Regulate the industry development of raw material drug drying process must be strictly in accordance with GMP requirements

December 17, 2021

Drying in raw material production is a common operation. Drying with intermediates also has finished drying. Therefore drying equipment appears to be crucial in the pharmaceutical process.

Today, Xiao Bian has summarized and arranged for everyone, the places where different raw material medicines need attention in the drying process, mainly in the following aspects:

During the drying process, no foreign substances such as dust and microorganisms can invade. The hot air, feed liquid, etc. entering the system must be sterilized and filtered; the crystals obtained in the aseptic condition should also be kept clean when entering the drying device. The capacity of the batch dryer is such that the batch can hold the normal operation of the batch. During the drying process of the drug, no sticky wall, no clumping, or uneven heating of the material is allowed to ensure the uniformity of the entire batch. In the continuous drying such as spray drying, the operating parameters of the entire drying process should be strictly controlled so that the entire batch of material is of uniform quality.

For spray drying, the hot air system should filter the heated air with a high efficiency filter that can withstand hot air temperatures. Do not allow the filter to be heated again so as to prevent oxides on the surface of the heater from falling off into the drug. Nebulizers require the use of purified, filtered compressed air atomized air atomizers. Due to the cleanliness of the high-pressure pump and the sealing of the high-speed shaft of the centrifugal atomizer, the pressure-type atomizer cannot guarantee the cleanliness requirements, and so far it has not been put into operation normally.

Crystalline bulk drugs commonly used double cone rotary vacuum dryer. Its characteristics are low drying temperature, faster drying speed, and good material uniformity. Special attention should be paid to the clearance between the exhaust outlet pipe and the rotating shaft on one side should also meet the requirements for in-situ cleaning and in-situ sterilization; the compressed air for recompression should also be clean filtered. If the volatiles are organic solvents, they should be trapped using a cryogenic condenser.

Boiling drying is also a method of drying solid particles. For drug drying, hot air is also required to filter after heating, and to meet the cleanliness requirements. Spraying clean liquid medicine or related material liquid while boiling dry can complete the granulation of the medicine and prepare it for tableting.

In addition to the clean air used for boiling and drying, the air temperature and air volume requirements can be precisely adjusted to ensure the dryness and normal boiling of the drug, as well as the sterilization of the boiling drying system prior to feeding. Boiling dryers also require in-situ cleaning and in-situ sterilization.

GMP has stringent requirements for hardware and software. In order to ensure that the quality of the raw material produced is not affected by the processing process, the drying process must strictly enforce the requirements and regulate the development of the industry.

前

お問い合わせ

Author:

Ms. Yi

Phone/WhatsApp:

+8618888297294