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%.
As for how to control the temperature and humidity problem, the industry also gave different Suggestions and views.For example, it is suggested to set up separate air treatment system for local areas (with special requirements on temperature and humidity).For example, add lithium bromide rotary dehumidifier;Increase daily monitoring of temperature and humidity meter, use MINITABLE to do trend analysis, get warning line, deviation line and other ways.
At the same time, some people believe that the material has undergone certain processing and stability verification before it becomes a product, and the preserved conditions only need to meet the storage conditions of the product, which has nothing to do with the material itself, unless the stability data of the product is not authentic.
Contact Person: Ms. Wei
Tel: 86-15372434551
Fax: 86-571-88615836
