Cover removal system for use in controlled environment enclosures

The present application is a divisional application of U.S. patent application Ser. No. 14/398,538, filed Nov. 3, 2014, which is a National Stage of PCT International Application Serial Number PCT/US13/39455, filed May 3, 2013, which claims priority under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application Ser. No. 61/642,430, filed May 3, 2012, the disclosures of which are incorporated by reference herein.This application is a Reissue of U.S. patent application Ser. No. 15/828,360, filed Nov. 30, 2017, now U.S. Pat. No. 10,781,091; which is a divisional application of U.S. patent application Ser. No. 14/398,538, filed Nov. 3, 2014, now U.S. Pat. No. 10,081,527; which is a National Stage of PCT International Application Serial Number PCT/US13/39455, filed May 3, 2013, which claims priority under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application Ser. No. 61/642,430, filed May 3, 2012, the disclosures of which are incorporated by reference herein.

This document relates generally to controlled environment enclosures and in particular to a method and apparatus for removing covers from sealed containers in controlled environment enclosures.

Controlled environment enclosures are known in the art and are used, for example, for containment of hazardous materials or to provide controlled environments with limited numbers of particulates.

In the art, controlled environment enclosures are typically fitted with ports for transfer of materials in and out of the enclosure and the ports are fitted with gloves for manual manipulation of equipment, parts or materials inside the enclosure. Such gloves are subject to significant risk of puncture, the consequences of which can be severe.

In some examples known in the art the controlled environment enclosure is also used to limit exposure to viable particulates such a bacteria and fungi. The controlled environment enclosures may be required for aseptic processing of cell cultures or for the manufacture of pharmaceutical products, medical devices, food or food ingredients. In such applications the requirement is for the controlled environment enclosure to be decontaminated. This can be done thermally using steam or chemically using chemical agents. Suitable chemical agents known in the art include hydrogen peroxide, ozone, beta-propiolactone, aziridine, formaldehyde, chlorine dioxide, ethylene oxide, propylene oxide, and peracetic acid. In most cases the decontamination and sterilization operations have to be preceded by a cleaning process. Such cleaning processes have the function of removing major contamination by simple mechanical and chemical action.

In some prior art examples the controlled environment also contains automated equipment. Such automated equipment can include machines for manipulation of parts or as containers, including test tubes, roller bottles, cell culture dishes, bottles, vials, ampoules and syringes. Typical examples of such manipulations are inspection, filling and capping.

Parts to be manipulated in controlled environment enclosures can be packaged in a container such as a tub. The container can be closed with a cover consisting of a sheet of flexible material, which generally is heat sealed to the container. The container and contents are decontaminated using a chemical agent, plasma or radiation.

The automated equipment located in the controlled environment is typically of such a size and complexity that it cannot be operated fully automatically without human intervention. Such human intervention typically requires the use of gloves with the associated risk of puncture. A typical example of human intervention that involves the use of gloves is the removal of container covers.

In view of the above background there remains a need for an apparatus and method for removal of container covers within controlled environments that does not require human intervention via the use of gloves.

In a first aspect a method is presented for removing within a controlled environment enclosure a container cover from a sealed container, the sealed container sealed by the container cover, the method comprising moving the container while holding a gripping area of the container cover substantially stationary. The moving of the container comprises holding the container with an articulated arm apparatus disposed within the controlled environment whilst removing the container cover by a first manipulation of the articulated arm apparatus. The method further comprises a second manipulating of the articulated arm apparatus to position along a trajectory the sealed container within a reach of a gripping apparatus disposed within the controlled environment, and gripping the gripping area with the gripping apparatus.

The positioning of the sealed container comprises placing the gripping area of the container cover between two gripping elements of the gripping apparatus, the first and second of the two gripping elements respectively comprising first and second mutually parallel and mutually engagable grip surfaces. The method further comprises rotating at least one of the gripping elements. The positioning of the gripping area can comprise placing the gripping area proximate and substantially facing the first grip surface. The rotating of at least one of the gripping elements can comprise moving the second of the two gripping elements in a plane substantially parallel to the first grip surface.

The positioning of the container can further comprise straightening the gripping area if the gripping area is bent toward the first grip surface by contacting to the first grip surface to one of the gripping area and a part of the cover in contact with the gripping area. The moving of the the second gripping element can comprise straightening the gripping area if the gripping area is bent toward the second gripping element by contacting the second grip surface to the other of the gripping area and the part of the cover in contact with the gripping area.

The method can further comprise lowering the container or rotating the container about an axis substantially in the plane of the cover. This is done by a third manipulating of the articulated arm apparatus. The rotating or raising of the gripping area is to an extent that allows the gripping apparatus to remain clear of the container during the removing the container cover.

