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Contained Offloading of Aurora Filters - Processing from Nutsche Filters 66 Offset canister The basic operational steps are performed for offloading the filter: 1 Attach the fill neck of the DoverPac ® to the ILC Dover supplied multiple o-ring canister and shuffle up some of the neck to create a clean zone for crimp separation 2. Bag out the stub from the previous liner 3. Open the valve on the vessel and use the sample sleeve to take a sample if required by the process 4. Finish filling 5. Pull down the clean zone, twist the neck, and apply the crimps. 6. Cut between the two crimps and close the caps on the crimps. Note that this leaves the stub that will be bagged out with the next DoverPac ® 7. Repeat steps 1 – 6. The same process is used to charge the next vessel except there is no sampling sleeve at that point. In the application below, an offset canister with the capability to offload to three 110L DoverPacs ® was installed on the sanitary flange of the 8” (200mm) Cora Valve on the discharge chute of the vessel. Once the filtration process is complete, the valve is opened and the Operator scoops powder through the chute and into the DoverPac ® using the glove ports that are supplied as part of the Aurora Filter. The DoverPac process outlined above is then followed. After processing, a Clean In Place (CIP) tundish is attached to the sanitary flange on the canister by bagging it in with the CIP sleeve. DoverPac ®
Contained Offloading of Aurora Filters - Processing from Nutsche Filters Flexible Enclosure Offloading Flexible Enclosures are a proven alternative to rigid gloveboxes. These can be provided in either a passive system or with a Ventilation System included. The enclosure is manufactured from clear ArmorFlex ® film that will allow room light to illuminate inside the enclosure for easy viewing. It is also equipped with a bag in/bag out sleeve which is used for introducing product and tools to and from the enclosure without breaking containment. In this application, a standard 8” multiple o-ring canister is attached to the outlet of the filter. The enclosure is then attached to the same canister to provide a contained connection during the transfer of powder. A 14” Continuous Liner is connected to the canister inside of the enclosure. This is a factory packed, 35’ long liner. Once the Continuous liner is filled, it is crimped and the bagged out using the BIBO Sleeve on the side of the Enclosure. 2 3 Isometric View View from the Glove port side 1 Mobile Frame 2 Flexible Enclosure 3 Glove ports 1 4 4 Attachment to Filter Outlet 5 BIBO Canister 5 67
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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 ®
Page 16 and 17: DoverPac ® Proven DoverPac ® Atta
Page 18 and 19: 18 DoverPac ® - Contained Powder D
Page 20 and 21: DoverPac ® - Contained Powder Disc
Page 22 and 23: DoverPac ® - Contained Powder Tran
Page 24 and 25: DoverPac ® - Contained Powder Tran
Page 26 and 27: Coaxial DoverPac ® - Nanogram Powd
Page 28 and 29: DoverPac ® Continuous Liner 23”
Page 36 and 37: Continuous Liner Bag in Bag out - C
Page 38 and 39: Antistatic Drum Liners 38 DoverPac
Page 40 and 41: Contained Processes - Flexible Encl
Page 42 and 43: Contained Processes - Flexible Encl
Page 44 and 45: Document Transfer Enclosure BENEFIT
Page 46 and 47: Drum Transfer System - Contained Dr
Page 48 and 49: Drum Transfer System - Contained Dr
Page 50 and 51: Mill Containment System Figure 2. S
Page 52 and 53: Drum Sampling Enclosure System FEAT
Page 54 and 55: Drum Sampling Enclosure FAQ’s Q:
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 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 98 and 99: FlexiVac OVERVIEW In an effort to
Page 100 and 101: Ventilated Enclosure System 100 The
Page 102: ILC Dover has been “creating what
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