WO2011035008A2 - Vessel incorporating film with enhanced anti-static properties and related methods - Google Patents

Vessel incorporating film with enhanced anti-static properties and related methods Download PDF

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Publication number
WO2011035008A2
WO2011035008A2 PCT/US2010/049098 US2010049098W WO2011035008A2 WO 2011035008 A2 WO2011035008 A2 WO 2011035008A2 US 2010049098 W US2010049098 W US 2010049098W WO 2011035008 A2 WO2011035008 A2 WO 2011035008A2
Authority
WO
WIPO (PCT)
Prior art keywords
film
layers
vessel
static agent
intermediate layer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2010/049098
Other languages
English (en)
French (fr)
Other versions
WO2011035008A3 (en
Inventor
Vishwas Pethe
Richard Bhella
Steven Vanhamel
Els Meesters
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
ATMI BVBA
Advanced Technology Materials Inc
Original Assignee
ATMI BVBA
Advanced Technology Materials Inc
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 ATMI BVBA, Advanced Technology Materials Inc filed Critical ATMI BVBA
Priority to IN3260DEN2012 priority Critical patent/IN2012DN03260A/en
Priority to EP10817817.9A priority patent/EP2477811A4/en
Priority to CN201080041282XA priority patent/CN102686394A/zh
Priority to US13/496,282 priority patent/US20120175283A1/en
Priority to SG2012018743A priority patent/SG179185A1/en
Publication of WO2011035008A2 publication Critical patent/WO2011035008A2/en
Publication of WO2011035008A3 publication Critical patent/WO2011035008A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00Layered products comprising a layer of synthetic resin
    • B32B27/32Layered products comprising a layer of synthetic resin comprising polyolefins
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B1/00Layered products having a non-planar shape
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00Layered products comprising a layer of synthetic resin
    • B32B27/06Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00Layered products comprising a layer of synthetic resin
    • B32B27/18Layered products comprising a layer of synthetic resin characterised by the use of special additives
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00Layered products comprising a layer of synthetic resin
    • B32B27/18Layered products comprising a layer of synthetic resin characterised by the use of special additives
    • B32B27/20Layered products comprising a layer of synthetic resin characterised by the use of special additives using fillers, pigments, thixotroping agents
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00Layered products comprising a layer of synthetic resin
    • B32B27/32Layered products comprising a layer of synthetic resin comprising polyolefins
    • B32B27/322Layered products comprising a layer of synthetic resin comprising polyolefins comprising halogenated polyolefins, e.g. PTFE
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2250/00Layers arrangement
    • B32B2250/24All layers being polymeric
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2270/00Resin or rubber layer containing a blend of at least two different polymers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00Properties of the layers or laminate
    • B32B2307/20Properties of the layers or laminate having particular electrical or magnetic properties, e.g. piezoelectric
    • B32B2307/21Anti-static
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00Properties of the layers or laminate
    • B32B2307/40Properties of the layers or laminate having particular optical properties
    • B32B2307/412Transparent
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00Properties of the layers or laminate
    • B32B2307/50Properties of the layers or laminate having particular mechanical properties
    • B32B2307/546Flexural strength; Flexion stiffness
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00Containers; Receptacles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00Containers; Receptacles
    • B32B2439/02Open containers
    • B32B2439/06Bags, sacks, sachets
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00Containers; Receptacles
    • B32B2439/40Closed containers
    • B32B2439/46Bags
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00Containers; Receptacles
    • B32B2439/80Medical packaging
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/31504Composite [nonstructural laminate]
    • Y10T428/31855Of addition polymer from unsaturated monomers
    • Y10T428/31909Next to second addition polymer from unsaturated monomers
    • Y10T428/31913Monoolefin polymer

