Oral Liquid Formulation Plant

1.Preparation Tank Unit: It includes two parts: one is 6000L  preparation tanks and another one is 1000L preparation tank. The preparation tanks are designed with full jackets, enabling heating and cooling functions. The tanks are equipped with 316L material frame-type agitators, 360° spray balls, 0.22μm hydrophobic breathers, etc., as well as weighing modules, temperature transmitters, residual oxygen detection probes and other devices. Dead-angle-free bottom diaphragm valves are installed at the bottom of the tanks.

2.Filtration System: Corresponding filters are configured according to process requirements. The filter material is 316L stainless steel, with the inner surface electrolytically polished. The gaskets are made of silicone rubber rings. The exhaust holes are arranged on the upper head, and the welding points are polished. The filter element is 0.45μm.

3.Sanitary Pumps and Valve Fittings: Domestic well-known brand sanitary pumps are adopted, with the pump head parts in contact with materials made of 316L stainless steel. Valves in contact with materials, clean compressed air and purified water are 316L sanitary valves, and the valves for the tank jacket pipeline are made of 304 stainless steel. The weighing module accuracy reaches C3 level.

4.Automation Control System: It is centered on Siemens PLC and modules, with a color touch screen for control. It has functions such as batch management, recipe management, authority management and audit trail. It can monitor and control parameters such as jacket temperature, material temperature and stirring speed, and is equipped with an emergency stop button.

5.Auxiliary Systems: It includes potential configurations related to CIP/SIP (for example, the CIP station is composed of a hot water tank, an alkali liquid tank, etc.), as well as a complete pipeline system. The pipelines are made of 316L or 304 stainless steel, with strict welding processes and heat preservation and cold preservation measures.

1.Efficient and Stable Performance

• It has high heating and cooling efficiency. For the 6000L preparation tank filled with 80% effective volume of water, the time to heat up to 80℃ does not exceed 1 hour, and the time to cool down to 15℃ does not exceed 2 hours, with a temperature control accuracy of ±2℃.

• The stirring system adopts frequency conversion speed regulation, with a rotation speed range of 10-80rpm and a tolerance of ±2.5%, ensuring uniform mixing of materials.

• The weighing system accuracy is not lower than ±0.1%, equipped with data printing, storage and alarm functions to ensure batching accuracy.

2. Strong Compliance

• Parts in direct contact with drugs are made of materials meeting GMP requirements such as 316L stainless steel, with the inner surface roughness Ra≤0.4μm and the outer surface mechanically polished to Ra≤0.8μm, without sanitary dead angles.

• Pipeline welding is strict. Welding records of automatic welds are kept and at least 20% of them are inspected by endoscope. 100% of manual welds are inspected by endoscope, which meets the requirements of the new GMP for pipeline layout.

• The automation system has an audit trail function to record user operations, parameter modifications, etc., meeting data traceability requirements. The software has clear permission levels, in line with pharmaceutical industry specifications.

3. Convenient Operation and Maintenance

• It realizes fully automatic operation, supports automatic program control of online cleaning and online disinfection. Cleaning can be set to recipe management mode, allowing users to set parameters by themselves.

• The equipment structure is reasonably designed, with valves and instruments arranged neatly and beautifully for easy operation. Designs such as quick-opening manholes and quick-clamp interfaces make disassembly and maintenance convenient, and instruments are easy to calibrate.

• Complete technical documents are provided, including installation drawings, maintenance manuals, operation manuals, etc. The manufacturer provides comprehensive training and after-sales support to ensure that users can skillfully operate and maintain the equipment.

4.Safety and Reliability

• The equipment has no sharp edges or corners. Mechanical moving parts are equipped with interlocking protection and sealing measures, and are provided with emergency stop switches. The system enters a safe state in case of power failure, ensuring the safety of operators and the equipment.

• Safety accessories such as safety valves and pressure gauges have inspection certificates, meeting relevant national safety standards.