WO2004037300A2 - Systemes, dispositifs et procedes de traitement aseptique - Google Patents

Systemes, dispositifs et procedes de traitement aseptique Download PDF

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Publication number
WO2004037300A2
WO2004037300A2 PCT/US2003/033689 US0333689W WO2004037300A2 WO 2004037300 A2 WO2004037300 A2 WO 2004037300A2 US 0333689 W US0333689 W US 0333689W WO 2004037300 A2 WO2004037300 A2 WO 2004037300A2
Authority
WO
WIPO (PCT)
Prior art keywords
container
closure
critical zone
filling
positioner
Prior art date
Application number
PCT/US2003/033689
Other languages
English (en)
Other versions
WO2004037300A3 (fr
Inventor
William Merrill
Thomas L. Thorpe
Original Assignee
William Merrill
Thorpe Thomas L
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by William Merrill, Thorpe Thomas L filed Critical William Merrill
Priority to AU2003301515A priority Critical patent/AU2003301515A1/en
Priority to US10/532,404 priority patent/US20060048844A1/en
Publication of WO2004037300A2 publication Critical patent/WO2004037300A2/fr
Publication of WO2004037300A3 publication Critical patent/WO2004037300A3/fr

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Classifications

    • 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
    • A61L9/00—Disinfection, sterilisation or deodorisation of air
    • 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
    • B65B31/025—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 specially adapted for rigid or semi-rigid containers
    • B65B31/027—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 specially adapted for rigid or semi-rigid containers closed by a stopper
    • 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
    • B65B55/12—Sterilising contents prior to, or during, packaging

