Welcome toINTERPHEX 2011<br />
Spraying Systems Co. US Facilities<br />Corporate Headquarters<br />Wheaton, Illinois<br />East Coast Facility<br />Hudson...
Global Manufacturing and Service<br />Spraying Systems Co. corporate headquarters is located in Wheaton, IL, just outside ...
Fluid Air Division Specializing In:<br /> Fluid bed processing <br /> High-shear granulation/one pot processing<br /> Size...
Fluid Bed Dryers, Granulators, and Coaters<br />Phase III: Production Scale<br />Phase II: Pilot Scale<br />Phase I: R&D S...
R&D/Pilot Scale Fluid Beds<br />
Production Scale Fluid Beds<br />
Predictable Scale-Up<br />
Conical Expansion Chamber<br /><ul><li>Fines stay out of upper filter region
Less filter pressure or plugging
Fines stay below spray nozzles when granulating
Less fines in finished batch increasing yields
No need for different chamber pieces used by competitors, taking up a smaller amount of bowl volume and reducing construct...
Fluid Bed Process Overview<br /><ul><li>Influid bed drying, conditioned gas flows through a bed of material, separating th...
Fluid bed granulation isan extension of the drying process where a binder solution is top-sprayed onto dry suspended fine ...
InWurster coating, also known as air suspension coating, theproduct particles are first separated from one another in an a...
R&D Scale Size Reduction Systems<br />
Production Scale Size Reduction Systems<br />
Flexible Containment for High Potency Compounds in R & D Applications<br />• Flexible enclosure set-up allows for use in b...
Particle Size Reduction Process Overview<br /><ul><li> GRANUMILL® systems can size reduce wet or dry powders in the range ...
 A typical Fluid Air milling system consists of an inlet, chamber with rotor, screen, and an outlet
 The particle size distribution generated is dependent upon the speed of the rotor, rotor type, screen hole size and the f...
 As both a screen mill and an impact mill in one machine, GRANUMILL ® systems offer two applications to suit differentproc...
PHARMX® High-Shear Granulators<br />Phase III: Production Scale<br />Phase II: Pilot Scale<br />Phase I: R&D Scale<br />
R&D/Pilot Scale Granulators<br />
One Pot Processors<br />
Production Scale Granulators<br />
Impeller and Chopper<br />
High-Shear Granulation Process Overview<br />High-shear granulation effectively turns powders into dense granules for tabl...
Process Controls<br /><ul><li>Batch Architect™
Manual equipment controls
Batch Architect Pro™
Fully automated 21 CFR Part 11 capable controls</li></ul>Typical through-the-wall control panel <br />with touch screen co...
Batch Architect™ Process Control Software<br />Flexible solution for controlling lab scale and portable equipment <br />Co...
                 Virtualization Technology and Disaster Recovery<br /> Batch Architect Pro operates in a virtualized contr...
Graphical User Interface Screen<br />
Recipe Editor for Automated Processing<br />
Tablet Coating Solutions <br />for the <br />Pharmaceutical Market<br />
Understanding the Coating Process<br />
Mode of Processing<br />
Atomization<br /><ul><li>Lowest form of energy for liquid droplets corresponds to the smallest  surface area (i.e., large ...
Therefore energy is needed to break up the droplets (i.e., larger surface area)
As energy dissipates, droplets coalesce
Better nozzle designs will result in less localized over-wetting
Nozzle design must be improved in the larger equipment in order to maintain the same coating time while maintaining the sa...
4 gun manifold with Teflon spacer weights 13.5lb (6.14kg)</li></ul>Benefits of lighter weight:<br /><ul><li>Easier to handle
Easier to maintain</li></li></ul><li>54000 Modular Air Atomizing Manifold<br /><ul><li>Custom manifolds to fit your vessel...
Excellent surface finish both internal and external
Manufacturing and quality systems meeting cGMP requirements
Design meeting ASME BPE requirements
Complete turnover package ships with every product</li></ul>Improve Spray Performance:<br /><ul><li>Ability to maintain ev...
Lower air consumption and pressure leading to a more stable environment in the coater and less bearding
Self locating spray setup feature (new!)</li></li></ul><li>54000 Modular Air Atomizing Manifold: Benefits<br />Easier main...