The removing the container cover can be removing the container cover simultaneously along two edges of the container. The first manipulating of the articulated arm apparatus can comprise moving the container with respect to the gripping apparatus. Moving the container with respect to the gripping apparatus can comprise moving the container substantially diagonally with respect to the gripping apparatus. The moving the container with respect to the gripping apparatus can comprise moving the container along a predetermined path within a predetermined space. One or both of the predetermined path and the predetermined space can be determined using a controller. The predetermined path can be a circular path.

The trajectory of the container can be based on information obtained from a sensor. The information can comprise one or both of position information and orientation information about the gripping area.

The method can further comprise inspecting the container cover using a sensor. The method can further comprise selecting an alternative gripping area of the container cover based on the inspecting; gripping the alternative gripping area with the gripping apparatus; and removing the container cover by moving the container.

The method can further comprise moving the gripping apparatus away from an operational area of the articulated arm apparatus after removing the container cover.

In a further aspect there is provided an apparatus comprising a controlled environment enclosure; and within the controlled environment enclosure an articulated arm apparatus and a rotary gripping apparatus. The articulated arm apparatus can be configurable for holding and moving a container in three dimensions; and the rotary gripping apparatus can be configured for gripping a gripping area of a container cover sealing the container. The rotary gripping apparatus can comprise two gripping elements having facing mutually engagable surfaces, at least one of the two gripping elements being rotatable about a common axis with the other of the two gripping elements to grip the gripping area of the container cover between the two facing mutually engagable surfaces. The the articulated arm apparatus can comprise at least two arm segments, at least one arm segment being configurable to hold the container.

The articulated arm apparatus and the rotary gripping apparatus can be separated by a distance large enough for the gripping apparatus to not interfere with the working of the articulated arm apparatus. The apparatus can further comprise a controller for controlling at least the articulated arm apparatus and the gripping apparatus. The moving the container can be moving the container along a path that is determined by the controller and the moving the container is contained within a space determined by the controller.

The apparatus can further comprise a sensor configured for supplying information to the controller for determining at least one of a location of the container cover gripping area and an orientation of the container cover. The articulated arm apparatus can be at least one of automatically controlled and reprogrammable. The gripping apparatus can be at least one of automatically controlled and reprogrammable.

shows an apparatuscomprising a controlled environment enclosure, a gripping apparatusand an articulated arm apparatus, both inside the controlled environment enclosureand arranged for positioning and relocation of a containerwithin the controlled environment enclosurewithout requiring direct human intervention and the associated use of gloves. Containercan be, for example, a tub. The term “tub” as used herein is used to describe any container suitable for holding parts, trays of nested arrangements of parts, a stack of trays with nested arrangements of parts, or combinations thereof.

The apparatuscan further comprise of a sensorfor sensing the container.

The controlled environment enclosurecan comprise windows, an inlet filter, an inlet valve, a blower, an outlet filterand an outlet valve. The characteristics of blower, inlet filter, and outlet filterare chosen to yield a controlled environment inside controlled environment enclosure. The contents of the controlled environment enclosurecan be protected by airflow while having one or more openings (not shown).

In another embodiment the controlled environment enclosurecan be fully sealed and be operated at a positive or negative pressure differential relative to the surroundings. Those skilled in the art will understand that several other filter and blower arrangements can be used to establish a controlled environment inside controlled environment enclosure. A suitable controlled environment can be obtained, for example without limitation, by means of any one or more of turbulent airflow, horizontal unidirectional airflow and vertical unidirectional airflow.

The operation of the gripping apparatusand the articulated arm apparatusis controlled by a means located outside of environment enclosure. In some embodiments the means of controlling apparatus, apparatusand enclosurerequire a local or remote operator input device such as joy stick control, push button control, emergency stop, touch screen human machine interface, keyboard, mouse, handheld device or the like. Typically one or more of such input devices are connected to a controller. In, a laptop computer programmed with suitable software is shown as an example of controller. In other embodiments controllercan be a variety of other means such as operator interface panel, programmable logic controller, programmable automation controller, a desktop computer or a remote I/O module with embedded logic functions. In some embodiments the controllercan consist of a plurality of the aforementioned controllers.

The controllerprovides control instructions to apparatusover control line. Control lineis a schematic representation of all of the required mechanical linkages, electrical wiring, pneumatic, hydraulic and wireless connections to operate apparatus.

The containercan be manipulated inside the controlled environment enclosureby mechanical means, for example, an articulated arm apparatus. Suitable robotic arm manipulation systems for mechanically manipulating the containerinclude, but are not limited to, 6-axis robotic arms, Selective Compliant Articulated Robot Arm (SCARA) systems, r-theta robots, and assemblies of linear actuators and rotary actuators, or combinations thereof.

