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FlexiVac OVERVIEW In an effort to provide a better solution for containment to the standard PTS / DCS system, FlexiVac was developed along with our partners CSV Life Sciences in Italy and Micro-Macinazione S.A. The resulting innovative solution improves the ergonomics of the system while containment levels have been verified to
FlexiVac SYSTEM FUNCTIONAL DESCRIPTION FlexiVac features an ArmorFlex ® 113 flexible isolator that can be attached within minutes. This safe isolator system is designed to minimize cleaning requirements while providing high containment. The flexible isolator is robust for use on many drums and then disposed. The improved ergonomics and head space above the drum allows operators, while dispensing, to easily take a spent drum liner with its residual level of powder and stow it until the next drum is attached. The residual powder is easily emptied into the next drum (maintaining high containment) eliminating batch shrinkage. A stretch fit ArmorFlex ® sleeve is used to dock the standard drum o’ring canister with the product drum. This is a fast and effective process to make a contained connection. After the powder is vacuumed from the drum, a high containment separation process using the CrimpLoc is performed. The drum and the FlexiVac remain contained and are ready to attach the next drum. This process has been used with isolators in many applications and proven effective. Designed for operator ergonomics, the drum connection has a pivoting position to allow the drum to be easily moved into position, connected, and then removed when empty. The FlexiVac system is available with or without a powder pump for compatibility with existing PTS units or other vacuum systems. The fully integrated FlexiVac uses dilute phase conveying technology for the best powder transfer possible. ARMORFLEX ® FILMS ArmorFlex ® 113 film’s superior visual clarity makes this the clear film of choice for flexible enclosures and flexible isolators. • Polyethylene base film provides excellent solvent resistance • Permanent antistat provides better than 1 x 1011 Ohms per square surface resistivity • No incineration off-gassing concerns • ArmorFlex ® is designed for high strength and has a 500% elongation before failure, assuring safety from tearing during typical use. ArmorFlex ® films contain no animal derived components and have a 5-year shelf life. CONTAINED DRUM TRANSFER OPTIONS DTS-Drum Transfer System VTS-Contained Drum Transfer Containment Systems ArmorFlex ® 114 film delivers permanent static dissipative properties while meeting FDA and 2002/72/EC requirements for food contact and EP 3.1.3 test conditions. • Complies with FDA 21 CFR • Passes USP Physicochemical Tests for Plastics • Passes USP Class VI (7 day implant) • Passes biological reactivity, in vitro • Passes Chilworth incendivity test to assure the static dissipative qualities of the flexible isolator • Tested for solvent resistance • DMF filed with FDA DSE-Drum Sampling Enclosure 99
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examining new methods yields new di
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Table of Contents Tablet Coater Con
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ArmorFlex ® Validated Containment
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8 ArmorFlex ® Family of Compliant
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ArmorFlex ® ArmorFlex 104 Film ®
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ArmorFlex ® ArmorFlex 113 Film ®
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ArmorFlex ® 114 Film ArmorFlex ®
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DoverPac ® Proven DoverPac ® Atta
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18 DoverPac ® - Contained Powder D
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DoverPac ® - Contained Powder Disc
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DoverPac ® - Contained Powder Tran
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DoverPac ® - Contained Powder Tran
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Coaxial DoverPac ® - Nanogram Powd
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DoverPac ® Continuous Liner 23”
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Continuous Liner Bag in Bag out - C
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Antistatic Drum Liners 38 DoverPac
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Contained Processes - Flexible Encl
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Contained Processes - Flexible Encl
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Document Transfer Enclosure BENEFIT
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Drum Transfer System - Contained Dr
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Page 50 and 51: Mill Containment System Figure 2. S
Page 52 and 53: Drum Sampling Enclosure System FEAT
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Page 56 and 57: DoverPac ® SF WHAT ARE THE APPLICA
Page 58 and 59: DoverPac ® SF (BioPharmaceutical)
Page 60 and 61: DoverPac ® Tray Dryer Enclosure Te
Page 62 and 63: Mill Containment System - Bohle BTS
Page 64 and 65: Tablet Coater Containment System -
Page 66 and 67: Contained Offloading of Aurora Filt
Page 68 and 69: Contained Offloading of Aurora Filt
Page 70 and 71: Mill Containment System - Jet Mills
Page 72 and 73: Granulator Containment Technology 7
Page 74 and 75: Granulator Containment Technology 7
Page 76 and 77: Process Area Barrier Curtains 76 WH
Page 78 and 79: 78 Contained Blending - Transfer Sl
Page 80 and 81: Contained Blending - Transfer Sleev
Page 82 and 83: 82 Contained Blending - Flexible En
Page 84 and 85: Contained Blending - Flexible Enclo
Page 86 and 87: Contained Blending - Flexible Enclo
Page 88 and 89: Sentinel Clear Clip system keeps ho
Page 90 and 91: 90 Weigh and Dispense System STATIC
Page 92 and 93: 92 CrimpLoc System Innovation Timel
Page 94 and 95: 94 ArmorFlex ® Family ArmorFlex ®
Page 96 and 97: Process Train Containment in CMO Op
Page 100 and 101: Ventilated Enclosure System 100 The
Page 102: ILC Dover has been “creating what
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