Solid Drug Layering

Detailed Information on Solid Drug Layering

It is a centrifugal processing of single unit operation. The process involves the deposition of successive layers of an active compound onto nonpareil seeds resulting in the formation of uniform size pellets. The operation is carried out using a Drug layering rotating plate, Dry powder dusted on nonpareils adheres, increasing their size and forming larger pellets. As per requirements. Growth occurs by a process of blending of powder / liquid binding and consolidation. After liquid addition and dusting creates the correct diameter pellets, then tumbling of the coalesced aggregates increases their sphericity. The requirements of process validation or Good Manufacturing practices (GMP) are simplified as the complete spheroid production process is restricted to a single processor, min. size possible 200 microns. FEATURES Setup and Preparation: Purge Air: First, we blow air to clear out any particles that might get stuck between the layering plate and the drum. Load Granules: We place the initial small granules (called starter granules) onto a rotating plate. Powder Feeder: We put the powder we will use into a funnel that feeds it onto the granules. Solution Tank: We prepare the liquid solution that will help the powder stick to the granules. Start Rotation: We start the plate rotating at the speed we need. Layering Process: Wet Granules: While the plate is spinning, we spray the starter granules with the liquid solution. Add Powder: At the same time, we dust the granules with the powder. This helps the powder stick to the wet granules. Build Up Layers: As the granules keep getting wet and dusted with powder, they start to grow in size. Shaping and Discharging: Tumbling: The growing granules are tumbled around to help them form a more rounded shape. Discharge: Once they reach the desired size and shape, they are automatically pushed out of the machine through a door that opens. The finished granules fall into a collection hopper. Control System: Electrical Panel: An electrical control panel or touchscreen (HMI panel) manages the whole process, adjusting settings and ensuring everything works smoothly. In summary, this process involves rotating a plate with starter granules, spraying them with a liquid, and dusting them with powder. The granules grow larger and become more spherical as they rotate and are treated with the liquid and powder. Once they are the right size and shape, they are discharged into a collection container. Advanced Twin Screw Feeder Configuration Efficient Powder Feeding: Utilizes a twin screw feeder for precise and consistent powder delivery, ensuring optimal layering and uniformity in pellet formation. Through-the-Wall Installation Space-Efficient Design: Can be installed through the wall to minimize the footprint within the GMP area, optimizing space usage in production environments. PERKS 1. Clean-in-Place (CIP) System: Top Cover Access: Features an entry point for CIP from the top cover, making cleaning more efficient and thorough, and reducing downtime between batches. 2. cGMP-Compliant Design: Seamless Construction: Designed with smooth surfaces and no external tubing or piping, facilitating easy and effective cleaning. This design ensures compliance with current Good Manufacturing Practices (cGMP) standards. 3. Integrated Full Opening Side Discharge: Efficient Product Handling: Includes a fully integrated side discharge mechanism that allows for the easy removal of even challenging products, enhancing operational efficiency. 4. User-Friendly Interface: Graphical Operator Panel: Equipped with a 12" industrial PC and PROCESS+ software, offering a user-friendly graphical interface for easy operation. This system integrates with all plant equipment, streamlining processes and improving control. 5. Flexible Processing Capabilities: Versatile Applications: Ideal for a range of wet granulation processes and products, providing flexibility to meet diverse production needs.

Highlights of Solid Drug Layering

Special FeaturesAdvantageOptional FeaturesVideo

• - Unique Layering plate with zero crushing arrangement for starter cores.
• - Minimal radial clearance between plate & drum and air purging from bottom.
• - Tangential Spray gun with peristaltic pump and ml/min. flow rate controls along with Loss in weight powder feeder controls.
• - Complete process Automation with PLC controls & HMI.
• - Pneumatic Lifting of Layering plate.

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