Definitions

  • the present invention relates generally to the material processing arts and, more specifically, to a vessel incorporating a film with enhanced anti-static properties and related methods.
  • vessels for at least temporarily receiving and containing materials.
  • hermetically sealable bags formed of flexible plastic film are often used for bulk intermediate storage, cell culture re- suspension, viral inactivation, final formulation, final fill, or as bioreactors.
  • these bags are formed of a thin and flexible film, which may comprise one or more layers adapted to provide the vessel with particular characteristics (such as, for example, a particular degree of light/gas transmissivity or resistance to particle shedding).
  • anti-static properties are a desirable characteristic for such a film when used in processing material susceptible to tribocharging, such as a powder or similar granular substance.
  • the anti-static properties should remain intact during a relatively long storage period and thus would not impact the performance of a vessel incorporating the film when used after such storage. Stated another way, the properties should be stable in the sense that they would not dissipate through the surface of the film over time and ultimately vanish. Performance of the film in terms of its anti-static properties should also not be highly dependent on external factors, such as humidity, as may be the case with surface coatings or agents.
  • the apparatus comprises a vessel, such as a bag, including a wall at least partially formed of a flexible film.
  • the film comprises at least one, and preferably at least two layers including an anti-static agent. In such case, the at least two layers sandwich an intermediate layer.
  • the intermediate layer is thicker than one or both of the at least two layers including the anti-static agent.
  • the at least two layers may comprise outer layers.
  • the film may be transparent. Preferably but optionally, the film has a thickness of between about 100 and 250 microns.
  • the anti-static agent comprises an ionomeric polymer and, most preferably, the anti-static agent comprises ENTIRA.
  • the layers may each comprise polyethylene, and preferably but optionally, low density polyethylene. Most preferably but optionally, the intermediate layer comprises ultra-low density polyethylene.
  • the vessel may comprise a flexible bag including at least one port.
  • the vessel may also include at least one weld for connecting a first portion of the film with a second portion of the film. Preferably, the weld bonds the intermediate layers of the first and second portions of the film.
  • the vessel includes a wall at least partially formed of a flexible film including at least one layer having a permanent anti-static agent and a port formed in the wall.
  • the apparatus comprises a vessel including a wall at least partially formed of a flexible film including at least one layer having a stable surface resistivity of less than about 10 n ohm/square for a period of at least twelve months.
  • a further aspect of the disclosure relates to an apparatus for use in material processing, comprising a vessel including a wall at least partially formed of a flexible film.
  • the film comprises at least two layers including an anti -static agent.
  • composition of matter comprising a film including at least two layers incorporating an anti-static agent and sandwiching an intermediate layer.
  • the film is animal derived component free.
  • the apparatus comprises a vessel including a wall at least partially formed of a flexible film.
  • the film comprises an anti-static agent and is animal derived component free.
  • Another aspect of the invention pertains to a method of forming a vessel for use in material processing.
  • the method comprises forming a wall of the vessel including a flexible film.
  • the film comprises at least two layers including an anti-static agent.
  • the at least two layers sandwich an intermediate layer.
  • the method may further include the steps of heating or applying pressure to the film.
  • the method may also comprise welding the film.
  • the welding step is preceded by withdrawing the at least two layers to expose the intermediate layer, and then welding the intermediate layer.
  • An aspect of the disclosure also relates to a method related to the processing a granular material susceptible to tribocharging.
  • the method comprises providing a vessel with an interior compartment bounded by a film including at least two layers comprising an anti-static agent.
  • the providing step may comprise welding the film to form the vessel.
  • the welding step comprises welding an intermediate layer of the film sandwiched between the at least two layers comprising the anti-static agent.
  • the welding step is preceded by withdrawing the at least two layers to expose the intermediate layer.
  • the providing step may further comprise extruding the film from a mixture of a polymer material and an anti-static agent as well as introducing the granular material to the interior compartment.
  • Yet a further aspect of the disclosure is a method of manufacturing a composition of matter, comprising forming a film comprising at least two layers including an anti-static agent sandwiching an intermediate layer.
  • the forming step may comprise extruding the film, and the method may further include the step of welding the film.
  • the welding step comprises welding the intermediate layer of the film.
  • the welding step is preceded by withdrawing the at least two layers to expose the intermediate layer.
  • Still another aspect of the disclosure is a method of manufacturing a composition of matter, comprising: (1) providing a first film comprising a first layer and a second layer including an anti-static agent, said second layer covering a surface of the first layer; (2) exposing the surface of the first layer; and (3) welding the first layer.
  • the welding step comprises welding the first layer to a second film.
  • the providing step comprises providing the first film having a third layer including an anti-static agent.
  • Figure 1 illustrates in partial cross-section a vessel including the anti-static film in accordance with the disclosure
  • Figure 2 is a schematic view of one possible embodiment of the film.
  • FIG. 1 illustrates a vessel 10 according to one aspect of the disclosure.
  • this vessel 10 is a bag of the disposable or single-use type typically used in processing materials under sterile conditions, such for preparing biological agents, pharmaceutical preparations, or the like.
  • the vessel 10 comprises at least one wall made of a thin, flexible film 12. This construction results in a vessel 10 that can be folded and, when filled, may adapt to the shape dictated by whatever is contained in the interior compartment.
  • a port P may also be providing for feeding, transmitting or transferring a flowable material, such as for example a granular substance or powder, to and from the interior compartment, which may be defined by corresponding seals formed by bonds or welds in one or more sidewalls of the vessel 10.
  • a flowable material such as for example a granular substance or powder
