Hazardous or potent material containment bag and system

Abstract

Doble lined containment bags are provided for secure storage, transfer, and charging with API and potent and / or hazardous materials. The bags adopts a bag inside a bag design, comprising an inner containment space for receiving the potent and / or hazardous material, and an outer containment space at least partially surrounding the inner containment space and separated from the inner containment space by a member. The outer containment space is separated from outside by bag by a secured bag opening. The member has an elongated tubular neck extending from the inner containment space and through the bag opening to outside the bag. The elongated neck is ideally intended for connection to a containment device (for example an isolator) such that the inner containment space forms a primary containment, while the outer containment space forms a secondary containment with the containment device.

Description

HAZARDOUS OR POTENT MATERIAL CONTAINMENT BAG AND SYSTEM TECHNICAL FIELD

[0001] The present disclosure relates high containment technology, and in particular containment bags for hazardous materials for coupling or linking with other containment devices.BACKGROUND

[0002] In recent years, there has been an acceleration of high containment technology. Potent & API substances are crucial in the Pharmaceutical & Chemical industries, particularly in the manufacture of oncology products to aid in the fight against cancer. Potent substances are also used in other areas such as the production of hormones and high potent drug substances that require high containment technology.

[0003] Existing containment technology uses isolators, also referred to as glove boxes. These glove boxes have been repurposed for the industry, for example, through the incorporation of controls. However, the technology remains rudimentary. The industry has moved towards single use containers (“one and done” containers). In the pharmaceutical industry, each time equipment, materials and products are used, they must be cleaned which is a complex process subject to stringent handling protocols and regulations. Further, existing isolators require small volumes of container bags so that these can be charged within the isolator. As a result, larger quantities of bags are used in daily operations since these bags are limited in size to maintain portability. Improved containment bags (such as development of OEB5 containment bags) are needed for the charging hazardous or highly potent material in medium and large volumes.SUMMARY OF INVENTION

[0004] In one aspect, there is provided a containment bag for a potent and / or hazardous material, the containment bag comprising: an inner containment space for receiving the potent and / or hazardous material for primary containment; an outer containment space at least partially surrounding the inner containment space and separated from the inner containment space by a member, the outer containment space defined by at least a portion of an outer wall of the containment bag having a bag opening, wherein the bag opening is adapted for secure and fluid connection with a containment chamber for secondary containment; the member having a tubular elongated neck in fluid communication with the inner containment space, wherein the elongated neck is adapted to extending through the bag opening, the elongated neck having a neck opening adapted for secure connection and for release of the potent and / or hazardous material.

[0005] In one embodiment, the potent and / or hazardous material is a liquid or a solid. In one embodiment, the potent and / or hazardous material is a high potent drug substance. In some embodiments, the inner containment space is defined by the member and at least a portion of the outer wall. In some embodiments, the member comprises an inner wall, and wherein the inner containment space is defined by the inner wall and at least a portion of the outer wall. In some embodiments, the inner containment space is encapsulated within the outer containment space, and wherein the member comprises an inner bag defining the inner containment space and the inner bag is at least partially attached to the outer wall. In some embodiments, the outer wall of the containment bag is made of a harder plastic material than the member. In some embodiments, the outer wall of the containment bag is made of a harder plastic material than the member. In some embodiments, the elongated neck is made from a soft plastic. In some embodiments, the elongated neck is made from a hard plastic configured to be folded within the outer containment space. In some embodiments, the outer wall comprises a plurality of attachment points positioned at different locations for keeping the containment bag taut when attached. In some embodiments, the containment bag comprises one attachment point at a top end of the containment bag opposite from the bag opening for suspending the containment bag. In some embodiments, the plurality of attachment points comprise two or more radially positioned gussets for attachment to a support structure. In some embodiments, the outer wall of the containment bag is tapered toward the bag opening. In some embodiments, the member is tapered toward the elongated neck. In some embodiments, the tapered portion of the member has an angle of between 20-70 degrees, preferably 35-50 degrees, and more preferably about 42 degrees. In some embodiments, the bag opening comprises a rapid transfer port (RTP) for coupling with the containment chamber for secondary containment. In some embodiments, the neck opening comprises a containment valve. In some embodiments, the elongated neck further comprises a clamp, a clip, a valve, a coupler, or combinations thereof. In some embodiments, the neck opening comprises a contained powder transfer system. In some embodiments, the neck opening comprises a passive unit of a Split Butterfly Valve (SBV) for primary containment.