Definitions

  • FIG. 5 is a flow chart of an exemplary embodiment of a method 5000;
  • FIG. 6 is a top view of an exemplary embodiment of a container positioning system 6000;
  • FIG. 8 is a top view of an exemplary embodiment of a stationary rail 6300
  • FIG. 9 is a top view of an exemplary embodiment of a guardrail 6400; and [12] FIG. 10 is a top view of an exemplary embodiment of a rod 6200.
  • a clean container can be devoid of chemical and/or biological contaminants that might jeopardize the efficacy and/or safety of a filling to be stored therein.
  • container - an enclosure for a filling having a closable opening via which the filling can be introduced.
  • a container include a vial, syringe, bottle, etc.
  • container positioner - a device for imparting directionally and temporally controlled motion to containers to transport the containers to, through, and/or from one or more processing stations.
  • critical zone a volume within which, during operation, a container is directly exposed to the airflow, and which is defined by an entry position of the container into, and an exit position of the container from, one or more processing locations at which (1) a filling is introduced to the container via a filling opening, and (2) the filling opening is at least partially covered by a closure, and all positions of the container therebetween the entry and exit positions.
  • a filling can be a pharmaceutical, parenterals, biological, growth media, medicament, chemical, radioactive, cosmetic, food product, beverage, powder, solid, liquid, slurry, gas, vapor, mixture, etc.
  • a filling is generally not intended to comprise a contaminant.
  • the source can be, for example, a hood, a duct, an outlet, a diffuser, and/or a filter, etc. that directs the airflow at the critical zone.
  • Filtered air can be provided to the container filling subsystem 1200 by a filtered gas subsystem 1500 (e.g., air, nitrogen, oxygen, etc.).
  • a filling can be provided to the containers by a filling pumping system 1600.
  • a non-electrical power subsystem 1800 can operate at least a portion of container filling subsystem 1200.
  • a programmable control system 1700 which can comprise an information device, such as for example a programmable logic controller (PLC), can control any of container supply subsystem 1100, container filling subsystem 1200, closure supply subsystem 1300, container packaging subsystem 1400, filtered air subsystem 1500, filling pumping system 1600, power subsystem 1800.
  • Container supply subsystem 1100, container filling subsystem 1200, and/or closure supply subsystem 1300 can be positioned in an operating zone 1800.
  • Certain exemplary embodiments of container filling subsystem 1200 can be suitable for an open class 100 clean room, a biohazard hood, and/or an isolator glove-box. Certain exemplary embodiments of container filling subsystem 1200 can be relatively small (e.g., about 18" deep by about 28" wide by about 48" tall, but not limited thereto). Certain exemplary embodiments of container filling subsystem 1200 can weigh less than from about 10 pounds to about 300 pounds (including all values therein, such as about 20, 30, 40, 50, 60, 70, 80, 90, 100, 125, 150, 200, and/or 250 pounds, etc., and subranges therein, such as from about 25 to about 45 pounds, from about 30 to about 55 pounds, etc.).
  • Certain exemplary embodiments of container filling subsystem 1200 can be manually disassembleable, manually transportable, manually loadable in an autoclave, and/or manually assembleable. Certain exemplary embodiments of container filling subsystem 1200 can be pneumatically-operated. Certain exemplary embodiments of container filling subsystem 1200 can include a clear shield to shelter the container path, filling zone, closing zone, and/or critical zone from the mechanical parts. The mechanical parts can be designed to avoid particulate generating and/or microbial-harboring elements. To further protect the product and/or product components, certain exemplary embodiments can have no hinged and/or particulate generating parts and/or contaminant generators in, above, below, upstream, and/or downstream of, the critical zone.
  • container filling subsystem 1200 can be placed in a washer to decontaminate and then inserted in an autoclave. This can generate considerably greater assurance than hand wiping and rinsing that container filling subsystem 1200 is decontaminated and sterile, without the potential introduction chemical disinfectant residues. Container filling subsystem 1200 can then be moved under a laminar airflow hood or filter and unwrapped.
  • Containers can be preloaded in container supply subsystem 1100, which can holds from about 1 to about 1000 containers, including all values and subranges therebetween.
  • Container supply subsystem 1100 can be a carousel, vibrating bowl, and/or hopper, etc. If implemented as a carousel, the containers can be preloaded as vertical strips, encased under a "cake lid” type shield, and sterilized.
