Key points for the production and management of tablets

Key points for the production and management of tablets

The original auxiliary materials, stamping dies, packaging materials and semi finished products during the production process in the process of production, turnover containers and appliances should be divided into special middle stations for management.

Key points for the production and management of tablets

Pretreatment of raw materials

(1) raw materials need to be checked for names, specifications and quantities before they are used. They should be checked and sieved.

(2) the processed raw materials should be labeled inside and outside the container. 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) screening or crushing equipment should have dust traps or dust traps. .

Key points for the production and management of tablets two

Burdening and granulating

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

(2) check the name, quantity, specification, batch number and production plant of raw materials before making batching. The calculation of ingredients, the review of materials, the operator and the reviewer should be signed on 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 of the temperature, concentration and quantity of the adhesive, the necessary technical parameters must be made according to the variety and characteristic, the operation is strictly controlled, and the pure water should be used when the water is pelletizing.

(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 tablets three

Particle drying

(1) formulate and control the thickness and quantity of wet granules according to 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 tablets four

Whole grain and mixing

(1) a permanent magnet should be installed in the hopper of the pellet machine to remove the iron dust from accident.

(2) the aromatic material is gradually added in the whole grain process according to the prescribed amount, so that the mixture is even. After adding the particles of the aromatic material, it should be kept in the container for more than 4 hours, so that it is easy to penetrate even.

(3) mixed particles should be placed in a clean container. Labels should be attached inside and outside the container, indicating the name, batch number, quantity, number, date and work number. Send the middle station in time.

(4) 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 tablets five

Compression plate

(1) the tabletting chamber temperature is 18~28 degrees, the relative temperature is 50% to 65%, and maintains negative pressure relative to the external chamber. Dust is excluded from the dust cover.

(2) the stamping chamber should be equipped with a die room, which is responsible for checking, testing, maintaining, maintaining and distributing the stamping dies. Before and after using the die, check the smoothness, groove, edge, corner, bursting and abrasion. In order to prevent chip weight difference, punch length must be controlled. .

(3) test the pressure before the tablet, and check the weight, hardness, disintegration and appearance of the tablet. The test pressure is qualified behind, and the average weight of the tablet should be checked regularly (once every 15~30 minutes and recorded), and the tablets in the test pressure should be reworked.

(4) the pressed semi-finished products are placed in a clean and dry container, closed and preserved, to prevent the tablets from absorbing damp or loose pieces or loose pieces. There should be labels inside and outside the container. The product name, batch number, specification, weight, time and number of operation and working number are written, and then transferred to the transfer station.

Key points for the production and management of tablets six

Coating

(1) the temperature of the coating operating room is 18~28 degrees, the relative humidity is 50% to 65%, and the external chamber is kept at a relatively negative pressure. The dust is removed by the dust hood.

(2) the coating room and preparation room with organic solvents must meet the requirements of fire protection and explosion protection and have strict safety operation system.

Degree.

(3) syrup must be made of pure water and boiled to remove impurities.

(4) glue and food colouring must be dissolved and filtered in pure water, and then added in syrup.

(5) the coating operation should be carried out in strict accordance with the coating process.

(6) before coating, the tablets should be sifted to remove fine powder and debris. The coating pot should be clean without foreign bodies and pigmentation.

(7) the bag made of sugar coated tablet is dry, loaded into the clean and dry container, and there is a label, indicating the name and specification of the coated product, the operating person and the operating time of the coating, and send it to the middle station at the prescribed time.

Key points for the production and management of tablets seven

Packing

(1) preprocessing of packaging materials:

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

(2) wash the glass bottles with water, sterilize them at high temperature, store in clean places, and store time for no more than three days.

(3) plastic bottles should be tightly packed and clean inside.

(1) the indoor temperature of the packing room is 18~28 "C and the relative humidity is 50% to 65%. The upper part of the rotary distributor and the aluminum plastic packaging machine should have a dust hood to remove the dust.

(II) several pieces of equipment should be specially checked, cleaned, stored and distributed.

3. The name, specification and batch number of the packaging label must be checked and proofread. After the end of the packaging, the number of the labels, the number of useful and the remaining number should be accurately counted, and the remaining labels and scrap labels should be treated according to the label management method.

Key points for the production and management of tablets

The original auxiliary materials, stamping dies, packaging materials and semi finished products during the production process in the process of production, turnover containers and appliances should be divided into special middle stations for management.

Key points for the production and management of tablets

Pretreatment of raw materials

(1) raw materials need to be checked for names, specifications and quantities before they are used. They should be checked and sieved.

(2) the processed raw materials should be labeled inside and outside the container.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) screening or crushing equipment should have dust traps or dust traps. .

Key points for the production and management of tablets two

Burdening and granulating

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

(2) check the name, quantity, specification, batch number and production plant of raw materials before making batching. The calculation of ingredients, the review of materials, the operator and the reviewer should be signed on 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 of the temperature, concentration and quantity of the adhesive, the necessary technical parameters must be made according to the variety and characteristic, the operation is strictly controlled, and the pure water should be used when the water is pelletizing.

(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 tablets three

Particle drying

(1) formulate and control the thickness and quantity of wet granules according to 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 tablets four

Whole grain and mixing

(1) a permanent magnet should be installed in the hopper of the pellet machine to remove the iron dust from accident.

(2) the aromatic material is gradually added in the whole grain process according to the prescribed amount, so that the mixture is even. After adding the particles of the aromatic material, it should be kept in the container for more than 4 hours, so that it is easy to penetrate even.

(3) mixed particles should be placed in a clean container. Labels should be attached inside and outside the container, indicating the name, batch number, quantity, number, date and work number. Send the middle station in time.

(4) 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 tablets five

Compression plate

(1) the tabletting chamber temperature is 18~28 degrees, the relative temperature is 50% to 65%, and maintains negative pressure relative to the external chamber.Dust is excluded from the dust cover.

(2) the stamping chamber should be equipped with a die room, which is responsible for checking, testing, maintaining, maintaining and distributing the stamping dies. Before and after using the die, check the smoothness, groove, edge, corner, bursting and abrasion. In order to prevent chip weight difference, punch length must be controlled. .

(3) test the pressure before the tablet, and check the weight, hardness, disintegration and appearance of the tablet. The test pressure is qualified behind, and the average weight of the tablet should be checked regularly (once every 15~30 minutes and recorded), and the tablets in the test pressure should be reworked.

(4) the pressed semi-finished products are placed in a clean and dry container, closed and preserved, to prevent the tablets from absorbing damp or loose pieces or loose pieces. There should be labels inside and outside the container. The product name, batch number, specification, weight, time and number of operation and working number are written, and then transferred to the transfer station.

Key points for the production and management of tablets six

Coating

(1) the temperature of the coating operating room is 18~28 degrees, the relative humidity is 50% to 65%, and the external chamber is kept at a relatively negative pressure. The dust is removed by the dust hood.

(2) the coating room and preparation room with organic solvents must meet the requirements of fire protection and explosion protection and have strict safety operation system.

Degree.

(3) syrup must be made of pure water and boiled to remove impurities.

(4) glue and food colouring must be dissolved and filtered in pure water, and then added in syrup.

(5) the coating operation should be carried out in strict accordance with the coating process.

(6) before coating, the tablets should be sifted to remove fine powder and debris. The coating pot should be clean without foreign bodies and pigmentation.

(7) the bag made of sugar coated tablet is dry, loaded into the clean and dry container, and there is a label, indicating the name and specification of the coated product, the operating person and the operating time of the coating, and send it to the middle station at the prescribed time.

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