Cleanroom tablet production process control
Cleanroom tablet production process control
Clean room tablet production packaging, first check the product name, manufacturer, batch number and quantity of the materials used, wipe the surface of the outer packaging of the materials with a cleaning cloth, and then remove the outer packaging, the materials that cannot be removed from the outer packaging Wipe the outer packaging of the material with 75% ethanol, and pass it into the equipment through the airlock...
Text label: clean room design and installation, clean room engineering, clean room tablet workshop
Clean Tablet Production Process Control
Clean room tablet production packaging, first check the product name, manufacturer, batch number and quantity of the materials used, wipe the surface of the outer packaging of the materials with a cleaning cloth, and then remove the outer packaging, the materials that cannot be removed from the outer packaging Wipe the outer packaging of the material with 75% ethanol, and pass it into the preparation room through the air lock; the crystalline raw and auxiliary materials need to be crushed and sieved, especially the materials that are insoluble in water. The fineness of special raw materials should be smaller; the crushing area is a Class D clean area, and a large amount of dust will be generated during the crushing process. Use a universal pulverizer with a dust removal system, which can capture the dust leaking from the powder collection bag during the pulverization process by a dust catcher.
The batching and feeding of preparations are the key production processes. It is necessary to ensure the accuracy of the prepared materials. Not only should the weighing of the materials be supervised, but also which container the materials are taken from and which new container they are transferred to should be determined by the first Two people review to confirm whether the weight is correct, whether the original container has a proper label, whether the new container is affixed with a proper label, etc. In order to reduce errors and check, the containers used should be marked with a barrel number. Wet granulation is the most widely used granulation method in tablet preparation, mainly using extrusion sieving granulation, high-speed stirring granulation and fluidized bed granulation. The mixing time of each variety of raw materials and auxiliary materials, as well as the granulation, stirring and chopping time should be determined through process verification. Taking high-speed stirring and granulation as an example, in the verification of granulation process parameters, the uniformity of mixing is detected by each mixing time period. The mixing time is determined, and the stirring and chopping time is determined by the mass of particles formed in each stirring and chopping time period. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for clean rooms and clean workshops.
Clean room In addition to fluidized bed granulation, the preparation and drying of granules can be completed in the same container in sequence, the wet granules prepared by the sieving method and the high-speed stirring method need to be dried by suitable methods such as blast drying Drying in a box or a circulating drying bed; when the wet granules are dried in the fluidized bed, the inlet air temperature, granulation temperature and drying time of the drying equipment should be set; the moisture content of the dry granules should be controlled within the specified range; Use the sieving method to remove large particles of dry granules, or use a rotary or swinging granulator for granulation to ensure uniform particles; send the granulated granules to the mixing room, fill in the operation records, and calculate the yield; clear the site and clean it equipment. Before the granules are mixed, the auxiliary materials that need to be added are weighed according to the process instructions, and poured into the mixer together with the granules and mixed according to the specified time. Sieve preliminary mixing.
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