[0006] In another aspect, there is provided a system for transporting, filling, and dispensing a potent and / or hazardous material, the system comprising: the containment bag as described herein; and a cart for carrying the containment bag in a taut configuration, the cart comprising: a frame shaped to hold the containment bag; a wheeled base connected to the frame; and a plurality of anchor points on the frame positioned in corresponding locations to the plurality of attachment points of the containment bag.

[0007] In some embodiments, the frame comprises a plurality of stacked curved arms positioned to encircle the containment bag. In some embodiments, the plurality of stacked curved arms are movably mounted on a vertical pillar, and wherein at least one of the curved arms is movable along the length of the pillar to adjust the spacing between the plurality of stacked curved arms. In some embodiments, frame comprises a neck support arm anchored to one of the curved armed at one end, and branched at a second end to support the bag opening of the containment bag. In some embodiments, the plurality of attachment points of the containment bag comprise two or more radially positioned gussets each with a coupling means for attachment to a corresponding anchor point on the frame. In some embodiments, the two or more radially positioned gussets each comprise a hole, and the plurality of anchor points comprise hooks for hooking onto the hole. In some embodiments, the frame is removably connected to the wheeled base for separate transport of the containment bag. In some embodiments, the frame is configured for coupling to the containment chamber for alignment of the containment bag to a containment chamber. In some embodiments, the frame is rotationally connected to the wheeled base for rotating the containment bag between an upright charging position and an inverted dispensing position.

[0008] In this respect, before explaining at least one embodiment in detail, it is to be understood that the embodiments are not limited in application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings.

[0009] Many further features and combinations thereof concerning embodiments described herein will appear to those skilled in the art following a reading of the instant disclosure.DESCRIPTION OF THE DRAWINGS

[0010] Embodiments of devices, apparatus, methods, and systems are described throughout reference to the drawings.

[0011] Fig. 1 shows 2.5L and 5L single-lined (SL) Charge Bags.

[0012] Fig. 2 shows 25L, 50L and 75L double-lined (DL) Charge Bags.

[0013] Fig. 3 shows a DL charge bag having a Split Butterfly Valve passive or other containment valve or system welded to the bag and a 28” Neck / chute.

[0014] Fig. 4 shows a DL charge bag with a 4” Tri-Clamp connection welded to the bag and a 31” Neck / chute.

[0015] Fig. 5 shows a 25L DL Charge Bag with RTP port, Weloc clamp, Tri-clamp connection, and 4” passive Chargepoint valve.

[0016] Fig. 6 shows a 50L DL Charge Bag with RTP port, Weloc clamp, Tri-clamp connection, and 4” passive Chargepoint valve.

[0017] Fig. 7 shows a 75L DL Charge Bag with RTP port, Weloc clamp, Tri-clamp connection, and 4” passive Chargepoint valve.

[0018] Fig. 8 shows a 25L DL Charge Bag with RTP port, Weloc clamp, and two Tri-clamp connection.

[0019] Fig. 9 shows a 50L DL Charge Bag with RTP port, Weloc clamp, and two Tri-clamp connection.

[0020] Fig. 10 shows a 75L 3D DL Charge Bag with RTP port, Weloc clamp, and two Tri-clamp connection.

[0021] Fig. 11 shows an alternate 25L DL Charge Bag with RTP Port, Weloc clamp, Tri-clamp connection and 4” passive Chargepoint valve.

[0022] Fig. 12 shows an alternate 25L DL Charge Bag with RTP port, Weloc clamp, and two Tri-clamp connection.

[0023] Fig. 13 shows a detailed view of a flush line comprising a tri-clamp connection, Teflon tube, and a pinch valve.

[0024] Fig. 14 shows a 25L DL Bag with hooks for easy attachment to a stand. The hooks are spaced around the bag diameter to keep the bag expanded, allowing for efficient charging / discharging, and smoother product displacement during rotation.