  • the vessel 10 may be considered a powder feed or transfer bag for delivering the powder to a vessel in which fluid processing is being completed.
  • the port P may be associated with a removable closure or cap, and may also be provided with a connector for connecting with a second vessel for receiving the contents of the vessel 10, as shown in Figure 1.
  • the film 12 forming the vessel 10, such as bag, is adapted to provide anti-static properties along the surface bounding the interior compartment. This is accomplished by forming the film 12 comprising at least one layer including a permanent anti-static agent.
  • the anti-static agent maintains a surface resistivity along the interior compartment of the vessel 10 bounded by the film 12 of less than or equal to about 10 1 1 ohm/square for a period of at least twelve months.
  • the film comprises multiple discrete layers and, most preferably, at least three contiguous layers 14, 16, 18.
  • the film 12 in this most preferred embodiment comprises first and second layers 14, 18 incorporating the anti-static properties that sandwich an intermediate or middle layer 16 that does not include such properties and is thus "regular" in terms of its material composition.
  • the vessel 10 consists essentially of this film, meaning that it does not include any additional layer that alters the basic properties of the film comprised of layers 14, 16, 18.
  • the film 12 may be comprised of inert, biocompatible materials, such as polymers.
  • the film 12 comprises polyethylene.
  • layers 14, 18 are the outermost layers of the film 12, as shown, and comprise low density polyethylene (LDPE) or a blend of LDPE and other materials.
  • the intermediate layer 16 may comprise LDPE, but most preferably comprises ultra-low density polyethylene (ULDPE) or a blend of ULDPE and other materials.
  • the thickness of the film 12 may range from about 100-250 microns (note dimension t in Figure 2). Outer layers 14, 18 comprise a minority of the thickness. For example, each of layers 14, 18 preferably comprises less than about 30% of the total thickness of the film 12, and most preferably 15-20%.
  • the intermediate layer 16 forms the remainder and, most preferably, the majority of the film, since the anti-static agent is more costly and thus should be provided as judiciously as possible while achieving the desired benefits.
  • the thickness of the intermediate layer may be about 150 micron, with the outer layers each having a thickness of about 45 micron, for a total thickness of film 12 of about 240 micron.
  • the film 12 is also preferably at least translucent and, most preferably, transparent.
  • Co-extrusion techniques may be used to form the film 12 having the three layers of the same or different composition.
  • the selected polyethylene materials may be introduced in pellet form to an extruder for simultaneously extruding the film 12 comprised of the at least three layers 14, 16, 18.
  • An exemplary device used in performing the extrusion may be an OMICRON co -rotating twin screw extruder distributed by STEER.
  • the extrusion is done at a temperature of between about 185°C-215°C and, most preferably, about 200°C.
  • the thickness settings of the extruder head correspond to the desired thickness of the layers 14, 16, 18.
  • the anti-static properties may be provided to the film 12 by blending an anti-static agent into the polymer material.
  • the anti-static agent comprises an ionomeric polymer material comprising an inorganic pigment, such as titanium dioxide and treated with a siloxane-based compound or "silanized.”
  • an agent is distributed by DuPont under the brand ENTIRA (and, most preferably, that distributed as ENTIRA SD 100).
  • This agent may be incorporated into the material prior to extrusion by mixing, and may also be provided in pellet form for mixing with the selected polymer pellets forming layers 14, 18.
  • the anti-static agent comprises less than 20% by weight of the material used for forming each layer incorporating the agent, such as layer 14 or layer 18, and most preferably between 1 -15% by weight.
  • the film 12 may be extruded in tube form, and cut to predetermined lengths.
  • One or both open ends of the tubular film 12 may then be bonded to form the interior compartment.
  • the bonding is achieved by the application of heat and pressure to opposed regions of two layers of the film 12, which results in at least two of the layers bonding with each other.
  • the bond is between the outer layers 14, 18 of different portions of the film 12.
  • the bond may be formed between the intermediate layers 16 of different portions of the film 12 by welding such that a portion of the material of one of these layers 16 melts to form the desired bond. In this case, the welding is most preferably done with the outer layers 14, 18 withdrawn, pushed back, or otherwise manipulated to expose the intermediate layer 16.
  • the spaced apart outer layers 14, 18 of the film 12 incorporate the anti-static agent in a permanent fashion, which means it is not subject to dissipation over reasonable periods of time.
  • This permanency and stability provides the vessel 10 incorporating the film 12 with a relatively long shelf life, as compared to dissipative-type films in which the anti-static properties vanish over periods as short as six months.
  • Bounding the interior compartment in this manner also avoids problems associated with powder attraction and collection at the surface of the film 12.
  • the use of a blended anti-static agent, as opposed to a surface coating also reduces or eliminates the effects of humidity on performance.
  • the lack of an agent or coating applied to the film 12 also helps to ease the manner in which it is bonded together, such as by welding, and also results in a seal of improved strength and integrity.
  • the film 12 is manufactured so that it is animal derived component free (ADCF).
  • ADCF-free film 12 having at least one layer including a permanent anti-static agent may be used to form a vessel 10, such as a bag.
  • the film 12 should meet or exceed certain cleanliness requirements of the life sciences industry.
  • the particle count of the film 12 is kept low due to the particles being chemically linked to the resin and not apt to migrate out of the film, and is thus USP VI compliant.
  • the film 12 is considered to be of medical grade.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Wrappers (AREA)
  • Bag Frames (AREA)
  • Laminated Bodies (AREA)
  • Extrusion Moulding Of Plastics Or The Like (AREA)
  • Containers Having Bodies Formed In One Piece (AREA)
PCT/US2010/049098 2009-09-16 2010-09-16 Vessel incorporating film with enhanced anti-static properties and related methods Ceased WO2011035008A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
IN3260DEN2012 IN2012DN03260A (enExample) 2009-09-16 2010-09-16
EP10817817.9A EP2477811A4 (en) 2009-09-16 2010-09-16 TANK INCORPORATING A FILM HAVING ENHANCED ANTISTATIC PROPERTIES AND ASSOCIATED METHODS
CN201080041282XA CN102686394A (zh) 2009-09-16 2010-09-16 结合具有增强的抗静电性质的膜的容器和相关方法
US13/496,282 US20120175283A1 (en) 2009-09-16 2010-09-16 Vessel incorporating film with enhanced anti-static properties and related methods
SG2012018743A SG179185A1 (en) 2009-09-16 2010-09-16 Vessel incorporating film with enhanced anti-static properties and related methods