  • closures also can be preloaded in a closure supply subsystem 1300, which can hold from about 1 to about 1000 closures, including all values and subranges therebetween.
  • Closure supply subsystem 1300 can be a carousel, vibrating bowl, and/or hopper, etc. If implemented as a carousel, the closures can be preloaded as vertical strips, encased under a "cake lid” type shield, and sterilized.
  • both the container and the closure carousels can be attached and/or attachable to the base unit. Both the containers and the closures can remain protected under the cake covers, thereby potentially avoiding exposure to the operator and/or to environmental contaminates.
  • the containers and closures can index down and can be deposited to the point of use, remaining covered until about their moment of use.
  • Certain exemplary embodiments of subsystem 1200 allow the containers to be supported by a rail having a number of holes therethrough to decrease the resistance of the rail to the airflow impinging on the rail. For example, from about 0 to about 75 percent of the projected surface area of the rail perpendicular to the airflow can be perforated.
  • the rail can comprise one or more horizontal round bars upon which the containers are vertically supported.
  • the rail can be one or more vertically- oriented knife-edges upon which the containers are vertically supported.
  • the containers in an airflow that is directed vertically upwards, the containers can be levitated by the airflow, such that no rail is needed to provide vertical support to the containers.
  • the rail can be designed to minimize aerodynamic drag, minimize projected surface area that is perpendicular to the airflow, and/or provide a surface and/or medium upon which the container can glide and/or be slid by the container positioner.
  • the containers can intermittently and/or continuously travel along the rail, above the floor, and or with nothing located between the rail and the floor. That is, no mechanical parts, motors, or pneumatic components need be located under the critical zone and or rail.
  • Such embodiments can allow full laminar airflow through the critical zone to keep this zone flushed with clean air. Also, such embodiments can allow spills to drop to the floor, thereby reducing and/or eliminating equipment contamination and/or facilitating cleanup.
  • the closure provider, applier, and/or inserter and the closure can protrude through the shield and be in place prior to the container being in position for affixing of the closure, or the provider, applier, and/or inserter and closure can protrude through the shield during or after positioning of the container for affixing of the closure.
  • system 1000 can be partially dismantled into its constituent subsystems and certain of those subsystems, such as for example container supply subsystem 1100, container filling subsystem 1200, and/or closure supply subsystem (but probably not container packaging subsystem 1400, filtered air subsystem 1500, filling pumping system 1600, programmable control system 1700, and/or power subsystem 1800), can be put in a washer and/or autoclaved (steam sterilized).
  • Certain exemplary embodiments of system 1000 and/or one or more of its subsystems can allow for any of the following: [51] compliance with the FDA "Guideline on Sterile Drug Products Produced by Aseptic Processing" (June 1987) and/or the FDA "Guidance for
  • a shielded critical zone - shielding can substantially shield open containers from environmental exposure to contaminants; [56] open bottom - can allow laminar air flow through at least container filling subsystem 1200; [57] open bottom - can allow product fall through to avoid collateral contamination; [58] no tool setup - use of pegs can allow relatively fast set-up and can minimize contamination from operator and/or environmental sources; [59] few parts - relatively quick and/or easy setup, decontamination, and/or sterilization; [60] pneumatic drives - autoclaveable and/or can potentially reduce and/or eliminate container breakage, and thereby potentially reduce and/or eliminate broken glass and the potential contamination and/or safety issues associated therewith, and/or an unwanted
  • FIG. 2 is a top view of an exemplary embodiment of a system 2000, which can comprise a container supply subsystem 2100, a container supply chute 2150, a critical zone 2200, an operation zone 2250, container positioner and/or container positioning subsystem and/or container transport and/or container transport subsystem 2300, an exterior shield 2420, and interior shield 2440, a container fill nozzle 2460, a first closure storage 2500, a first closure provider/applier/inserter 2540, second closure storage 2600, a second closure provider/applier/inserter 2640, a filled container discharge chute 2700, and/or a frame 2800, etc.
  • a container supply subsystem 2100 can comprise a container supply subsystem 2100, a container supply chute 2150, a critical zone 2200, an operation zone 2250, container positioner and/or container positioning subsystem and/or container transport and/or container transport subsystem 2300, an exterior shield 2420, and interior shield 2440, a container fill nozzle 2460, a
