This document provides an overview of Spraying Systems Co., including their facilities, products, and fluid bed and granulation processes. Key points: - Spraying Systems Co. is headquartered in Wheaton, IL and has 10 manufacturing facilities and 85 sales offices globally. - They offer fluid bed dryers, granulators, and coaters from R&D to production scale with predictable scale-up. - Their granulation, size reduction, and coating systems use high-shear and fluid bed processes to efficiently bind and coat particles. - Batch Architect software controls processes and ensures compliance with regulations like 21 CFR Part 11.

1. Welcome toINTERPHEX 2011

2. Spraying Systems Co. US Facilities Corporate Headquarters Wheaton, Illinois East Coast Facility Hudson, New Hampshire

3. Global Manufacturing and Service 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.

4. Fluid Air Division Specializing In: Fluid bed processing High-shear granulation/one pot processing Size reduction Material handling Process automation Engineering services Retrofits: Fluid Air & non-Fluid Air

5. Fluid Bed Dryers, Granulators, and Coaters Phase III: Production Scale Phase II: Pilot Scale Phase I: R&D Scale

6. R&D/Pilot Scale Fluid Beds

7. Production Scale Fluid Beds

8. Predictable Scale-Up

10. Less filter pressure or plugging

11. Fines stay below spray nozzles when granulating

12. Less fines in finished batch increasing yields

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

17. R&D Scale Size Reduction Systems

18. Production Scale Size Reduction Systems

19. Flexible Containment for High Potency Compounds in R & D Applications • Flexible enclosure set-up allows for use in both containment and non-containment applications, eliminating the need to purchase a second machine solely for containment use • Capable of meeting an OEB5 classification • Achievable containment level of 1.0 μg/m3 on a task basis

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 needsLarge agglomerates (before milling) Granules (after milling)

24. PHARMX® High-Shear Granulators Phase III: Production Scale Phase II: Pilot Scale Phase I: R&D Scale

25. R&D/Pilot Scale Granulators

26. One Pot Processors

27. Production Scale Granulators

28. Impeller and Chopper

29. High-Shear Granulation Process Overview High-shear granulation effectively turns powders into dense granules for tableting or coating A large impeller located in the bowl bottom blends the product while liquid is added A chopper located in the bowl shears the granules until desired size and density is achieved

31. Manual equipment controls

32. Batch Architect Pro™

33. Fully automated 21 CFR Part 11 capable controlsTypical through-the-wall control panel with touch screen control

34. Batch Architect™ Process Control Software Flexible solution for controlling lab scale and portable equipment Compatible with virtually any batch-type processing equipment, including: coating pans, pellet-making process trains, and liquid delivery systems Equipped with a graphical user interface (GUI) which provides users with current status information of critical machine functions through animation and text Recipe editor feature allows batches to be reproduced with minimal user intervention Offers convenient electronic batch record data logging and report creation services CFR 21 Part 11 FDA capable (Batch Architect ProTM)

35. Virtualization Technology and Disaster Recovery Batch Architect Pro operates in a virtualized control environment, which allows multiple simulated "virtual" computers to run on a single host computer. This enables multiple systems to be configured in a distributed architecture to provide cost savings and simplified administration. 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. 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.

36. Graphical User Interface Screen

37. Recipe Editor for Automated Processing

38. Tablet Coating Solutions for the Pharmaceutical Market

39. Understanding the Coating Process

40. Mode of Processing

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

48. Excellent surface finish both internal and external

49. Manufacturing and quality systems meeting cGMP requirements

50. Design meeting ASME BPE requirements

52. Lower air consumption and pressure leading to a more stable environment in the coater and less bearding

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!)

58. We can develop brackets to fit your needs and retrofit exiting coaters

60. Automatic gun, air actuated (cylinder air)

61. Air atomizing

63. Modular design

64. Sanitary design

65. Similar set-ups

66. More consistent spray distribution

68. Proven design, widely used

70. Automatic gun, air actuated (cylinder air)

71. Air atomizing

73. Provides a fair amount of adjustability

74. Proven design, widely used

77. Around the fan air jets

79. The material being sprayed

80. The air cap and fluid tip design

82. New ear design places the fan jets further away from the cap face

85. Thinner ears, less surface area around the fan jets for material to build up on

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

93. Fluid Bed Nozzles

95. Top-Spray and Bottom Spray

96. Materials 316L stainless steel

100. Pharmaceutical

101. Biotech (pilot to production scale processes)

102. Laboratory

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)

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

118. Small number of parts

119. Simple to maintain / clean

120. Rotating head with:

121. Solid Stream

122. Flat Spray

125. Heat codes are marked on lance

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: Certificate of conformity Material test reports Welder certification Certificate of inspection

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 standardPolypro Lance with Teflon 28500 Polypro Lance with new polypro Sprayball

137. Solid Model Vessel Review/Sprayball Mapping

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