Strong ability to resist staining
Excellent finish for both internal and external surfaces
Extended needle assembly to ease its removal from the nozzle body (new!)
Easy to switch spray setups – captured O-ring</li></ul>Advantages:<br /><ul><li>Spraying Systems Co. is able to service an...
We can develop brackets to fit your needs and retrofit exiting coaters
We offer a unique design for both continuous and batch coaters</li></li></ul><li>Typical Spray Guns<br />VAU and VMAU Spra...
Automatic gun, air actuated (cylinder air)
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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.

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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.
  • Pharmaceutical Tradeshow Interphex Presentation

    1. 1. Welcome toINTERPHEX 2011<br />
    2. 2. Spraying Systems Co. US Facilities<br />Corporate Headquarters<br />Wheaton, Illinois<br />East Coast Facility<br />Hudson, New Hampshire<br />
    3. 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. 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. 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. 6. R&D/Pilot Scale Fluid Beds<br />
    7. 7. Production Scale Fluid Beds<br />
    8. 8. Predictable Scale-Up<br />
    9. 9. Conical Expansion Chamber<br /><ul><li>Fines stay out of upper filter region
    10. 10. Less filter pressure or plugging
    11. 11. Fines stay below spray nozzles when granulating
    12. 12. Less fines in finished batch increasing yields
    13. 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. 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. 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. 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. 17. R&D Scale Size Reduction Systems<br />
    18. 18. Production Scale Size Reduction Systems<br />
    19. 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. 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. 21. A typical Fluid Air milling system consists of an inlet, chamber with rotor, screen, and an outlet
    22. 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. 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. 24. PHARMX® High-Shear Granulators<br />Phase III: Production Scale<br />Phase II: Pilot Scale<br />Phase I: R&D Scale<br />
    25. 25. R&D/Pilot Scale Granulators<br />
    26. 26. One Pot Processors<br />
    27. 27. Production Scale Granulators<br />
    28. 28. Impeller and Chopper<br />
    29. 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. 30. Process Controls<br /><ul><li>Batch Architect™
    31. 31. Manual equipment controls
    32. 32. Batch Architect Pro™
    33. 33. Fully automated 21 CFR Part 11 capable controls</li></ul>Typical through-the-wall control panel <br />with touch screen control<br />
    34. 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. 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. 36. Graphical User Interface Screen<br />
    37. 37. Recipe Editor for Automated Processing<br />
    38. 38. Tablet Coating Solutions <br />for the <br />Pharmaceutical Market<br />
    39. 39. Understanding the Coating Process<br />
    40. 40. Mode of Processing<br />
    41. 41. Atomization<br /><ul><li>Lowest form of energy for liquid droplets corresponds to the smallest surface area (i.e., large droplets)
    42. 42. Therefore energy is needed to break up the droplets (i.e., larger surface area)
    43. 43. As energy dissipates, droplets coalesce
    44. 44. Better nozzle designs will result in less localized over-wetting
    45. 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. 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. 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. 48. Excellent surface finish both internal and external
    49. 49. Manufacturing and quality systems meeting cGMP requirements
    50. 50. Design meeting ASME BPE requirements
    51. 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. 52. Lower air consumption and pressure leading to a more stable environment in the coater and less bearding
    53. 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. 54. Strong ability to resist staining
    55. 55. Excellent finish for both internal and external surfaces
    56. 56. Extended needle assembly to ease its removal from the nozzle body (new!)
