EP4329828A1 - Anordnung zur aseptischen zuführung von komponenten in einen pharmazeutischen isolator - Google Patents
Anordnung zur aseptischen zuführung von komponenten in einen pharmazeutischen isolatorInfo
- Publication number
- EP4329828A1 EP4329828A1 EP22817600.4A EP22817600A EP4329828A1 EP 4329828 A1 EP4329828 A1 EP 4329828A1 EP 22817600 A EP22817600 A EP 22817600A EP 4329828 A1 EP4329828 A1 EP 4329828A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- bag
- decontamination
- components
- isolator
- nozzle
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000005202 decontamination Methods 0.000 claims abstract description 75
- 230000003588 decontaminative effect Effects 0.000 claims abstract description 75
- 239000012212 insulator Substances 0.000 claims description 13
- 239000012530 fluid Substances 0.000 claims description 7
- 239000003795 chemical substances by application Substances 0.000 claims description 5
- 230000003247 decreasing effect Effects 0.000 claims 1
- 238000007789 sealing Methods 0.000 description 3
- 238000000034 method Methods 0.000 description 2
- 230000004913 activation Effects 0.000 description 1
- 230000006978 adaptation Effects 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003889 eye drop Substances 0.000 description 1
- 229940012356 eye drops Drugs 0.000 description 1
- 230000005484 gravity Effects 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000007665 sagging Methods 0.000 description 1
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
- B65B55/02—Sterilising, e.g. of complete packages
- B65B55/027—Packaging in aseptic chambers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/22—Phase substances, e.g. smokes, aerosols or sprayed or atomised substances
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B61/00—Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages
- B65B61/04—Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages for severing webs, or for separating joined packages
- B65B61/06—Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages for severing webs, or for separating joined packages by cutting
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/10—Apparatus features
- A61L2202/12—Apparatus for isolating biocidal substances from the environment
- A61L2202/121—Sealings, e.g. doors, covers, valves, sluices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/10—Apparatus features
- A61L2202/12—Apparatus for isolating biocidal substances from the environment
- A61L2202/123—Connecting means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/21—Pharmaceuticals, e.g. medicaments, artificial body parts
Definitions
- the invention relates to an arrangement according to the preamble of claim 1 .
- the isolator can be used, for example, to fill containers with medicines that are shielded from the environment, for example small, malleable plastic bottles with eye drops.
- the vials are supplied sterile from the outside, for example in a closed container, and must be loaded into the isolator under aseptic conditions.
- RTP Rapid Transfer Port
- the containers are comparatively heavy and usually require their own manipulator in the form of a freely movable robot arm to handle them.
- the invention is based on the object of improving a generic arrangement in such a way that it can be designed in a structurally simple and correspondingly inexpensive manner and enables the handling of a large number of components with little effort.
- the invention proposes making it possible to fill the insulator from a bag.
- the bag together with the components contained therein, be stored on a storage table that can be set up in front of the isolator, in particular in front of its filling opening.
- a gas-tight plastic bag can be used so that the components in the bag can be kept sterile.
- the low weight of the bag enables it to be handled manually without any problems, even if it contains a large number of components, so that the loading of the isolator with new components—or the bag changing—is required at advantageously large intervals.
- a clamping bar is provided, by means of which the bag can be divided into two sections, namely into two separate chambers.
- the clamping strip can accordingly be brought closer to or removed from the bag, for example in the form that it is mounted on the storage table so that it can move in height or pivot.
- the clamping bar grasps the bag lying on the delivery table, and with the further movement of the clamping bar when it is pressed against the delivery table, the bag is divided into two gas-tight chambers between the delivery table and the clamping bar .
- the components are located in a rear compartment section of the bag, namely in the section farther from the insulator, while a front section of the bag, located between the terminal block and the insulator, is empty, i.e. contains no components. After the bag has been divided into the two sections using the clip bar, the front section of the bag can be cut open in preparation for emptying the bag.
- the present proposal further provides for a decontamination nozzle which can be arranged in front of the filling opening of the isolator and which enables the isolator to be loaded with components from the bag.
- the open end of the bag can be pushed onto the decontamination nozzle and applied gas-tight to the decontamination nozzle, for example with a strap that is stretched around the bag and the decontamination nozzle, or in other ways known to those skilled in the art.
- the pouch When the pouch is opened, its front section loses its sterile properties. After the bag has been connected gas-tight to the decontamination nozzle, decontamination of this front section of the bag and also of the interior within the decontamination nozzle is provided.
- the decontamination nozzle therefore has an outlet nozzle for a decontamination agent, which opens into the interior of the decontamination nozzle, so that the volume of space enclosed by the decontamination nozzle and the front section of the bag can be disinfected.
