Dust-free purification workshop program for pharmaceutical factories
1. Workshop design requirements 1The layout of the workshop should be reasonable, in line with GMP requirements, and avoid cross-contamination.
2.Reasonable cleaning areas and polluted areas should be set up in the workshop, and obvious signs should be set up.
3.Dust-proof, moisture-proof, anti-static and other facilities should be installed in the workshop to ensure product quality and production safety.
4.A reasonable ventilation and lighting system should be set up in the workshop to ensure adequate air circulation and lighting.
2. Air purification system 1The air purification system should meet the requirements of GMP to ensure that the air quality in the workshop meets the regulations.
2.The air purification system should include air filtration, filtration, ultraviolet disinfection, etc., to ensure air cleanliness and microbial control.
3.The air purification system should be regularly maintained and serviced to ensure its normal operation and service life.
3. Cleaning and disinfection procedures 1Detailed cleaning and disinfection procedures should be developed in the workshop, including cleaning areas, cleaning tools, detergents, disinfectants, etc.
2.Cleaning and disinfection procedures should be carried out regularly to ensure environmental hygiene and product quality in the workshop.
3.Cleaning and disinfection procedures should be documented for traceability and management.
Fourth, personnel and material management 1Personnel should wear protective equipment that meets the regulations, follow the operating procedures, and avoid cross-contamination.
2.Materials should be stored separately and clearly marked to avoid confusion and contamination.
3.Personnel and materials should enter and exit the workshop in accordance with the prescribed procedures, and strict disinfection and cleaning procedures should be carried out.
5. Air monitoring and recording1An air quality monitoring system should be set up in the workshop to monitor and record the air quality regularly.
Describe Winter 2 in one pictureAir quality monitoring data should be analyzed and evaluated, and timely measures should be taken to improve it.
3.Air quality monitoring data should be kept in good condition for traceability and management.
6. Equipment maintenance and maintenance1The equipment should be regularly maintained and maintained to ensure its normal operation and service life.
2.Equipment maintenance and upkeep records should be kept in good condition for traceability and management.
3.When the equipment fails, it should be repaired and replaced in time to ensure production safety and stable quality.
7. Safety and emergency measures 1Safety warning signs and emergency equipment should be set up in the workshop to ensure the safety awareness of employees.
2.Safety training and education should be provided to employees to improve their safety awareness and response capabilities.
3.Emergency plans should be developed and drilled to ensure that effective measures can be taken quickly in the event of an emergency.
8. Training and operation specifications 1Train and educate new employees and employees in key positions to improve their skill level and awareness of operating norms.
2.Detailed operating specifications and flow charts should be developed to ensure that employees are able to operate equipment and instruments correctly.
3.Employees should be regularly trained and assessed to ensure that they have the necessary skills and knowledge.