Capsule Preparation Workshop Wet Fluidized Bed Closed Line

Name: Wet Fluidized Bed Closed Line (Integrating vacuum automatic feeding system, automatic binder liquid supply, wet granulator, wet milling, closed online discharge, fluidized bed granulation/drying, lifting and tilting discharge, online milling—granules are sealed into mixing drums and other processes, with online cleaning functionality)

1. During the feeding process, the feeding device must be sealed when connected to the wet feed inlet to prevent material leakage.

2. The feeding and discharging heights of equipment such as wet granulators, wet mills, fluidized beds, and dry mills are matched. The wet granulator is designed with a high-level configuration, and the connecting pipes use silicone hoses with quick-install connections. The length is appropriate and easy to assemble and disassemble, facilitating the transfer of wet materials to the fluidized bed and ensuring no clogging of wet granules occurs.

3. The wet granulator is equipped with a material conveying three-way valve, connected to the negative pressure suction of fluid bed drying, with an air supplement port.

4. After the fluidized bed material bin is pulled out, it is docked with the lifting and flipping granulator for discharge.

5. Metal components in contact with the drug shall be made of 316L (1Cr18Ni9Ti) stainless steel, with welded joints polished to a surface roughness requirement of Ra < 0.2μm. All external sealing plates (surfaces of the equipment not in contact with the product) shall be made of SUS304 stainless steel (0Cr18Ni9Ti), complying with GMP requirements, with a surface roughness requirement of Ra < 0.8μm. All concave and convex parts on both the internal and external surfaces of the equipment shall be designed with rounded transitions (R ≥ 10mm) or chamfered transitions at an angle of no less than 135 degrees. Fastening methods shall not use exposed screws, ensuring no dead corners and easy cleaning. Non-metallic materials (such as sealing gaskets) must meet pharmaceutical/food-grade requirements, exhibit good chemical stability, be resistant to shedding, and be easy to clean. Valid material quality certificates must be provided.

6. Provide quality certifications for materials, components, or control elements that may directly or indirectly affect the quality of the user's product.

7. The equipment components should be equipped with high-quality **energy-saving products**, and the selected outsourced parts and materials, as well as the brand, model, specifications, quantity, material, performance parameters, and manufacturer of the electrical automatic control system components, must be listed in detail.

8. The material loss for wet granulation and fluidized bed processes should not exceed 0.5% respectively; the material yield of the enclosed wet fluidized bed line in the capsule preparation workshop should be ≥99%.