- the filling opening of the isolator which is closed by means of a closure device on the isolator, can be opened in a manner known per se, and the terminal strip can be removed from the storage table, so that the components can now be removed from the rear section of the bag through the now sterile front portion of the bag and also now sterile Decontamination nozzles can get into the filling opening and thus into the isolator.
- the tray table may be moveable, for example pivotable, so that its inclination is adjustable and the rear end of the tray table can be selectively raised to assist in emptying the bag. In this way, the bag does not have to be handled manually.
- the lifting of the storage table can be supported, for example, by an electric motor, by a gas pressure spring or similar elements, so that the operating personnel can handle the storage table while it is being raised with little effort.
- the bag can advantageously be fixed in its rear area, so that it does not slip forward on the storage table, form folds and the emptying of the components from the bag is prevented. Therefore, advantageously at a distance from the clamping strip, namely in order to grasp the rear section of the bag, a holder can be arranged on the storage table, which holder selectively holds or releases this section of the bag on the storage table.
- a holder can be designed, for example, as a spring-loaded holding strip, which can be lifted off the storage table against the spring action and, when released, rests spring-loaded on the storage table, possibly with the bag arranged between them being clamped.
- such a holder can be designed as a holding strip, which can be clamped against the storage table by means of an eccentric lock.
- a circumferential seal can advantageously be arranged on the outside of the decontamination connection piece. This seal is not only pressed against the bag from the inside, so that any leaks that could result from sagging and expansion of the bag are excluded. Rather, a clamping ring is provided, which can be pushed onto the outside of the decontamination nozzle and the end of the bag pushed onto it until the clamping ring surrounds the seal on the outside, so that the clamping ring can be used to ensure that the bag rests against the seal in a gas-tight manner.
- the clamping ring can be moved in such a way that it can be removed from this sealing position so that the cut end of a bag can first be pushed onto the decontamination nozzle and its seal and the emptied bag can later be pulled off the decontamination nozzle again.
- a seal that is arranged on the decontamination connector for sealing the bag can be designed as a so-called activatable seal that can be optionally expanded.
- the seal has a hollow profile, into which a pressure fluid can be introduced, so that the cross section of the hollow profile is enlarged under the influence of the pressure fluid. If the seal runs on the outside of the decontamination nozzle, its outer diameter increases accordingly. The variable diameter of the seal makes handling the bag easier, as it can be easily pushed onto the decontamination nozzle and its deactivated seal and later removed again.
- the seal should be provided on the inside of the clamping ring, its inner diameter increases when the seal is activated, so that the mobility of the clamping ring in relation to the decontamination nozzle is facilitated when the seal is deactivated. Irrespective of whether the seal is arranged on the decontamination nozzle or on the clamping ring, or whether these two components are provided with a seal that can be activated, the desired gas-tight connection is achieved after activation of the seal. Closure of the bag at the decontamination nozzle is ensured.
- the proposed arrangement has a permanently installed cutting device, so that handling a loose cutting tool can be avoided in the interest of safety.
- a movable cutter bar can be arranged on the storage table. This cutter bar is located in the area of the tray table adjacent to the decontamination nozzle so that the cutter bar can act on the first portion of the bag.
- the cutting bar can be designed in the manner of a swiveling cutter bar.
- the cutting strip can have a movable blade that can be moved transversely to the longitudinal axis of the storage table—and thus of the bag. The pulling cut made possible in this way produces a straight cutting edge in a particularly reliable manner, so that when the open bag is pushed onto the decontamination nozzle, the desired gas-tight connection, e.g. in conjunction with the mentioned seal, can be guaranteed.
- the decontamination nozzle can have a pressure sensor
- the proposed arrangement can have an electronic control or connection means in order to be able to be connected to an existing electronic control, eg the control of the isolator.
- the sensor signals of the pressure sensor can be used to detect the pressure that prevails inside the decontamination nozzle. If the filling opening of the isolator is still closed and the front section of the bag is still separated from the sterile len rear portion of the bag is severed, and after the decontamination agent has been introduced into the decontamination nozzle, it can be automatically checked using the pressure sensor and the controller whether a pressure loss occurs within a predetermined period of time. If no loss of pressure is detected, the sterile atmosphere that prevails in this area after decontamination can be guaranteed so that the filling opening and the terminal strip can now be opened and the components can be transferred from the bag into the isolator.
- the drawing shows a perspective view of an arrangement 1 which is used for the aseptic delivery of components into a pharmaceutical isolator.
- the insulator itself is not shown, rather the arrangement 1 can be used to retrofit an already existing insulator in order to enable it to be filled with components from a bag 2 .
