The main points of the production and management of the granules

The main points of the production and management of the granules

Key points for the production and management of the granules one

Pretreatment of raw materials

(1) before the use of raw materials, the names, specifications and quantities should be checked and screened.

(2) after processing, the raw and auxiliary materials should be marked with labels inside and outside the container, indicating the name, specifications and weight, and making good records. The remaining raw and excipient materials should be returned to the middle station immediately.

Key points for the production and management of the granules two

Burdening and granulating

(1) fine powder and thick paste (extract) transferred from the preceding process shall be inspected through the intermediate station or full-time quality inspector, and the inspection certificate shall be attached.

(2) check the name, quantity, specification, batch number and production plant of raw materials before making batching. Ingredient calculation, weighing and feeding should be reviewed. Operators and reviewer should sign the record.

(3) when granulation is made, powder must be mixed evenly, then gradually add thick paste or adhesive. When a batch number is granulated several times, the particle size and elasticity should be consistent.

(4) for the technical conditions such as temperature, concentration and quantity of adhesives, the necessary technical parameters must be worked out according to the varieties and characteristics, and the operation must be strictly controlled. Pure water should be used when granulating water.

(5) weighing instruments should be calibrated before use and calibrated regularly.

(6) the containers used should be clean and free of foreign objects.

Key points for the production and management of the granules three

Particle drying

(1) control the thickness and quantity of wet granules in the drying tray according to the regulations of the varieties.

(2) strictly control and record the temperature of the drying room regularly, open the circulating ventilation device regularly, prevent the particles from melting and deteriorating, and control the moisture of the particles within the specified range.

(3) the uniformity of the oven temperature should be checked regularly.

(4) when the fluidized bed drying is used, the air used should be purified and dusting, and the corresponding technical parameters should be worked out.

(5) after drying, the particles should be cool down and put down in a clean container.

Key points for the production and management of the granules four

Whole grain and mixing

(1) sift out unqualified particles and powder.

(2) a permanent magnet should be installed in the hopper of the whole grain machine to remove the iron scrap from the sticky accident.

(3) the aromatic material is gradually added in the whole grain process according to the prescribed amount, so that the mixing is uniform. After adding the particles of the aromatic material, it should be kept in the container for more than four hours, so that it is easy to penetrate even.

(4) the prepared particles are packed in a clean container, with labels attached inside and outside the container, indicating the name, number, number, number, date, number, and timely delivery of the intermediate station.

(5) special toxic species should be produced in closed rooms. Operators should be isolated and operated. Indoor dust storage devices should be installed. Dust excluded should be centralized.

Key points for the production and management of the granules five

Sorting

(1) the name, specification, batch number and quantity of the semi finished products should be matched before the sub shipment.

(2) personnel should be responsible for the commissioning, maintenance and storage of the loading equipment and tools.

(3) the machine should be installed before loading, check the sealing situation and the difference of loading, the test installed after the qualified can open the machine, the process should be regularly sampled to check the volume difference and seal, and adjust the machinery or tools in time. Trial loading of unqualified semi-finished products should be done in a timely manner.

(4) weighing instruments used for weighing and testing should be corrected before use and checked regularly.

(5) the semi finished product is loaded into a clean and dry container. The container should be labelled inside and outside the container, indicating the name, batch number, specification, quantity, number, date, and number, and then turn to the process or intermediate station.

Key points for the production and management of the granules six

Packing

(1) the internal packaging materials for direct contact with drugs should be properly sterilized, sterilized and sealed after drying.

(2) the indoor temperature of the packing room is 18~28 degrees, and the relative humidity is 50% to 60%.

Dust removal.

(3) the names, specifications and batch numbers of bags and labels must be checked and proofread. After packaging, the number of packages and labels, number of practical items and remainder should be accurately counted. The remaining and scrap packaging bags and labels shall be treated according to the label management method.