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18 DoverPac ® - Contained Powder Discharge FLEXIBLE FLEXIBLE C ONTA C ONTA INMENT INMENT TECHNOLOGIES Basic Basic Offloading Offloading Process Process Steps Steps Attach Attach Bag out Bag stubout stub To sample, To sample, extend sleeve extend and sleeve fill and fill Place crimp Place cap crimp on crimp cap on body crimp body Materials ArmorFlex ® is ILC Dover's proprietary family of films used exclusively in the DoverPac ® Materials ArmorFlex family of high potency flexible containment products. Details are available in a databook upon request. ® is ILC Dover's proprietary family of films used exclusively in the DoverPac ® family of high potency flexible containment products. Details are available in a databook upon request. Offloading Offloading Canister Canister and Transition and Transition Adapter Adapter The canister pictured at the right shows the set up on a straight transition adapter at ILC’s test facility. While canisters typically are 316L stainless steel, Hastelloy ® The canister pictured at the right shows the set up on a straight transition adapter at ILC’s test facility. While canisters typically are 316L stainless steel, Hastelloy canisters also are available. This unit has an initial groove for the canister end cap, additional grooves for liner attachment (typically 5 or 10 grooves depending on process requirements and available height), and 1 Canister and groove for the cleaning sleeve or clean-in-place (CIP) Transition Adapter sleeve attachment. Attached to ILC Dover Test Rig. The canister is supplied with a 12” sanitary flange on each end. This allows for a common design for attach- This hardware is ment to vessel specific transition adapters and our CIP supplied with a 240 grit (15RA) internal tundish. finish and a 180 grit The custom transition adapter is fitted with a flange on (32 RA) external fin- one end that interfaces with the vessel flange (or valve ish. Other materials that is in-line on the vessel flange). The opposite end is and finishes can be a 12” sanitary flange that interfaces with the canister. quoted separately. For flanges smaller than 12", a conical transition adapter is used to allow powder flow directly into the vessel without accumulation on the hardware. The adapter also is fitted with a vacuum flange port with a 1/2” sanitary flange for attachment to the vacuum and nitrogen sources to allow inert processing. ® canisters also are available. This unit has an initial groove for the canister end cap, additional grooves for liner attachment (typically 5 or 10 grooves depending on process requirements and available height), and 1 Canister and groove for the cleaning sleeve or clean-in-place (CIP) Transition Adapter sleeve attachment. Attached to ILC Dover Test Rig. The canister is supplied with a 12” sanitary flange on each end. This allows for a common design for attach- This hardware is ment to vessel specific transition adapters and our CIP supplied with a 240 grit (15RA) internal tundish. finish and a 180 grit The custom transition adapter is fitted with a flange on (32 RA) external fin- one end that interfaces with the vessel flange (or valve ish. Other materials that is in-line on the vessel flange). The opposite end is and finishes can be a 12” sanitary flange that interfaces with the canister. quoted separately. For flanges smaller than 12", a conical transition adapter is used to allow powder flow directly into the vessel without accumulation on the hardware. The adapter also is fitted with a vacuum flange port with a 1/2” sanitary flange for attachment to the vacuum and nitrogen sources to allow inert processing. Purge/Vacuum Arrangement Arrangement Containment Systems Note: Common Note: Common vacuum/purge vacuum/purge supply connection supply connection to to HEPA HEPA filter provides filter provides backwash backwash function function to extend to filter extend life. filter life. 2 ILC 2 Dover ILC Dover www.doverpac.com customer_service@ilcdover.com Ph 1.302.335.3911 Ph 1.302.335.3911 or 1.800.631.9567 or 1.800.631.9567 ONE M ONE OONWALKER M OONWALKER RD., FREDERICA, RD., FREDERICA, D ELAWDARE ELAW U SA ARE 19946-2080 U SA 19946-2080
DoverPac ® - Contained Powder Discharge FlexLoc Clamp The FlexLoc clamp is used to secure the neck of the liner to the canister. Construction of the molded clamp is of FDA compliant elastomer with integrated stainless steel band clamp. The clamp has a molded ridge along one surface to help install it in the correct orientation. The FlexLoc functions to prevent powder from going between the inside of the liner and the outside of the canister to minimize cleaning operations. The clamp is designed to operate in the offloading and the charging operations. Crimp Separation Kit Contained separation between vessels and DoverPacs ® is achieved through a Crimp Separation Kit, using ILC's uniquely designed crimp system. Crimps are color coded to assure that the right crimp is selected for the right product. Red crimps are used for the 14” necks, blue crimps are for the 23" diameter continuous liners, and yellow crimps are for the 4" diameter sample sleeve on the DoverPacs ® FlexLoc Clamp . A Crimp Separation Kit includes: • 200 Crimps • 1 Crimp Hand tool • 1 Cutter • 100 Cable Ties (7” Nylon) • 1 User's Manual Additional spare items can be ordered separately by their individual model/part numbers. The crimps have been designed and tested to compress the standard diameters liners made with ArmorFlex ® film. Use on any other system will preclude the crimps from closing correctly, which could result in operator and product exposures. The hand tool applies two crimps at once. The cutter is used to cut between the two crimps, and then the cap is slid onto the closed crimp body. www.doverpac.com customer_service@ilcdover.com Ph 1.302.335.3911 or 1.800.631.9567 ONE M OONWALKER RD., FREDERICA, D ELAW ARE U SA 19946-2080 ILC crimps have been designed and tested to compress standard diameter liners and sleeves made with ArmorFlex ® film Load crimp into installation tool Position crimp Squeeze tool until crimps are engaged -- then release tool Cut and separate Containment Systems Containment Systems Install crimp cap on crimp body ILC Dover 193
Page 1: examining new methods yields new di
Page 4 and 5: Table of Contents Tablet Coater Con
Page 6 and 7: ArmorFlex ® Validated Containment
Page 8 and 9: 8 ArmorFlex ® Family of Compliant
Page 10 and 11: ArmorFlex ® ArmorFlex 104 Film ®
Page 12 and 13: ArmorFlex ® ArmorFlex 113 Film ®
Page 14 and 15: ArmorFlex ® 114 Film ArmorFlex ®
Page 16 and 17: DoverPac ® Proven DoverPac ® Atta
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 66 and 67: Contained Offloading of Aurora Filt
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Contained Offloading of Aurora Filt
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Mill Containment System - Jet Mills
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Granulator Containment Technology 7
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Granulator Containment Technology 7
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Process Area Barrier Curtains 76 WH
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78 Contained Blending - Transfer Sl
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Contained Blending - Transfer Sleev
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82 Contained Blending - Flexible En
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Contained Blending - Flexible Enclo
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Contained Blending - Flexible Enclo
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Sentinel Clear Clip system keeps ho
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90 Weigh and Dispense System STATIC
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92 CrimpLoc System Innovation Timel
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94 ArmorFlex ® Family ArmorFlex ®
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Process Train Containment in CMO Op
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FlexiVac OVERVIEW In an effort to
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Ventilated Enclosure System 100 The
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ILC Dover has been “creating what
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