    57. 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. 58. We can develop brackets to fit your needs and retrofit exiting coaters
    59. 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. 60. Automatic gun, air actuated (cylinder air)
    61. 61. Air atomizing
    62. 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. 63. Modular design
    64. 64. Sanitary design
    65. 65. Similar set-ups
    66. 66. More consistent spray distribution
    67. 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. 68. Proven design, widely used
    69. 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. 70. Automatic gun, air actuated (cylinder air)
    71. 71. Air atomizing
    72. 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. 73. Provides a fair amount of adjustability
    74. 74. Proven design, widely used
    75. 75. Large number of set up types / sizes available</li></li></ul><li>Improve Coating Process<br />
    76. 76. Typical Bearding<br />Where:<br /><ul><li>Around the air annulus
    77. 77. Around the fan air jets
    78. 78. Around the fluid tip orifice (not common with the VAU or VMAU)</li></ul>Causes:<br /><ul><li>Over spray
    79. 79. The material being sprayed
    80. 80. The air cap and fluid tip design
    81. 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. 82. New ear design places the fan jets further away from the cap face
    83. 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. 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. 85. Thinner ears, less surface area around the fan jets for material to build up on
    86. 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. 87. 316L stainless steel construction
    88. 88. High impingement fan jets
    89. 89. Excellent spray pattern
    90. 90. Low air pressure
    91. 91. Runs twice as long without bearding
    92. 92. Patent pending</li></li></ul><li>Fluid Bed Applications<br />
    93. 93. Fluid Bed Nozzles<br />
    94. 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. 95. Top-Spray and Bottom Spray
    96. 96. Materials 316L stainless steel
    97. 97. Custom lances available</li></li></ul><li>Complete Vessel Cleaning Solutions<br />For the Pharma and BiopharmaMarket<br />
    98. 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. 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. 100. Pharmaceutical
    101. 101. Biotech (pilot to production scale processes)
    102. 102. Laboratory
    103. 103. Clinical analysis</li></li></ul><li>Metallic Spray Balls<br />Specifications:<br /><ul><li>316L Stainless Steel
    104. 104. Materials made and fabrication done in the U.S.A.
    105. 105. Acorn design allows cleaning of the nozzle and lance entry port
    106. 106. Mapping of sprayball
    107. 107. Passivated
    108. 108. Full penetration welds per ASME BPE using purge gas
    109. 109. Surface finish 20 ui Ra Max. ( 0.5 Microns)
    110. 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. 111. Non-Metallic Spray Balls<br />Spraying Systems Co. Biopharmaceutical Spray Ball – Non-Metallic:<br /><ul><li>Suitable for CIP/SIP
    112. 112. Non-metallic nozzles will not contribute to rouge formation
    113. 113. Will not damage metallic vessel surfaces / glass lined tanks
    114. 114. Design and manufactured along cGMP and ASME BPE requirements
    115. 115. Materials compliant with USP Class VI FDA, PER 21 CFR 177.1550 (Teflon) to 21 CFR Part 177.1520 (Polypropylene)
    116. 116. Available in Polypropylene, PVDF (Kynar) and Teflon
    117. 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. 118. Small number of parts
    119. 119. Simple to maintain / clean
    120. 120. Rotating head with:
    121. 121. Solid Stream
    122. 122. Flat Spray
    123. 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. 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. 125. Heat codes are marked on lance
    126. 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. 127. D41800E With Butt Weld Connection<br />Specifications:<br /><ul><li>All 316L stainless steel
    128. 128. Passivated, Electropolished
    129. 129. Full penetration welds per ASME BPE using purge gas
    130. 130. Surface finish 20 uiRa ( 0.5 microns)
    131. 131. Standard turnover package:</li></ul> Certificate of conformity<br /> Material test reports<br /> Welder certification<br /> Certificate of inspection<br />
    132. 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. 133. Nonmetallic will not contribute to rouge formation
    134. 134. Polypro continuous operating temperature is 180 ºF (50 ºC). PVDF 200 ºF (61 ºC)
    135. 135. Polypro maximum operating pressure is 150 psi (10 bar)
    136. 136. Turnover package comes standard</li></ul>Polypro Lance with Teflon 28500<br />Polypro Lance with new polypro Sprayball<br />
    137. 137. Solid Model Vessel Review/Sprayball Mapping<br />
    138. 138. Nozzle Integration<br /><ul><li>Nozzle location in the tank
    139. 139. Specify the relevant spray lance:
    140. 140. Mounting on the vessel
    141. 141. Nozzle mounting
    142. 142. Material
    143. 143. Geometry
    144. 144. Surface finish
    145. 145. Weld
    146. 146. Material
    147. 147. Passivation</li></li></ul><li>Thank You<br />

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