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Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
Pharmaceutical Tradeshow Interphex Presentation
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Pharmaceutical Tradeshow Interphex Presentation

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Pharmaceutical solutions to all your tablet coating, vessel cleaning and process equipment needs.

Pharmaceutical solutions to all your tablet coating, vessel cleaning and process equipment needs.

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  • Spraying Systems Co corporate headquarters is in Wheaton IL right outside of Chicago. With 10 manufacturing facilities located in North and South America, Europe and Asia, we can quickly deliver our products to customers anywhere in the world. And with 85 sales engineering offices around the world, there is a local representative you can call on to provide hands on assistance with your application. For instance we have Mathieu located right here at Lachute, Quebec.
  • We can have vessels reviewed and modeled by our engineering staff to utilize custom spray ball patterns specific to that vessel. This shows a custom spray pattern in the works. Baffles, agitators, spargers, critical vessel areas can all be taken in to consideration when a custom spray pattern is used. This also allows greater efficiency of available resources….purified water…chemicals…etc.
  • Transcript

    • 1. Welcome toINTERPHEX 2011<br />
    • 2. Spraying Systems Co. US Facilities<br />Corporate Headquarters<br />Wheaton, Illinois<br />East Coast Facility<br />Hudson, New Hampshire<br />
    • 3. Global Manufacturing and Service<br />Spraying Systems Co. corporate headquarters is located in Wheaton, IL, just outside of Chicago. With 10 manufacturing facilities and 85 sales engineering offices located in North and South America, Europe, and Asia, we are able to provide hands-on assistance and quickly deliver our products to customers anywhere in the world.<br />
    • 4. Fluid Air Division Specializing In:<br /> Fluid bed processing <br /> High-shear granulation/one pot processing<br /> Size reduction <br /> Material handling<br /> Process automation <br /> Engineering services<br /> Retrofits: Fluid Air & non-Fluid Air <br />
    • 5. Fluid Bed Dryers, Granulators, and Coaters<br />Phase III: Production Scale<br />Phase II: Pilot Scale<br />Phase I: R&D Scale<br />
    • 6. R&D/Pilot Scale Fluid Beds<br />
    • 7. Production Scale Fluid Beds<br />
    • 8. Predictable Scale-Up<br />
    • 9. Conical Expansion Chamber<br /><ul><li>Fines stay out of upper filter region
    • 10. Less filter pressure or plugging
    • 11. Fines stay below spray nozzles when granulating
    • 12. Less fines in finished batch increasing yields
    • 13. No need for different chamber pieces used by competitors, taking up a smaller amount of bowl volume and reducing construction costs</li></li></ul><li>Bowl Agitator Rake<br />
    • 14. Fluid Bed Process Overview<br /><ul><li>Influid bed drying, conditioned gas flows through a bed of material, separating the particles and causing the bed to behave like a fluid. The fluidized particles transfer moisture to the process gas quickly and efficiently, drying the material
    • 15. Fluid bed granulation isan extension of the drying process where a binder solution is top-sprayed onto dry suspended fine particles to bind them into granules which are then dried in the same vessel
    • 16. InWurster coating, also known as air suspension coating, theproduct particles are first separated from one another in an air (gas) stream. The desired coating formulation is then sprayed from a bottom-mounted spray nozzle onto the particles while they are suspended</li></li></ul><li>GRANUMILL® Size Reduction Systems<br />Phase III: Production Scale<br />Phase II: Pilot Scale<br />Phase I: R&D Scale<br />
    • 17. R&D Scale Size Reduction Systems<br />
    • 18. Production Scale Size Reduction Systems<br />
    • 19. Flexible Containment for High Potency Compounds in R & D Applications<br />• Flexible enclosure set-up allows for use in both containment and non-containment<br />applications, eliminating the need to purchase a second machine solely for containment use<br />• Capable of meeting an OEB5 <br />classification<br />• Achievable containment level of 1.0 μg/m3 on a task basis<br />
    • 20. Particle Size Reduction Process Overview<br /><ul><li> GRANUMILL® systems can size reduce wet or dry powders in the range of 10 to 400 mesh (2000-27 microns)
    • 21. A typical Fluid Air milling system consists of an inlet, chamber with rotor, screen, and an outlet
    • 22. The particle size distribution generated is dependent upon the speed of the rotor, rotor type, screen hole size and the feed rate of the product