  • Various components of system 2000 can be supported by a frame 2800, which can provide a relatively open architecture that can allow the airflow through and/or adjacent critical zone 2200 to sweep particles away from the open containers.
  • the minimization of horizontal surfaces in frame 2800 also can facilitate the decontamination of system 2000 by eliminating many surfaces on which contaminants and or spilled filling can accumulate.
  • few or no electrical and/or mechanical devices are attached and/or present beneath a top portion of frame 2800.
  • Container supply subsystem 2100 Positionable, supportable, and/or mountable on frame 2800 can be a container supply subsystem 2100, which can store, protect, and/or deliver containers. Any of many potential embodiments for container supply subsystem 2100 can be utilized, such as for example, a container carousel, hopper, bowl feeder, and/or conveyor, etc. Container supply subsystem 2100 can be preloaded and covered prior to sterilization, thereby protecting the containers from handing and environmental contaminates.
  • Container chute 2150 can reorient (if necessary) containers arriving from the container supply subsystem 2100. Container chute 2150 can also protect the open containers from handling and contaminants. Container chute 2150 can be installed onto frame 2800 prior to sterilization of frame 2800. Container chute 2150 can be in place prior to the attachment of container supply subsystem 2100.
  • Container chute 2150 can be shaped to accommodate each size of container used.
  • Container chute 2150 can be manufactured of solid or welded stainless steel, such as type 316L, if container chute 2150 will be steam sterilized. Other materials of suitable strength and rigidity may be substituted.
  • Container chute 2150 can present the containers to a container transport subsystem 2300 that transports the containers through a critical zone 2200 within which the containers can be filled and/or at least partially closed while an interior of the container is directly exposed to the airflow.
  • Container positioner and/or container transport subsystem 2300 can transport containers to, through, and/or from a series of various processing stations, such as a container entry position 2330, a container fill position 2340, a container first closure affixing position 2350, a container dwell position 2360, a container second closure affixing position 2370, and/or a container exit position 2380, etc.
  • a container entry position 2330 a container fill position 2340
  • a container first closure affixing position 2350 a container dwell position 2360
  • a container second closure affixing position 2370 and/or a container exit position 2380, etc.
  • a container discharge chute 2700 Upon exiting container transport subsystem 2300, a container can enter a container discharge chute 2700, which can lead to a filled
  • Rivard shuttle 2310 having a plurality of shuttle pins 2320 is implemented. At least a portion of Rivard shuttle 2310 can be located in and/or immediately adjacent critical zone 2200 and can move the vertical containers from the outlet of container supply chute 2150 and advance them through the series of processing stations. Rivard shuttle 2310 can be powered non-electrically, such as hydraulically and/or pneumatically, by for example, a pneumatic actuator 2390, which can comprise a sterilizable pneumatic cylinder.
  • Rivard shuttle 2310 can provide an open architecture and/or an absence of gears and/or hinges. In operation, Rivard shuttle 2310 can allow the containers to travel along a stationary rail that can be perforated to facilitate laminar airflow and/or avoid adding substantial impediments and/or turbulence to the airflow.
  • the containers can be advanced by a rod having notches on one side for the container to seat into. Inserted perpendicularly into the rod behind each notch can be a shuttle pin 2320 that can prod an adjacent container along the rail when the rod is slid in a forward direction. When the container has reached the next station, the rod can rotate 90 degrees along its axis.
  • the shuttle pins are now pointed down (or upward if desired), thereby disengaging from their adjacent containers, and the containers can be bumped slightly away from the rod as the notches also rotate down with the pins and the full surface of the rod now contacts the container.
  • the containers can seat into slight notches in a guardrail at each station. While the container remains at a particular station, the rod can slides in a reverse direction. The rod can then rotate 90 degrees along its axis, which can return the pins to the horizontal position.
  • the rod is now prepared to move in a forward direction again. When the rod moves in the forward direction, the pins bump the containers out of the slight notches at each station and prod the containers along to the next station.
  • System 2000 can comprise a first closure storage apparatus 2500, and potentially a second closure storage apparatus 2600, each of which can hold and protect sterile closures.
