EP2534052B1 - Verfahren und einheit zur sterilen füllung eines finalen grundbehälters mit für den biopharmaziebereich vorgesehenen inhalten - Google Patents

Verfahren und einheit zur sterilen füllung eines finalen grundbehälters mit für den biopharmaziebereich vorgesehenen inhalten Download PDF

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Publication number
EP2534052B1
EP2534052B1 EP11711610.3A EP11711610A EP2534052B1 EP 2534052 B1 EP2534052 B1 EP 2534052B1 EP 11711610 A EP11711610 A EP 11711610A EP 2534052 B1 EP2534052 B1 EP 2534052B1
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EP
European Patent Office
Prior art keywords
filling
sterile
chamber
elements
internal
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Revoked
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EP11711610.3A
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English (en)
French (fr)
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EP2534052A1 (de
Inventor
Isabelle Gay
Nicolas Mendyk
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Sartorius Stedim FMT SAS
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Sartorius Stedim FMT SAS
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Application filed by Sartorius Stedim FMT SAS filed Critical Sartorius Stedim FMT SAS
Publication of EP2534052A1 publication Critical patent/EP2534052A1/de
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    • 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
    • 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

Definitions

  • the invention relates to the field of sterile filling of a final elementary container with a biopharmaceutical fluid originally located in a source container, also in a sterile manner.
  • the invention relates to a process for the sterile filling of at least one final elementary container with a content that can be distributed in a fluid manner and that is originally in a sterile source container.
  • the invention relates to a sterile filling unit for at least one final elementary container with a content that can be dispensed in a fluid manner and that is originally located in a sterile source container, especially intended for the implementation of the method according to the invention.
  • the invention aims, according to a third aspect, a unitary assembly for the implementation of a filling process according to the invention and the production of a sterile filling unit according to the invention.
  • the invention relates to a sterile fluid transfer and filling line specially intended for a sterile filling unit of at least one final container with contents that can be distributed in a fluid manner, according to the invention. invention.
  • biopharmaceutical field It is constant in the biopharmaceutical field to produce methods and units for filling a final elementary container with a biopharmaceutical fluid in which a plurality of parts such as containers, tubes or ports integrated in more or less complex assemblies are used. may comprise several containers, several tubes, several functional means associated with each other.
  • a biopharmaceutical fluid is a fluid derived from biotechnology - culture media, cell cultures, buffer solutions, artificial nutrition liquids, blood products and blood products derivatives - or a pharmaceutical fluid or more generally a biological fluid. fluid for use in the medical field.
  • the maintenance operations have the disadvantage of considerably increasing the time required between each filling operation since they require, alternatively or successively, to extract certain parts of the sterile enclosure to replace them with other parts. Sterile and sterilize the remaining stainless steel parts in place in this sterile enclosure.
  • the multiplication of these maintenance operations considerably increases the production costs since these operations require the intervention of personnel to manage the decontamination.
  • the invention aims to meet this need which corresponds to specific requirements of the biopharmaceutical field.
  • the outer means and members of the single-use type are also chosen for the intended filling.
  • the at least one filled end container is discharged from the inside of the enclosure towards the outside of it, in a sterile manner.
  • the communication means are selected from the group consisting of pipes, tubes, conduits and the like
  • the distribution means are selected from the group comprising the pumps and the like
  • the filling members are selected from the group comprising injection needles, nozzles and the like.
  • the filling members and the final containers are chosen so that initially a filling member is either dissociated or at least partly integrated with a final container.
  • a final container is selected from the group consisting of open or closed containers, vials, syringes, vials and bottles, pouches or single-use bag system or not.
  • At least one other means or functional element intended to be integrated in the transfer and filling line such as filtration means, is also available.
  • buffer storage means, connecting means which, being assembled to the communication means, to the dispensing means and at least one filling member, form the sterile fluid transfer and filling line, and there is or is formed a such a line of transfer and filling.
  • At least one of at least one other means or functional member intended to be integrated in the transfer and filling line is a disposable means or member for filling. considered said outside being located outside the enclosure.
  • the filling step or reiteration of filling steps includes at least one operation of filling another container, such as a container for testing, traceability, or experimentation.
  • the filling operation of another container is carried out during the filling step of one or more final containers.
  • there is at least one set sterile unitary unit of inner means and members comprising a sterile pocket of inner means and members having a wall limiting a sterile internal space and provided with an opening and a complementary associated door of a door of the enclosure adapted to allow, unit unit being associated with the enclosure and the doors being in the open state, a sterile transfer of these means and inner members between the internal space of the pocket and the interior of the enclosure, these means and inner organs in the sterile state being placed in the internal space of the pocket.
  • the method comprises a prior phase in which, having internal means and organs and a pocket of means and inner members whose internal space is empty of these means and organs, the at least one assembly is formed. unit means and internal organs and for this purpose is placed these means and inner organs in the internal space, it brings the door of the pocket of inner means and organs in the closed state and brings the at least one unitary assembly in the sterile state.
  • this other means or functional organ when in the step prior to the filling step, at least one other means or functional element is available, this other means or functional organ is placed in the internal space of the pocket of means and internal organs.
  • a sterile unitary assembly of external means and members comprising a sterile pocket of means and external members having a wall limiting a sterile internal space and provided with an opening and an associated door complementary to a door the enclosure adapted to allow, the unit assembly being associated with the enclosure and the doors being in the open state, a sterile transfer of these means and outer members between the internal space of the pocket and the interior of the enclosure, these means and external bodies in the sterile state being placed in the internal space of the pocket.
  • the method comprises a prior phase in which, having external means and members and a pocket of means and external members whose internal space is empty of these means and organs, the unitary set of means is constituted. and outer members and for this purpose are placed these means and outer members in the internal space, brings the door of the pocket of means and outer members in the closed state and brings the unitary assembly to the sterile state.
  • the door before associating the door of the unitary assembly of external means and members and the corresponding door of the enclosure, the door is separated from the at least one unitary assembly of inner means and members and the corresponding door of the enclosure, the latter being brought to the closed state, the door corresponding to the unitary assembly of means and outer members and the door corresponding to the unitary assembly of means and inner members may be the same door.
  • the door of the unitary assembly of external means and members and the corresponding door of the enclosure when the door of the unitary assembly of external means and members and the corresponding door of the enclosure are associated, the door of the at least one unitary assembly of inner means and members and the corresponding door are held together. of the enclosure, the door corresponding to the unitary assembly of means and external members and the door corresponding to the unitary assembly of means and internal organs may be distinct.
  • a unitary assembly of external means and members and a unitary assembly of common internal means and organs and, successively, the door of the unitary assembly of internal and external means and members is associated.
  • a door of the enclosure and, after opening the doors, a sterile transfer of the inner means and members between the internal space of the pocket of means and inner and outer members and the inside of the enclosure is introduced.
  • extreme downstream portion of the crossing communication conduit section inside the enclosure is introduced.
  • the unitary assembly of internal means and members and / or the unitary assembly of external means and members associated with the enclosure and the door (s) of the unitary units of the unit are maintained. means and internal and / or external organs and the enclosure in the open state.
  • the unitary assembly of means and inner members and / or the unitary assembly of external means and members being associated with the enclosure and the respective doors of the unitary assembly and the enclosure being in the state open, it communicates the interior of the enclosure and the internal space of the pocket of means and internal organs and / or the pocket of external means and bodies and is realized a total space comprising the internal space of the pocket of means and internal organs and / or the internal space of the pocket of means and external members and the interior of the enclosure, of volume greater than the volume of the interior of the enclosure alone.
  • the means and constituent organs of the transfer line and filling include at least one means or external member of a space not allowing passage through a door of the enclosure.
  • the various means and organs intended to be part of the part of the transfer line and filling to the inside of the enclosure are all assembled to each other and these means and organs are introduced into the enclosure thus assembled.
  • the various means and organs intended to be part of the part of the transfer line and filling to the inside of the enclosure are all disassembled from each other and these means and organs are introduced inside the enclosure and disassembled, and are assembled to each other once located inside the enclosure .
