With the continuous development of pharmaceutical technology, the use of clean rooms is becoming more and more widespread, and its role is becoming more and more important. How to maintain cleanliness in clean rooms and how to reasonably control pollution sources are issues that pharmaceutical companies care about and attach great importance to. This article introduces how to keep a clean room clean from several aspects: cleaning requirements and precautions, maintenance and management of clean room equipment, clean room staff management, management of materials entering and exiting the clean room, and operation and maintenance of the air conditioning system.

Cleaning requirements and precautions

1. When cleaning the clean room walls, special clean room dust-free cloth and special cleaning agent should be used;

2. Prepare a cleaning agent with 90% deionized water and 10% isopropyl alcohol;

3. Check the trash can every day and clean it in time;

4. The floor must be vacuumed regularly, and the completion of the work should be marked on the chart every time a shift is handed over;

5. Use a special mop to clean the clean room floor, and wax the floor in strict accordance with the plan and cleaning procedures, and anti-static wax must be used;

6. A special vacuum cleaner with a high-efficiency filter should be used for vacuuming in the clean room;

7. All clean room steel purification doors need to be inspected and wiped dry;

8. Vacuum and wipe regularly under the raised floor and in the air return wall;

9. When working, you must remember to always wipe from top to bottom, and wipe from the farthest point to the direction of the door.

10. After the cleaning work is completed, all cleaning supplies must be stored in the designated cleaning room and stored separately from ordinary tools to avoid cross-contamination and placed neatly.

Maintenance and management of clean room equipment

1. Material selection: In order to keep the interior of the clean room clean for a long time, material selection is very important. Materials should be selected that are smooth and do not produce their own pollution. They are also durable, corrosion-resistant, sterilization-resistant, and easy to clean. Otherwise, microorganisms will breed. place.

2. Cleaning work: Clean and wipe the equipment before moving it into the clean room. Before cleaning, you must understand the clean room equipment, know the correct disassembly method, cleaning sequence, and cleaning precautions, which can make the cleaning work more in line with specifications. At the same time, Avoid damaging equipment during cleaning.

3. Regular cleaning: Carry out regular cleaning and disinfection according to the requirements of clean rooms of different levels, and keep records. Cleaning of sterile equipment, especially parts and components that are in direct contact with drugs, must be sterilized, and the date of sterilization must be marked, and microbiological verification must be carried out if necessary.

4. Cleaning frequency: The cleaning frequency of the equipment should be determined based on the usage of the equipment, production process requirements and other factors. For example, when the same equipment continuously processes the same sterile product, it must be cleaned and sterilized between each batch; when the same equipment processes the same non-sterile product, comprehensive cleaning must be carried out at least every week or after every three batches of production.

5. Cleaning agent selection: Choose a cleaning agent suitable for clean room equipment. Cleaning agents should be environmentally friendly products with low volatility and low residue to avoid pollution to the indoor environment.

6. Reduce personnel operations: Cleaning of clean room equipment should be carried out by dedicated maintenance personnel to minimize the operation of the equipment by other personnel and avoid contamination of the equipment.

Clean room staff management

In clean rooms, people are an important source of particulate pollutants. For staff entering the clean room, they should undergo corresponding training and assessment. Only those who pass the assessment can enter the clean room.

1. Pre-job training: New employees should receive professional pre-job training and master the characteristics and structure of the clean room, basic knowledge of cleanliness, personnel purification procedures and material purification route requirements, the use, cleaning and sterilization requirements of clean clothes, and cleanliness requirements. Room cleaning, cleaning and disinfection, clean room safety facilities and safety management regulations.

2. Strict room entry management:

(1) Personnel entering the clean room must limit the number of people, wear special clean clothes, clean shoes, hats, masks and other personal protective equipment, and undergo air showers, hand disinfection and other procedures before entering.

(2) Items that are not related to production and are prone to dust are not allowed to be brought into the clean room.

(3) The following people are not allowed to enter the clean room: patients with colds, coughs, eczema and other diseases; those who have not washed off cosmetics, nail polish and wear clean work clothes as required; staff should wash their hair, change clothes and cut their nails frequently.

3. Strict work specifications:

Staff should abide by strict work regulations, such as not leaving their jobs at will, smoking, eating, and performing non-productive activities in the clean room, and using unapproved tools.

4. Good behavioral habits:

(1) When walking around in the clean room, you should move lightly and avoid large movements that can easily generate dust to avoid affecting the air flow.

(2) In order not to interfere with the air flow, no objects can be placed on the upstream side of the work area. Production is generally carried out on a clean workbench or upstream of the air flow.

5. Regular health examinations: In order to ensure the purity of the clean indoor environment, staff should conduct regular health examinations, such as body temperature, respiratory system, skin, etc., to ensure that there is no pollution to the environment.

Management of materials entering and exiting the clean room

The clean room is one of the important places where products are produced. In order to ensure the environmental quality in the clean room, material management is very important. Things to note are as follows:

1. Material preparation: All materials entering the clean room should be cleaned and purified to ensure that they are dust-free and free of microorganisms. At the same time, try to choose materials that do not produce violent volatile matter and dust.

2. Material packaging: Materials entering the clean room should be sealed and packaged to avoid contamination by external air and microorganisms. Packaging materials should comply with clean room requirements.

3. Material transfer: When transferring materials, the number of times personnel enter and exit the clean room should be minimized to reduce the contamination of microorganisms, dust and other impurities in the air. Items of small items enter the interior through the pass-through window. Personnel transferring materials should wear protective equipment such as work clothes, hats, masks, and gloves that meet clean room requirements.

4. Material storage: The storage of materials in the clean room should comply with the requirements of the clean room, and the humidity and temperature should be strictly controlled to avoid the material absorbing moisture and volatile matter. At the same time, materials should be classified and labeled to facilitate management and use.

5. Material cleaning: After using the materials, the residues should be cleaned up in time to avoid contamination of the clean indoor environment.

6. Material recycling: Pay attention to cleaning and handling when recycling materials to avoid bringing in pollutants when entering the clean room again.

Operation and maintenance of air conditioning system

The air conditioning system device is the main equipment to ensure the cleanliness level of indoor air, including various types of filters, clean workbench, laminar flow hood, air shower, transfer window, air conditioning device, etc. Their normal maintenance and regular inspection are important to ensure the clean room Important condition for cleanliness.

1. Regularly replace the filter: In order to ensure the cleanliness of the air entering the clean room and prevent the air supply system from bringing dust particles into the room, the filter should be replaced regularly to ensure the filtration efficiency of the filter.

2. Regular cleaning: Cleaning of the clean room air conditioning system should be carried out by professional maintenance personnel. The frequency of cleaning should be determined based on the usage of the equipment.

3. Air conditioning maintenance records: The maintenance of the clean room air conditioning system should be recorded in detail, including maintenance time, maintenance personnel, maintenance content, maintenance results and other information. These records help equipment managers understand the status of the equipment and discover and solve problems in a timely manner.

The cleaning effect of the clean room directly affects the safety and quality of medicines. Strict management and control of clean rooms are implemented to ensure the purity of the clean room environment and prevent environmental pollution, thereby ensuring the normal operation of the clean room and at the same time ensuring the safety of medicines. Quality is guaranteed.

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