  • closures may be rubber stoppers, syringe plungers, screw caps, and or over-caps, etc.
  • any closure storage apparatus 2500, 2600 can be implemented as a carousel, hopper, and or vibrating bowl feeder, etc.
  • An exemplary carousel can be constructed using two pieces, a rack and a cover. The carousel can hold between about 1 and about 1000 closures, including all values and subranges therebetween. The closures can be pre-loaded onto the carousel and the entire carousel covered prior to sterilization. If constructed of appropriate materials, the carousel can be moist heat sterilized to about 121 degrees C. Once sterilized, the carousel can be place onto a closure carousel plate of system 2000.
  • a closure carousel can be milled from a solid cylinder of aluminum, however, Teflon, welded 16-gage stainless steel sheet (such as type 316L), or other materials of suitable strength and rigidity may be substituted.
  • the carousel can be ringed with vertical slots that can hold closures.
  • the base of the carousel can be a solid disk except for one portal on the bottom that can allow the closures to drop through. After a vertical row has emptied of closures, the carousel can index to move a full vertical row of closures over the open portal.
  • the closures can promptly drop through he portal and into a closure chute 2520, which can deliver the closures to a closure provider/applier/inserter 2540, 2640.
  • the outside carousel dimensions can be about 10 inch diameter x 10 inches high.
  • This carousel can have about 20 vertical slots, each holding 13 stoppers and thus holding a total of about 260 stoppers.
  • One additional, empty, and/or blank slot can be included to enable the carousel to be transported without stoppers dropping through the portal.
  • Other sizes and modifications are possible for the carousel, stoppers, syringe plungers, screw caps, and/or over-caps.
  • Closure chute 2520 can orient and/or reorient (if necessary) closures arriving from the closure storage apparatus 2500. Closure chute 2520 can protect the closures from handling and contaminants. Closure chute 2520 can be placed and/or attached onto frame 2800 prior to sterilization of frame 2800. Therefore, closure chute 2520 can be in place prior to the attachment of the closure storage apparatus 2500. In certain exemplary embodiments, each closure storage apparatus can have one or more closure chutes 2520 associated therewith. In certain exemplary embodiments, multiple closure storage apparatus 2500, 2600 can share a single closure chute 2520.
  • Closure chute 2520 can be shaped to accommodate each size of closure used.
  • Closure chute 2520 can be manufactured of solid or welded stainless steel, such as type 316L, if the container chute will be steam sterilized. Other materials of suitable strength and rigidity may be substituted. These include Teflon and aluminum, for example. Surfaces of closure chute 2520 can be smooth and slope adjusted to assure that the closures are consistently presented to the closure provider/applier/inserter 2540, 2640.
  • Each closure provider/applier/inserter 2540 can obtain and/or lift a closure from its closure chute 2520, deposit the closure on a container, partially insert the closure into the container, fully insert the closure into the container, affix the closure to the container, crimp the closure, etc.
  • a single device provides each desired function, however, other embodiments may utilize a separate device for certain functions.
  • a first closure provider/applier/inserter 2540 affixes a first closure, such as a stopper, to a container
  • a second closure provider/applier/inserter 2640 affixes a second closure, such as an overcap, to the first closure.
  • the closure provider/applier/inserter can be hollow, with a hole located underneath the tip, pointing down.
  • a vacuum can be drawn through the closure provider/applier/inserter that can lift the closure off the closure chute.
  • the closure provider/applier/inserter can be pneumatically raised while remaining horizontal.
  • the closure provider/applier/inserter can advance forward, through a port in interior shield 2440, until the suspended closure is directly above the open container.
  • the closure provider/applier/inserter then can be lowered until it affixes the closure upon the open container.
  • the vacuum can be shut off, and the closure inserter can be raised up, retracted, and then lowered to grasp the next closure.
  • FIG. 3 is a front view of an exemplary embodiment of a system 3000, which can comprise a critical zone 3200, an operation zone 3250, container transport subsystem 3300, and/or a frame 3800, etc.
  • An airflow 3900 can proceed relatively unimpeded by system 3000.
  • Container transport subsystem 3300 can transport containers through a series of various processing stations, such as a container entry position 3330, a container fill position 3340, a container first closure affixing position 3350, a container dwell position 3360, a container second closure affixing position 3370, etc.