  • a part of the various means and organs intended to be part of the part of the transfer line and filling inside the enclosure are assembled to each other and another part disassembled from each other, the means and assembled members are introduced into the enclosure thus assembled, the means and disassembled bodies are introduced inside the enclosure and disassembled, and are assembled to each other and the means and organs already assembled once located inside the enclosure.
  • the various means and members intended to be part of the part of the transfer and filling line outside the enclosure are either all assembled to each other, either all disassembled from each other or a part is assembled to each other and another part is disassembled from each other. These different means and organs are assembled for the filling step.
  • downstream end portion of the part of the transfer and filling line outside the enclosure and the upstream end portion of the part of the transfer line and fillers inside the enclosure are either assembled to one another or disassembled from one another. These two parts of the transfer and filling line are assembled for the filling step.
  • the final container (s) and / or the other container (s) are introduced inside the enclosure by a door of the enclosure through which the interior means and organs and / or the at least one means or inner functional member.
  • the final container (s) and / or the other container (s) are placed in the internal space of the pocket of such a set unitary and are introduced inside the enclosure from this unit assembly associated with the enclosure.
  • sterile removal is carried out for the first time.
  • interior of the enclosure to the outside of it means and inner organs and the at least one means or inner functional member.
  • internal space of the pocket of such a unitary assembly and in that the same unitary unit can be implemented for the introduction of these means and organs inside the enclosure and the evacuation of these means and organs from the enclosure.
  • the method comprises several steps of introduction inside the enclosure of means and internal organs and / or several steps of evacuation from inside the enclosure of means and internal organs, combined with connection or disconnection operations with the means and inner organs held in the enclosure, before or after one or more filling steps, so as to adapt the number of outputs of the transfer line during the implementation of the filling process, according to the needs.
  • the external means and members are also of single-use type for the intended filling.
  • the communication means are selected from the group consisting of pipes, tubes, ducts and the like, and the dispensing means are selected from the group consisting of pumps and the like.
  • a filling member is dissociated or at least partly integrated with a final container.
  • the filling unit further comprises at least one other means or functional member intended to be integrated in the transfer and filling line, such as filtration means, buffer storage means, connection means.
  • another means or functional member is disposable for the intended filling and located inside the enclosure.
  • another means or functional member is located outside the enclosure.
  • another means or external functional member is disposable for the intended filling.
  • the means and internal members comprise at least communication means, the dispensing means, the at least one filling member and, where appropriate, the at least one other single-use means or internal functional member.
  • the filling unit also includes at least one sterile unitary assembly of inner means and members comprising a sterile pocket of inner means and members having a wall limiting a sterile internal space and provided with an opening and a associated complementary door of a door of the enclosure adapted to allow, the unit assembly being associated with the enclosure and the doors being in the open state, a sterile transfer of these means and inner members between the internal space of the pocket and the interior of the enclosure, these means and inner organs in the sterile state being placed in the internal space of the pocket of means and internal organs.
  • the filling unit also comprises at least one other means or inner functional member, and the at least one other means or inner functional member is placed in the internal space of the pocket of means and internal organs.
  • the filling unit also includes at least one sterile unitary assembly of outer means and members comprising a sterile pocket of outer means and members having a wall limiting a sterile internal space and provided with an opening and a complementary associated door of a door of the enclosure adapted to allow, the unit assembly being associated with the enclosure and the doors being in the open state, a sterile transfer of these means and outer members between the internal space of the pocket and the inside of the enclosure, these means and external organs in the sterile state being placed in the internal space of the pocket of means and internal organs.
  • the filling unit includes a unitary assembly of external means and members and a unitary assembly of inner means and members and, moreover, the unitary assembly of external means and members and the unitary unit of means and inner organs are distinct.
  • the filling unit includes a unitary assembly of external means and members and a unitary assembly of inner means and members and, moreover, the unitary assembly of external means and members and the unitary unit of means and inner organs are common.
  • the means and constituent organs of the transfer line and filling include at least one means or external member of a space not allowing passage through a door of the enclosure.
  • the various means and organs intended to be part of the part of the transfer line and filling to inside the enclosure are all assembled to each other.
  • the various means and organs intended to be part of the part of the transfer line and filling to inside the enclosure are all disassembled from each other.
  • a part of the various means and organs intended to be part of the part of the transfer line and filling inside the enclosure are assembled to each other and part disassembled from each other.
  • the various means and members intended to be part of the part of the transfer and filling line outside the enclosure are either all assembled to each other, either all disassembled from each other or partly assembled to each other and for another part disassembled from each other.
  • downstream end portion of the part of the transfer and filling line outside the enclosure and the upstream end portion of the part of the transfer line and fillers within the enclosure are either assembled to one another or disassembled from each other, being assembled for the filling step.
  • the filling unit further comprises means for introducing inside the enclosure empty final containers and means for evacuating from inside the enclosure of the final containers filled.
  • a pocket of such a unitary assembly is part or constitutes the means of introduction and / or the means disposal of final containers.
  • the unitary assembly also includes at least one section of crossing communication conduit placed in the internal space of the pocket and at least one supply communication section placed outside the pocket, forming part of external means and organs.
  • the pocket has a flexible wall or a rigid wall or a partially flexible and partially rigid wall.
  • the unitary assembly comprises at least one other means or functional member placed in the internal space of the pocket.
  • the various means and members intended to be part of the transfer line and filling and located in the internal space of the pocket are originally all assembled to each other, or all disassembled from each other either partly assembled to each other and for another part disassembled from each other.
  • in the internal space of the pocket are also placed one or more end containers.
  • the internal space of the pocket is adapted to receive the means and internal organs for single use after use for their evacuation.
  • the invention relates to the sterile filling of at least one - and generally a plurality - of n final elementary containers cf with fluid-ready contents that are originally in a CS source container in a sterile manner.
  • the invention applies to the biopharmaceutical field and the content in question is a biopharmaceutical fluid, as defined.
  • the source container CS may be a flexible pouch or not whose volume may be larger or smaller, for example from 20 liters to 500 liters or more.
  • the final container cf may be chosen from the group comprising open or closed containers, vials, syringes, bottles and bottles, pockets or bag systems for single use or not.
  • the final container cf has a capacity that is a fraction of the capacity of the source container, especially at a volume that can be very small.
  • the invention relates to the sterile filling process in question, a sterile filling unit specially designed for the implementation of the process, a unitary unit which, in one embodiment, is used in the process and included in the process. unit and finally a transfer line and filling unit specially designed for such a sterile filling unit, comprising such a unitary unit formed from all or part of the means and members of the transfer and filling line.
  • the invention provides a sterile enclosure 1, having at least one sterile entry door 2a and / or outlet 2b, associated with an opening 2c formed in a wall 3 of the enclosure 1. These are different doors structurally or the same door fulfilling different functions, respectively for the introduction inside the enclosure 1 or for the evacuation from the inside of the enclosure 1.
  • Such an enclosure 1 has one or more walls 3 delimiting it. Such an enclosure may be large and the walls 3 rigid.
  • the source container CS is located outside the enclosure 1.
  • the final containers cf are located inside the enclosure 1.
  • the invention provides a transfer and filling line 4 which is produced by the assembly in sterile communication of different means and organs: communication means 5, distribution means 6, filling members 7, where appropriate one or several other means or functional organs 8.
  • the communication means 5 are typically selected from the group consisting of pipes, tubes, ducts and the like.
  • the dispensing means 6 are typically selected from the group consisting of pumps and the like.
  • Filling members 7 are typically selected from the group consisting of injection needles, nozzles and the like.
  • Another means or functional element 8 is for example a filtering means, a buffer storage means, a connection means.
  • a means or functional member 8 is either dissociated from a final container cf, or is at least partly integrated with a final container cf.
  • a final container cf may be a closed bag including means for supplying the filling content.
