Clean room environmental hygiene management system

1. Purpose

Establish A Clean Room environmental sanitation management system, clarify environmental sanitation standards, and keep the environment clean.

2. Scope

This system applies to the sanitation management of the Clean room environment.

(Figure 1: Clean room environment)

3. Responsibilities

The clean room personnel are responsible for the cleanliness of their respective positions, the workshop director and the process engineer are responsible for supervision and management, and the QA is responsible for supervision and inspection.

4. Content

4.1 In addition to implementing the general production area environmental sanitation management system: the clean room environmental sanitation must ensure that all building surfaces are smooth, clean, and intact, without penetration, and can withstand repeated cleaning and disinfection with a variety of detergents.

4.2 The transfer window and all locking devices of the clean room should be intact, and the doors on both sides cannot be opened at the same time

4.3 The door must be closed during work to minimize the number of entries and exits.

4.4 The number of operators in the clean room should be kept to a minimum, and non-operating personnel should be restricted from entering. Various operating activities should be stable, accurate, and light, and no actions unrelated to work should be performed.

4.5 Items not related to production are not allowed to be brought into the clean room. All kinds of utensils, containers, equipment and tools must be made of dust-free materials and must be cleaned and disinfected according to the prescribed procedures before entering the clean room. Items in the clean room must not be taken to non-clean rooms for use.

4.6 Recording paper and pens must be cleaned and disinfected before they can be brought into the clean room. The paper and pen used must not produce dust. Pencils and erasers cannot be used. Black water-based pens should be used.

4.7 In addition to meeting the cleaning requirements of general production areas, the clean room and cleaning tools in the clean room should also be kept ventilated and dry. Cleaning tool tables, mops, rags, etc. should be dried in time to prevent the generation of toxic bacteria. Cleaners and disinfectants should be used alternately to prevent microorganisms from developing drug resistance.

4.8 The waste barrels in the clean room should be clean and dust-free and placed in designated locations. Waste generated during the production process should be promptly placed in clean plastic bags in the waste barrel for sealed storage, and removed from the clean room through a special transfer window in time after the work is completed as required.

4.9 Three-shift production shall not be arranged in the clean room, and there must be enough time for cleaning and disinfection every day. When changing varieties, there should be enough time for interval, clearing, cleaning and disinfection.

4.10 Maintenance of manual instruments and instruments must be cleaned and disinfected before entering the clean room, and no pollution should be caused to the clean room.

4.11 Environmental control requirements and testing in the clean room area

4.11.1 In order to ensure the purification environment and cleanliness of the clean room (room), the clean room (room) needs to be monitored regularly. If there are special requirements, they can be stipulated separately.

4.11.2 Temperature and humidity: It is advisable to wear clean work clothes without feeling uncomfortable. Under normal circumstances, the temperature of the clean room is controlled at 18~26℃ and the relative humidity is 45~65%. The temperature and humidity of the clean room for producing special varieties should be determined according to the production process requirements.

(Figure 2: Clean room Testing)

4.11.3 Pressure difference: The clean room must maintain a certain positive pressure, which can be achieved by making the air supply is large and the exhaust is large. The static pressure between adjacent rooms (areas) with different air conditioning levels, the static pressure difference between the clean room and the outdoors should be 210Pa. For processes that generate a large amount of dust, harmful substances, flammable and explosive substances, the operating room should maintain a relative negative pressure with other rooms or areas.

4.12.1 If the following conditions are found, the high-efficiency filter should be replaced:

• The air flow rate is reduced to the minimum, and the air flow rate cannot be increased even after the primary and medium-efficiency Air Filters are replaced.

• The air volume of the high-efficiency air filter is 70% of the original air volume

• The high-efficiency air filter has irreparable leakage.

4.12.2 Illumination is generally not less than 300LX.

4.13 Construction and decoration

4.13.1 The surface of the clean room is smooth, crack-free, corrosion-resistant, with tight interfaces, no particulate matter falling off, and easy to clean and disinfect.

4.13.2 The windows, ceilings and the connection points between the entrances to the room and the pipes, vents, lamps and walls or ceilings of the clean room should be sealed.

4.13.3 Wooden and plastic products cannot be used for doors and windows in the clean room and its indoor items.

4.13.4 The dressing room and floor drains in the clean room (area) shall not have adverse effects on the clean room (area).

4.13.5 There are buffer facilities between the clean room (area) and the non-clean room (area).

4.13.6 The decoration materials of the clean room (area) shall not generate dust.

4.13.7 Cleaning of the clean workshop: in accordance with the cleaning and disinfection operation procedures of the 100,000-level clean workshop

4.13.7.1 After each batch of products is produced, the site shall be cleared, and the floor, doors and windows, indoor appliances, equipment surfaces, pools, floor drains, etc. shall be cleaned.

4.13.7.2 After production every month, the workplace, walls, floors, ceilings, lamps, exhaust, floor drains and other auxiliary devices shall be fully wiped and disinfected.

4.13.7.3 The air, equipment and facilities in the clean workshop shall be disinfected regularly.

4.13.7.3.1 Disinfectant: 75% ethanol, 0.2% chlorhexidine, 10ppm ozone:

4.13.7.3.2 Equipment: Irradiate with ozone once every 15 days, and wipe with 75% ethanol once a month;

4.13.7.3.3 Clean operating room: Irradiate with ozone once every 15 days, and do it at the same time as the equipment; wipe with 75% ethanol or 0.2% chlorhexidine once a month; wipe the doors, windows, walls, ceilings, indoor appliances, and wipe the floor with 0.2% chlorhexidine. 75% ethanol and 0.2% chlorhexidine should be used alternately every month. The air volume of the high-efficiency air filter is 70% of the original air volume.

4.14 Clean room maintenance

(Figure 3: Clean room maintenance)

4.14.1 Establish a comprehensive system of clean room safety measures, set up fire alarm, smoke exhaust, fire protection, emergency lighting and other facilities, and take corresponding safety measures according to the different properties of corrosive, explosive, flammable, self-igniting, toxic and other items, chemicals, and gases.

4.14.2 The maintenance and management of the clean room should include the establishment of corresponding management systems for the clean room air purification Equipment, materials used in production, and clean room operators, clarify the management content, methods and responsible persons, and the implementation should be recorded.

4.14.3 In addition to relying on the daily management of users, maintenance personnel should regularly inspect and maintain the clean room air conditioning system and Clean Room air purification equipment. The quality management department shall designate a special person to regularly check the regional process hygiene and cleanliness, and record after inspection.

4.15 The environmental control standards for clean workshops can be found in "Clean Room Air Cleanliness Level Control Standards.

Air cleanliness level control standard for clean rooms (areas)

Clean room monitoring table