Special intermediate stations should be set up for the management of raw and auxiliary materials, blanking dies, packaging materials and semi-finished products, revolving containers and tools from the previous process.
Key points of tablet production management 1
Pretreatment of raw materials
(1) the name, specification and quantity of the raw and auxiliary materials shall be checked before use, and the products shall be inspected and screened. In case of liquid, the foreign substances shall be filtered and removed.
(2) the raw and auxiliary materials after treatment shall be labeled inside and outside the container. State the name, specification and weight of the product and make a record. The remaining raw and auxiliary materials should be returned to the intermediate station immediately.
(3) the screening or crushing equipment shall have a dust catcher or dust suction device. .
Tablet production management key points two
Ingredients and granulation
(1) the fine powder and thick paste (paste) transferred from the previous process shall be inspected by the intermediate station or full-time quality inspectors, and the inspection certificate shall be attached.
(2) the name, quantity, specification, batch number and production factory of the original auxiliary materials should be checked before the ingredients are prepared, which should be consistent with the inspection certificate to prevent wrong investment. Ingredient calculation, feeding review, operator and reviewer should sign the record.
(3) when granulating, the powder must be mixed evenly, and gradually add thickening paste or adhesive. When granulation is divided into several times by batch number, the particle size and looseness should be consistent.
(4) for the temperature, concentration, quantity and other technical conditions of the adhesive, the necessary technical parameters must be formulated according to the variety and characteristics, and the operation shall be strictly controlled.
(5) the weighing apparatus used for weighing shall be calibrated and periodically calibrated before use.
(6) the container used shall be clean and free of foreign matter.
Tablet production management key points three
(1) determine and control the thickness and quantity of wet particles in the drying dish according to the variety. During the drying process, materials should be frequently turned over and recorded.
(2) strictly control and record the temperature of the oven, turn on the circulating ventilation device regularly to prevent the particles from melting, melting, coking and deterioration, and control the water content within the specified range.
(3) the uniformity of oven temperature should be checked regularly.
(4) when using the fluidized bed to dry, the air used should be purified and dedusted, and relevant technical parameters should be worked out. During the operation, it should constantly check whether there is any material condensation.
(5) the dry particles should be cool and put into a clean container for downward rotation.
Tablet production management key points four
Whole grain and mixture
(1) permanent magnet shall be installed in the hopper of the whole machine to absorb iron particles that accidentally enter the particles.
(2) the aromaticity materials in accordance with the provisions, after calculating the dosage gradually add in the granulation process, so that the mixing, mixed with aromaticity material particles, should be sealed in a container to store more than 4 hours, to facilitate penetration uniform.
(3) the mixed particles shall be stored in a clean container, and the inside and outside of the container shall be labeled with the name of the product, batch number, quantity, number of pieces, date and work number. Get to the intermediate station in time.
(4) special toxic varieties shall be produced in a closed room, and the operators shall operate in isolation. The indoor dust collection device shall be installed, and the dust removed shall be treated centrally.
Tablet production management key points 5
(1) tablet operation room temperature 18 ~ 28 ℃, relative humidity 50% ~ 65%, relatively negative pressure with outside the room. Dust is removed by a dust cap.
(2) the stamping die room shall be set up in the stamping section, and special persons shall be responsible for the checking, testing, maintenance, custody and distribution of the stamping die. Before and after the use of stamping die should be first checked the smoothness, there is no groove, edge, missing Angle, blasting and wear. The length of punch must be controlled to prevent weight difference. .
(3) before the tablet should be pressure test, and check the tablet weight, hardness, disintegration degree and appearance, and pressure testing of qualified rear can drive a car, drive should be regular sampling inspection after the average piece of heavy (once every 15 ~ 30 minutes and records), pressure testing of pills, should handle rework.
(4) the suppression of good semi-finished products on clean and dry container, sealed preservation, prevent tablets damp agglomerate or loose, the container should be both inside and outside label, and specify the product name, batch number, specification, weight, and the operation time and working status, and then send.
Key points of tablet production management
(1) the coating operation room temperature 18 ~ 28 ℃, relative humidity 50% ~ 65%, relatively negative pressure with outer chamber, dust by dust hood.
(2) the coating room and preparation room using organic solvent must meet the requirements of fire prevention and explosion protection, and have strict safety operation system
(3) the syrup must be prepared and boiled in pure water to remove impurities.
(4) the glue and food coloring shall be dissolved and filtered in pure water, and then added into the syrup to stir well and set aside.
(5) the dressing operation shall be carried out strictly in accordance with the coating technology.
(6) before dressing, the tablet should be screened to remove fine powder and debris, and the coating pan should be clean without foreign matter and pigment deposition.
(7) package system is good after it dry, in clean, dry container inner, outer label, indicating the name of coating products, specifications and coating operation and operation time, according to the rules of time after drying to standing in the middle.
Tablet production management key points seven
(I) pretreatment of packaging materials:
(1) the internal packaging materials that directly contact with the drugs shall be cleaned and sterilized in an appropriate way, and kept dry and sealed after sterilization.
(2) the glass bottle shall be cleaned with water, sterilized and dried at high temperature, and stored in the cleaning place. The storage time shall not exceed three days.
(3) the outer packaging of plastic bottles should be strict and the inside clean.
The temperature in the interior of the packing room is 18 to 28"C, and the relative humidity is 50 to 65 percent. The rotary separator and the aluminum packaging machine should have dust absorbers to eliminate dust.
A number of cartoon devices shall be inspected, cleaned, stored and distributed by special persons.
Test and verify the name, specification, batch number of the packaging label. After the end of packaging, the number of label requisition, utility number and remaining number should be accurately counted. The remaining labels and scrap labels should be handled according to the label management method.
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