  • the transfer and filling line 4 comprises once made an inlet 9 intended to be associated in sterile communication with the source container CS.
  • It comprises at least one output and most often a plurality of outputs corresponding to a plurality of filling elements 7.
  • the transfer and filling line 4 passes through the wall 3 of the enclosure in a sterile manner.
  • the inlet 9 is located outside the chamber 1.
  • the filling members 7 are located inside the enclosure 1 and positioned to be operable with respect to the final containers cf.
  • the enclosure 1 is provided with means 10 carrying means and members 5, 6 and 7 of the transfer line and filling 4 located inside the enclosure 4.
  • Such carrier means 10 are for example hooks, brackets, support parts. They are sufficient in number to be able to accommodate any disposition of the part of the transfer line and filling located in the enclosure 1. They are positioned in the enclosure 1 in any location appropriate to their use.
  • Such carrier means 10 are in a fixed position or are arranged movable, depending on the desired flexibility requirements.
  • the method comprises a step or operation in which the final container or containers cf are introduced inside the chamber 1 in a sterile manner. It also comprises a step or operation in which the final containers cf are structurally associated with the filling units to the filling members 7. This structural association is made in any suitable manner to allow filling. As previously indicated, it is intended that the communication means 5, the distribution means 6 and the inner filling members 7 O be positioned in the enclosure 1 so that they can be operated by means of the load-bearing means 10. .
  • the method also comprises a filling step in which the content of the source container CS is taken, is passed through the transfer and filling line then installed to be operated and finally the desired quantity is delivered in the final containers. .
  • At least the inner means and members OI are selected, so that they have a clearance allowing the passage through a door such as 2a and, secondly, of the use type. unique for the intended filling.
  • the outer means and members OE are also chosen so that they are of the single-use type for the intended filling.
  • other OFI internal means or functional members are also chosen so that they have a space permitting passage through a door such as 2a and that they are of the single-use type for the intended filling. And, where appropriate, one also chooses the means and external functional organs OFE single-use type for the filling envisaged.
  • the invention can be viewed from several angles.
  • n final containers cf are structurally associated with the n filling members 7.
  • This embodiment is well adapted to the case of a limited number of final containers cf and thus of filling members 7.
  • a second embodiment is well suited to the case of a larger number of end containers cf, while the number of filling members 7 remains limited, p being equal to or less than n.
  • a number q1 of final containers cf is structurally associated with a number q1 of filling members 7, q1 being equal to or less than n and, as previously indicated, in a filling step, the desired quantity of contained in each of the q1 end containers.
  • the filling step is repeated one or more times, respectively with numbers.
  • the numbers q1, q2, q3, qi are identical. In other realizations, depending on the case and the needs, they are different.
  • the inner means and members OI are also of disposable type for the successive steps of filling envisaged.
  • the method is such that, in a first phase, a first sterile filling of at least one first final elementary container is carried out with a first content originally located in a first source container CS. Then, in a second phase, a second sterile filling of at least one second final elementary container is carried out with a second content originally located in a second source container CS2.
  • a first transfer and filling line such as 4 is formed and after the corresponding filling step, the corresponding first final containers and the corresponding first filling members 7 are dissociated.
  • a second transfer and filling line of the same type as the first line 4 is formed, but adapted to the second filling and, after the corresponding filling step, the second final containers corresponding to the second corresponding second filling members 7.
  • Each phase corresponds to the complete filling process. Between the first phase and the second phase, therefore, the means and internal members OI and OFI of the first transfer and filling line 4 from the inside of the enclosure are evacuated towards the outside of the enclosure 1. 1 and then instead and place, in the chamber 1 and from outside of it, the means and internal organs OI and OFI of the second line of transfer and filling 4.
  • the method also comprises a step subsequent to the filling step in which the filled end containers are removed from the inside of the chamber 1 towards the outside of it, in a sterile manner.
  • the filling step or the reiteration of filling steps includes at least one operation of filling a container other than the final containers cf.
  • Such another ca container may be a container for testing, traceability or experimentation purposes.
  • the filling operation of such another container CA is carried out during the filling step of one or more final containers cf.
  • one or more filling members are specially dedicated to the one or more other container (s) ca.
  • the sterile filling unit comprises the sterile enclosure 1, the transfer and filling line 4 and its various means and members: communication means 5, distribution means 6, filling members 7, other means or functional members 8 and, also means capable of introducing in a sterile manner inside the enclosure 1 the inner means and members OI and, if appropriate, the single-use internal organs and functional devices OFI which, in a stage prior to the filling stage were outside the chamber 1.
  • Such a unitary assembly 12 comprises a sterile pocket 13 called means and internal organs.
  • the pocket 13 has a wall 14 which limits a sterile internal space 14a.
  • This wall 14 is provided with a door 15 associated with an opening 15a of the wall 14.
  • the door 15 is complementary to the door 2a, 2b of the enclosure 1.
  • the door 15 includes a flange 15b rigid association removable to the chamber 1, itself provided with a corresponding flange 16b part of the door 2a, 2b.
  • the two flanges 15b and 16b are complementary and can be associated rigidly and removably, by means of association and maneuvering means provided for this purpose.
  • Such means of association and such maneuvering means may comprise systems with pins and complementary grooves, with cams and levers or the like, for example.
  • the unitary assembly 12 can itself be rigidly and removably associated with the enclosure 1, towards the outside of it, the respective doors 15 and 2a, 2b coming in correspondence.
  • the door 15 also includes a leaf (not shown) movable between a closed state where it cooperates in a complementary manner with the flange 15b by closing the opening 15a and an open state where it is clear of the flange 15b leaving the opening open. 15a.
  • the door 2a, 2b also includes a movable leaf between a closed state where it cooperates in a complementary manner with the flange 16b by closing the opening 2c and an open state where it is clear of the flange 16b leaving the opening open. 2c.
  • maneuvering means of the leaf of the door 2a, 2b, which opens towards the inside of the enclosure 1.
  • maneuvering means can comprise articulations, levers, motors or the like, for example .
  • association means may include magnetic devices or the like, for example.
  • the leaves of the doors 2a, 2b and 15 being in the closed state and their associated leaves, it is possible to operate the leaf of the door 2a, 2b to open and bring it to the open state, the leaf being open simultaneously and clear of the flange 15b.
  • the internal space 14a of the pocket 13 is in communication with the interior of the enclosure 1 and it is possible to transfer from one to the other, either to introduce something that is was in the internal space of the pocket 13 inside the chamber 1 is, conversely, to evacuate something that was inside the enclosure 1 and bring it into the internal space of the pocket 13.
  • the combination of the unitary assembly 12 and the enclosure is made sterile, so that the transfer of introduction or evacuation referred to is itself also sterile.
  • the unitary assembly 12 comprises, in addition to the pocket 13, the inner means and members OI and, where appropriate, the means or inner functional members OFI. It is for this reason that the unitary unit 12, like the pocket 13, can be called "internal means and organs".
  • the means and organs OI and OFI are in the sterile state and placed in the internal space 14a of the bag 13. According to one embodiment, such a unitary assembly 12 can be produced in advance and independently of the filling process. Such a unitary assembly can be stored, transported and implemented as and when required.
  • such a unitary assembly 12 is produced in the very context of the filling process.
  • the filling method comprises a prior phase in which, having internal means and members OI and, where appropriate, internal means or organs OFI and a pocket 13, there is provided unitary assembly 12 and for this purpose these means and inner members OI, OFI are placed in the internal space 14a, the door 15 then being in the open state, then the door 15 is brought to the closed state.
  • the unit unit 12 is brought into the sterile state, for example by a y-ray treatment or the like.
  • unitary units 12 for the same filling sequence, for example if the total space requirement of the inner means and members OI, OFI is greater than the internal space of a single pocket 13.
  • Such a unitary assembly 17 comprises a sterile bag 18 called external means and bodies.
  • the pocket 18 has a wall 19 which limits a sterile internal space 19a.
  • This wall 19 is provided with a door 20 associated with an opening 20a of the wall 19.
