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热门关键字：食品净化车间 医药洁净车间 低温车间 洁净室 无尘洁净室
What is the standard of GMP cleanroom?
GMP cleanrooms are designed to eliminate potential bioactivity, dust, and contaminants, and to fundamentally eliminate substances that affect the production of high quality. Therefore, GMP cleanroom should follow the relevant design requirements to ensure the quality of the final product meets the regulatory requirements. Today, we will take the GMP cleanroom of food factory as an example and analyze the design requirements of GMP cleanroom in detail.
I. Design of purification structure
1. the production links should be connected to each other, but also to facilitate sanitary control during processing to avoid cross-contamination.
2. in the layout, to follow the order of the processing process of the product, so that the product processing from the unclean link transition to the clean link, do not allow cross and backflow in the processing process.
3. The workshop is set up in the apparatus cleaning area, disinfection room, configuration of public apparatus cleaning, disinfection with the cleaning tank, disinfection tank and rinsing tank. If necessary, hot and cold water is also available, but the temperature of hot water should not be lower than 82℃.
4. cleanroom should have good dust removal ventilation and ensure that the direction of airflow should flow from clean to non-clean areas.
5. Workshop lamps should be equipped with protective cover.
II. Design of human flow and logistics
1. To avoid cross-contamination, operators and materials entering the clean area should not use the same entrance, and should set up their own purification rooms or take corresponding purification measures.
2. only production-related equipment should be set up in the clean production area to avoid contamination of food.
3. ensure that the passage of the clean area directly reaches each production post, intermediate or inner package material storage room, which can effectively prevent cross-contamination of different varieties of food caused by material transportation and operator flow.
4. Without affecting the process flow and process operation equipment arrangement, if the air conditioning system parameters are the same, the adjacent clean operation room can open the door on the partition wall, open the transfer window or set up a conveyor belt used to transfer materials.
III. Installation and design of air conditioning system
The different design of air supply and return air system is the decisive factor to decide the different cleanliness level of the cleanroom.
1. Standard combined air conditioning cabinet + air filtration system + clean room ventilation insulation duct + HEPA high efficiency air supply outlet + clean room return air duct system. This form can continuously circulate and supplement the new air into the clean room workshop to achieve the cleanliness required by the production environment.
2. Cleanroom ceiling installation FFU industrial air purifier directly to the clean room air supply + return column return air system + ceiling-mounted air conditioning unit cooling. This form is generally used in the environment cleanliness requirements are not very high occasions, and the cost is relatively low.
GMP purification is a complex and comprehensive project, the production environment, process, production equipment, auxiliary equipment, testing means and personnel quality and other professional knowledge are involved. In future articles, Shanghai Lizhen will introduce other aspects of cleanroom in detail, if you have more questions or needs, you can visit our official website "Shanghai Tobetter" for consultation and understanding.
After Yuwell set up a working group to prevent the epidemic in mid-January, many workshops of the company, such as injection molding, electronics, general assembly and sterilization filling, have never stopped working to ensure the supply of materials during the epidemic.
Refrigeration program should be based on the cooling requirements (cooling consumption, cooling mode, chilled water temperature, etc.), the construction area of the water source (water temperature, water quality, water quantity, etc.) and power supply, heat source preparation party and technical and economic comparison. Both require better economic indicators, but also to consider the local possibilities. The selection of refrigeration devices is the central link in the process of determining the refrigeration program, the main types of refrigeration devices are as follows.
Using hot water or steam passed through the air heater, the process of heating air and other moisture can be realized. Air heaters are usually used for primary and secondary heating of air conditioning systems, which can provide a larger supply of heat and are more economical. The use of electric heaters is to let the current through the resistance wire heat to heat the air. Electric heaters have the advantages of uniform heating, stable heat, high efficiency, compact structure and easy control. Therefore, it is widely used in air conditioning units and small air conditioning systems. In the large air conditioning system and purification air conditioning system with high requirements for constant temperature precision, electric heaters are also often used on the air supply branch to control local heating, which is the so-called third heating or called fine heating. However, the use of electric heaters to consume more electrical energy, so it is not appropriate to use in places with large heating requirements.
Common air-conditioning supply modes can be divided into centralized and local. In addition, the purification system needs coarse efficiency, medium efficiency and high efficiency filters. Combined with the dual requirements of air conditioning and purification, the purification air conditioning system can be divided into centralized purification air conditioning system and decentralized purification air conditioning system.
The purification treatment method that creates the same clean environment in the whole room by centralized purification air conditioning system is called whole room purification. This is one of the earliest developed methods in clean technology and is still used today. This method is suitable for the place where the process equipment is tall, the number is large and the room requires the same cleanliness. However, this method has large investment, complicated operation and management, and long construction period.
The purification workshop has high requirements for the environment, what kind of laying material is used for the floor of the purification workshop? The purification workshop is generally using PVC flooring, some benefits of using PVC flooring. Purification workshop PVC flooring has a variety of colors, and the color can be determined according to the overall situation of the workshop. You can choose the right color according to the needs of each workshop.