    • 23. As both a screen mill and an impact mill in one machine, GRANUMILL ® systems offer two applications to suit differentprocessing needs</li></ul>Large agglomerates (before milling)<br />Granules<br /> (after milling)<br />
    • 24. PHARMX® High-Shear Granulators<br />Phase III: Production Scale<br />Phase II: Pilot Scale<br />Phase I: R&D Scale<br />
    • 25. R&D/Pilot Scale Granulators<br />
    • 26. One Pot Processors<br />
    • 27. Production Scale Granulators<br />
    • 28. Impeller and Chopper<br />
    • 29. High-Shear Granulation Process Overview<br />High-shear granulation effectively turns powders into dense granules for tableting or coating <br />A large impeller located in the bowl bottom blends the product while liquid is added<br />A chopper located in the bowl shears the granules until desired size and density is achieved<br />
    • 30. Process Controls<br /><ul><li>Batch Architect™
    • 31. Manual equipment controls
    • 32. Batch Architect Pro™
    • 33. Fully automated 21 CFR Part 11 capable controls</li></ul>Typical through-the-wall control panel <br />with touch screen control<br />
    • 34. Batch Architect™ Process Control Software<br />Flexible solution for controlling lab scale and portable equipment <br />Compatible with virtually any batch-type processing equipment, including: coating pans, pellet-making process trains, and liquid delivery systems<br />Equipped with a graphical user interface (GUI) which provides users with current status information of critical machine functions through animation and text<br />Recipe editor feature allows batches to be reproduced with minimal user intervention<br />Offers convenient electronic batch record data logging and report creation services<br />CFR 21 Part 11 FDA capable (Batch Architect ProTM)<br />
    • 35. Virtualization Technology and Disaster Recovery<br /> Batch Architect Pro operates in a virtualized control environment, which allows multiple simulated "virtual" computers to run on a single host computer. <br />This enables multiple systems to be configured in a distributed architecture to provide cost savings and simplified administration. <br />Once a control system is in place and operational, virtualization technology helps to simplify disaster recovery procedures. By accessing a copy of the virtual machine, software engineers are able to restore the end user’s malfunctioning control system to an operational state, greatly reducing downtime in the event of system failure. <br />Virtualization also enables end users to meet federal regulations for data retention; a virtual system that has been removed or replaced can easily be copied to another computer to maintain data access after it is decommissioned.<br />
    • 36. Graphical User Interface Screen<br />
    • 37. Recipe Editor for Automated Processing<br />
    • 38. Tablet Coating Solutions <br />for the <br />Pharmaceutical Market<br />
    • 39. Understanding the Coating Process<br />
    • 40. Mode of Processing<br />
    • 41. Atomization<br /><ul><li>Lowest form of energy for liquid droplets corresponds to the smallest surface area (i.e., large droplets)
    • 42. Therefore energy is needed to break up the droplets (i.e., larger surface area)
    • 43. As energy dissipates, droplets coalesce
    • 44. Better nozzle designs will result in less localized over-wetting
    • 45. Nozzle design must be improved in the larger equipment in order to maintain the same coating time while maintaining the same coating uniformity</li></li></ul><li>54000 Modular Air Atomizing Manifold<br />Light Overall Weight<br /><ul><li>Constructed from 316L SS and Teflon or FEP
    • 46. 4 gun manifold with Teflon spacer weights 13.5lb (6.14kg)</li></ul>Benefits of lighter weight:<br /><ul><li>Easier to handle
    • 47. Easier to maintain</li></li></ul><li>54000 Modular Air Atomizing Manifold<br /><ul><li>Custom manifolds to fit your vessel</li></li></ul><li>54000 Modular Air Atomizing Manifold: Benefits<br />Reduce Contamination Risk:<br /><ul><li>FDA compliant materials of construction
    • 48. Excellent surface finish both internal and external
    • 49. Manufacturing and quality systems meeting cGMP requirements
    • 50. Design meeting ASME BPE requirements
    • 51. Complete turnover package ships with every product</li></ul>Improve Spray Performance:<br /><ul><li>Ability to maintain even pressure across its length ensures even flow distribution across the pill bed
    • 52. Lower air consumption and pressure leading to a more stable environment in the coater and less bearding
    • 53. Self locating spray setup feature (new!)</li></li></ul><li>54000 Modular Air Atomizing Manifold: Benefits<br />Easier maintenance:<br /><ul><li>Lightweight
    • 54. Strong ability to resist staining
    • 55. Excellent finish for both internal and external surfaces
    • 56. Extended needle assembly to ease its removal from the nozzle body (new!)