  • the door 20 is complementary to the door 2a, 2b of the enclosure 1.
  • the door 20 includes a flange 20b rigid association removable to the enclosure 1.
  • the two flanges 20b and 16b are complementary and can be associated rigidly and removably, through association means and maneuvering means provided for this effect, as before.
  • the unitary assembly 17 can itself be rigidly and removably associated with the enclosure 1, towards the outside of it, the respective doors 20 and 2a, 2b coming in correspondence.
  • the door 20 also includes a leaf (not shown) movable between a closed state where it cooperates in a complementary manner with the flange 20b by closing the opening 20a and an open state where it is clear of the flange 20b leaving the opening open. 20a.
  • the leaves of the doors 2a, 2b and 20 being in the closed state and their associated leaves, it is possible to operate the leaf of the door 2a, 2b to open it and bring it to the open state, the leaf being open simultaneously and released from the flange 20b.
  • the internal space 19a of the pocket 18 is in communication with the interior of the enclosure 1 and it is possible to transfer from one to the other, in a manner analogous to that which was seen for the unitary set 12.
  • the combination of the unitary assembly 17 and the enclosure is made sterile, so that the transfer of introduction or evacuation referred to is itself also sterile.
  • the unitary assembly 17 comprises, in addition to the pocket 18, the outer means and members OE, including the crossing communication pipe section 11, and, where appropriate, the external functional means or members OFE. It is for this reason that the unitary assembly 17, like the pocket 18, can be called “external means and organs".
  • the means and organs OE and OFE are in the sterile state and placed in the internal space 19a of the pocket 18.
  • such a unitary assembly 17 can be produced in advance and independently of the filling process. According to another embodiment, such a unitary assembly 17 is produced in the very context of the filling process, in a manner similar to that which has been explained for the unitary assembly 12. Also, as for the unitary assembly 12, the unit unit 17 is brought to the sterile state.
  • a pocket 13, 18 comprises a flexible wall for example a plastic film or a rigid wall or a partially flexible and partially rigid wall.
  • the unitary assembly of inner means and members 12 and the unitary assembly of external means and members 17 are two structurally distinct sets.
  • the unitary assembly of means and inner members 12 is associated with the chamber 1 and, as previously stated, a sterile transfer of the inner means and members OI and OFI is carried out between the internal space 14a of the pocket 13 internal means and organs and the interior of the enclosure 1.
  • the unitary assembly of means and external members 17 is associated with the chamber 1 and, after the doors 2a, 2b, 20 have been opened, the downstream end portion 11a of the pipe section is introduced. crossing communication 11 inside the enclosure 1 and is associated in sterile communication with the upstream end portion 21 of the means and internal organs OI.
  • the door 15 is separated from the unitary assembly internal means and members 12 and the corresponding door 2a, 2b of the chamber 1, which is brought to the closed state.
  • the door 2a, 2b of the enclosure 1 corresponding to the unitary assembly 12 and the door 2a, 2b of the enclosure 1 corresponding to the unitary assembly 17 may be the same door.
  • the door 15 of the unitary unit 12 is held together with the corresponding door 2a, 2b of the enclosure 1.
  • the door 2a, 2b of the enclosure corresponding to the unitary assembly 12 and the door 2a, 2b of the enclosure 1 corresponding to the unitary assembly 17 may be distinct.
  • the unitary assembly of inner means and members 12 and the unitary assembly of means and outer members 17 form a single common unit 12/17.
  • this assembly 12/17 comprises a single pocket 13/18, a single wall 14/19, a single internal space 14a / 19a, a single door 15/20, a single opening 15a / 20a, a single flange 15b / 20b and a single leaf.
  • the door 15/20 is associated with the door 2a, 2b of the enclosure 1, then, after the doors 15/20 and 2a, 2b have been opened, a sterile transfer of the inner means and members OI and, if appropriate, OFI is performed. between the internal space 14a / 19a of the pocket 13/18 and the inside of the enclosure.
  • the downstream end portion 11a of the crossing communication conduit section 11 is introduced inside the enclosure and is associated in sterile communication with the upstream end portion 21 if they were not previously assembled.
  • these end portions 11a and 21 are pre-assembled in sterile communication so that there is no need to assemble them later.
  • the unitary assembly 12 and / or 17 associated with the enclosure 1 and the door or doors 15, 20 are kept in the open state.
  • the interior of the chamber 1 is placed in communication with the internal space 14a and / or 20a.
  • a total space is made comprising the internal space 14a and / or 20a of the pocket 14 and / or 20 and the interior of the enclosure 1.
  • This internal space is therefore larger in volume than the volume of the only inside the enclosure 1.
  • the space of the enclosure 1 can be increased.
  • the various means and organs OI, OFI, intended to be part of the part of the transfer line and filling 4 inside the enclosure 1 are all assembled to each other. Assemblies are meant to be connected in a sterile way. These means and organs OI, OFI are introduced inside the chamber 1 thus assembled.
  • the various means and organs OI, OFI are all disassembled from each other.
  • these means and members OI, OFI are introduced inside the chamber 1 thus disassembled, then are assembled to each other once located inside the chamber 1.
  • a part of the different means and organs OI, OFI are assembled to each other and another part disassembled from each other.
  • the means and members OI, OFI assembled are introduced inside the chamber 1 thus assembled, the means and organs OI, disassembled OFI are introduced inside the enclosure 1 and disassembled, then are assembled to each other and to means and organs OI, OFI already assembled once located inside the enclosure 1.
  • the various means and bodies OE, OFE intended to be part of the part of the transfer line and filling 4 outside the enclosure 1 are either all assembled to each other, or all disassembled from each other, or a part is assembled to each other and another part is disassembled from each other.
  • downstream end portion 11a of the part of the transfer and filling line 4 outside the enclosure and the upstream end portion 21 of the part of the transfer and filling line 4 to inside the enclosure are either assembled to one another or disassembled from each other. Of course, these two end portions are assembled for the filling step.
  • the sterile filling process and the sterile filling unit are provided so that, on the one hand, prior to the filling step, it can be introduced inside the enclosure 1, from the outside. of it, the final containers cf and / or the other empty container, on the other hand, after the filling step, to evacuate from the inside of the enclosure 1 towards the outside of it the final containers cf and / or the other container filled.
  • this evacuation can be achieved by means of one or more doors (or airlock) of the enclosure 1.
  • this evacuation can be achieved by means of one or more doors by which or by which the inner means and members OI and, where appropriate, OFI are introduced into the chamber or through which the contents are introduced from the source container CS to the final containers cf.
  • the sterile filling process and the sterile filling unit are provided in such a way that, after the filling step, it is possible to evacuate from the inside of the enclosure 1 towards the outside of it the means and OI internal organs and where appropriate OFI once they have been used for filling considered once completed, and need to be replaced by others, also for single use for another filling.
  • This evacuation can be achieved by means of one or more doors of the enclosure 1 and in particular by means of one or more doors by means of which or by which it has previously been introduced into the enclosure the means and OI internal organs and where appropriate OFI or by which the content has been introduced from the source container CS to the final containers cf.
  • the same unitary assembly 12, 17 is used for the introduction of the means and organs OI, OFI inside the enclosure 1 and the evacuation of these means and organs OI, OFI since the inside of enclosure 1.
  • a pocket 13, 18 of a unitary assembly 12, 17 may form part of or constitute the means of introduction and / or the means of evacuation of the containers cf and ca and form part or constitute the means of introduction and / or or the means of evacuation means and organs OI, OFI.
  • the method described allows the greatest flexibility, not only to allow the filling of one or more other containers ca, but also to adapt the number of filling members 8 to the needs, either to increase or to diminish it.
  • the filling process may comprise several steps of introduction inside the chamber 1 of means and internal organs OI, OFI and / or several evacuation steps from inside the enclosure 1 of internal means and organs OI, OFI. These steps are then combined with connection or disconnection operations of the means and members introduced or discharged with the means and inner organs held in the enclosure 1. These operations can, as necessary, intervene before or after one or more steps of 'filling.
