Drug Gmp Cleanroom

The management system of the drug-free workshop is gradually formed afterthe establishment of the workshop. (Jilida purification has a complete purification workshop management pdf file,Website:, which can be obtained from our construction personnel), and the workshop decoration process must also conform to the workshop management. The needs of the process, the operation of the JLD purification equipment and the purification system are also one of the most important projects in the clean room of the drug.1. The management system of the drug purification project is managed by the factory manager. The QS person in charge is responsible for the quality. The workshop supervisor arranges the personnel to carry out the necessary sanitation cleaning work and the machine equipment cleaning record table every day.2. according to the requirements of air cleanliness (national standard) level to do clean engineering, and specify the production of pharmaceutical processes and processes to ensure that the contaminated area has buffer, negative pressure area to prevent pollution, such as some toxic process, employees wear protective gloves, protective mask Etc., installation cleaning procedures, including: cleaning personnel, cleaning methods, cleaning sequence, organized 15 minutes before work every day, cleaning or disinfection, cleaning tools after storage location.Drug clean roomtypePurificationlevel requirementGMP requirementsAir pressurerequirementParticularitySolid medicinecleanroom100-100000classGMP compliant5-45PaSeparation ofpeople flowLiquid medicinecleanroom10-100000classGMP compliant5-30PaOzonesterilizationPowder medicinecleanroom100-100000classGMP compliant15-30PaExplosion proof3. Clean equipment also needs to be cleaned regularly in the clean room of the drug, including: cleaning at the bottom of the air shower, cleaning of the cargo, ozone sterilization of the central air conditioning duct, and sterilization of the transmission window.4. According to the requirements of production and air cleanliness level, the container cleaning procedure of the drug workshop should be established. The surface of the container should not have water and dust. The content includes: cleaning method (can be managed by 5s), interval (clean once a week), used 84 disinfectant, cleaning method and storage location of cleaning tools.5. The dust-free workshop of the pharmaceutical factory cannot store non-productive items including personal items of employees, such as mobile s. When the production is completed within one time, the raw material waste and the produced garbage need to be treated in a timely and harmless manner.6. The dust-free workshop production area is regularly disinfected. It can be disinfected with ultraviolet rays every day at noon. It can use medical disinfectant. The machine part can use 84 disinfectant. When personnel enter, it needs to be disinfected and washed. Disinfectants must be non-contaminating to equipment, materials and products.7. The air quality of the clean room of the pharmaceutical factory needs regular monitoring. The results of the air test need to be recorded and archived. The cleanliness can be checked free of charge by Jie Lida. You can contact the website at , we will arrange professional engineers within 48 hours. Go to the door for cleanliness testing (do not pay for the return fee).8. The selection of work clothes in the clean room should be consistent with the production operation and air cleanliness 14401-1 grade requirements, and should not be mixed. The materials of the clean overalls should be wear-resistant and smooth, anti-static, breathable and mildewproof, do not fall off fibers and particles, and be cleaned regularly. Moreover, the GMP-required drug-free workshop clothes and general production area uniforms are separately cleaned, dried, and finished. (Pure water equipment is required, must be laid with 304 stainless steel pipes, rust-proof, anti-bacterial) Disinfect or sterilize if necessary (Ozone anti-virus must be done once every other time). Clean cleansing work clothes must have a specified service life.9. The production area in the drug workshop can only allow employees in the area and the allowed employees to enter. GMP requires sub-regional control and dispatches personnel to supervise. Personnel entering the clean room shall enter according to the procedure. (Air shower is an essential step). If the cleaning process is not carried out according to the regulations, fines or penalties shall be imposed. Cosmetics and accessories shall not be worn. Mobile cameras are prohibited from direct contact with semi-finished products without gloves. Finished product.10. drug clean room production staff need to establish a health file, every year from February to February can go to the hospital for inspection, the production of semi-finished products in the workshop, the finished product staff at least once every six months, the cost of about 200-1200 everyone, group companies can have A little discount. If there are infectious diseases, skin diseases and employees with wounds on the body surface, activities or production of direct contact with pharmaceutical products should be prohibited.11. The dust-free workshop central air-conditioning and air cabinet needs to adjust the pressure difference every year. The humidity-demanding area also needs to adjust the humidity to ensure the pressure difference between the rooms to ensure no cross-contamination. The air filter also needs to be replaced once a year. Times.

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