How to control the temperature and humidity of the empty capsule

Empty capsule is necessary to pharmaceutical production. Its purchase, storage and use should follow the requirements of material management. In terms of its storage, the empty capsule is easy to fragment if the water content is too little, and it is easy to soften and deform if the water content is excessive. In accordance with the requirements of the 2010 edition of the Chinese Pharmacopoeia,the empty gelatin capsule should be stored in a closed space with the temperature of 10-25 degrees centigrade and the relative humidity of 35%-65%. Generally, the temperature of the air conditioning system in clean area is 18-26 degrees centigrade, and the relative humidity is 45%-65%. If one row material of the capsule is easy to absorb moist, it is required that the temperature is less than 15 degrees centigrade and the relative humidity is less than 45%.

According to industrial reflection, the temperature of the workshop in actual production is 18-26℃, and the relative humidity is less than 65%. It may be hard to achieve storage condition. The question is whether this case is reasonable? If it is not, how to control the temperature and humidity of the empty capsule in the production? As far as I know, this problem also troubles many people in the industry. 

Some people think, the temperature and humidity can be controlled according to normal production. If there are any worries, it is advised that you can take into consideration some quality studies that have been done before to do a risk assessment, or the risk assessment can be done when making process validation. However, whether it is feasible or not still depends on the company’s own situation. 

According to information, it is a normal phenomenon that there is difference between the control for temperature and humidity in the production process and the control for temperature and humidity in the process of storing finished products. For example, the product which should be stored in a cool place does not always need a shady environment in the production process. As it is hard to control the temperature and humidity in the actual production, the difference should be taken into consideration generally when studying the new product, and it is acceptable within a certain production circle.

“If some empty capsules do have strong hygroscopicity, we should strengthen to control the temperature and humidity. As to the control quantity, it depends on the product and what the production company can offer.”some industry insiders say.

As for how to control the temperature and humidity, industry insiders have given different advice, such as separately set air-handling system for some devices which has special requirements for temperature and humidity, add the rotary lithium bromide dehumidifier, add the thermometer and humidometer for daily monitoring, and make trend analysis with mini table to get warning line and correction line.

However, some people think, if the material is processed and its stability is verified before it becomes the well-packed product, the material can be stored in an environment where the product is stored. The material storage has nothing to do with the material itself, unless the data of product stability is not true.

Industry insiders believe, if the temperature and humidity have great effect on the product quality in normal condition, the device for adjusting local temperature and humidity can be installed. When it is installed, the effect on the environment of the clean area should be taken into consideration. But as it involves with capital investment, whether to install the temperature and humidity adjustment equipment depends on the enterprise itself.By the way, the method of sectional production also can be adopted.

As far as I know, empty capsule solves the medicine problem of poor taste for patients, realizing that a good medicine can no longer taste bitter. In recent years, with the continuous advancement of medicine product industry and health product industry, the demand for empty capsule has been increasingly expanded. It is estimated that China’s empty capsule industry will occupy a place in the future market. In this context, it is necessary to strictly control the production and storage of the product.