Pharmaceutical Tradeshow Interphex Presentation

Welcome to

INTERPHEX 2011

www.spray.com | www.fluidairinc.com

Corporate HeadquartersWheaton, Illinois

East Coast FacilityHudson, New Hampshire

Spraying Systems Co. US Facilities


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.


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


Phase II: Pilot ScalePhase I: R&D Scale

Phase III: Production Scale

Fluid Bed Dryers, Granulators, and Coaters


R&D/Pilot Scale Fluid Beds


Production Scale Fluid Beds


Predictable Scale-Up


• 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 construction costs

Conical Expansion Chamber


Bowl Agitator Rake


• In Wurster coating, also known as air suspension coating, the product 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

• In fluid 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

• Fluid bed granulation is an 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

Fluid Bed Process Overview


Phase II: Pilot Scale

Phase I: R&D Scale


GRANUMILL® Size Reduction Systems


R&D Scale Size Reduction Systems


Production Scale Size Reduction Systems


• Flexible enclosure set-up allows for use in both containment and non-containmentapplications, 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

Flexible Containment for High Potency Compounds in R & D Applications


• GRANUMILL® systems can size reduce wet or dry powders in the range of 10 to 400 mesh (2000-27 microns)

• 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 feed rate of the product

• As both a screen mill and an impact mill in one machine, GRANUMILL ® systems offer two applications to suit different processing needs

Large agglomerates (before milling)

Granules (after milling)

Particle Size Reduction Process Overview


Phase II: Pilot Scale

Phase I: R&D Scale


PHARMX® High-Shear Granulators


R&D/Pilot Scale Granulators


One Pot Processors


Production Scale Granulators


Impeller and Chopper


• 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

High-Shear Granulation Process Overview


• Batch Architect™ • Manual equipment controls

• Batch Architect Pro™• Fully automated 21 CFR Part 11 capable controls

Process Controls

Typical through-the-wall control panel with touch screen control


• 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)

Batch Architect™ Process Control Software


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.


Graphical User Interface Screen


Recipe Editor for Automated Processing


Tablet Coating Solutions for the

Pharmaceutical Market


Target Carrier Gas

SprayMixing

Drying air

Spray atomization

Mixingof bed

Attrition

Exhaust (dust, solvent)

Target Carrier Gas

SprayMixing

Drying air

Spray atomization

Mixingof bed

Attrition

Exhaust (dust, solvent)

Understanding the Coating Process


Continuous Coating Batch CoatingTypically used for commodity products

Typically used for specialty products

More economical, but product control could be very problematic

Batch processes are transient, therefore:• Steps leading to the coating step and after the coating step are very important in successful coating• Robustness of the process can be built in through operational controls• Process variability can result from poor process characterizations

Mode of Processing


• Lowest form of energy for liquid droplets corresponds to the smallest surface area (i.e., large droplets)

• 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 same coating uniformity

Atomization


Light Overall Weight• Constructed from 316L SS and Teflon or FEP • 4 gun manifold with Teflon spacer weights 13.5lb (6.14kg)

Benefits of lighter weight:• Easier to handle• Easier to maintain

54000 Modular Air Atomizing Manifold


• Custom manifolds to fit your vessel

54000 Modular Air Atomizing Manifold


Reduce Contamination Risk:• FDA compliant materials of construction• 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

Improve Spray Performance:• Ability to maintain even pressure across its length ensures even flow

distribution across the pill bed• Lower air consumption and pressure leading to a more stable environment in

the coater and less bearding• Self locating spray setup feature (new!)

54000 Modular Air Atomizing Manifold: Benefits


Easier maintenance:• Lightweight• 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

Advantages:• Spraying Systems Co. is able to service and support our equipment worldwide • We can develop brackets to fit your needs and retrofit exiting coaters• We offer a unique design for both continuous and batch coaters

54000 Modular Air Atomizing Manifold: Benefits


VAU and VMAU Spray Gun• Liquid line• Automatic gun, air actuated (cylinder air)• Air atomizing• Air line to shape the spray pattern (fan air)

VMAU Spray gun:• VMAU spray gun is next generation VAU • Modular design• Sanitary design• Similar set-ups• More consistent spray distribution• Reduced maintenance

Typical Spray Guns


VAU / VMAU Spray Gun

Advantages:• Greater level of adjustability• Proven design, widely used• Large number of set up types / sizes available

Typical Spray Guns


JAU Spray Gun• Liquid line• Automatic gun, air actuated

(cylinder air)• Air atomizing• Same air supply as air atomization

for some set-ups

Typical Spray Guns


JAU Spray Gun

Advantages:• Less control required• Provides a fair amount of adjustability• Proven design, widely used• Large number of set up types / sizes available

