1. raw materials
(1) before the use of the raw materials, the name, specification and quantity should be checked and screened and screened, such as liquid should be filtered to remove foreign objects.
(2) after the treatment of raw materials should be labelled in the container inside and outside. Write the name, specification and weight, and make a good record. The remaining raw and excipient materials should be returned to the middle station immediately.
(3) the equipment for dust catching or dust absorption shall be due to the screening or crushing equipment.
2. mixing and granulating
(1) from the former process to fine powder, paste (grab paste) through the intermediate station or full-time quality inspection personnel inspection and inspection certificate of.
(2) before the proportioning, the name, quantity, specification, batch number and production plant of the raw materials should be checked first, which should be in conformity with the laboratory tests in order to prevent the misplacement. The calculation of the ingredients, the rechecking of the material, the operator and the reviewer should be signed on the record.
(3) when granulating, the powder must be mixed evenly, and gradually add the thickening paste or adhesive. When a batch number is divided several times, the size of the particle is consistent.
(4) for the technical conditions of adhesives such as temperature, concentration and quantity, we must make necessary technical parameters according to the varieties and characteristics, strictly control operation, and use pure water when water granulation.
(5) weighing apparatus used for weighing should be corrected before use and check regularly.
(6) the containers used should be clean and free of foreign objects.
3. particle drying
(1) to make and control the thickness and quantity of wet particles in the dry tray according to the variety and to keep the material in the drying process and record it.
(2) strictly control and record the temperature of the drying room regularly, and open the circulation ventilator at regular intervals, so as to prevent particles from melting, scorching, spoilage and controlling the moisture content of particles within the prescribed limits.
(3) the uniformity of the oven temperature should be checked regularly.
(4) when the fluidized bed is used to dry, the air used to be used is to purify the dust and draw up the relevant technical parameters.
(5) the dry particles should be put in a clean container and turn in a cool container.
4. Granulating and mixing
(1) the whole machine is provided with a permanent magnet should fall in the hopper, suction accidentally enter the particles of iron.
(2) aromatic materials are added into the whole grain process according to the prescribed amount, so that they can be mixed evenly. After mixing the aromatic particles, they should be stored in containers for more than 4 hours, so that they are easy to penetrate evenly.
(3) the mixed particles are packed in a clean container, and both inside and outside the container shall be attached with labels indicating the name, number, number, number, date, and number of the goods. Send the middle station in time.
(4) special toxic varieties, should be produced in the closed chamber, operators should be isolated operation, indoor air suction device should be installed, the dust to be excluded should be centralized treatment.
(1) the temperature of the pressing operating room is 18~28 degrees C, the relative temperature is 50% ~ 65%, and the relative negative pressure is maintained with the outer chamber. The dust suction hood to exclude.
(2) the stamping section should be set up in the die room, which is responsible for checking, testing, maintaining, keeping and distributing the die. The finish of the die should be examined before and after the use of the die. There are no grooves, winding edges, lack of angle, burst and wear. In order to prevent the difference of weight, the length of the punch must be controlled.
(3) press the press before pressing and check the weight, hardness, disintegration and appearance of the tablet. After the test is qualified, it can start the car. After driving, the average slice weight should be sampled regularly (once every 15~30 minutes, and record). The tablets in the test should be reprocessed.
(4) the semi finished products should be kept in a clean and dry container, kept in a closed manner to prevent tablets from moisture absorption, caking or loosening. Labels should be included inside and outside the container, including product name, batch number, specification, weight and operation time and work number, and then sent to transfer station.