In one embodiment of the apparatusthe articulated arm apparatuscan be the articulated arm apparatus described in U.S. Provisional Patent application 61/596,698, which is incorporated herein by reference.

The controlled environment enclosure, in some examples, includes a sensorfor sensing the containerand a container coverfor the container. In the example shown inthe sensor is mounted to the top surface of the controlled environment enclosure. In other embodiments it can be mounted at another suitable location to monitor the interior of controlled environment enclosure. The sensor, in one example is an optical sensor. In other examples the sensorcan be one of a variety of other types of sensors, such as a camera system, a laser system or an ultrasonic sensing system. In yet other examples the sensoris an assembly that consists of a plurality of sensing elements. The sensorhas a sensing cone (not shown) or multiple sensing cones than can cover a small, a large area or both; depending on the characteristics of the sensorused.

In other embodiments of this invention the controlled environment chambercontains articulated arm apparatusplus at least one further articulated arm apparatus (not shown in the interest of clarity). The additional at least one further articulated arm apparatus can be used, for example, for activities that can follow removal of the container coverfrom the container. Apparatuscan be used for functions preceding the function of the filling system described in U.S. patent application Ser. No. 12/393,183, which is incorporated herein by reference.

In yet another embodiment gripping apparatusis added to a filling system as described in U.S. patent application Ser. No. 61/033,682, with element 30 of U.S. patent application Ser. No. 61/033,682 as the equivalent of articulated arm apparatusof the present specification, chamber 20 of U.S. patent application Ser. No. 61/033,682 as the equivalent of controlled environment enclosureof the present specification, and optical sensor 12 of U.S. patent application Ser. No. 61/033,682 as the equivalent of sensorof the present specification. U.S. patent application Ser. No. 61/033,682 is hereby incorporated by reference.

The articulation of arm apparatuscan be remoted operated by the operator. In another embodiment the articulated arm apparatuscan be an automatically controlled articulated arm. In yet another embodiment the articulated arm apparatus can be a reprogrammable automatically controlled articulated arm.

shows a bottom view of an example of the container. The containercan be made of a metal, glass, plastic or a composite material, but typically the tubis a single use thin walled container. Thin walled single use containers are typically made by a low cost process, such as thermoforming or injection molding. As shown in, the containercan have features such as tapered sidewalls that assist in manufacturability, but are more difficult to hold than an object with rigid parallel walls. All four walls forming the sides of the containercan have a step.

shows a detail view of container. The kind of containertypically employed in the pharmaceutical industry is characterized by a top lipthat provides a surface area for a sealed connection to the container cover. The term “cover” is used here to describe any surface material, including but not limited to a flexible sheet made of plastic material, a polymeric membrane or an impermeable laminated foil.

The container covercan extend outside the outline of the top lipof the tubin at least one location, and typically extends outside the outline of the top lipin a plurality of locations. The at least one area of container coverthat extends outside the outline of the top lipprovides a gripping areathat can be used as access for clamping. Clamping on the gripping areacan be complicated by the flexibility of the material of the container cover. The gripping areacan be level, bent upwards, or bent downwards.

shows an example embodiment of the gripping apparatus. An upper armis rotatably connected to a main shaftby a radial seal. The main shaftis rigidly connected to a lower armby a fully sealed joint. The main shaftis rotatably connected to a base flangeby a radial seal. The base flangeis scalably connected to controlled environment enclosure. The tip of lower armand the tip of upper armhave mutually facing and mutually engagable grip surfacesandrespectively such that the mutually facing flat grip surfacesandare mutually engagable in the absence of any material, such as container cover material, being disposed between the surfaces. The grip surfacecan be an upper surface of the tip of lower armand the grip surfacecan be a lower surface of the tip of the upper arm.

In one embodiment of the gripping apparatusthe lower armis stationary and upper armis rotatable about a cylindrical axis of main shaft. In another embodiment of the gripping apparatusthe upper armis stationary and lower armis rotatable about the cylindrical axis of main shaft. In yet a further embodiment both upper armand lower armare rotatable about the cylindrical axis of main shaft.

The gripping apparatuscan be remotely operated by the operator. In another embodiment the gripping apparatuscan be automatically controlled. In yet another embodiment the gripping apparatuscan be a reprogrammable automatically controlled gripping apparatus.

We now describe at the hand of,,, and, as well as the flow diagrams in,,,,,and, a method for using the apparatusto remove the coverof the container. The method comprises using the sensorto detect an orientation of the gripping area, and to communicate with the controllerover control line. The method further comprises planning the trajectory of the containerusing the controllerso that gripping apparatuscan access the gripping area.