  • sterile as used shall be understood as meaning free of microbial germ, virus or other unwanted substance, object or toxic product, according to the uses of the relevant field of application.
  • the invention provides means and disposable organs. Such means and members are for example made of plastic.
  • enclosure or "sterile enclosure” shall be understood to include clean rooms and related controlled environments with respect to air quality, as defined in ISO 14644 or USP Chap. 16.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Basic Packing Technique (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Filling Of Jars Or Cans And Processes For Cleaning And Sealing Jars (AREA)

Claims (31)

  1. Steriles Füllverfahren wenigstens eines elementaren Endbehälters (cf) mit einem Inhalt, der geeignet ist, fluid ausgegeben zu werden und sich ursprünglich steril in einem Quellbehälter (CS) befindet, bei dem:
    - über eine sterile Einfassung (1) verfügt wird, die wenigstens einen sterilen Eingangs- (2a) und / oder Ausgangsbehälter (2b) hat, und über den Quellbehälter (CS) verfügt wird, der den Inhalt enthält und sich an der Außenseite der Einfassung (1) befindet,
    - über Kommunikationsmittel (5), Ausgabemittel (6) und wenigstens ein Füllorgan (7) vom sterilen fluidischen Typ verfügt wird, die, wenn sie alle zusammengebaut sind, eine sterile fluidische Transfer- und Fülllinie (4) bilden, die einen Eingang (9) und wenigstens einen Ausgang hat, und über eine derartige Transfer- und Fülllinie (4) derart verfügt wird oder diese gebildet wird, dass sie für die Füllstufe die Wand (3) der Einfassung (1) steil durchquert, wobei sich der Eingang (9) an der Außenseite der Einfassung (1) und in steriler fluidischer Kommunikation mit dem Quellbehälter befindet, wobei das wenigstens eine Füllorgan am Ausgang sich im Innern der Einfassung (1) befindet und positioniert ist, um betriebsfähig zu sein, wobei eines oder mehrere so genannte interne Mittel und Organe (OI) sich im Wesentlichen im Innern der Einfassung (1) befinden und eines oder mehrere der so genannten externen Mittel und Organe (OE) sich im Wesentlichen an der Außenseite der Einfassung (1) befinden und einen Abschnitt einer Kommunikationsleitung, bezeichnet als Überbrückung (11), beinhalten, die geeignet ist, die Wand (3) der Einfassung (1) steril zu durchqueren,
    - wenigstens ein Endbehälter (cf) wird steril ins Innere der Einfassung (1) eingeführt,
    - zum Füllen wird strukturell wenigstens ein Endbehälter (cf) wenigstens einem Füllorgan (7) zugeordnet,
    - in einer Füllstufe wird Inhalt aus dem Quellbehälter (CS) entnommen, er wird in die Transfer- und Fülllinie (4) übertragen und die gewünschte Menge wird in wenigstens einen Endbehälter (cf) ausgegeben, dadurch gekennzeichnet, dass:
    - wenigstens die internen Mittel und Organe (OI) mit einem Platzverbrauch gewählt werden, der den Durchgang durch eine Tür der Einfassung (1) erlaubt und vom Typ zum einmaligen Gebrauch für das beabsichtigte Füllen ist,
    - in einer früheren Füllstufe über interne Mittel und Organe (OI) im sterilen Zustand verfügt wird, wobei diese Mittel und Organe sich an der Außenseite der Einfassung (1) befinden,
    - in einer späteren Einführstufe ebenfalls vor der Füllstufe der internen Mittel und Organe (OI) in die Einfassung (1), werden die internen Mittel und Organe (OI) zum einmaligen Gebrauch, die sich zuvor an der Außenseite der Einfassung (1) befanden, steril in das Innere der Einfassung (1) eingeführt,
    derart, dass nach dem realisierten Füllen ein weiteres Füllen durchgeführt werden kann, ohne dass das Innere der Einfassung (1) sterilisiert werden muss.
  2. Steriles Füllverfahren gemäß Anspruch 1, dadurch gekennzeichnet, dass ebenfalls externe Mittel und Organe (OE) vom Typ zum einmaligen Gebrauch zum beabsichtigten Füllen gewählt werden.
  3. Steriles Füllverfahren gemäß Anspruch 1 und 2 zum Füllen einer Struktur aus n Endbehältern (cf), jeden mit derselben Menge an Inhalt, bei dem:
    - über eine Struktur aus n Endbehältern (cf) verfügt wird,
    - über p Füllorgane, eine Transfer- und Fülllinie (4) verfügt wird, die einen Eingang (9) und p Ausgänge hat, wobei p gleich oder größer als n ist,
    - die n Endbehälter (cf) in die Einfassung (1) eingeführt werden,
    - die n Endbehälter (cf) strukturell n Füllorganen (7) zugeordnet werden,
    - und in einer und derselben Füllstufe die n End-container (cf) gefüllt werden.
  4. Steriles Füllverfahren gemäß Anspruch 1 und 2 zum Füllen einer Struktur von n Endbehältern (cf), jeder mit derselben Menge an Inhalt, dadurch gekennzeichnet, dass:
    - über eine Struktur von n Endbehältern (cf) verfügt wird,
    - über p Füllorgane (7) verfügt wird, wobei eine Transfer- und Fülllinie (4) einen Eingang (9) und p Ausgänge hat, wobei p gleich oder kleiner als n ist,
    - strukturell eine Anzahl von q1 Endbehältern (cf) einer Anzahl von q1 Füllorganen (7) zugeordnet wird, wobei q1 gleich oder kleiner als n ist,
    - in einer Füllstufe die gewünschte Menge an Inhalt in jeden der q1 Endbehälter (cf) ausgegeben wird,
    - die q1 Endbehälter (cf) und die q1 Füllorgane (7) voneinander getrennt werden und die Füllstufe bei gleichzeitiger Beibehaltung der Betriebsbereitschaft der zuvor umgesetzten internen Mittel und Organe (OI) ein oder mehrere Male mit den Zahlen q2, q3, qi der Endbehälter (cf) bis zum Füllen der n Endbehälter (cf) wiederholt wird, wobei die internen Mittel und Organe (OI) vom Typ zum einmaligen Gebrauch für die sukzessiven beabsichtigten Füllstufen sind.
  5. Steriles Füllverfahren gemäß Anspruch 1 bis 4, bei dem in einer ersten Phase das sterile Füllen wenigstens eines ersten elementaren Endbehälters (cf) mit einem ersten Inhalt vorgenommen wird, der sich ursprünglich in einem ersten Quellbehälter (CS) befindet, und in einer zweiten sterilen Füllphase wenigstens eines zweiten elementaren Endbehälters (cf) mit einem zweiten Inhalt, der sich ursprünglich in einem zweiten Quellbehälter (CS2) befindet, bei dem:
    - in der ersten Phase eine Transfer- und Fülllinie (4) gebildet wird und nach der Füllstufe der wenigstens eine erste Endbehälter (cf) und das wenigstens eine erste Füllorgan (7) voneinander getrennt werden,
    - in der zweiten Phase eine zweite Transfer- und Fülllinie (4) gebildet wird und nach der Füllstufe den wenigstens einen zweiten Endbehälter (cf) und das wenigstens eine zweite Füllorgan (7) voneinander getrennt werden,
    - und von der ersten Phase zur zweiten Phase übergegangen wird, ohne das Innere der Einfassung (1) erneut zu sterilisieren.