[0025] Fig. 15 shows a 50L DL Bag with hooks for easy attachment to a stand. The hooks are spaced around the bag diameter to keep the bag expanded, allowing for efficient charging / discharging, and smoother product displacement during rotation.

[0026] Fig. 16 shows a 75L DL Bag with hooks for easy attachment to a stand. The hooks are spaced around the bag diameter to keep the bag expanded, allowing for efficient charging / discharging, and smoother product displacement during rotation.

[0027] Fig. 17 shows a bag support frame.

[0028] Fig. 18 shows a bag support frame in 25L, 50L and 75L DL bag configuration. The frame has a lifting hook for attachment to hoist, for easy and safe lifting. Adjustable bag tensioner allows adjustability for different bag sizes, and easily adjusted by up and down movement of frame stanchions. RTP connector support keeps bag expanded allowing for efficient charging / discharging, and holds neck of bag during rotation.

[0029] Fig. 19 shows an inversion trolley.

[0030] Fig. 20 shows the bag support frame fitted onto the inversion trolley.

[0031] Fig. 21 shows 3 step process of using the bag support frame and trolley. A) Loading bag support frame to inversion trolley, and securing into position with a retention pin; B) Pulling the index plunger and rotating the handle on the inversion trolley to invert the bag support frame. Once 180 degrees is reached the index plunger will lock the bag in the inverted position. The bag can then be maneuvered under an isolator for charging. C) After charging, the bag can be removed from under the isolator, rotating the bag 180 degrees again, and hoisting the bag onto the top of the isolator.DETAILED DESCRIPTION

[0032] Currently the industry mainly utilizes a series of primary, secondary, and tertiary containment for handling hazardous materials, with the tertiary containment being the containment room itself. This requires isolating the containment room from the rest of the building. In addition, current technology uses an isolator as the primary containment or a split butterfly valve. Isolators in their current form are typically sizeable and impractical. Hence, industry practices require large amounts of labour and care when moving containments.

[0033] To address these challenges, creating a smaller and more practical isolator that can optionally be disposed is desired. The present disclosure provides potent or hazardous material containment systems and methods to improve / enhance current containment technology. As used herein, “potent or hazardous material” refers to substances, such as solids, liquids, or gases that pose or has the potential to pose risks, detriment, irritation, or negative impacts to human health, safety, property, and the environment due to properties like toxicity, flammability, corrosivity, or reactivity.

[0034] An exemplary containment system according to the present disclosure comprises: i) high density double bags, specifically Single-Lined (SL) and / or Double-Lined (DL) bags; ii) bag transfer cart; iii) a Rapid Transfer Port (“RTP”); and iv) Split Butterfly Valve or other containment valve technology. Containment bags for potent or hazardous materials are provided by utilizing port technology which allows for the creation of a “bag inside a bag”. The system uses Rapid Transfer Port (“RTP”) assemblies designed to make and break connections inside a charge. If a combination of valve technology is used and contaminated products are placed through a port, containment levels can be attained which protect the operator and allow the operator to work with less protective material.

[0035] In some embodiments, a containment bag comprises an inner containment space for receiving the hazardous material, and an outer containment space at least partially surrounding the inner containment space. This double containment space design is adopted to meet, forexample, Occupational Exposure Band (OEB) 5 level containment for Active Pharmaceutical Ingredient (API) API and potent and / or hazardous material handling when used in conjunction with an rigid or flexible singe chamber isolator. The containment bags described herein are intended for use in, for example, potent solids subdivision process which involves the Subdivision Isolator and the reactor potent charge process which involves the Reactor Charge / Sample Isolator. The containment spaces are encased by containers or bags made from inert materials that do not react with the potent and / or hazardous material. An exemplary containment bag 10 is shown in Fig. 1 having an outer wall 15 and a bag opening 17 at a first end of the containment bag. A second end of the containment bag, preferably opposite to the first end, is configured or anchoring or hanging the containment bag, such a hook hole 19. The bag opening is defined by a connector for secure attachment means, such as a valve or couplings for sealed transfer of material in or out of the containment bag. The containment bag is also shaped for ease of flow of materials in or out of the containment bag.

