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The first is the problem of layout
This problem is particularly acute in the graphic design of pharmaceutical cleanrooms and biosafety laboratories. The main problem is that the plane is too complex. Indeed, in the graphic design of pharmaceutical factories, it is necessary to ensure that the clean areas are not polluted, to achieve reasonable division, clean and separate, and the flow of people and logistics is obvious, but we must avoid overcorrection. Because some industry authorities lack professional knowledge when formulating acceptance criteria, and do not know enough about the principles and characteristics of clean rooms, the clean room is too mysterious and complicated, so the layout of the clean room is too harsh, causing many unnecessary troubles. . This problem is particularly prominent in the setting of the buffer chamber.
For example, when the China Southern Purification Company designed a pharmaceutical factory customer, the process of the pharmaceutical factory personnel is like this: change shoes, one more, buffer, two, wash hands, disinfection, buffer, clean corridor, three more, buffer or hand The high-level clean room is eliminated and poisoned. Therefore, before entering the high-level clean room, the staff needs to enter and exit 9 rooms and open and close 18 doors. The complexity can be imagined. In addition, many pharmaceutical companies have small investment and small plant, so that the area of ​​each auxiliary room is only a few square meters, or even only 2 square meters, so the staff can barely accommodate two people in the room at the same time. Stopping the door, turning around, closing the door, so that it almost fainted.
Strict requirements are a good thing, but if you are over-corrected, it will be counterproductive. Many workers have to close many doors in order to facilitate access. Many rooms are ineffective. It is a solution to this problem by merging rooms that can be merged and canceling the room that is not necessary. For example, hand sanitization can be used as a buffer room. In addition, between low-level clean rooms, such as 10,000 and 100,000 clean rooms, it is not necessary to set a buffer chamber. In some occasions, the setting of the three is also considered. . The setting of the buffer room is mainly to open the air-gate isolation by opening and exiting the two doors. If strictly managed, some auxiliary rooms can be used as a buffer.
In addition, there is no need to set buffers in 100,000 and 10,000 rooms. The dust concentration in the 100,000-class and 10,000-class rooms is not 10 times different than that expected by some non-professionals. When the door is opened, it will be polluted. In fact, the two are similar. For example, the veterinary drug GMP (2002) stipulates that the minimum air exchange rate for a 100,000-class room is 15 times/h, and the minimum air exchange rate for a 10,000-class room is 20 times/h. The volume is generally small. For example, for a 4m2 room, the air exchange rate of 5 times/h is only about 50m3/h, and the air supply volume of 50m3/h is difficult to adjust. In addition, no matter the design and construction. It is necessary to leave a certain margin as appropriate. Therefore, from the perspective of several pharmaceutical companies tested by the author, in some small rooms on the entry and exit route, in addition to the nominal cleanliness level, the number of air exchanges and air dust concentration There is no difference.
The same problem has also appeared in the construction of a three-level biosafety laboratory. In addition to requiring a lot of buffers, the competent authorities of the industry also require that people, logistics, ware, and dirt be separated from each other and completely separated, but the facts are It is impossible to do it, and it is not necessary. Some policy makers emphasize irrespectiveness or cater to some needs. The argument that “biosecurity cannot be overemphasized†is irresponsible. For engineers and technicians, everything must be done from reality and everything must be done. As long as it can fully meet the security needs, layer-plus code is the lack of professional knowledge and lack of self-confidence. The author believes that the P3 laboratory proposed since SARS has set the requirements of “three districts and two mitigations†(that is, the laboratory is divided into clean areas, semi-polluted areas and polluted areas, and buffers must be set between different areas). Some data can also be seen. In some developed countries, the biosafety laboratory plane is much simpler than ours. Some low-risk laboratories set up “two districts and one slowdownâ€. The people who have formulated the "three districts and two mitigations" may not have much contact with the design work. In fact, because the biosafety laboratory has extremely strict requirements on the pressure difference, the "three districts and two mitigations" often have six or seven floors, and the layers are under negative pressure. And it must be strictly guaranteed, no matter from design, construction and self-control, it is extremely difficult to guarantee. Therefore, it is still necessary to proceed from reality and make the biosafety laboratory truly safe, practical, economical and feasible.