  • Container transport subsystem 3300 can comprise a Rivard shuttle 3310 having a plurality of shuttle pins 3320. At least a portion of Rivard shuttle 2310 can be located in and/or immediately adjacent critical zone 3200. Rivard shuttle 2310 can be powered non-electrically, such as hydraulically and/or pneumatically, by for example, a pneumatic actuator 3390, which can comprise a sterilizable pneumatic cylinder.
  • FIG. 4 is a block diagram of an exemplary embodiment of an information device 4000, which can represent information device 1700 of FIG. 1.
  • Information device 4000 can include well-known components such as one or more communications interfaces 4100, one or more processors 4200, one or more memories 4300 containing instructions 4400, one or more input/output (I/O) devices 4500 coupled to one or more user interfaces 4600, etc.
  • I/O input/output
  • a communications interface means any device, system, or subsystem capable of coupling an information device to a network and/or another information device.
  • a communications interface can be a telephone, cellular phone, cellular modem, telephone data modem, fax modem, wireless transceiver, infrared transceiver, ethernet card, cable modem, serial communications port, parallel communications port, PCMCIA slot and/or card, digital subscriber line interface, bridge, hub, router, or other similar device.
  • Data and/or instructions transferred via a communications interface can be in the form of signals, which may be electronic, electromagnetic, optical, and/or other signals capable of being received by a network interface.
  • Such signals can be provided to a network interface via a communications path (i.e., channel), which can be implemented using wire or cable, fiber optics, a phone line, a cellular phone link, an RF link, an infrared link, and/or other communications media.
  • a communications path i.e., channel
  • a "memory device” means any hardware and/or firmware element capable of storing data and/or instructions.
  • Memory devices can comprise non-volatile memory, volatile memory, Random Access Memory, RAM, Read Only Memory, ROM, PROM, EPROM, EEPROM, flash memory, magnetic media, a hard disk, a floppy disk, a magnetic tape, an optical media, an optical disk, a compact disk, a CD, a digital versatile disk, a DVD, and/or a raid array, etc.
  • a memory device can be removable, can include an interface (such as a drive, controller, socket, driver software, etc.), and/or can function as a computer-readable medium and/or as a machine-readable medium.
  • firmware means machine-readable instructions that are stored in a read-only memory (ROM).
  • ROM's can comprise PROMs, EPROMs, and EEPROMs.
  • I/O device means any device capable of providing input to, and/or output from, an information device.
  • An I/O device can be any sensory-oriented input and/or output device, such as an audio, visual, tactile (including temperature, pressure, pain, texture, etc.), olfactory, and/or taste- oriented device, including, for example, a monitor, display, keyboard, keypad, touchpad, pointing device, microphone, speaker, video camera, camera, scanner, and/or printer, potentially including a port to which an I/O device can be attached or connected.
  • user interface means any device for rendering information to a user and/or requesting information from the user.
  • user interface 4600 of information device 4000 can provide one or more elements for programming, monitoring, alerting, adjusting, and/or logging any activity of any component of any of systems 1000, 2000, and/or 3000, such as for example, the source of the airflow, the pump, and/or the pneumatic cylinders (which can actuate the Rivard shuttle, a carousel, and/or a closure inserter, etc.), etc.
  • the step sequence can easily be set and/or manipulated to control the timing of each step. If sensors are used, such as on the pneumatic cylinders, information device 4000 can monitor each pneumatic action and/or activate the pump at the appropriate time.
  • user interface 4600 can provide a live operational status window of various operational parameters; control of process instrumentation operation on-the-fly; and/or control of multiple filling systems and/or subsystems.
  • FIG. 5 is a flow chart of an exemplary embodiment of a method 5000.
  • containers and/or closures can be loaded and/or preloaded.
  • the containers and/or closures can be sterile.
  • Activity 5200 a container can be shielded from contaminants while outside and/or inside a critical zone.
  • a container can be positioned at a desired station, such as a station for purging, filling, closing, crimping, and/or lyophilizing, etc.
  • the station can be located in and/or immediately adjacent a critical zone positioned in an airflow encountering no Class 100, 1000, and/or 10,000 contaminant generators upstream from the critical zone.
  • a filling can be introduced to the container via a filling inlet (e.g., mouth, top, etc.) of the container.
  • a filling inlet e.g., mouth, top, etc.