[0036] Turning to Fig. 2, a preferred embodiment of the containment bag 20 is shown having an inner containment space 21 and an outer containment space 22. In some embodiments, the outer containment space is separated from the inner containment space by a member, such that contents of the inner containment space does not escape into the outer containment space. The member divides the space within the containment bag into two compartments. In some embodiments, the member expends across the interior space of the containment bag. In some embodiments, the member is shaped for easer of flow of materials in and out of the inner containment space.

[0037] As shown in Fig 2, the space inside the containment bag is divided into two compartments, the inner containment space 21 and the outer containment space 22. The outer containment space is bounded and defined by at least a portion of an outer wall 25 of the containment bag having a bag opening 27 at a first end. In some embodiments, the bag opening connects the outer containment space to the bag exterior. The bag opening is adapted for secure and fluid connection with a containment chamber, such as an isolator, a fume hood, a reactor, tanks, or other equipment that require potent material charging. As used herein, “charging” refers to fulling a containment mag with a potent and / or hazardous material. In one embodiment, the bag opening comprise a 190 Beta RTP. The member dividing the inner and outer containment space comprise an elongated neck 23 which can be folded and stored within the outer containment space, and unfolded to extend through the bag opening and out of the containment bag. The elongated neck comprise a tube in fluid communication with the inner containment space on one end and has a neck opening 24 on the other end for secure connection and for release ofthe hazardous material. For example, the neck opening comprise a 4 inch TC / SBV passive valve. The elongated neck and member together prevents contents of the inner containment bag from escaping into the outer containment space, as well as the exterior of the containment bag.

[0038] In one embodiment, the inner containment space occupies an upper portion of the bag, and the outer containment space occupies a lower portion of the bag, with the bag opening located at the bottom of the bag. In this case, the inner containment space is bounded by the member and at least an upper portion of the outer wall. The elongated neck extends down from the member and through the bag opening at the bottom, such that the neck opening extends out of the containment bag. In another embodiment, the inner containment space occupies an upper portion of the bag and is encircled by the outer containment space. In this case, the member comprises an inner cylindrical wall terminating as the elongated neck, and wherein the inner containment space is defined by the inner wall and shares a common portion of the outer wall with the outer containment space. In yet another embodiment, the inner containment space is engulfed within the outer containment space. In this case, the member comprises an inner bag defining the inner containment space and the inner bag is attached to the outer wall.

[0039] In some embodiments, the containment bag is made of plastic. In one embodiment, the bags are made from malleable plastic. In one embodiment, the bags are made from soft plastic. In one embodiment, the bags are made from rigid plastic. In one embodiment, the bags are made from soft and hard plastic. In order to provide structural integrity, a harder plastic is desired for the outer wall of the containment bag, while a softer plastic is desired for the member and elongated neck to provide flexibility. In one embodiment, the outer wall of the containment bag is made of a harder plastic material than the member. In one embodiment, the elongated neck is made from a soft plastic. Alternatively, the elongated neck can be made from a hard plastic with groves or fold lines for folding the elongated neck.

[0040] The containment bags described herein are designed to contain hazardous material, such as a liquid or a solid hazardous material. In one embodiment, the hazardous material is a granular or particulate material. In one embedment, the hazardous material is a high potent drug substance. The bags are configured for easy release of the hazardous material through gravity. In some embodiments, the member is tapered towards the elongated neck for easier flow of granular material from the inner containment space and out through the elongated neck. For example, the member is cone shaped with the slope of the cone defining the taper. In one embodiment, the member has a taper that corresponds to the angle of repose of the granular material. In one embodiment, the member is tapered at an angle of between 20-70 degrees, preferably 30-60 degrees, more preferably 35-50 degrees, more preferably between 40-50degrees, and more preferably between 40-45 degrees. In one embodiment, the taper is at an angle of about 42 degrees. In some embodiments, the taper angle is selected based on the intended material to be contained by the bag. Similarly, the outer wall of the containment bag may also be tapered for ease of handling. In some embodiments, the outer wall of the containment bag is tapered toward the bag opening. In one embodiment, the outer wall is tapered at an angle of between 20-70 degrees, preferably 30-60 degrees, more preferably 35-50 degrees, more preferably between 40-50 degrees, and more preferably between 40-45 degrees. In some embodiment, the taper is at an angle of about 43 degrees. In one embodiment, the taper of the outer wall is the same angle as the taper of the member. In one embodiment, the taper of the outer wall is a greater angle than the taper of the member. In one embodiment, the taper of the outer wall is a smaller angle than the taper of the member.