  6. Steriles Füllverfahren gemäß Anspruch 1 bis 5, gekennzeichnet durch die Tatsache, dass wenigstens über einen Endbehälter (cf) und einen Quellbehälter (CS) derart verfügt wird, dass der wenigstens eine Endbehälter (cf) ein Fassungsvermögen hat, das ein Bruchteil des Fassungsvermögens des Quellbehälters (CS) ist; und / oder dass Kommunikationsmittel (5) aus der Gruppe ausgewählt sind, die Schläuche, Röhren, Leitungen und dergleichen umfassen, die Ausgabemittel (6) aus der Gruppe ausgewählt sind, die Pumpen und dergleichen umfassen, die Füllorgane (7) aus der Gruppe ausgewählt sind, die Einspritznadeln, Düsen und dergleichen umfassen; und / oder die Füllorgane (7) und die Endbehälter (cf) derart ausgewählt sind, dass ursprünglich ein Füllorgan (7) von einem Endbehälter (cf) entweder getrennt oder wenigstens zum Teil in ihn integriert ist; und / oder ein Endbehälter (cf) aus der Gruppe ausgewählt ist, die offene oder geschlossene Behälter, Fläschchen, Spritzen, Flakons und Flaschen, Beutel oder Systeme mit Beuteln zum einmaligen oder mehrmaligen Gebrauch umfasst.
  7. Steriles Füllverfahren gemäß Anspruch 1 bis 6, gekennzeichnet durch die Tatsache, dass in einer Stufe nach der Füllstufe vom Innern der Einfassung (1) zur Außenseite derselben der wenigstens eine Endbehälter (cf) steril gefüllt wird; und / oder gekennzeichnet durch die Tatsache, dass in der Stufe vor der Füllstufe darüber hinaus über wenigstens ein weiteres funktionales Mittel oder Organ (8) verfügt wird, das dazu bestimmt ist, in die Transfer- und Fülllinie (4) integriert zu werden, wie z. B. Filtermittel, Pufferspeichermittel, Anschlussmittel, insbesondere zum einmaligen Gebrauch zum so genannten externen beabsichtigten Füllen, das sich an der Außenseite der Einfassung (1) befindet, die, da sie an die Kommunikationsmittel (5), die Ausgabemittel (6) und wenigstens ein Füllorgan (7) angeschlossen ist, die sterile fluidische Transfer- und Fülllinie (4) bilden, und über eine derartige Transfer- und Fülllinie (4) verfügt oder sie bildet.
  8. Steriles Füllverfahren gemäß Anspruch 7, gekennzeichnet durch die Tatsache, dass für die Füllstufe wenigstens ein von wenigstens einem weiteren funktionalem Mittel oder Organ (8), das dazu bestimmt ist, in die Transfer- und Fülllinie (4) eingeführt zu werden, ein so genanntes internes Mittel oder Organ (OI) ist, das sich im Innern der Einfassung (1) befindet, und durch die Tatsache, dass:
    - das wenigstens eine von wenigstens einem weiteren internen funktionalen Mittel oder Organ (OI) vom Typ zum einmaligen Gebrauch für das beabsichtigte Füllen gewählt wird,
    - in einer Stufe vor der Füllstufe über wenigstens ein weiteres internes funktionales Mittel oder Organ (OFI) verfügt wird, wobei dieses interne funktionale Mittel oder Organ (OFI) sich an der Außenseite der Einfassung (1) befindet,
    - in einer Stufe nach der Einführung des wenigstens einen internen funktionalen Mittels oder Organs (OFI) in die Einfassung (1) ebenfalls vor der Füllstufe dieses interne funktionale Mittel oder Organ (OFI) zum einmaligen Gebrauch, das sich zuvor an der Außenseite der Einfassung (1) befand, in das Innere der Einfassung (1) steril eingeführt wird.
  9. Steriles Füllverfahren gemäß Anspruch 1 bis 8, gekennzeichnet durch die Tatsache, dass, um betriebsfähig sein zu können, in die Einfassung (1) wenigstens Kommunikationsmittel (5), Ausgabemittel (6) und das wenigstens eine Füllorgan (7) und ggf. ebenfalls das wenigstens eine von einem weiteren internen funktionalen Mittel oder Organ (OFI) zum einmaligen Gebrauch eingeführt wird.
  10. Steriles Füllverfahren gemäß Anspruch 1 bis 9, gekennzeichnet durch die Tatsache, dass in der Stufe vor der Füllstufe über interne Mittel und Organe (OI) im sterilen Zustand verfügt wird, die sich an der Außenseite der Einfassung (1) befinden, über wenigstens eine sterile Einheitsstruktur (12/17) aus internen Mitteln und Organen (OI) verfügt wird, die einen sterilen Beutel (13), für interne Mittel und Organe (OI) mit einer Wand (14) umfassen, die einen sterilen internen Raum (14a) begrenzt, und mit einer Öffnung (15a) und einer Tür (15) versehen ist, die komplementär einer Tür (2a, 2b) der Einfassung (1) zugeordnet ist und geeignet ist, einen sterilen Transfer dieser internen Mittel und Organe (OI) zwischen dem internen Raum des Beutels (13) und dem Innern der Einfassung (1) zu erlauben, wenn die Einheitsstruktur (12/17) der Einfassung (1) zugeordnet ist, und sich die Türen in offenem Zustand befinden, wobei diese internen Mittel und Organe (OI) im sterilen Zustand in den internen Raum des Beutels (13) platziert sind.
  11. Steriles Füllverfahren gemäß Anspruch 10, gekennzeichnet durch die Tatsache, dass es eine vorherige Phase umfasst, in der, wenn über interne Mittel und Organe (OI) und einen Beutel (13) für interne Mittel und Organe (OI) verfügt wird, deren interner Raum (14a) diese Mittel und Organe nicht enthält, die wenigstens eine Einheitsstruktur (12) aus internen Mitteln und Organen (OI) gebildet wird und zu diesem Zweck diese internen Mittel und Organe (OI) in den interne Raum (14a) platziert werden, die Tür (15) des Beutels (13) für interne Mittel und Organe (OI) in den geschlossenen Zustand verbracht wird und die wenigstens eine Einheitsstruktur (12) in den sterilen Zustand verbracht wird.
  12. Steriles Füllverfahren gemäß Anspruch 10 und 11, gekennzeichnet durch die Tatsache, dass in der Stufe vor der Füllstufe in der über externe Mittel und Organe (OE) im sterilen Zustand verfügt wird, die sich an der Außenseite der Einfassung (1) befinden, darunter auch der Abschnitt einer Kommunikationsleitung zur Überbrückung, über eine sterile Einheitsstruktur (17) aus externen Mitteln und Organen (OE) verfügt wird, die einen sterilen Beutel (18) für externe Mittel und Organe (OE) mit einer Wand (19) umfassen, die einen sterilen internen Raum (19a) begrenzt und mit einer Öffnung (20a) und einer Tür (20) versehen ist, die komplementär einer Tür (2a, 2b) der Einfassung (1) zugeordnet ist und geeignet ist, einen sterilen Transfer dieser externen Mittel und Organe (OE) zwischen dem inneren Raum (19a) der Tür (18) und dem Inneren der Einfassung (1) zu erlauben, wenn die Einheitsstruktur (17) der Einfassung (1) zugeordnet ist und die Türen (2a, 2b, 20) sich im offenen Zustand befindet, wobei diese externen Mittel und Organe (OE) im sterilen Zustand in den internen Raum (19a) des Beutels (18) platziert sind.
  13. Steriles Füllverfahren gemäß Anspruch 10 und 11, gekennzeichnet durch die Tatsache, dass über eine Einheitsstruktur (17) aus externen Mitteln und Organen (OE) und eine Einheitsstruktur (12) aus gemeinsamen internen Mitteln und Organen (12) verfügt wird und sukzessive die Tür (15) der Einheitsstruktur (12) aus internen (OI) und externen (OE) Mitteln und Organen und eine Tür (2a, 2b) der Einfassung (1) zugeordnet werden und nach der Öffnung der Türen ein steriler Transfer der internen Mittel und Organe (OI) zwischen dem internen Raum des Beutels (13) für interne (OI) und externe (OE) Mittel und Organe und dem Innern der Einfassung (1) realisiert wird, der nachgeschaltete Endteil (11a) des Abschnitts der Kommunikationsleitung zur Überbrückung (11) ins Innere der Einfassung (1) eingeführt wird.