  • one or more closures can be affixed to the container. Any one or group of activities 5100 through 5500 can be repeated as desired. Any one or group of activities 5300 through 5500 can be performed in isolation from a human operator and/or contaminants.
  • the system can be manually disconnected, such as from any pumping system and/or non-electrical power system (e.g., pneumatic connections).
  • the system can be manually loaded into a sterilization and/or decontamination device, such as an autoclave.
  • the system can be sterilized and/or decontaminated.
  • the system can be manually connected, such as to a pumping system and/or nonelectrical power system, such that the system can be operational again, and any one or group of activities 5100 through 5900 can be repeated as desired.
  • FIG. 7 is a front view of an exemplary embodiment of a Rivard shuttle 6100, such as that shown in FIG. 6.
  • FIG. 8 is a top view of an exemplary embodiment of a stationary rail 6300, which can define holes 6320 to allow the airflow to pass therethrough.
  • FIG. 9 is a top view of an exemplary embodiment of a guardrail 6400, which can comprise notches 6420 that can engage with containers at various processing stations.
  • FIG. 10 is a top view of an exemplary embodiment of a rod 6200, which can comprise notches 6220 and/or shuttle pins 6240 that can engage with containers at and/or between various processing stations.
  • Supply air pressure can be about 80-100 PSI.
  • Regulated air pressure to the pneumatic power system 1800 can be approximately 60-80 PSI.
  • Regulated air pressure to each pneumatically-driven component of the machine can read approximately as follows:
  • the vial turntable cam cylinder will extend to set the cam against the turntable drive plate.
  • the vial turntable cylinder will extend causing the turntable to rotate.
  • the cam cylinder will retract and then the turntable cylinder will retract.
  • the stopper pick-up plate cam cylinder will extend to set the cam against the stopper pick-up drive plate.
  • the stopper pick-up plate cylinder will extend to rotate causing stoppers to be picked-up and allowing stoppers to fill the dispensing chute.
  • the cam cylinder will retract and then the pick-up plate cylinder will retract.
  • the Stopper Queue Input sensor will illuminate On causing the stopper pick-up plate to stop rotation at the end of its cycle. When this sensor no longer detects the presence of stoppers in the dispensing chute, rotation of the stopper pick-up plate will resume immediately.
  • the stopper present input sensor will illuminate On indicating that a stopper is present and the stopper components of the machine are ready for a vial.
  • the shuttle travel cylinder extends causing the shuttle to index a vial from the queue position to the fill position.
  • the shuttle pin rotate cylinder extends causing the shuttle pins to rotate to the down position. This positions the vial in its nest for filling or for stopper insertion, and allows the shuttle travel rod to return to the home position to pickup the next vial.
  • a stopper is placed on the filled vial as follows (these actions are taking place while the vial is being filled so that the stopper is waiting over-top of the filled vial as it moves into the stopper position on the shuttle).
  • the stopper insert cylinder extends to pick-up a stopper.
  • the stopper insert cylinder retracts .
  • the stopper rotate cylinder extends to position the stopper insert arm over the filled vial.
  • the stopper insert cylinder extends to press the stopper onto the filled vial.
  • the shuttle indexes to move another vial from the queue position to the fill position, to move a filled vial from the fill position to the stopper position, and to move a stoppered vial from the stopper position toward the shuttle discharge position where the vial moves from the shuttle into a collection tray.
  • a cycle count of filled vials is made to determine when the number of vials needed to complete a tray has been filled. When this number of vials has been filled and has been indexed to the discharge position, the machine will stop until the operator replaces the tray and presses the Batch Complete button and then the Automatic button to resume processing. Note: the machine will pause prior to the fill cycle of the next vial so a filled vial does not wait exposed to air while the tray is being changed. At the end of a run, vials remaining in the shuttle can be lifted out or cleared by running the Single Step Mode.
  • any activity can be repeated, any activity can be performed by multiple entities, and/or any element can be duplicated. Further, any activity or element can be excluded, the sequence of activities can vary, and/or the interrelationship of elements can vary. Accordingly, the descriptions and drawings are to be regarded as illustrative in nature, and not as restrictive. Moreover, when any number or range is described herein, unless clearly stated otherwise, that number or range is approximate. When any range is described herein, unless clearly stated otherwise, that range includes all values therein and all subranges therein.