[0041] For secure connection, the containment bags described herein have secure couplings to maintain a continuous containment space between a containment bag and a containment chamber, such as an isolator. The bags provided herein aim to minimize the number of chambers required on an isolator to achieve the Containment Performance Target (CPT) level of at most 10 nanograms per cubic metre (ng / m3), preferably less than 10 ng / m3, task base performance. In some embodiments, the bag opening comprises a rapid transfer port (RTP) for coupling with the containment chamber. A RTP port reduces containment levels and form secondary containment as part of the Isolator to achieve 100 nanograms per cubic metre (ng / m3), or alternatively other ports achieving the same level of containment may be used. Similarly, the elongated neck is fitted with means for controlling the flow of potent and / or hazardous material there through. In some embodiments, the elongated neck comprises one or more of a clamp, a clip, a valve (such as a National Pipe Thread Taper (NPT) valve), or a coupler to control flow of hazardous material through the elongated neck. In some embodiments, the neck opening comprises a containment valve for coupling to a container in the isolator. In one embodiment, the neck opening comprises a passive unit of a Split Butterfly Valve (SBV) for coupling to an active SBV unit of a container inside the isolator. In other embodiments, the neck opening may comprise other contained powder transfer technology / systems, for example: Safeport™ Transfer System, Ezi-Dock™ High Containment Transfer System, or Flecotec™ Material Transfer System. Turning to Fig. 13 a bag with a flush line attached to the elongated neck is shown, with its own valve and clamp connection.

[0042] For ease of transport and / or filing or charging the bag, attachment points are provided on the bag for attachment to corresponding anchor points on a support structure. Example attachment points include, but are not limited to, holes, hooks, or clips. In the embodiment shown in Fig. 2, the bag has one or more flanges at the top of the bag opposite the bag opening. Theflanges have holes 29 for hooking onto a suspension hook. The bag may alternatively or in conjunction be attached to a support structure for hoisting the bag. In the embodiments shown in Figs. 5-10, the containment bag is secured to a lift frame 59 at the top of the containment bag. The containment bag is connected to the lift frame by carabiners. The lift frame comprises multiple arms, anchored to different points of the containment bag thereby maintaining the extended shape of the containment bag. The lift frame comprises one or more holes configured for hooked suspension.

[0043] As well, containment chambers and bag are ideally maintained at negative pressure to avoid leakage or contamination of hazardous materials outside the chamber. In some embodiments, the outer wall comprises a plurality of attachment points positioned at different locations for keeping the containment bag taut, for keeping the bag in an extended position. These attachment points are ideally positioned at opposite ends or radially arranged around the bag. Turning to Figs. 14-16, a bag is shown with 8 hooks 1401 or clips around a perimeter of the bag. The hooks 1401 are for ease of attachment to a bag stand. The hooks positioned evenly spaced apart around the bag diameter, such that the bag is kept evenly extended and expanded when attached to a support structure. The extended state of the bad allows for efficient charging / discharging, and smoother product displacement during rotation. The containment bag may also have a clamp 1402 clipped to the elongated neck to keep the potent and / or hazardous material contained within the bag during bag manipulation. In some embodiments, the bags have two or more radially positioned gussets 28 having, for example, holes, hooks, or clips for attachment to a support structure. The gussets are positioned at opposite ends or radially arranged around the bag in order to keep the bag evenly extended.

