The complete embodiment of clean technology is what we usually call the clean room of the pharmaceutical factory, which is mainly divided into two categories: industrial clean room and biological clean room.The main task of industrial clean room is to control the pollution of non-biological particles, while the main task of biological clean room is to control the pollution of biological particles.GMP is the standard of pharmaceutical manufacturing and quality management, which effectively ensures the safety and quality of medicines. In the process of design, construction and operation of clean rooms in the pharmaceutical industry, the relevant standards of clean rooms and the requirements of quality management specifications for pharmaceutical production should be followed. Next, we will talk about the design of the clean room of the pharmaceutical clean factory in accordance with the regulations on interior decoration in the “Design Specifications for the Clean Factory of the Pharmaceutical Industry”, combining with Shanghai IVEN’s experience in the engineering design of integrated pharmaceutical factories.
In industrial clean rooms, pharmaceutical plants are the engineering designs we often encounter. According to the requirements of GMP for clean rooms, there are several important parameters that should be paid attention to.
1. Cleanliness
The problem of how to correctly select parameters in the craft product workshop. According to different technology products, how to choose the design parameters correctly is the fundamental problem in the design. An important indicator is proposed in GMP, that is, the air cleanliness level. The air cleanliness level is the core indicator for evaluating air cleanliness. If the air cleanliness level is inaccurate, the phenomenon of big horses pulling small cart will appear, which is neither economical nor energy-saving. For example, the new packaging specification of 300,000-level standard which is not appropriate to use it in the main product process at present, but which is very effective for some auxiliary rooms.
Therefore, the choice of what level is directly related to the quality and economic benefits of the product. The dust sources that affect the cleanliness mainly come from the dust production of items in the process of production, the flow of operators and the atmospheric dust particles brought by the outdoor fresh air. In addition to the use of closed exhaust and dust removal devices for the dust-producing process equipment, the effective means to control the entry of dust sources into the room is to use primary, medium and high-efficiency three-stage filtration for the new return air of the air-conditioning system and the shower room for personnel passage.
2. Air exchange rate
Generally, the number of air changes in an air-conditioning system is only 8 to 10 times per hour, while the lowest level of air changes in an industrial clean room is 12 times, and the highest level is hundreds of times. Obviously, the difference in the air exchange rate causes a great difference in air volume and energy consumption.In the design, on the basis of accurate positioning of cleanliness, it is necessary to ensure sufficient ventilation times. Otherwise, a series of problems may appear, such as the operation results are not up to standard, the anti-interference capacity of the clean room is poor.
3. Static pressure difference
The pressure difference between clean rooms and non clean rooms at different levels shall not be less than 5pa, and the pressure between clean rooms and outdoor rooms shall not be less than 10Pa. The method of controlling the static pressure difference is mainly to supply a certain positive pressure air volume. The positive pressure devices often used in the design are the residual pressure valve, the differential pressure electric air volume regulator and the air damping layer installed at the return air outlet. In recent years, it is often adopted in the design that the supply air volume is larger than the return air volume and the exhaust air volume in the initial commissioning without the positive pressure device, and the corresponding automatic control system can achieve the same effect.
4. Air distribution
The air distribution form of the clean room is the key factor to ensure the cleanliness. The air distribution form often adopted in the current design is determined according to the cleanliness level. For example, the 300,000-class clean room often adopts the top-send and top-back method, the 100,000-class and 10,000-class clean rooms usually adopt the air flow method of upper and lower side return, and the higher-class clean room adopts the horizontal or vertical one-way flow.
5. Temperature and humidity
In addition to special processes, from the perspective of heating, ventilation and air conditioning, it is mainly to maintain the comfort of operators, that is, suitable temperature and humidity. In addition, there are several indicators that should arouse our attention, such as the cross-sectional wind speed of the air duct, noise, illuminance and the ratio of fresh air volume etc, all of which cannot be ignored in the design.
Biological clean rooms are mainly divided into two categories; general biological clean rooms and biological safety clean rooms. For industrial clean rooms, in the professional design of heating, ventilation and air conditioning, the important methods to control the cleanliness level are through filtration and positive pressure. For biological clean rooms, in addition to using the same methods as industrial clean rooms, it also should be considered from the perspective of biological safety，and sometimes it is necessary to use negative pressure means to prevent the pollution of the product to the environment. The operation of high-risk pathogenic factors is involved in the production process of the in-process product, and its air purification system and other facilities should also meet special requirements. The difference between a biosafety clean room and an industrial clean room is to ensure that the operating area maintains a negative pressure state. Although the level of such production area is not very high, it will have a high level of biohazard. Regarding the biological risk, there are corresponding standards in China, WTO and other countries in the world. Generally, the measures adopted are secondary isolation. First, the pathogen is isolated from the operator by the safety cabinet or isolation box, which is mainly a barrier to prevent the overflow of dangerous microorganisms. Secondary isolation refers to the isolation of the laboratory or work area from the outside by turning it into a negative pressure area.For the air purification system, certain measures are also taken accordingly, such as maintaining a negative pressure of 30Pa~10Pa indoors, and setting up a negative pressure buffer zone between the adjacent non-clean area.
Shanghai IVEN always maintains a high sense of responsibility and adheres to every standard while helping clients build pharmaceutical factories. As a company with decades of experience in providing integrated pharmaceutical engineering, IVEN has hundreds of experience in global international cooperation. Every project of Shanghai IVEN is in line with EU GMP/US FDA GMP, WHO GMP, PIC/S GMP and other principles standard. In addition to providing customers with high-quality services, IVEN also adheres to the concept of “providing health for human beings”.
Shanghai IVEN is looking forward to working with you.
article source: https://www.iven-pharma.com/news/design-of-clean-room-in-pharmaceutical-factory/
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