c), de sorte à créer une liaison de type tubulaire fermée sur l'espace extérieur (16) entre l'intérieur du sachet (1) et le liner intérieur (4a, 4b, 4c), à travers laquelle l'au moins un objet (1') est transféré dans la salle blanche (15), le sachet (1) comportant un logement (12) en forme de sac pour une partie d'extrémité (13) du liner intérieur (4c) fermée par une soudure (11), le logement (12) étant réalisé à double paroi et dans une matière plastique soudable à l'extérieur et non soudable à l'intérieur et par les parois du logement étant délimitées deux zones séparées (12a, 12b), dont une zone (12b) est fermée par rapport au sachet (1) et l'autre zone (12a) est en liaison avec l'intérieur du sachet (1), pour le transvasement du contenu du sachet, la partie d'extrémité (13) du liner intérieur (4c) étant disposée dans le logement (12) de sorte que la soudure (11) vienne se placer à l'intérieur du logement (12), suite à quoi, on soude le logement (12) et la partie (13) du liner intérieur (4c) qui s'y trouve, de sorte à créer entre le bord du logement (12) et la soudure (11) déjà existante du liner intérieur (4c) une soudure supplémentaire (11a), suite à quoi, on sectionne la soudure supplémentaire (11a), de sorte qu'une partie (13') du liner intérieur (4c) contenant la soudure (11) de la partie d'extrémité (13) fermée du liner intérieur (4c) soit sectionnée et contenue dans un espace (13a) formé par le fond du logement (12) et une paroi latérale intérieure (12b') de la zone (12b) fermée par rapport au sachet (1) et par une partie de paroi latérale sectionnée (12 a") d'une paroi latérale intérieure (12a') de la zone (12a) ouverte par rapport au sachet (1), la zone (12a) du logement (12) qui est en liaison avec l'intérieur du sachet (1) et le liner intérieur (4c) formant une liaison tubulaire pour le transvasement de l'au moins un objet dans la salle blanche.
  11. Procédé selon la revendication 10, caractérisé en ce qu'après un transvasement de l'au moins un objet (1') dans la salle blanche (15), on interrompt la liaison de type tubulaire entre le sachet (1) et le liner intérieur (4c) par application d'une soudure et on procède à un sectionnement du liner intérieur (4c) du sachet, le liner intérieur (4e, 4b, 4c) étant formé de préférence par un film tubulaire continu placé en direction axiale autour d'une entrée de la salle blanche.
EP09766215A 2008-06-17 2009-05-08 Procédé pour introduire un objet dans une chambre propre Not-in-force EP2291244B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH9202008 2008-06-17
PCT/IB2009/051912 WO2009153676A1 (fr) 2008-06-17 2009-05-08 Procédé pour introduire un objet dans une chambre propre

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EP2291244A1 EP2291244A1 (fr) 2011-03-09
EP2291244B1 true EP2291244B1 (fr) 2012-04-25

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EP09766215A Not-in-force EP2291244B1 (fr) 2008-06-17 2009-05-08 Procédé pour introduire un objet dans une chambre propre

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US (1) US20110142574A1 (fr)
EP (1) EP2291244B1 (fr)
AT (1) ATE554857T1 (fr)
WO (1) WO2009153676A1 (fr)

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DE102021104221A1 (de) 2021-02-23 2022-08-25 Syntegon Technology Gmbh Vorrichtung und Verfahren zur Überführung einer Verpackungseinheit in ein Barrieresystem für Pharmazeutika

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FR3034405B1 (fr) 2015-03-30 2017-04-07 Lourd'innov Sachet pour le transfert et l'emballage de composants d'une enceinte confinee
DE102017010737A1 (de) * 2017-11-21 2019-05-23 Flecotec Ag Verfahren zum umweltdichten Verbinden einer Schutzhülle mit einer Sicherheitshülle
EP3909880A1 (fr) 2020-05-13 2021-11-17 Lugaia AG Procédé et dispositif pour créer une connexion étanche à l'environnement entre deux régions
CN112657562B (zh) * 2020-12-11 2022-05-17 浙江省海洋水产研究所 一种实验室用多用途材料存放装置
DE102021114896B4 (de) 2021-06-09 2023-10-05 Pharmpur Gmbh Transferbeutel, Transferverfahren und Transferset

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GB2306376B (en) * 1995-10-25 1998-12-23 Extract Technology Ltd Glove box
FR2785301B1 (fr) * 1998-10-29 2001-01-26 Electrolux Syst Blanchisserie Procede et installation de blanchissage barriere et dispositif de transfert etanche de linge utilisable dans une telle installation
US20010047162A1 (en) * 2000-02-17 2001-11-29 Yasumi Yugari Injection kit and injection device
DE10044117A1 (de) * 2000-09-07 2002-03-21 Ruediger Haaga Gmbh Verfahren zum Sterilisieren von Gegenständen
US7243787B2 (en) * 2003-03-26 2007-07-17 Nipro Corporation Medicine bag

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Publication number Priority date Publication date Assignee Title
DE102021104221A1 (de) 2021-02-23 2022-08-25 Syntegon Technology Gmbh Vorrichtung und Verfahren zur Überführung einer Verpackungseinheit in ein Barrieresystem für Pharmazeutika
EP4100330B1 (fr) * 2021-02-23 2023-09-27 Syntegon Technology GmbH Dispositif et procede de transfert d'une unite de conditionnement dans un systeme barriere pour produits pharmaceutiques

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WO2009153676A1 (fr) 2009-12-23
US20110142574A1 (en) 2011-06-16
EP2291244A1 (fr) 2011-03-09
ATE554857T1 (de) 2012-05-15

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