  14. Steriles Füllverfahren gemäß Anspruch 1 bis 13, gekennzeichnet durch die Tatsache, dass vor dem Einführen der internen Mittel und Organe (OI) und des wenigstens einen internen funktionalen Mittels oder Organs (OFI) in die Einfassung (1), entweder die unterschiedlichen Mittel und Organe, die dazu bestimmt sind, Bestandteile des Teils der Transfer- und Fülllinie (4) im Innern der Einfassung (1) zu sein, alle miteinander zusammengebaut werden, wobei sie somit zusammengebaut ins Innere der Einfassung (1) eingeführt werden, oder diese unterschiedlichen Mittel und Organe werden alle jeweils auseinandergebaut, wobei sie somit auseinandergebaut ins Innere der Einfassung (1) eingeführt und dann zusammengebaut werden, nachdem sie sich im Innern der Einfassung (1) befinden, oder ein Teil dieser unterschiedlichen Mittel und Organe wird zusammengebaut und ein anderer Teil wird auseinandergebaut, wobei die zusammengebauten Mittel und Organe somit zusammengebaut ins Innere der Einfassung (1) eingeführt werden, wobei die auseinandergebauten Mittel und Organe somit auseinandergebaut ins Innere der Einfassung (1) eingeführt werden, dann jeweils zusammengebaut und mit den bereits zusammengebauten Mitteln und Organen zusammengebaut werden, nachdem sie sich im Innern der Einfassung (1) befinden.
  15. Steriles Füllverfahren gemäß Anspruch 1 bis 14, gekennzeichnet durch die Tatsache, dass vor der Einführstufe die unterschiedlichen Mittel und Organe (OE), die dazu bestimmt sind, den Teil der Transfer- und Fülllinie (4) an der Außenseite der Einfassung (1) zu bilden, entweder alle zusammengebaut sind oder alle auseinandergebaut sind oder ein Teil jeweils zusammengebaut ist und ein anderer Teil jeweils auseinandergebaut ist, wobei sich diese unterschiedlichen Mittel und Organe für die Füllstufe zusammengebaut befinden; und / oder der nachgeschaltete Endteil (11a) des Teils der Transfer- und Fülllinie (4) an der Außenseite der Einfassung (1) und der vorgeschaltete Endteil (21) des Teils der Transfer- und Fülllinie (4) im Innern der Einfassung (1) sind entweder jeweils zusammengebaut oder jeweils auseinandergebaut, wobei diese zwei Teile der Transfer- und Fülllinie (4) sich für die Füllstufe zusammengebaut befinden.
  16. Steriles Füllverfahren gemäß Anspruch 1 bis 15, gekennzeichnet durch die Tatsache, dass der oder die Endbehälter (cf) und / oder der oder die anderen Behälter durch eine Tür (2a, 2b) der Einfassung (1), durch die die inneren Mittel und Organe (OI) und / oder das wenigstens eine interne funktionale Mittel oder Organ (OFI) in die Einfassung (1) eingeführt werden, ins Innere der Einfassung (1) eingeführt werden.
  17. Steriles Füllverfahren gemäß Anspruch 1 bis 16, gekennzeichnet durch die Tatsache, dass nach der Füllstufe in einer Austragsstufe der internen Mittel und Organe (OI) und des wenigstens einen internen funktionalen Mittels oder Organs (OFI), das für das realisierte Füllen umgesetzt wird, die internen Mittel und Organe (OI) und das wenigstens eine interne funktionale Mittel oder Organ (OFI) vom Innern der Einfassung (1) zu ihrer Außenseite steril ausgetragen wird.
  18. Sterile Fülleinheit wenigstens eines elementaren Endbehälters (cf) mit einem Inhalt, der geeignet ist, fluid ausgegeben zu werden und sich steril ursprünglich in einem Quellbehälter (CS) zu befinden, die speziell für die Umsetzung des Verfahrens gemäß Anspruch 1 bis 17 bestimmt ist, umfassend:
    - eine sterile Einfassung (1), die wenigstens eine sterile Eingangs- (2a) und / oder Ausgangstür (2b) hat,
    - Kommunikationsmittel (5), Ausgabemittel (6) und wenigstens ein Füllorgan (7) vom sterilen fluiden Typ, die, wenn sie alle zusammengebaut sind, eine sterile, fluidische Transfer- und Fülllinie (4) bilden, die einen Eingang (9) und wenigstens einen Ausgang derart hat, dass sie für die Füllstufe die Wand (3) der Einfassung (1) steril durchquert, wobei der Eingang (9) sich an der Außenseite der Einfassung (1) und in steriler fluidischer Kommunikation mit dem Quellbehälter (CS) befindet, wobei das wenigstens eine Füllorgan (7) am Ausgang sich im Innern der Einfassung (1) befindet und positioniert ist, um betriebsfähig zu sein, wobei ein oder mehrere als interne Mittel oder Organe bezeichnete Mittel oder Organe (OI) sich hilfsweise im Innern der Einfassung (1) befinden und ein oder mehrere als externe Mittel und Organe bezeichnete Mittel und Organe (OE), insbesondere vom Typ zum einmaligen Gebrauch zum beabsichtigten Füllen sich im Wesentlichen an der Außenseite der Einfassung (1) befinden und einen Abschnitt eines Kommunikationsleiters zur so genannten Überbrückung (11) geeignet ist, die Wand (3) der Einfassung (1) steril zu durchqueren und deren nachgeschalteter Endteil (11a) geeignet ist, mit dem vorgeschalteten Endteil (21) der internen Mittel und Organe (OI) in sterile Kommunikation gebracht zu werden, wobei die internen Mittel und Organe (OI) einen Platzverbrauch aufweisen, der den Durchgang durch eine Tür (2a, 2b) der Einfassung (1) zulässt und vom Typ zum einmaligen Gebrauch für das beabsichtigte Füllen sind,
    - und Mittel, die geeignet sind, die internen Mittel und Organe (OI) zum einmaligen Gebrauch steril ins Innere der Einfassung (1) einzuführen und die in einer Stufe vor der Füllstufe sich an der Außenseite der Einfassung (1) befanden.
  19. Sterile Fülleinheit gemäß Anspruch 18, gekennzeichnet durch die Tatsache, dass sie p Füllorgane (7) für n Endbehälter (cf) umfasst, wobei p entweder gleich oder größer als n ist, wobei die Fülleinheit speziell für die Umsetzung des Verfahrens gemäß Anspruch 3 bestimmt ist, oder gleich oder kleiner als n ist, wobei die Fülleinheit speziell für die Umsetzung des Verfahrens gemäß Anspruch 4 bestimmt ist.
  20. Sterile Fülleinheit gemäß Anspruch 18 oder 19, gekennzeichnet durch die Tatsache, dass sie darüber hinaus wenigstens ein anderes funktionales Mittel oder Organ (8) umfasst, das dazu bestimmt ist, in die Transfer- und Fülllinie (4) integriert zu werden, wie z. B. ein Filtermittel, ein Pufferspeichermittel, ein Anschlussmittel, wobei das genannte andere funktionale Organ (8) entweder zum einmaligen Gebrauch zum beabsichtigten Füllen ist und sich im Innern der Einfassung (1) befindet, oder sich an der Außenseite der Einfassung (1) befindet.
  21. Sterile Fülleinheit gemäß Anspruch 18 bis 20, gekennzeichnet durch die Tatsache, dass die internen Mittel und Organe (OI) wenigstens Kommunikationsmittel (5), Ausgabemittel (6), das wenigstens eine Füllorgan (7) und ggf. das wenigstens eine andere funktionale interne Mittel oder Organ (OFI) zum einmaligen Gebrauch umfassen.