Typical Spray Guns


Improve Coating Process


Where:• Around the air annulus• Around the fan air jets• Around the fluid tip orifice (not

common with the VAU or VMAU)

Causes:• Over spray• The material being sprayed• The air cap and fluid tip design• External forces

Typical Bearding


What Changes with VAU Anti-Bearding Set-Ups?• Extended fluid orifice• New ear design places the fan jets further

away from the cap face• Changed the impact of the fan jets on the

spray to form the fan at lower air pressure

VAU Anti-Bearding Set-Up


Both air caps sprayed OPADRY® for the same time periodOPADRY® is a registered trade mark of Colorcon

Standard Air Cap Anti-Bearding Air Cap

VAU Anti-Bearding Set-Up


What changes with VMAU Anti-Bearding Set-Ups?• Based on the VAU AB set-ups but with added

features• Thinner ears, less surface area around the fan

jets for material to build up on• Further reduction of build-up on the air cap

because of reduced surface area

VMAU Anti-Bearding Set-Up


• Designed for minimum surface area • 316L stainless steel construction• High impingement fan jets• Excellent spray pattern• Low air pressure• Runs twice as long without bearding• Patent pending

Next Generation Anti-Bearding Set-Up


Fluid Bed Applications


Fluid Bed Nozzles


Nozzles and lances for fluid bed coating and granulationDesigned to simplify your scale-up and validation, reduce maintenance, and improve product quality

• Available for R & D , Pilot and Production

• Top-Spray and Bottom Spray

• Materials 316L stainless steel

• Custom lances available


Complete Vessel Cleaning SolutionsFor the Pharma and Biopharma Market


Sprayballs • Meets ASME BPE and 3A standards

Dynamic Fluid-Driven Nozzles• Reactionary Force • Reactionary with Constant Speed

Vessel Cleaning


• Ideal for DI (deionized water), RO (reverse osmosis), WFI (water for injection) systems

• Pharmaceutical• Biotech (pilot to production scale processes)• Laboratory• Clinical analysis

Applications


Specifications:• 316L Stainless Steel• Materials made and fabrication done in the U.S.A.• Acorn design allows cleaning of the nozzle and lance entry port• Mapping of sprayball• Passivated• Full penetration welds per ASME BPE using purge gas• Surface finish 20 ui Ra Max. ( 0.5 Microns)• Standard turnover package:

Certificate of conformityMaterial test reportsWelder certificationCertificate of inspection

• Options:ElectropolishImproved surface finishCustom configuration

Metallic Spray Balls


Spraying Systems Co. Biopharmaceutical Spray Ball – Non-Metallic:• Suitable for CIP/SIP• Non-metallic nozzles will not contribute to rouge formation• Will not damage metallic vessel surfaces / glass lined tanks• Design and manufactured along cGMP and ASME BPE requirements• Materials compliant with USP Class VI FDA, PER 21 CFR 177.1550 (Teflon) to

21 CFR Part 177.1520 (Polypropylene)• Available in Polypropylene, PVDF (Kynar) and Teflon• Standard Turn Over Package

Non-Metallic Spray Balls


Spinner nozzles with fluidic type bearing• No friction parts, fluid bearing formed by the

fluid being sprayed• Small number of parts• Simple to maintain / clean• Rotating head with:

• Solid Stream• Flat Spray

• Added flexibility when selecting the proper nozzle for the application

Spinner Nozzles


Specifications:• Passivated• Full penetration welds per ASME BPE using purge gas are ground to parent material ID and OD.• Surface finish 20 ui Ra ( 0.5 microns)• Heat codes are marked on lance• Standard turnover package:


• Options:ElectropolishBetter surface finishCustom configuration

Metallic Lances Fabricated Using 316L Tube and Ferrules


Specifications:• All 316L stainless steel• Passivated, Electropolished• Full penetration welds per ASME BPE using purge gas • Surface finish 20 ui Ra ( 0.5 microns)• Standard turnover package:


D41800E With Butt Weld Connection


Specifications:

• 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

• Nonmetallic will not contribute to rouge formation• Polypro continuous operating temperature is 180 ºF (50 ºC). PVDF 200 ºF (61 ºC)• Polypro maximum operating pressure is 150 psi (10 bar)• Turnover package comes standard

Polypro Lance with Teflon 28500 Polypro Lance with new polypro Sprayball

Non-Metallic Lances


Solid Model Vessel Review/Sprayball Mapping


• Nozzle location in the tank• Specify the relevant spray lance:

o Mounting on the vesselo Nozzle mountingo Materialo Geometryo Surface finisho Weldo Materialo Passivation

Nozzle Integration

Thank You

Business

Pharmaceutical Tradeshow Interphex Presentation