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Purpose
Establish a management system for preventing pollution in clean areas without sitting rooms.
Scope of application
Clean production areas without sitting rooms.
Responsible persons
Clean area staff and management personnel.
(Figure 1: Clean room clean area)
Text
1. Strictly abide by the "Factory Environmental Sanitation and Greening Management System".
2. Strictly abide by the "Management System for Preventing Insects and Other Animals from Entering the Factory (Warehouse)".
3. Strictly abide by the "General Production Area Sanitation Management System" and the "Clean Area Sanitation Management System".
4. Cleaning tools in the clean area can only use sponge mops, sponge blocks, hard nylon brushes, and plastic buckets; the tables and chairs should be made of materials that are free of shedding, easy to clean, and rust-free.
5. Personnel and materials entering the clean area shall be implemented in accordance with the "Standard Operating Procedures for Personnel Entering and Exiting the Clean Area" and the "Standard Operating Procedures for Materials Entering and Exiting the Clean Area". Only production operators in the clean area and personnel approved by the workshop director are allowed to enter: temporary outsiders must be guided and supervised.
6. Doors, windows, various pipes, lamps, vents, and the junction between walls and the ground should be kept clean and free of floating dust.
7. The floor drain should be clean, disinfected regularly, and the upper cover should be tightly closed.
8. The inside and outside of the wash basin and tool washing pool should be kept clean and free of floating dust.
9. The two doors of the transfer window and buffer room cannot be opened at the same time. When not working, pay attention to closing.
10. When operating in the clean area, the movements should be steady, light, and few; do not make movements unrelated to the operation and unnecessary conversations.
11. All materials in the clean area should be placed according to the technical requirements.
12. The waste from the production process should be put into plastic bags in time. The plastic bags should be sealed in time and discarded with the garbage after one-time use.
13. The clean room shall not arrange three-shift production, and sufficient time should be left every day for cleaning and disinfection.
(Figure 2: Clean room personnel management)
14. Clean the primary and medium-efficiency air filters regularly and replace the high-efficiency Air Filters. The primary filter should be cleaned once a month, and the medium-efficiency air filter should be cleaned once a quarter. For high-efficiency air filters, when the air volume drops to 70% of the original Air volume or there is an irreparable leakage, it must be replaced. Generally, it is replaced every two years.
15. Regularly monitor the environment of the clean room, find problems, and take corresponding measures in time until the clean level requirements are met.
16. After each sampling in the weighing and sampling room, the inner wall of the sampling room should be fully cleaned.
17. The work clothes and clothing of clean room personnel should be implemented in accordance with the "Management System for the Selection and Dressing of Work Clothes".
18. The dressing room is cleaned by a dedicated person in accordance with the "Dressing Room Hygiene Management System".
Clean room clean area hygiene management system
1. Purpose
Establish A Clean Room clean area hygiene management system to prevent drug contamination and cross contamination.
2. Scope of application
Sanitary management of clean areas without sitting rooms.
3. Responsible person
Operators in the clean area.
4. Text
1. Doors, windows, pipes, lamps, vents and public facilities, the junction between walls and the ground, etc. should be kept clean and free of floating dust.
2. After the floor drain is clean and disinfected, cover it tightly.
3. Facilities such as wash basins and tool washing pools should be kept clean inside and outside, free of floating dust, dirt spots and water marks.
4. When the transfer window is not working, close the double doors, and at least close one door when working.
5. Limit the number of people entering the clean area. The personnel entering the clean room are limited to the production operators, managers and personnel approved by the workshop director in the area.
6. When operating in the clean room, the movements should be steady, light and few, and no movements unrelated to the operation and unnecessary conversations should be made.
7. There are no unnecessary items unrelated to production in the clean room.
8. Cleaning tools should be cleaned in time and placed in the specified position of the sanitary ware room in the clean area. They cannot be mixed and used with cleaning tools in non-clean areas, and disinfectants should be used alternately regularly.
9. Documents, stationery, etc. must be cleaned before entering the clean room.
10. Three-shift production shall not be arranged in the clean room. Sufficient time should be left every day for cleaning and disinfection. When changing varieties, sufficient time should be ensured for intervals for cleaning and disinfection.
11. Regularly monitor the environment of the clean room.
12. The workshop quality control personnel shall inspect the cleanliness of the clean area every day and record it in the "Clean Area Cleanliness inspection Record".
(Figure 3: Clean room hygiene management system)
Frequently asked questions
What is a clean room pollution prevention and hygiene management system?
Users want to understand what constitutes a clean room management system focused on pollution prevention, including the key components such as air filtration, surface cleaning, and contamination control.
What are the main sources of contamination in a clean room?
People are interested in learning about common contaminants in clean rooms, such as airborne particles, microorganisms, static, and chemical contaminants, and how to control them.
How do you prevent contamination in a clean room?
This question focuses on the best practices for preventing contamination in a clean room, including air filtration, gowning procedures, proper cleaning protocols, and personnel behavior.
What are the hygiene management protocols for clean rooms?
Users want to know the hygiene protocols required for clean room maintenance, such as personal hygiene, hand washing, gowning requirements, and the use of sanitizing agents.
What type of cleaning procedures should be followed in a clean room?
This question involves details on cleaning techniques, the use of disinfectants, frequency of cleaning, and what tools and materials are safe for use in clean rooms.
How often should Clean Room surfaces be cleaned and disinfected?
People are interested in the recommended frequency of cleaning and disinfecting surfaces in clean rooms to maintain the desired cleanliness levels.
What is the role of air filtration in a clean room hygiene management system?
Users want to understand how air filtration systems, including HEPA (High-Efficiency Particulate Air) filters, help reduce airborne contamination and maintain the cleanliness of the air in clean rooms.
How do gowning and personal protective equipment (PPE) help in pollution prevention?
This question focuses on the importance of gowning protocols and PPE (such as gloves, masks, and coveralls) to prevent the introduction of contaminants into the cleanroom environment.
What are the monitoring and testing methods for cleanliness in a clean room?
Users want to know how cleanliness is monitored in clean rooms, including particle count testing, microbial sampling, and the use of contamination indicators to ensure compliance with cleanroom standards.
What are the industry standards for clean room cleanliness and hygiene management?
People often seek information on the standards and regulations that govern clean room operations, such as ISO 14644 (cleanroom classification), GMP (Good Manufacturing Practice), or other industry-specific hygiene requirements.