    • 57. Easy to switch spray setups – captured O-ring</li></ul>Advantages:<br /><ul><li>Spraying Systems Co. is able to service and support our equipment worldwide
    • 58. We can develop brackets to fit your needs and retrofit exiting coaters
    • 59. We offer a unique design for both continuous and batch coaters</li></li></ul><li>Typical Spray Guns<br />VAU and VMAU Spray Gun<br /><ul><li>Liquid line
    • 60. Automatic gun, air actuated (cylinder air)
    • 61. Air atomizing
    • 62. Air line to shape the spray pattern (fan air)</li></ul>VMAU Spray gun:<br /><ul><li>VMAU spray gun is next generation VAU
    • 63. Modular design
    • 64. Sanitary design
    • 65. Similar set-ups
    • 66. More consistent spray distribution
    • 67. Reduced maintenance</li></li></ul><li>Typical Spray Guns<br />VAU / VMAU Spray Gun<br />Advantages:<br /><ul><li>Greater level of adjustability
    • 68. Proven design, widely used
    • 69. Large number of set up types / sizes available</li></li></ul><li>Typical Spray Guns<br />JAU Spray Gun<br /><ul><li>Liquid line
    • 70. Automatic gun, air actuated (cylinder air)
    • 71. Air atomizing
    • 72. Same air supply as air atomization for some set-ups</li></li></ul><li>Typical Spray Guns<br />JAU Spray Gun<br />Advantages:<br /><ul><li>Less control required
    • 73. Provides a fair amount of adjustability
    • 74. Proven design, widely used
    • 75. Large number of set up types / sizes available</li></li></ul><li>Improve Coating Process<br />
    • 76. Typical Bearding<br />Where:<br /><ul><li>Around the air annulus
    • 77. Around the fan air jets
    • 78. Around the fluid tip orifice (not common with the VAU or VMAU)</li></ul>Causes:<br /><ul><li>Over spray
    • 79. The material being sprayed
    • 80. The air cap and fluid tip design
    • 81. External forces</li></li></ul><li>VAU Anti-Bearding Set-Up<br />What Changes with VAU Anti-Bearding Set-Ups?<br /><ul><li>Extended fluid orifice
    • 82. New ear design places the fan jets further away from the cap face
    • 83. Changed the impact of the fan jets on the spray to form the fan at lower air pressure</li></li></ul><li>VAU Anti-Bearding Set-Up<br />Both air caps sprayed OPADRY® for the same time period<br />OPADRY® is a registered trade mark of Colorcon<br />Standard Air Cap<br /> Anti-Bearding Air Cap<br />
    • 84. VMAU Anti-Bearding Set-Up<br />What changes with VMAU Anti-Bearding Set-Ups?<br /><ul><li>Based on the VAU AB set-ups but with added features
    • 85. Thinner ears, less surface area around the fan jets for material to build up on
    • 86. Further reduction of build-up on the air cap because of reduced surface area</li></li></ul><li>Next Generation Anti-Bearding Set-Up<br /><ul><li>Designed for minimum surface area
    • 87. 316L stainless steel construction
    • 88. High impingement fan jets
    • 89. Excellent spray pattern
    • 90. Low air pressure
    • 91. Runs twice as long without bearding
    • 92. Patent pending</li></li></ul><li>Fluid Bed Applications<br />
    • 93. Fluid Bed Nozzles<br />
    • 94. Nozzles and lances for fluid bed coating and granulation<br />Designed to simplify your scale-up and validation, reduce maintenance, and improve product quality<br /><ul><li>Available for R & D , Pilot and Production
    • 95. Top-Spray and Bottom Spray
    • 96. Materials 316L stainless steel
    • 97. Custom lances available</li></li></ul><li>Complete Vessel Cleaning Solutions<br />For the Pharma and BiopharmaMarket<br />
    • 98. Vessel Cleaning<br />Sprayballs<br /><ul><li> Meets ASME BPE and 3A standards</li></ul>Dynamic Fluid-Driven Nozzles<br /><ul><li>Reactionary Force
    • 99. Reactionary with Constant Speed</li></li></ul><li>Applications<br /><ul><li>Ideal for DI (deionized water), RO (reverse osmosis), WFI (water for injection) systems
    • 100. Pharmaceutical
    • 101. Biotech (pilot to production scale processes)
    • 102. Laboratory
    • 103. Clinical analysis</li></li></ul><li>Metallic Spray Balls<br />Specifications:<br /><ul><li>316L Stainless Steel
    • 104. Materials made and fabrication done in the U.S.A.