[0044] Support structures described herein are intended for keeping the containment bag extended, for ease of transport of the containment bag, and / or ease of filing or charging the bag, as well as dispensing the contents of the bag from an elevated height. In some embodiments, the support structure is a cart comprises a frame shaped to hold the containment bag and a wheeled base connected to the frame. The frame has a plurality of anchor points on the frame positioned in corresponding locations to the plurality of attachment points of the containment bag. In one embodiment, the frame has anchor points positioned to couple to the gussets of the containment bag. As well, the frame has a complementary shape to that of the containment bags. For example as shown in Figs. 17 and 18, fora cylindrical containment bag, the frame 1700 comprises curved arms 1701 for encircling the containment bag 1750. The frame 1700 also comprises a vertical pillar 1703 to anchor and support the curved arms 1701. In one embodiment, the frame has multiple vertically stacked curved arms 1701 mounted to the vertical pillar 1703 such that thehorizonal plane defined by the curved arms is perpendicular to the axis of the vertical pillar. Preferably, the horizontal plane of each curved arm is coplanar. Preferably, the curved arms 1701 are movably mounted to the vertical pillar 1703. The spacing between each arm is adjustable to accommodate cylindrical containment bags of different sizes and volumes. For example, the frame comprises adjustable bag tensioner for positioning and spacing the curved arms as the curved armed are movably translated along the length of the vertical pillar, allowing for adjustability to accommodate different bad sizes. The frame is easily adjusted by use of index plungerto allow up and down movement of the curved arms along a vertical pillar 1703. The frame configuration is optimized for keeping the bag expanded allowing for efficient charging / discharging. In some embodiments, the frame 1700 has a neck support arm 1702 extending from the top curved arm 1701. The neck support arm 1702 is anchored to the top curved arm on one end and branches out on a second end. The branched end is configured to hold the containment bag neck or bag opening, allowing for secure transport as well as for efficient charging / discharging. The bottom curved harm optionally comprises a handle 1704 for ease of carrying.

[0045] Turning to Figs. 19-21, the frame 1700 is removably connected to a wheeled base 1900 for ease of transport. Together, the frame 1700 mounted on the wheeled base 1900 has a height that allows for the structure to fit under an isolator (for example, less than 90cm when RTP connector is lowered onto the RTP support at the bag opening). In one embodiment, the height from floor to the base of the RTP support is 844mm. In one embodiment, the height from floor to the top of RTP connector is 930mm. (See Fig. 20.) When the containment bag is attached to the frame at the anchor points, the position of the curved arms can be adjusted to prevent excessive stretching of the containment bag while keeping the containment bag extended.

[0046] In embodiments where frame 1700 is removably connected to a wheeled base 1900, the vertical pillar comprises an inversion trolley connector 2101 that is tethered to the wheeled base 1900 by a retention pin 2102 (see panel A of Fig. 21). Once the frame 1700 is secured to the wheeled base 1900, an index plunger 2103 locking the rotation mechanism 2104 in place is released, to rotate the frame. Once 180 degrees is reached, the index plunger will lock the frame in position. (See panel B of Fig. 21).

[0047] Referring to panel C of Fig. 21, when in use the containment bag is positioned under an isolation by the frame which is rotated in an upright position to hold the bag with the bag opening upward for charging. After charging, the containment bag can be removed from underthe isolator. Where the containment bag opening comprises an RTP connector, the RTC connected is unsecured from the RTP support. The elongated neck of the containment bag is clamped or rolleddown into the outer containment space of the containment bag. The frame supporting the containment bag is rotated 180 to an inverted position, decoupled from the wheeled based and hoisted off to on top of the isolator.

[0048] When hoisting the containment bag, the frame is decoupled from the wheeled base such that the containment bag and frame can be hoisted off together. In one embodiment, the frame is decoupled from the wheeled base by removing a tethered retention pin. The frame may be further configured for proper coupling or alignment of the containment bag to a containment chamber. In some embodiments, the frame is connected to the wheeled base at a pivot point. In alternate embodiments, when attached, the frame rotates (ideally to predetermined fixed positions) for rotating the containment bag between an inverted fill / charge position and an upright dispensing position.EXAMPLES

[0049] Charge bags were made from high density plastic, with volumes ranging from 5 litres to 100 litres. Higher or lower volume bags can be provided. However, the process described herein estimates that 50 litres will be the most functional size. The bags are single use and disposed of after their intended use. The SL Charge Bags have capacities of 2.5 and 5L (see Fig. 1 and Table 1). The cylindrical DL Charge Bags have capacities of 25, 50, and 75L (see Figs. 2-10 and Table 2). The flat DL Charge Bag have a capacity of 25L (see Figs. 11-12, and Table 3).