- the components are sterile inside the hermetically sealed bag 2.
- the bag 2 is shown schematically in a cylindrical shape and lies on the table surface 3 of a storage table 4.
- the storage table 4 has a table frame 5 below the table surface 3, which is formed from a large number of struts and contains, among other things, connecting struts 6 and floor supports 7.
- the connecting struts 6 are provided with connecting plates which have bores through which screws can be passed, so that the support table 4, in particular its connecting struts 6, and specifically its connecting plates, can be screwed to the front of an insulator.
- the floor supports 7 have base plates which, in the exemplary embodiment shown, are designed as closed plates. Deviating from this the base plates also have holes in order to be able to screw the storage table 4 to the floor.
- the table surface 3 rests on the table frame 5 and can be moved near its front end, shown on the left in the drawing, about a pivot axis 8, so that its inclination can be adjusted and its rear end, shown on the right in the drawing, is optionally raised or tilted shown horizontal position can be lowered.
- the adjustment is made manually by means of a hand crank 9, with a telescopic cylinder 10 supporting the raising of the table surface 3, for example by being designed as a hydraulic cylinder which is actuated by means of the hand crank 9, or by being designed as an energy accumulator, e.g. in the form of a gas spring or the like.
- the rear end of the bag 2 shown on the right in the drawing deviates in practice from the cylindrical shape shown schematically and rather lies flat on the table surface 3 . It can be fixed on the table surface 3 by means of a holder 11, which has an elongated holding strip 12, so that the bag 2 cannot slide forward, to the left in the drawing, when the storage table 4 has been raised by means of the hand crank 9 , namely the rear end of the table surface 3 shown on the right has been raised and the table surface 3 has been inclined about the pivot axis 8 .
- a handle 14 is used to move the retaining bar 12 so that it can be raised or approached in the manner of an eccentric clamp with respect to the table surface 3 .
- the bag 2 extends further than indicated schematically in the drawing, namely beyond the front end of the table surface 3 .
- a terminal strip 15 extends across the table top 3 and is on the side of the table top 3 facing away from the viewer in the drawing is pivotally mounted, which is indicated at 16.
- the terminal strip 15 can be selectively opened by means of a locking clamp 17 so that it can be lifted off the table surface 3 in a pivoting movement.
- a front area of the bag 2 can be placed under the clamping strip 15.
- the bag 2 has previously been held vertically, so that all of the components therein which are to be processed in the isolator collect in the lower area of the bag 2 .
- the bag 2 has then been placed on the table surface 3 in such a way that all of the components are located inside the bag 2 behind the clamping strip 15 . This is checked and components that may have slipped forward are moved inside the bag 2 behind the terminal block 15.
- the clamping strip 15 is then lowered and pressed firmly against the table surface 3 by means of the locking clamp 17 .
- the rear section which contains the components, is fixed on the table top 3 by the holder 11 and the clamping strip 15 .
- the front section extends from the clamping strip 15 to beyond the front end of the table surface 3 and hangs down there so that it rests against a cutting strip 18 .
- the cutter bar has an elongated housing, which runs transversely to the table surface 3, and within the housing a longitudinally movable blade and a handle which protrudes forward from the housing, ie to the left in the drawing and thus facing away from the viewer. Due to the fact that the connecting struts 6 extend even further forward in relation to the table surface 3 up to the insulator, there is a free space which enables the cutting strip 18 to be actuated without any problems.
- the arrangement 1 also contains a decontamination nozzle 19 which has been attached to the insulator, namely in front of its filling opening, and which is now firmly and gas-tightly connected to the insulator.
- the closure that the insulator has at its filling opening remains fully functional.
- the decontamination nozzle 19 also has a closure, which is designed as a closure cover 20 that can be handled loosely. Covered by the closure cover 20, a pneumatically activatable seal designed as a hollow profile runs around the decontamination socket 19. This ring seal can optionally be filled with a pressure fluid such as B. compressed air are charged so that it expands and strives to adopt a larger outer diameter.
- a clamping ring 21 is also hinged to the decontamination connection piece 19 and is pivoted up into its release position in the drawing, namely when the closure cover 20 is mounted on the decontamination connection piece 19 .
- the clamping ring 21 can be lowered and guided over the decontamination nozzle 19, so that the clamping ring 21 around the ring seal of the decontamination muff 19 runs around in the same way as the collar of the closure cap 20, so that the ring seal can be applied to the clamping ring 21 as well as the collar, namely when it is activated, ie is pressurized from the inside.
- the ring seal is first depressurized and then the closure cover 20 is removed so that the decontamination nozzle 19 is exposed.
