Pharmaceutical Tablet Coater with Exchangeable Drums

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1 Pharmaceutical Tablet Coater with Exchangeable Drums The new definition of tablet coating

2 Manufacturing solution... The new Accela-Cota FLEX 500 is a manufacturing solution to increase tablet coating productivity while maintaining product quality, consistency, and process reliability. The FLEX 500 has a unique combination of features to help reduce down time for batch-to-batch change over, giving the coater more process time to coat tablets enhanced utilization, higher throughput, better profit! With almost limitless possibilities, the FLEX 500 is the preferred choice for processing tablets using film, sugar, functional, and drug layer coatings. Built for today s needs adaptable for tomorrow s. The ultimate in versatility. INNOVATION Production Scale Coater with Exchangeable Drums Enhanced coater utilization Removable drum for inspection and cleaning Exchangeable drums for unmatched flexibility Interchangeable mixing baffles Patented Thomas Spray Bar Adjustable gun-to-bed angle/distance for all load sizes VERSATILITY Superior Performance for a Range of Processes Aqueous film coatings Functional and modified release coatings Coating with one or more drug layers Sugar coating FLEXIBILITY Easily Configured to Best Suit a Process Five exchangeable drum configurations available Process batch loads from 25% to 100% of drum capacity Dedicate drums to product classes or to contract manufacturing clients Interchangeable spray bar and gun manifolds Easy to use graphic HMI with multiple languages Adapt easily to future needs Choose the original choose success! CLEANABILITY Total Access Design Optimized chamber design for enhanced cleanability Faster and more effective cleaning Reduced cleaning validation expense Supports automated or assisted wash options Range of affordable WIP options

3 Innovative Drum Exchange Thomas Engineering is the originator of the fully perforated side-vented drum. Today, Thomas continues our legacy of imaginative and practical coater design with the introduction of the FLEX 500. The FLEX 500 is the only production class tablet coater with exchangeable drums. The compelling simplicity of the design makes routine drum exchange fast and easy. Imagine the possibilities Choose a drum configuration and mixing baffles to best suit requirements of the process Dedicate drums to specific drug compounds or to individual clients Reduce risk of cross-contamination Achieve faster cleanings and product changeovers for enhanced utilization Reduce facility improvement costs and operating expenses build and staff one coating suite for the FLEX 500 instead of two or more suites for ordinary tablet coaters Drum Exchange All illustrations and specifications are subject to change without notice Pre-WIP Disengage Drum Extraction Coater WIP Drum Exchange

4 Imagine the Possibilities The FLEX 500 Flexibility Routine exchange of drums within the coating suite Wide turndown volume of 50 to 700 liters in same machine 5 drum sizes available Process batch loads from 25% to 100% of drum capacity Externally position spray bar for optimal angle and distance to bed Exchangeable mixing baffles Install Through-the-Wall, Rear Flush, or Free Standing Adapt easily to future manufacturing needs...is the most versatile and flexible tablet coater on the market today. It is the first production class coater to offer drum exchange, versatility and flexibility for enhanced utilization and cleanability. Drum Exchange Choose a drum to best suit the process Reduce cross contamination; lower costs for cleaning validation studies Dedicate drums to product families or contract manufacturing clients Faster batch-to-batch changeover time More throughput with fewer coaters Enhanced utilization higher productivity Thomas Spray Bar Streamlined sanitary design Eliminates air and solution lines over spray zone Schlick ABC anti-bearding spray nozzles as standard Independent control of pattern and atomizing air Tool-less gun inserts and bar assemblies for fast, easy service Light weight sections for easy handling Service cart for convenient maintenance and optional spray pattern testing Solution Delivery Peristaltic pump with single or dual element head Recirculation to reduce settling of solids in solution lines Choice of volumetric or mass flowmeter Solution pressure monitoring Automated solution switching All illustrations and specifications are subject to change without notice

5 Tomorrow s Coater Today Automation Large color touch-screen operator interface (HMI) Multiple languages Switch between languages at the touch of a button Receptacle for detachable keyboard and mouse Comprehensive recipe and report management Sub-batch and campaign management Enables compliance with 21 CFR Part 11 Cleanability Total Access design for swabbing and routine inspection Optimized chamber design for enhanced cleanability Continuously welded interior with rounded corners Smooth chamber surface finishes throughout Water-tight inflatable seals on access doors Mixing Baffles Removable for easy off-line cleaning and inspection Exchange and select baffles to best suit a process Designed for tool-less removal and assembly Choice of plough or TEI helical High and low profile designs Integrated Peripherals Range of affordable manual, assisted and automated WIP executions Optional devices for assisted loading using IBCs or drums Convenient front utility panel for scales and drum inverters Purpose-built dollies for drum exchange and storage Solution preparation equipment and delivery tanks

6 Process Versatility The Accela-Cota FLEX 500 is a versatile coating platform that accommodates a wide range of coating applications. Some processes may use just a single spray solution. More complex matrices may require a series of cycles or stages - often with widely varied fluid properties - to develop functional layers, or layers containing active drugs. While there can be many processes all with their own unique variables, they all have one demand in common they need to be implemented on a tablet coater that is efficient, highly available, easy to clean and capable of delivering consistently good product quality. That coater is the FLEX 500! Aqueous Film Sugar Functional Drug Layer The most widely used coating process, these coating films are used to produce color and clear finishes on tablet cores, and for overcoating tablets with previously applied sugar, functional, and drug layer materials. Solution viscosities are moderate and most coating processes are fairly simple to optimize. The sugar coating process is characterized by its many iterations of a dose-distribute-dry sequence using a heavy sugar syrup. This produces a very thick layer of solid material around the tablet core. Sugar coatings are commonly applied in conjunction with functional seal coatings, sometimes a drug layer, and concluding with a color or clear finish coat. The process requires a coater with broad process capabilities, such as the FLEX 500. Functional coatings contain materials that modify the release profile of tablet cores. In many cases, the materials consist of high molecular weight polymers in a high viscosity suspension. Solution delivery systems are required to efficiently provide solution and air supply for droplet atomization to ensure quality film formation; selection of spray nozzles is essential to prevent gun bearding. Coating suspensions containing active drugs are applied to the tablet core in layers, sometimes with protective barrier layers between them. These highly specialized processes are often characterized by viscous suspensions containing very low drug concentrations. Layer development typically requires long processing times with low bed depth to achieve high content uniformity. A FLEX 500 coating drum with appropriate geometry for desired batch size and bed depth may be selected for the process. Capabilities For more than 50 years, Thomas Engineering has been a partner in the solid dosage manufacturing industry, helping customers develop solutions to boost productivity and reduce manufacturing costs. With the Accela-Cota FLEX 500, Thomas is now positioned to help even more by offering this innovative coating platform to provide unprecedented manufacturing flexibility. An investment in flexible technology gives our customers a competitive advantage, allowing them to react quickly to changing market demands and product mix priorities. Our customers appreciate the value of a partnership with Thomas Engineering, the market leader dedicated to tablet coating. These customers know that their investment extends beyond a system of machines and controls they also benefit from our expertise and competency resulting from decades of experience with tablet coating systems in the field. The dividend is their assurance that their TEI coating system will deliver reliable performance and consistently good finished products for many years. Choose the original choose success choose Thomas Engineering. Thomas Engineering Inc. 575 West Central Road Hoffman Estates, IL / F. 847/ All illustrations and specifications are subject to change without notice

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