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Granulator Containment Technology 74 WHAT ARE THE FEATURES AND BENEFITS OF THIS TECHNOLOGY? Features Retrofit to existing equipment design Process and Technical areas separated Validated containment technology Clear film Passive system Flexible materials Disposable components Adaptable to other equipment WHAT CONTAINMENT LEVEL PROVIDED? OEB 5 with results in the nanogram range. This is based on customer test data, other proven applications, third party testing to the “SMEPAC” protocols on similar designs, and the 100% inflation tests performed on the deliverable systems. OEB 1 OEB 2 OEB 3 OEB 4 OEB 5 10,000 to 1000 1,000 to 100 100 to 50 50 to 10 10 to 1 1 to 0.1 0.1 to 0.01 Occupational Exposure Levels above are in μg/m3. WHY USE THIS OVER OTHER TECHNOLOGIES? Benefits Provides the lowest overall cost of process ownership through low capital and operating cost including reduced cleaning and cleaning validation Fastest turnaround of a processing suite for subsequent manufacturing campaigns Process is contained without contamination of motor, drive shaft, and controls with flange mount design Nanogram containment levels achieved Supports visibility for maintenance Does not affect ATEX and Ex ratings Ergonomics maximized Speed of implementation The cost of ownership, ergonomic advantages, and speed of delivery benefits of this flexible solution far outweigh those of rigid isolation systems. Tools such as Lean Manufacturing come into play more and more. For example, the time to clean and validate the cleaning are major bottlenecks for processing efficiencies in the plant. Being able to minimize this part of the process results in getting products to market faster and at an overall reduction in operating costs when considering labor, utilities, and waste disposal costs. It also supports getting multiple products to market faster within an existing facility without risking product safety.
Process Area Barrier Curtains OVERVIEW Process Area Barrier Curtains are a useful tool in improving the containment levels in existing installations as a method to reduce operational exposure risk and to restrict access. Examples of these types of applications include, but are not limited to, down flow booth curtains and room access barriers. Down flow booths, for example, work by pulling air across a drum or piece of processing equipment which typically provide a containment level of 100 μg/m3 on an 8 hour time weighted average (TWA). While this draws the powder into a set of filters, the airflow is disrupted when an operator is working at this type of station. When that occurs, eddy currents of air and entrapped powder start to swirl which disrupts containment. The barriers described in this guide are a tool in improving this type of application. Similarly, restricting access to another part of a processing suite has been a demonstrated need as well. Here, a barrier can be added to a doorway, for example, to restrict the flow of personnel between the suites. HOW DOES IT WORK? By isolating the operator’s breathing zone from the point of exposure with this form of secondary containment the operator is protected from the product and vice versa. The curtains are manufactured from clear ArmorFlex ® 113 film that will allow room light to illuminate inside the barrier and not restrict visibility. This rugged film provides a safe working environment while enabling the enhancements developed through numerous installations using this flexible containment technology. Typically, the ArmorFlex ® 113 is patterned to interface with the opening to be contained. This can be a flat sheet or a three dimensional design. The barrier is attached using flanges and U-Groove channel as a locking mechanism or by grommets. Cord to secure Panel in rolled up position Zipper to close or open Panel of Curtain Closed Panel of Curtain 3 Pair Butyl Glove Sleeve Doorway Vinyl Trim can be removed to roll up one or both Curtain sides Glove sleeves are incorporated into the panel as needed by the specific process. These can include right handed, left handed, or ambidextrous gloves. There are myriad flow booths installed and as such no one curtain design fits everyone’s needs. As such, customization is provided to make sure the process and ergonomics are covered correctly. Bungee Cord included with Enclosure Rolled up Panel of Curtain 75
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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
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
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Page 64 and 65: Tablet Coater Containment System -
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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 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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Q - Jetsolutions SA

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