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 invention relates to a lock for a clean room for introducing at least one article packed in a bag through an inlet opening.
• 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 seal on the
• Container sealed 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.
• This object is achieved by a method of the type mentioned in the present invention, that 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 a hose-like connection between the interior closed to the outside 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 the inside of the inlet to the outside of the endless film tube and on the other hand at the same place the inside of the
• Endlosfolienschlauch connects, whereupon the peelable inside of the endless film tube (Ia) dissolved and the bag is peeled and opened in the direction of the clean room for transferring the at least one object.
• 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 with its side facing away from the inlet with a bag-shaped sealing film is connected, the bag bottom is within the transition foil and the bag edge connected to the inlet side facing away from the transition foil, for example, is welded, wherein for the sealing a plastic is selected, the good is weldable, and the bag-shaped sealing film is arranged around the outside of the pouch containing the at least one object so that the weld closing this bag comes to lie within the bag, wherein the bag containing the at least one object is welded to the sealing film, so that between the existing weld of the at least one article containing bag and the free edge of the sealing film at least one continuous new weld seam preferably double weld arises, on the one hand the inside of the sealing film with the outside of the at least a sachet containing the
• 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 dividing 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.
• the object mentioned above can also be achieved, according to the invention, with a lock of the type mentioned at the beginning, in that the lock has an inner liner passing through the inlet opening, which connects the clean room to an outer space, wherein welding means are provided to connect the inner liner to the bag.
• the innerliner is closed before the transfer to the outside space.
• the innerliner is formed here as a weldable, on its inside after the peeling peelable endless tubular film, thereby easy opening of the inner liner can be ensured in the direction of the bag after welding with this.
• a further advantageous variant of the invention provides that the lock has an annularly arranged around an inlet of the clean room chamber, in which the inner liner is mounted axially around the inlet opening.
• FIG. 2 shows a view of a welded endless tubular film above an inlet of an inner liner to be filled
• Fig. 3 is a side view of the illustration of Fn; ?;
• Fig. 4 is a view of the welded endless tubular film of i ⁇ ; J after insertion into the inlet of the inner liner to be filled;
• Fig. 5 is a side view of the representation of 1 i *> 4;
• Fig. 6 is the view of Fig. 1; 4- with attached weld;
• Fig. 7 is a side view of the representation of t u; O; 30
• Fig. 8 is a view of a welded and then peeled endless tube film according to iX »s
• Fig. 9 is a side view of the representation of ⁇ ip, ⁇ ; 35
• Fig. 11 is a side view of the representation of He., ⁇ 0;
• Fig. 13 is a side view of the representation of t u; I. ";
• Fig. Heine view of a continuous tube film acc. Ti.; ? above a bag according to the invention at an inlet;
• 15 is a side view of the representation according to ⁇ ip. 1 4;
• Fig. 16 is a view of the structure according to Tn; i 4, with the endless tubular film in the bag was inserted;
• Fig. 17 is a side view of the representation according to Fig l ö;
• FIG. 18 is a view of the representation according to FIG. 16, but with additionally attached weld seam at a second location;
• FIG. 25 is a view of the representation according to FIG. 16, but with additionally attached weld seam at a second location;
• FIG. 19 is a side view of the illustration according to FIG.
• FIG. 20 shows a view of the illustration according to FIG. 8, but with a severed token
• Fig. 22 is a view of the structure of Fig. 20, wherein the endless tubular film has been peeled (opened) at its first welding location;
• FIG. 23 shows a side view of the illustration according to FIG.
• FIGS. 24 and 25 show the structure of FIG. 22 after a separating weld has been re-attached to the endless tubular film at a third position;
• Figure 26 is a side view of a bag with a bag-shaped receptacle for an end portion of an inner liner, wherein the end portion is inserted into the receptacle.
• FIG. 27 shows a side view of the arrangement from FIG. 19, wherein the end section of the inner liner is connected to side walls of the receptacle with a welded seam, FIG.
• Fig. 28 is a side view of the arrangement of Fig. 26 after separation of the weld and after aufpcclen the Endlosschla ⁇ chcs
• 29 shows a schematic cross section through a lock according to the invention for a clean room.
• FIGS. 12 and 13 wherein the welding of freely protruding remnants of the inlet can be dispensed with, since the severed lower part of the endless tubular film already serves as closure of the inner liner or inlet.
• this clean room is designated by the reference numeral 15.