[0050] The Bag Transfer Cart is able to transfer 1 cylindrical DL Charge Bag with capacities of 24L to 75L or 1 flat DL Charge Bag of 25L from the Subdivision Isolator to the Charge / Sample Isolator (see Figs. 17-21 and Table 4)Example 1: Single-Lined Charge Bag

[0051] In the subdivision process, the 2.5L and 5L 2D SL Charge Bags (see Fig. 1) will enter the pack-off chamber of the Subdivision Isolator via a 270 RTP. The Charge Bags will have a Split Butterfly Valve passive that will dock onto the 4” split butterfly valve active within the pack-off chamber. The bags are then filled, cone side up, with a measured amount of potent solids. The bags are disconnected and exited through the 270 RTP. The bags are transferred to Charge / Sample Isolator via transfer trolley. The bags enter the Charge / Sample Isolator by docking the 270 RTP containing the Charge Bag to the Discharge / Sample Chamber of the Isolator which is located on the right wall of the chamber. The Charge Bag is pulled through the Discharge / Sample Chamber and hung cone side down over the 4” Split Butterfly Valve activewithin the chamber. Once in position, the 4” passive is docked and locked onto the active valve. Upon the completion of solids dispensing, the SBV is closed and the bag is disconnected and the connection is wiped down. The Charge Bag is rolled / folded up and removed via the 10” Bag-out port into a continuous liner on the left-hand chamber wall.Table 1: Single-Lined Charge Bag RequirementsExample 2: Cylindrical Double-Lined Charge Bag

[0052] During the subdivision process, the 25, 50, and 75L 3D DL Charge Bags shall be cone side up and supported by the Transfer Cart. The Charge Bag will dock onto the 190 RTP under the pack-off chamber of the Subdivision Isolator. The Charge Bags will be filled with a measured amount of potent solids through the Subdivision Isolator. The large DL bags are then inverted and transported on a Bag Transfer Cart to the Charge / Sample Isolator. The Transfer Cart docks onto the side of the Charge / Sample Isolator and a lifting device, specifically a crane, is used to hoist the bag off the cart, over to the Charge / Sample Isolator docking area, and lower to dock onto the Charge / Sample Isolator to be charged into a reactor. Once the solids charge is complete, the bag will be undocked from the Charge / Sample Isolator and hoisted back onto the cart.

[0053] The DL Charge Bags will have an inner liner that holds the dispensed solids and an outer liner for improved containment. The inner liner with a long “neck” that creates a chute forthe solids to flowthrough. Either a 4” Split Butterfly Valve (SBV) passive or 4” tri-clamp connection is welded to the bag to allow docking within the Subdivision Isolator and Charge / Sample Isolators. The outer liner shall have a 190 mm RTP welded to the bag to allow the inner liner neck to be pulled through for filling and dispensing the solids.TABLE 2: Cylindrical Double-Lined Charge Bag RequirementsExample 3: Flat Double-Lined Charge Bag RequirementsTABLE 3: Flat Double-Lined Charge Bag RequirementsExample 4: Charge Bag Transfer CartTABLE 4: Charge Bag Transfer Cart Requirements

Claims

CLAIMS:

1. A containment bag for a potent and / or hazardous material, the containment bag comprising:an inner containment space for receiving the potent and / or hazardous material for primary containment;an outer containment space at least partially surrounding the inner containment space and separated from the inner containment space by a member, the outer containment space defined by at least a portion of an outer wall of the containment bag having a bag opening, wherein the bag opening is adapted for secure and fluid connection with a containment chamber for secondary containment;the member having a tubular elongated neck in fluid communication with the inner containment space, wherein the elongated neck is adapted to extending through the bag opening, the elongated neck having a neck opening adapted for secure connection and for release of the potent and / or hazardous material.