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  • Mechanical Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Filling Of Jars Or Cans And Processes For Cleaning And Sealing Jars (AREA)
  • Basic Packing Technique (AREA)

Abstract

Dans certaines formes de réalisation, cette invention concerne un système comprenant un positionneur automatique de contenant qui, dans une forme de réalisation opérationnelle, positionne un contenant de manière à permettre l'introduction d'un produit de remplissage dans le contenant à travers une entrée de remplissage de ce dernier. Dans certaines formes de réalisation, le contenant peut être placé dans une zone critique disposée dans un flux d'air, ne rencontrant aucun générateur de contaminants de classe 100 en amont de la zone critique. Dans certaines formes de réalisation, le positionneur peut être placé en aval de l'entrée de remplissage du contenant.
PCT/US2003/033689 2002-10-23 2003-10-22 Systemes, dispositifs et procedes de traitement aseptique WO2004037300A2 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2003301515A AU2003301515A1 (en) 2002-10-23 2003-10-22 Systems, devices, and methods for aseptic processing
US10/532,404 US20060048844A1 (en) 2002-10-23 2003-10-22 Systems, devices and methods for aseptic processing

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US42069102P 2002-10-23 2002-10-23
US60/420,691 2002-10-23

Publications (2)

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WO2004037300A2 true WO2004037300A2 (fr) 2004-05-06
WO2004037300A3 WO2004037300A3 (fr) 2004-07-08

Family

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PCT/US2003/033689 WO2004037300A2 (fr) 2002-10-23 2003-10-22 Systemes, dispositifs et procedes de traitement aseptique

Country Status (3)

Country Link
US (1) US20060048844A1 (fr)
AU (1) AU2003301515A1 (fr)
WO (1) WO2004037300A2 (fr)

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US10259607B2 (en) 2008-03-04 2019-04-16 Vanrx Pharmasystems Inc. Aseptic robotic filling system and method
US9789986B2 (en) 2009-02-26 2017-10-17 Vanrx Pharmasystems Inc. Robotic filling systems and methods
DE102008030268B3 (de) * 2008-06-19 2010-02-04 Arzneimittel Gmbh Apotheker Vetter & Co. Ravensburg Verfahren zum Befüllen von Doppelkammersystemen in vorsterilisierbaren Trägersystemen und vorsterilisierbares Trägersystem
DE102009000299A1 (de) * 2009-01-19 2010-07-22 Robert Bosch Gmbh Schlauchpumpe
AU2010276522B2 (en) 2009-07-29 2016-03-10 Icu Medical, Inc. Fluid transfer devices and methods of use
EP3208202B1 (fr) * 2010-08-06 2019-11-20 Hospira Australia Pty Ltd Systeme de production de flacons contenant une substance comprenant une formulation sensible a l'oxygene
US10524980B2 (en) * 2016-09-13 2020-01-07 Vanrx Pharmasystems, Inc. Apparatus and method for aseptically filling pharmaceutical containers with a pharmaceutical fluid using rotary stage
US10723497B2 (en) * 2014-11-03 2020-07-28 Vanrx Pharmasystems Inc. Apparatus and method for monitoring and controlling the filling of a container with a pharmaceutical fluid in an aseptic environment
EP2793978B1 (fr) 2011-12-22 2023-03-08 ICU Medical, Inc. Dispositifs de transfert de fluide et procédés d'utilisation
WO2015023924A2 (fr) 2013-08-16 2015-02-19 Vanrx Pharmasystems Inc. Procédé, dispositif et système de remplissage de contenants pharmaceutiques
ES2805051T3 (es) 2013-11-25 2021-02-10 Icu Medical Inc Procedimientos y sistema para llenar bolsas I.V. con líquido terapéutico
KR102438604B1 (ko) * 2015-10-28 2022-08-31 반알엑스 파마시스템즈 인크. 무균 로봇 충전 시스템 및 방법
CA3233913A1 (fr) 2015-12-04 2017-06-08 Icu Medical, Inc. Systemes, procedes et composants pour le transfert de fluides medicaux
USD851745S1 (en) 2016-07-19 2019-06-18 Icu Medical, Inc. Medical fluid transfer system
AU2017302557B2 (en) 2016-07-25 2022-10-13 Icu Medical, Inc. Systems, methods, and components for trapping air bubbles in medical fluid transfer modules and systems
US11530064B2 (en) * 2016-09-13 2022-12-20 Vanrx Pharmasystems Inc. Apparatus and method for monitoring and controlling the removal of a cover from a sealed tube in an aseptic environment
US11826310B2 (en) 2018-10-19 2023-11-28 Amol S. Matharu Portable apparatus and method for sterile pharmaceutical manufacturing
US11590057B2 (en) 2020-04-03 2023-02-28 Icu Medical, Inc. Systems, methods, and components for transferring medical fluids
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Also Published As

Publication number Publication date
AU2003301515A8 (en) 2004-05-13
AU2003301515A1 (en) 2004-05-13
US20060048844A1 (en) 2006-03-09
WO2004037300A3 (fr) 2004-07-08

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