• a bag 1 may contain a single article 1' or else 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 sterilely into the clean room by means of the inner liner joining the outer space according to the invention, and thus pass from the interior of the bag 1 into the clean room without requiring further on-site sterilization is.
• the bag 1 is made of an endless film tube Ia, which is weldable on its outside and inside.
• the inside of the endless film tube Ia is peelable after welding and the bag 1 is closed after its filling by welding.
• the bag 1 is connected to an inner liner 4a which connects the clean room to an outer space and is then opened on a region facing the inner liner 4a, so that a closed to the outside, tubular connection between the interior of the bag 1 and the inner liner 4a is formed, through which an emptying of the bag can be done 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.
• Figs. 8 and 9 now show the process of opening the hose connection to enable the transfer operation: the first weld 3a and the second weld 6a are peeled, i. From the outside, an operator grasps the endless tubular film Ia and pulls it apart, whereby the inner 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 Ia and the inlet 2a remains.
• the innerliner 4a is tightly connected to the bag 1. In this state, 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.
• 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.
• a bag-like sealing foil 6 is welded edge-tightly.
• the sealing film 6 is made of pure PE and good weldability on all sides.
• the inner liner 4b is with the
• Transition foil 5 tightly welded 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.
• 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 foil 6 and welded to the inlet formed as a bag 7:
• the endless tube foil Ia or the bag 1 is inserted into the bag-shaped recess the sealing film 6 of the inner liner to be filled 4b inserted.
• the outer sides of the sealing film 6 thus touch the outer sides of the endless tubular film Ia 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.
• FIGS 18 and 19 now show the process in which the nested endless tubular film Ia of the bag 1 and the sealing film 6 are welded: - With a welder (not shown, because in itself conventional), the endless tubular film Ia and the sealing film are welded together, so in that two tight weld seams 8a, 8b are formed between the endless film tube 1a and the bag 7. In this process, the endless tubular film Ia is also mitverschweisst. 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 film 6 or with the endless tubular film Ia.
• FIGS. 20 and 21 show the process of separating the token 10: The token falls down into the inner liner 4b and is taken from the clean room side.
• FIGS. 22 and 23 show the process of peeling in which the endless tubular film 1a and with it the sealing film 16 are opened. The welding between the endless tubular film Ia and the sealing film 16, however, remains. As a result, the innerliner 4b is tightly connected to the bag 1. In this state, the inner liner 4b is filled or emptied sterile.
• Cleanroom can act both in a horizontal as well as a vertical conveying process.
• a horizontal sluice is realized because it can be used to ensure better protection against contamination.
• Welded seam 3b are separated.
• the process in the plant as well as the inner liner 4b are thus closed and sterile, since the separating seam 3b triggers an edge weld.
• the separating seam 3b would correspond with its edge welding to the weld seam 3a on the endless tubular film 1.
• FIGS. 26-28 show a further variant of the method according to the invention.
• 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 areas 12a, 12b are limited, one of which is closed to the bag 1 out 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 recording 12 and the already existing weld 11 of
• Inner liner 4c another weld I Ia arises. Then a dividing seam can be set to separate the weld seam 1 Ia. Then, the further weld 1 1 a is separated so that the weld 13 of the closed end portion 13 of the inner liner 4 c containing portion 13 'of the inner liner 4 c is separated and contained in a space 13 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 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 according to the invention for a clean room 15.
• 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.
• 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 sealed at its end portion located in the outer space 16 by attaching the weld seam I 1a by means of welding apparatuses which are conventional per se and therefore not shown, arranged on both sides of an imaginary extension of the axis of the inlet opening 14.
• inner liner 4a, 4b, 4c and bag 1 are such that the bag 1 at a connection edge 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.
• Peelability as indicated for the welding above. "Welding” is therefore to be understood in a very broad sense.

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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)

Applications Claiming Priority (2)

Publications (2)

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ID=40834548

Family Applications (1)

Country Status (4)

Cited By (1)

Families Citing this family (6)

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• 2009
  • 2009-05-08 AT AT09766215T patent/ATE554857T1/de active
  • 2009-05-08 US US12/988,113 patent/US20110142574A1/en not_active Abandoned
  • 2009-05-08 EP EP09766215A patent/EP2291244B1/fr not_active Not-in-force
  • 2009-05-08 WO PCT/IB2009/051912 patent/WO2009153676A1/fr not_active Ceased

Non-Patent Citations (1)

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