In one example embodiment, shown inand expanded on inand, the method comprises the sensorsensing [] information concerning the gripping areaand communicating [] the sensed information to the controllerover control line. The sensed information can be the position of the gripping areaor the orientation of gripping areaor both. The sensed information can be used as input information by the controllerfor determining [] a trajectory for the articulated arm apparatusalong which to position the sealed containerwithin a reach of the gripping apparatus.

The cover gripping sequence can be initiated by rotating [] the upper armand the lower armof the gripping apparatuswith respect to each other by an angle that separates the mutually facing grip surfacesandlocated on respectively lower armand upper armby at least the width of the container. This can be done by rotating one or both of the armsand.

The method further comprises manipulating [] articulated arm apparatusto move the containeralong the trajectory that places the gripping areaabove the grip surfaceof the lower arm. This has the result of moving [] the containertowards the lower armin a trajectory that results in a bottom surface of the top lipof containernearing or contacting the grip surfaceof the lower arm. At least during the last section of the approach, the containercan be moved to cause the bottom surface of the top lipto substantially slide along the grip surfaceof the lower arm. During this section of the approach, the tip of the lower armcan be bending [] the gripping areaupward in the case where gripping areahappens to be orientated downward to below the top lip.

The method further comprises rotating [] upper armto grip the gripping area. This comprises moving [] the tip of upper armcomprising the surfaceover the container coverduring its travel to the gripping area. As the upper armapproaches the gripping area, it can slide over the container coverabove the top surface of top lip. During this action, the tip of the upper armcan be bending [] down to a substantially horizontal orientation any upward bent parts of cover, including specifically the gripping area.

In another example embodiment of the method, shown inand expanded on inand, the sensoralso senses the orientation of the gripping areaand communicates the sensed orientation to the controllerover control line. The sensed orientation of the gripping areacan, as before, be used as input information by controllerto determine a trajectory for the articulated arm apparatusalong which to position the sealed containerwithin a reach of the gripping apparatus.

The cover gripping sequence can, as above, be initiated with the rotating [] of the upper armand the lower armof the gripping apparatuswith respect to each other by an angle that separates the mutually facing grip surfacesandlocated on respectively lower armand upper armby at least the width of the container.

The method further comprises manipulating [] articulated arm apparatusto move the containeralong the trajectory that places the gripping areabelow the grip surfaceof the upper arm. This has the result of moving [] the containertowards the upper armin a trajectory that results in a top surface of the top lipof container, covered by cover, nearing or contacting the grip surfaceof the upper arm. At least during the last section of the approach, the containercan be moved to cause the top surface of the top lip, covered by cover, to substantially slide along the surfaceof the upper arm. During this section of the approach, the tip of the upper armcan be bending [] the gripping areadownward in the case where gripping areahappens to be orientated upward to above the top lip.

The method further comprises rotating [] the lower armto grip the gripping area. This comprises moving [] the tip of lower armcomprising the grip surfaceunder the bottom surface of top lipduring its travel to the gripping area. As the lower armapproaches the gripping area, it can slide along the bottom surface of top lip. During this action, the tip of the lower armcan be bending [] up to a substantially horizontal orientation any downward bent parts of cover, including specifically the gripping area.

The gripping apparatusworks for a wide range of thickness of the container coverby clamping the gripping areaof container coverin between the mutually facing grip surfacesandlocated on respectively the lower armand the upper arm.

The method provides for removing [] the container coverin the controlled environment enclosure. This is shown in expanded form in. Once the gripping apparatushas gripped the gripping areaand is holding the gripping areasubstantially stationary, the method can proceed further with manipulating [] the articulated arm apparatusto either lower the containeror rotate the containerabout an axis substantially in the plane of the cover. This manipulating [] is to a degree that positions and/or orients the containerand coversuch that clearance is established for the two armsandof the gripping apparatusto clear the coverand containerduring the subsequent removal of the coverfrom the container.

Referring to the articulated arm apparatusand the gripping apparatusas shown in, the container covercan be removed by moving the containerin a substantially diagonal trajectory by manipulating [] articulated arm apparatuswhile the gripping apparatusis holding the gripping areasubstantially stationary. The term substantially diagonal is used in this specification to describe a direction of motion parallel to the diagonal of the containerbetween the two sides of the containerthat terminate jointly at the location of the gripping area. The substantially diagonal trajectory minimizes a total length of adhesive that is being opened at any given time. As shown in, the substantially diagonal trajectory can be obtained by rotating the articulated arm apparatusin direction A. This particular choice of motion can keep all moving parts participating in removing the container coverconfined to a small space within the controlled environment enclosure. The controllercan be configured for predetermining the small space before the motion is conducted by predetermining the path for the containerto follow while being held by the articulated arm apparatus. The predetermined path can be, but is not limited to, a circular path.