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US24309209P 2009-09-16 2009-09-16
US61/243,092 2009-09-16

Publications (2)

Publication Number Publication Date
WO2011035008A2 true WO2011035008A2 (en) 2011-03-24
WO2011035008A3 WO2011035008A3 (en) 2011-07-14

Family

ID=43759267

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2010/049098 Ceased WO2011035008A2 (en) 2009-09-16 2010-09-16 Vessel incorporating film with enhanced anti-static properties and related methods

Country Status (7)

Country Link
US (1) US20120175283A1 (enExample)
EP (1) EP2477811A4 (enExample)
KR (1) KR20120097373A (enExample)
CN (1) CN102686394A (enExample)
IN (1) IN2012DN03260A (enExample)
SG (2) SG179185A1 (enExample)
WO (1) WO2011035008A2 (enExample)

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US9820755B2 (en) 2013-03-15 2017-11-21 Zimmer Biomet CMF and Thoracic, LLC Sternal closure cerclage, plate implant and instrumentation

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Publication number Priority date Publication date Assignee Title
US9788878B2 (en) 2013-03-15 2017-10-17 Zimmer Biomet CMF and Thoracic, LLC Sternal closure cerclage, plate implant and instrumentation
US9801672B2 (en) 2013-03-15 2017-10-31 Zimmer Biomet CMF and Thoracic, LLC Sternal closure cerclage, plate implant and instrumentation
US9820755B2 (en) 2013-03-15 2017-11-21 Zimmer Biomet CMF and Thoracic, LLC Sternal closure cerclage, plate implant and instrumentation
US10307193B2 (en) 2013-03-15 2019-06-04 Zimmer Biomet CMF and Thoracic, LLC Sternal closure cerclage, plate implant and instrumentation
US10639084B2 (en) 2013-03-15 2020-05-05 Zimmer Biomet CMF and Thoracic, LLC Sternal closure method and system
US10939927B2 (en) 2013-03-15 2021-03-09 Zimmer Biomet CMF and Thoracic, LLC Sternal closure method
US10952756B2 (en) 2013-03-15 2021-03-23 Zimmer Biomet CMF and Thoracic, LLC Sternal closure system
US11678895B2 (en) 2013-03-15 2023-06-20 Zimmer Biomet CMF and Thoracic, LLC Sternal closure system

Also Published As

Publication number Publication date
CN102686394A (zh) 2012-09-19
WO2011035008A3 (en) 2011-07-14
US20120175283A1 (en) 2012-07-12
EP2477811A4 (en) 2013-07-31
SG179185A1 (en) 2012-04-27
EP2477811A2 (en) 2012-07-25
SG10201405719WA (en) 2015-01-29
KR20120097373A (ko) 2012-09-03
IN2012DN03260A (enExample) 2015-10-23

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