  22. Sterile Fülleinheit gemäß Anspruch 18 bis 21, gekennzeichnet durch die Tatsache, dass sie ebenfalls wenigstens eine sterile Einheitsstruktur (12) aus internen Mitteln und Organen (OI) beinhaltet, die einen sterilen Beutel (13) für interne Mittel und Organe (OI) umfassen, der eine Wand (14) hat, die einen sterilen internen Raum (14a) begrenzt und mit einer Öffnung (15a) und einer Tür (15) versehen ist, die komplementär einer Tür (2a, 2b) der Einfassung (1) zugeordnet ist, die geeignet ist, einen sterilen Transfer dieser internen Mittel und Organe (OI) zwischen dem internen Raum (14a) des Beutels (13) und dem Innern der Einfassung (1) zu erlauben, wenn die Einheitsstruktur (12) der Einfassung (1) zugeordnet ist und die Türen (2a, 2b, 15) sich im offenen Zustand befinden, wobei diese internen Mittel und Organe (OI) im sterilen Zustand in den internen Raum (14a) des Beutels (13) für interne Mittel und Organe (OI) platziert sind.
  23. Sterile Fülleinheit gemäß Anspruch 18 bis 22, gekennzeichnet durch die Tatsache, dass sie ebenfalls wenigstens eine sterile Einheitsstruktur (17) aus externen Mitteln und Organen (OE) beinhaltet, die einen sterilen Beutel (18) für externe Mittel und Organe (OE) umfasst, der eine Wand (19) hat, die einen sterilen internen Raum (19a) begrenzt und mit einer Öffnung (20a) und einer Tür (20) versehen ist, die komplementär einer Tür (2a, 2b) der Einfassung (1) zugeordnet ist, die geeignet ist, einen sterilen Transfer dieser externen Mittel und Organe (OE) zwischen dem inneren Raum (19a) des Beutels (18) und dem Innern der Einfassung (1) zu erlauben, wenn die Einheitsstruktur (17) der Einfassung (1) zugeordnet ist und die Türen (2a, 2b, 20) sich im offenen Zustand befinden, wobei diese externen Mittel und Organe (OE) im sterilen Zustand im internen Raum (14a) des Beutels (13) für interne Mittel und Organe platziert sind.
  24. Sterile Fülleinheit gemäß Anspruch 18 bis 23, gekennzeichnet durch die Tatsache, dass die Mittel und Organe, die die Transfer- und Fülllinie (4) bilden, wenigstens ein externes Mittel oder Organ (OE) mit einem Platzverbrauch beinhalten, der den Durchgang durch eine Tür (2a, 2b) der Einfassung (1) nicht erlaubt.
  25. Sterile Fülleinheit gemäß Anspruch 18 bis 24, gekennzeichnet durch die Tatsache, dass vor dem Einführen der internen Mittel und Organe (OI) und des wenigstens einen internen funktionalen Mittels oder Organs (OFI) in die Einfassung (1) entweder die unterschiedlichen Mittel und Organe, die dazu bestimmt sind, den Teil der Transfer- und Fülllinie (4) im Innern der Einfassung (1) zu bilden, alle jeweils zusammengebaut sind, oder diese unterschiedlichen Mittel und Organe alle jeweils auseinandergebaut sind, oder ein Teil dieser unterschiedlichen Mittel und Organe jeweils zusammengebaut ist und ein anderer Teil jeweils auseinandergebaut ist.
  26. Sterile Fülleinheit gemäß Anspruch 18 bis 25, gekennzeichnet durch die Tatsache, dass die unterschiedlichen Mittel und Organe, die dazu bestimmt sind, den Teil der Transfer- und Fülllinie (4) an der Außenseite der Einfassung (1) zu bilden, vor der Füllstufe entweder alle jeweils zusammengebaut sind oder alle jeweils auseinandergebaut sind oder zum Teil jeweils zusammengebaut und zu einem anderen Teil jeweils auseinandergebaut sind; und / oder der nachgeschaltete Endteil (11a) des Teils der Transfer- und Fülllinie (4) an der Außenseite der Einfassung (1) dem vorgeschalteten Endteil (21) des Teils der Transfer- und Fülllinie (4) im Innern der Einfassung (1) entweder jeweils zusammengebaut sind oder jeweils auseinandergebaut sind und sich für die Füllstufe zusammengebaut befinden.
  27. Sterile Fülleinheit gemäß Anspruch 18 bis 25, gekennzeichnet durch die Tatsache, dass sie darüber hinaus Einführmittel der leeren Endbehälter (cf) und der Austragsmittel ins Innere der Einfassung (1) der gefüllten Endbehälter (cf) vom Innern der Einfassung (1) umfasst.
  28. Einheitsstruktur (12/17), die zur Umsetzung eines Füllverfahrens gemäß Anspruch 1 bis 17 und zur Realisierung einer sterilen Fülleinheit gemäß Anspruch 18 bis 27 bestimmt ist und dass eine Einheitsstruktur (12/17) vorgesehen ist, umfassend:
    - einen sterilen Beutel (13/18) für interne Mittel und Organe (OI), der eine Wand (14) hat, die einen sterilen internen Raum (14a) begrenzt und mit einer Öffnung (15a) und einer Tür (15) versehen ist, die komplementär einer Tür (2a, 2b) der Einfassung (1) zugeordnet ist, die geeignet ist, einen sterilen Transfer des Inhaltes des Beutels (13/18) im Innern der Einfassung (1) zu erlauben, wenn die Einheitsstruktur (12/17) der Einfassung (1) zugeordnet ist und die Türen sich im offenen Zustand befinden,
    - und die internen Mittel und Organe (OI), die Teil der Transfer- und Fülllinie (4) sind, mit einem Platzverbrauch, der den Durchgang durch eine Tür (2a, 2b) der Einfassung (1) erlaubt und vom Typ zum einmaligen Gebrauch für das beabsichtigte Füllen sind, wenn sie im internen Raum des Beutels platziert sind.
  29. Einheitsstruktur (12/17) gemäß Anspruch 28, gekennzeichnet durch die Tatsache, dass sie ebenfalls wenigstens einen Abschnitt einer Kommunikationsleitung zur Überbrückung (11) beinhaltet, die im inneren Raum (14a/19a) des Beutels (13/18) platziert ist, und wenigstens einen Abschnitt der Zuführkommunikation, der an der Außenseite des Beutels (13/18) platziert ist und Teil der externen Mittel und Organe (OE) ist.
  30. Einheitsstruktur (12/17) gemäß Anspruch 28 und 29, gekennzeichnet durch die Tatsache, dass der Beutel (13/18) eine elastische Wand (14/19) oder eine steife Wand (14/19) oder eine teilweise elastische und teilweise steife Wand (14/19) umfasst; und / oder gekennzeichnet durch die Tatsache, dass sie wenigstens ein anderes funktionales Mittel oder Organ (8) umfasst, das im internen Raum (14a/19a) des Beutels (13/18) platziert ist.
  31. Einheitsstruktur (12/17) gemäß Anspruch 28 bis 30, gekennzeichnet durch die Tatsache, dass die unterschiedlichen Mittel und Organe, die dazu bestimmt sind, Teil der Transfer- und Fülllinie (4) zu sein, und sich im internen Raum (14a/19a) des Beutels (13/18) befinden, ursprünglich entweder alle jeweils zusammengebaut sind oder alle jeweils auseinandergebaut sind oder zum Teil jeweils zusammengebaut sind und zu einem anderen Teil jeweils auseinandergebaut sind.
EP11711610.3A 2010-02-10 2011-02-09 Verfahren und einheit zur sterilen füllung eines finalen grundbehälters mit für den biopharmaziebereich vorgesehenen inhalten Revoked EP2534052B1 (de)

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PCT/FR2011/050272 WO2011098724A1 (fr) 2010-02-10 2011-02-09 Procede et unite d'emplissage sterile d'un conteneur elementaire final avec un contenu destine au domaine biopharmaceutique

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CN102947186B (zh) 2015-04-08
US20200407085A1 (en) 2020-12-31
US11655058B2 (en) 2023-05-23
CN102947186A (zh) 2013-02-27
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US20230286681A1 (en) 2023-09-14
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