The hollow capsule belongs to the material needed for drug production, and the material management requirements should be followed in the process of purchase, storage, distribution and use. In terms of storage, the hollow capsule has the characteristics of too little water content and easy to break, too much and easy to soften and deform. According to the requirements of Chinese pharmacopoeia 2010, the storage condition of the hollow gelatin capsule is: airtight. It is stored in the condition of temperature 10~25 ℃, relative humidity 35 ~65%.Clean area air conditioning system general temperature 18-26 degrees, 45%~65%. If the raw material of a capsule is wetting, the required temperature is less than 15 ° c and the relative humidity is less than 45%.
How to Control Humidity?
To address humidity-related issues in hollow capsule storage and production, industry experts suggest several practical solutions:
Independent air treatment system
Installing an independent air treatment system in a specific area (such as a storage room with special requirements for temperature and humidity) can accurately adjust the temperature and humidity of the local environment and avoid waste of resources caused by large-scale adjustment.
High-efficiency dehumidification equipment
The introduction of high-efficiency dehumidification equipment such as lithium bromide rotary dehumidifiers can significantly reduce the ambient humidity and ensure that the capsule storage environment always meets the standards.
Temperature and humidity monitoring and trend analysis
By increasing the daily monitoring frequency of the thermometer and hygrometer, combined with data analysis tools such as MINITABLE, trend analysis is performed, warning lines and deviation lines are set, and corrective measures are taken in time to prevent problems before they occur.
Stability verification and quality control
Some people believe that the raw materials have undergone certain processing and stability verification before becoming finished products, so the storage conditions only need to meet the requirements of the finished products, unless the stability data of the product is untrue. Even so, it is still necessary to strictly verify the impact of storage conditions on capsule performance to ensure the reliability of product quality.
Conclusion
Effective humidity control is a key link in the production process of hollow capsules, which is directly related to the physical properties of capsules and the safety of drugs. By adopting advanced air treatment systems, efficient dehumidification equipment, and scientific monitoring and analysis methods, pharmaceutical companies can effectively solve the problem of humidity control, ensure the quality and stability of hollow capsules, and provide reliable protection for drug production.
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