1. Strict control of environmental humidity and temperature: Environmental control is the first line of defense against caking and sticking during tablet pressing. Based on production experience, the operating room temperature should be maintained between 18–22°C, and the relative humidity should be kept within the range of 45–55%. Practical recommendations include installing industrial dehumidifiers and temperature control systems in the tablet pressing area to ensure stable environmental parameters. Before each production shift, use a portable hygrometer to measure and record the environmental conditions; production should not commence if the values exceed the specified range. 2. Optimization of particle moisture content and particle size distribution: The moisture content of the particles and the proportion of fine powder directly affect the tablet pressing process. - Moisture control: The moisture content of the particles should be strictly controlled between 2% and 3%. Excess moisture can lead to caking, while too little moisture may result in loose tablets. - Particle size optimization: The proportion of fine powder in the particles should not exceed 10%. It is recommended to use an 80-mesh sieve to remove excess fine powder and re-granulate the material. - Uniformity assurance: Ensure that the raw materials and excipients have consistent particle sizes and are mixed evenly. 3. Scientific selection and optimization of lubricants: The choice of lubricant is crucial, depending on the characteristics of the raw materials. For example, sodium stearate fumarate is an ideal choice for AKG tablets as it is compatible with AKG and provides excellent anti-caking properties. - Optimize the amount of lubricant used: The typical dosage range is 0.5%–5%, and the optimal proportion should be determined through small-scale tests. - Application method: Add the lubricant at the end of the mixing process to avoid reducing its effectiveness due to excessive mixing. 4. Tailored formulation and process adjustments: Based on the properties of the raw materials, the following adjustments can be made: - Add an absorbent: If the raw materials are highly hygroscopic, 2–3% calcium hydrogen phosphate can be added as an absorbent. - Optimize the binder: Select an appropriate binder and ensure its concentration and dosage are sufficient to improve particle cohesion. - Adjust the tablet pressing parameters: Lowering the pressing speed and extending the compression time can help reduce caking. Also, ensure that the pressure is moderate to prevent the punch temperature from rising too high. 5. Punch management and equipment maintenance: The condition of the punches directly affects the occurrence of caking and sticking. - Surface treatment: Regularly check the surface finish of the punches and replace them promptly if wear is detected. - Cleaning: New punches may contain residual rust-preventive oil, which should be thoroughly cleaned before use. - For engraved punches, a small amount of liquid paraffin can be applied to the surface to enhance lubrication. - Temperature monitoring: The equipment may generate heat during tablet pressing; regularly check its operating conditions to prevent mechanical heat from causing caking.