2. The containment bag of claim 1 , wherein the potent and / or hazardous material is a liquid or a solid.

3. The containment bag of claim 1 or 2, wherein the potent and / or hazardous material is a high potent drug substance.

4. The containment bag of any one of claims 1-3, wherein the inner containment space is defined by the member and at least a portion of the outer wall.

5. The containment bag of any one of claims 1-3, wherein the member comprises an inner wall, and wherein the inner containment space is defined by the inner wall and at least a portion of the outer wall.

6. The containment bag of any one of claims 1-3, wherein the inner containment space is encapsulated within the outer containment space, and wherein the member comprises an inner bag defining the inner containment space and the inner bag is at least partially attached to the outer wall.

7. The containment bag of any one of claims 1 -6, wherein the outer wall of the containment bag is made of a harder plastic material than the member.

8. The containment bag of any one of claims 1-7, wherein the elongated neck is made from a soft plastic.

9. The containment bag of any one of claims 1-7, wherein the elongated neck is made from a hard plastic configured to be folded within the outer containment space.

10. The containment bag of any one of claims 1-9, wherein the outer wall comprises a plurality of attachment points positioned at different locations for keeping the containment bag taut when attached.

11. The containment bag of claim 10, comprising one attachment point at a top end of the containment bag opposite from the bag opening for suspending the containment bag.

12. The containment bag of claim 10 or 11 , wherein the plurality of attachment points comprise two or more radially positioned gussets for attachment to a support structure.

13. The containment bag of any one of claims 1-12, wherein the outer wall of the containment bag is tapered toward the bag opening.

14. The containment bag of any one of claims 1-13, wherein the member is tapered toward the elongated neck.

15. The containment bag of claim 14, wherein the tapered portion of the member has an angle of between 20-70 degrees, preferably 35-50 degrees, and more preferably about 42 degrees.

16. The containment bag of any one of claims 1-15, wherein the bag opening comprises a rapid transfer port (RTP) for coupling with the containment chamber for secondary containment.

14. The containment bag of any one of claims 1-13, wherein the neck opening comprises a containment valve.

15. The containment bag of claim 14, wherein the elongated neck further comprises a clamp, a clip, a valve, a coupler, or combinations thereof.

16. The containment bag of claim 14 or 15, wherein the neck opening comprises a contained powder transfer system.

17. The containment bag of any one of claims 14-16, wherein the neck opening comprises a passive unit of a Split Butterfly Valve (SBV) for primary containment.

18. A system fortransporting, filling, and dispensing a potent and / or hazardous material, the system comprising:the containment bag of claim 10; anda cart for carrying the containment bag in a taut configuration, the cart comprising: a frame shaped to hold the containment bag;a wheeled base connected to the frame; anda plurality of anchor points on the frame positioned in corresponding locations to the plurality of attachment points of the containment bag.

19. The system of claim 18, wherein the frame comprises a plurality of stacked curved arms positioned to encircle the containment bag.

20. The system of claim 19, wherein the plurality of stacked curved arms are movably mounted on a vertical pillar, and wherein at least one of the curved arms is movable along the length of the pillar to adjust the spacing between the plurality of stacked curved arms.

21. The system of claim 19 or 20, wherein the frame comprises a neck support arm anchored to one of the curved armed at one end and branched at a second end to support the bag opening of the containment bag.

22. The system of any one of claims 18-21 , wherein the plurality of attachment points of the containment bag comprise two or more radially positioned gussets each with a coupling means for attachment to a corresponding anchor point on the frame.

23. The system of claim 22, wherein the two or more radially positioned gussets each comprise a hole, and the plurality of anchor points comprise hooks for hooking onto the hole.

24. The system of any one of claims 18-23, wherein the frame is removably connected to the wheeled base for separate transport of the containment bag.

25. The system of claim 24, wherein the frame is configured for coupling to the containment chamber for alignment of the containment bag to a containment chamber.

26. The system of any one of claims 18-25, wherein the frame is rotationally connected to the wheeled base for rotating the containment bag between an upright charging position and an inverted dispensing position.

Images