Operation process
Preparation before production
(1) Operators must put on work clothes, shoes and hats according to the requirements of the Standard Operating Procedures for Personnel Entering and Leaving the General Production Area before entering the operation room.
(2) Check whether the operation room has been cleaned and cleared according to the prescribed cleaning and clearing procedures and whether there is a cleaning and clearing certificate, and it is within the validity period.
(3) Check whether the containers, facilities, etc. have been cleaned and qualified, and whether there is a certificate of conformity, and prepare the required status identification plates to indicate the status of equipment and materials.
(4) Check whether the equipment has green “equipment intact” and “cleaned” status signs.
Production operation
(1) Check whether the equipment is running normally, and start the equipment according to the “Standard Operating Procedures for Hot Air Circulation Oven”.
(2) First discharge the condensate in the steam pipe, and set the drying temperature on the operation panel according to the process requirements.
temperature. Open the total power switch, press the circulating fan power switch, and test run, no abnormal situation and abnormal sound, hang the “running” sign.
(3) Put the material into the drying tray of the oven, put the material in the forest flat, and the thickness of the material should be not more than 20mm. The drying process can be adjusted according to the process drying temperature.
(4) After the operation is completed, close the fan, and natural steam, and close the total power switch after the material is taken out.
(5) After drying, weigh the materials and transfer them to the next process, and fill in the operation records according to the requirements of the “Record Filling Regulations” in time.
Clean and clear the field
(1) After the operation is over, according to the “Clearance Management Procedures” and “Hot air circulation oven cleaning procedures” clear and clean the field, and hang up the state identification plate.
(2) Sort out the waste of this post and deal with it according to the “Waste Disposal Management Regulations”.
(3) After the cleaning, fill out the “cleaning records, after the QA inspection qualified, issued the cleaning certificate, the production records, cleaning records, and cleaning certificate collation summary to the workshop management, and close the water and electricity switch, doors and windows before leaving.
Caution
(1) Pay attention to the drying time, steam pressure and drying temperature when drying.
(2) Check whether the material is dried to meet the process requirements.
(3) The dried materials should be bagged and tied up in time to prevent the materials from rewetting.
(4) The processed herbs shall not be dried in the open air.
Quality control focus
Temperature control at 60℃-80℃ is appropriate, and water content control at 3%-5% is appropriate.
Job Duties
(1) To carry out the production according to the work plan arranged by the shift leader of pre-treatment section 1 and ensure that the production is carried out under GMP conditions and prevent all possible errors, drug mixing and cross contamination during the production process.
(2) Strictly follow the SOP of drying post in production, when an abnormal situation occurs in production that cannot be carried out according to GMP requirements, stop production immediately and inform the section shift manager to request for handling.
(3) Keep the environment and personal hygiene of this post in production, strictly implement the general production area dressing system and ensure the implementation of a civilized hygiene system.
(4) The use of ovens in the production process should be effective, loving and safe, and the SOP for safe production should be strictly implemented in production.
(5) Obey the management of QA, ensure the quality of products, and carefully implement all quality management procedures and process procedures.
(6) After the end of production, clear the field according to the SOP of drying post-clearing.