    • 105. Acorn design allows cleaning of the nozzle and lance entry port
    • 106. Mapping of sprayball
    • 107. Passivated
    • 108. Full penetration welds per ASME BPE using purge gas
    • 109. Surface finish 20 ui Ra Max. ( 0.5 Microns)
    • 110. Standard turnover package:</li></ul> Certificate of conformity<br /> Material test reports<br /> Welder certification<br /> Certificate of inspection<br /><ul><li>Options:</li></ul> Electropolish<br /> Improved surface finish<br /> Custom configuration<br />
    • 111. Non-Metallic Spray Balls<br />Spraying Systems Co. Biopharmaceutical Spray Ball – Non-Metallic:<br /><ul><li>Suitable for CIP/SIP
    • 112. Non-metallic nozzles will not contribute to rouge formation
    • 113. Will not damage metallic vessel surfaces / glass lined tanks
    • 114. Design and manufactured along cGMP and ASME BPE requirements
    • 115. Materials compliant with USP Class VI FDA, PER 21 CFR 177.1550 (Teflon) to 21 CFR Part 177.1520 (Polypropylene)
    • 116. Available in Polypropylene, PVDF (Kynar) and Teflon
    • 117. Standard Turn Over Package</li></li></ul><li>Spinner Nozzles<br />Spinner nozzles with fluidic type bearing<br /><ul><li>No friction parts, fluid bearing formed by the fluid being sprayed
    • 118. Small number of parts
    • 119. Simple to maintain / clean
    • 120. Rotating head with:
    • 121. Solid Stream
    • 122. Flat Spray
    • 123. Added flexibility when selecting the proper nozzle for the application</li></li></ul><li>Metallic Lances Fabricated Using 316L Tube and Ferrules<br />Specifications:<br /><ul><li> Passivated
    • 124. Full penetration welds per ASME BPE using purge gas are ground</li></ul> to parent material ID and OD.<br /><ul><li>Surface finish 20 uiRa ( 0.5 microns)
    • 125. Heat codes are marked on lance
    • 126. Standard turnover package:</li></ul> Certificate of conformity<br /> Material test reports<br /> Welder certification<br /> Certificate of inspection<br /><ul><li>Options:</li></ul> Electropolish<br /> Better surface finish<br /> Custom configuration<br />
    • 127. D41800E With Butt Weld Connection<br />Specifications:<br /><ul><li>All 316L stainless steel
    • 128. Passivated, Electropolished
    • 129. Full penetration welds per ASME BPE using purge gas
    • 130. Surface finish 20 uiRa ( 0.5 microns)
    • 131. Standard turnover package:</li></ul> Certificate of conformity<br /> Material test reports<br /> Welder certification<br /> Certificate of inspection<br />
    • 132. Non-Metallic Lances<br />Specifications:<br /><ul><li>Materials of construction polypropylene, PVDF (Kynar), and Teflon. All materials are compliant with USP class VI FDA Regulations, Per 21 CFR 177.1550 to 21 Part 177
    • 133. Nonmetallic will not contribute to rouge formation
    • 134. Polypro continuous operating temperature is 180 ºF (50 ºC). PVDF 200 ºF (61 ºC)
    • 135. Polypro maximum operating pressure is 150 psi (10 bar)
    • 136. Turnover package comes standard</li></ul>Polypro Lance with Teflon 28500<br />Polypro Lance with new polypro Sprayball<br />
    • 137. Solid Model Vessel Review/Sprayball Mapping<br />
    • 138. Nozzle Integration<br /><ul><li>Nozzle location in the tank
    • 139. Specify the relevant spray lance:
    • 140. Mounting on the vessel
    • 141. Nozzle mounting
    • 142. Material
    • 143. Geometry
    • 144. Surface finish
    • 145. Weld
    • 146. Material
    • 147. Passivation</li></li></ul><li>Thank You<br />

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