An outstanding problem in the construction of biological clean room is the use of arc angles.
The biological clean room is mainly based on the control of microorganisms such as bacteria, and the microorganisms are easy to breed in some corners. Therefore, the biological clean room should be easy to clean and minimize the dead angle. Therefore, in JGJ 71-90 "Cleanroom Construction and Acceptance Specifications" Article 2.3.8 stipulates that the part of the skirting board should be flush with the wall surface or slightly retracted by 2~3mm. When the skirting board is the same as the floor material, it can be made into small rounded corners, and the corner radius R should be greater than or equal to 50mm; when the skirting board is different from the floor material, the elastic material is embedded. Except for the corners of the ground and the wall, rounded corners are required, and other parts are not specified. It is now common practice to add aluminum alloy fillets to all the corners. Due to the rough production, many of the rounded corners of the project flow in the form, and even the effect is counterproductive. For the between the walls, the rounded corner between the wall and the ceiling, the effect is not very large, and now it is the "figure cloth" that the construction unit covers the rough joint. The angle between the wall and the ground is actually very important, but it is often a place to hide dirt and bacteria. The reason is: due to the thickness of the arc angle, two small joints will be formed at the two corners of the round corner and the wall and the ground. Because the ground and the wall are not flat, there are often many gaps at the joints, many constructions. Units cut corners, no glue seals, and some even cracked when cracked. Therefore, the original purpose is to eliminate the health corner, but the actual situation has increased a lot of hidden dangers. This kind of situation is not obvious in normal times. It will be exposed when the clean room is cleaned. Once there is water on the ground, the water will seep into the next room through the gap. The rounded corners are often full of water stains, which is a good breeding ground for bacteria. site. The root cause of this situation is that the provisions of the norms are not really understood, but only in form. The author believes that for the construction of biological clean room in China, we can not only be satisfied with the level of “have and notâ€. We must improve the level and make it practical, instead of coping with certification work, not only must be built, but must also be built. it is good. There are several ways to recommend: 1. After installing the rounded corners, lay a certain thickness of the self-flowing floor to completely eliminate the ground joints; 2. After installing the rounded corners, lay the entire coiled floor, and then roll the coil along the rounded corners. Spread to the siding to make the fillet and the ground integrated. 3. Use a building material (such as rubber sand) to build an arc-shaped siding base. The pedestal and the ground do the same treatment, such as brushing the paint, so that the ground and the base are integrated, and the base is used as the kicking part. Level with the wall or below the wall.
As a clean room floor, the cast-in-place terrazzo has the characteristics of wear resistance, integrity, corrosion resistance, brushing resistance and low cost. It can be completely used in low-grade clean rooms. However, some projects using terrazzo ground have problems: the dust concentration in the air is high, especially the large particles of ≥5μm are seriously exceeded, and the possibility of leakage of the filter is excluded, and the root cause is found on the terrazzo floor. Many places are ash, and even powder can be drawn with nails. The reason for this problem is because the cement label is not enough. In section 2.2.2 of JGJ 71-90 "Cleanroom Construction and Acceptance Specifications", there is such a provision for the clean floor surface: the cement marking of the cement floor of the clean room paint floor shall not be lower than 425; the terrazzo floor shall be For cast-in-place, the diameter of the pebbles used is 6~15mm. After the whetstone is finely ground, it should be coated with non-volatile protective material. Some certification personnel believe that the idea that terrazzo ground is not feasible is one-sided. As long as the specifications are met, the watering millstone can be a good and inexpensive floor material. Some construction units cut corners, using low-grade cement, glass inserts, and the surface is not treated. This reminds the construction units and design units to pay attention to this issue and to ensure good quality.
The characteristics of the biological clean room are still many, and there are many problems in the actual project. Only by fully understanding the different requirements and characteristics of different types of clean rooms, and familiar with the regulations, can we really build the biological clean room.
This article is organized by professional purification engineering, purification equipment, and air filter in China Southern (http://).