- the clamping ring 21 is then partially lowered, but not yet over the ring seal of the decontamination connection piece 19, but only so far that a gap between the clamping ring 21 and the decontamination connection piece 19 remains.
- the front end of the bag 2 is threaded through this gap and pushed onto the decontamination nozzle 19 over the ring seal.
- the clamping ring 21 is then pivoted further and guided into its clamping position, in which it runs around the ring seal on the outside.
- the ring seal is now activated by being pressurized by means of the pressure fluid and being stretched outwards in this way, so that the bag 2 is sealed in a gas-tight manner relative to the decontamination nozzle 19 .
- a pressure sensor 22 detects the pressure prevailing inside the decontamination nozzle 19 .
- a fluid is now introduced into the decontamination nozzle 19 so that the space delimited by the decontamination nozzle 19, by the closure of the filling opening of the isolator, and by the front section of the bag 2 up to the terminal block 15 is pressurized. Then, for a predetermined period of time, the pressure sensor 22 measures whether this pressure is being maintained or is falling.
- the arrangement 1 and in particular its pressure sensor 22 is connected to an electronic controller, which can be a separate system controller of the arrangement 1 or possibly by the already existing control of the isolator, which was functionally expanded in adaptation to the arrangement 1.
- the exemplary embodiment shown is a double nozzle with two outlets for a gaseous decontamination agent aligned in different directions, the double nozzle being rotatable and having a rotary drive 23 .
- the decontamination follows a predetermined program sequence, for example with regard to the dosage of the decontamination agent and its exposure time.
- the closure of the filling opening of the isolator can be opened in a manner known per se, so that the components from the bag 2 can now be can be introduced into the insulator.
- the delivery table 4 is raised, i. H. its table surface 3 is brought to an angle of inclination about the pivot axis 8 by means of the hand crank 9 such that the components contained in the bag 2 slide out of the bag 2 and into the insulator with the aid of gravity.
Landscapes
- Health & Medical Sciences (AREA)
- Mechanical Engineering (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Hematology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Chemical & Material Sciences (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE202021106178.2U DE202021106178U1 (de) | 2021-11-11 | 2021-11-11 | Anordnung zur aseptischen Zuführung von Komponenten in einen pharmazeutischen Isolator |
PCT/EP2022/081545 WO2023083996A1 (de) | 2021-11-11 | 2022-11-10 | Anordnung zur aseptischen zuführung von komponenten in einen pharmazeutischen isolator |
Publications (1)
Publication Number | Publication Date |
---|---|
EP4329828A1 true EP4329828A1 (de) | 2024-03-06 |
Family
ID=80000898
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP22817600.4A Pending EP4329828A1 (de) | 2021-11-11 | 2022-11-10 | Anordnung zur aseptischen zuführung von komponenten in einen pharmazeutischen isolator |
Country Status (4)
Country | Link |
---|---|
US (1) | US20240076085A1 (de) |
EP (1) | EP4329828A1 (de) |
DE (1) | DE202021106178U1 (de) |
WO (1) | WO2023083996A1 (de) |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5447699A (en) * | 1993-11-17 | 1995-09-05 | The West Company | Combination container for holding sterilized elements and a sterilizable transfer port |
US6969497B2 (en) * | 2002-07-08 | 2005-11-29 | Giuseppe Sacca | Decontamination system for use with a rapid transfer port |
DE102004010500A1 (de) * | 2004-03-04 | 2005-09-29 | Schlösser GmbH Anlagentechnik | Abfüllverfahren sowie Greifvorrichtung für eine Abfülleinrichtung |
DE102016001027A1 (de) * | 2016-01-29 | 2017-08-03 | Atec Pharmatechnik Gmbh | Verfahren zum Transport und zur Übergabe von sterilem schüttfähigem Gut in einen Isolator, sowie Behälter und Isolator |
DE102016009678A1 (de) * | 2016-08-09 | 2018-02-15 | Atec Pharmatechnik Gmbh | Verfahren und Behälter zum Transport und zur Übergabe von sterilem schüttfähigem Gut in einen Isolator |
-
2021
- 2021-11-11 DE DE202021106178.2U patent/DE202021106178U1/de active Active
-
2022
- 2022-11-10 WO PCT/EP2022/081545 patent/WO2023083996A1/de active Application Filing
- 2022-11-10 EP EP22817600.4A patent/EP4329828A1/de active Pending
-
2023
- 2023-11-14 US US18/389,538 patent/US20240076085A1/en active Pending
Also Published As
Publication number | Publication date |
---|---|
WO2023083996A1 (de) | 2023-05-19 |
US20240076085A1 (en) | 2024-03-07 |
DE202021106178U1 (de) | 2022-01-10 |
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