With the process of global economic integration, China's enterprises not only have fierce competition with domestic enterprises, but also have wider and more fierce competition with foreign enterprises, so our current enterprises have to carry out transformation, upgrading and innovation, because only in this way can we survive. In this business environment, we will pay more and more attention to the dust-free workshop, because the dust-free workshop can not only ensure the health of staff, but also have a significant effect on the quality, accuracy, yield, stability of products.
Next, I will introduce the monitoring requirements of clean workshop construction in detail:
I. key points of cleanliness control of ventilation and air conditioning
Clean air conditioning construction is the most important in the installation and construction of mechanical and electrical equipment in GMP plant. Therefore, the construction quality must be strictly controlled. The following items shall be noted during construction:
1. For the production of clean air duct, it is necessary to build a special room for the production of air duct temporarily. The area can be large or small as required. It is divided into two rooms, one 15m2 buffer room and one 40m2-60m2 production room.
2. The cleanliness quality control must be carried out from the first process of construction, the materials shall be strictly mobilized, and the purchased galvanized iron sheet shall be stacked indoors and covered with plastic cloth. When it is put into use, each iron sheet shall be cleaned and dried with detergent and water, and then sent to the buffer room. In the air duct assembly room, the ground shall be supplemented with carpet, so as to ensure the quality of air duct production and assembly.
3. The production site of ventilation pipe must be strictly required, or the consequences will be endless. We must strictly control every link from transportation → stacking → cleaning → disinfection → production → sealing. Only in this way, the clean quality can be guaranteed to reach the standard and truly meet the requirements of the clean workshop for the ventilation pipe.
II. Key points of cleanliness control in electrical discipline
1. According to the requirements of code for construction and acceptance of clean room (jgj71-90), the distribution box in clean room shall be installed without dust inside. The exposed surface of the box shall be clean, smooth and easy to clean. The joint between the box and the wall must be sealed. Therefore, the installation of distribution box on the wall can refer to the following installation methods (as shown in the figure below):
The size of the surface cover of the distribution box shall be customized with reference to the thickness of the wall (color steel plate), and it shall be noted that the thickness of the exposed part of the box shall match the depth of the surface cover, so as to avoid the gap phenomenon that the surface cover of the distribution box does not stick to the color steel plate after installation.
2. After the pharmaceutical equipment in the GMP plant is in place, all kinds of power source (water, electricity, steam) pipes shall be connected to the machine position in the form of concealed pipes to avoid exposed pipes as much as possible. If it is impossible to install the concealed pipe, it will directly come down from the ceiling and connect to the part of the machine, but it must be covered with stainless steel circular pipe outside, so as to solve the problems of open pipe and beauty and cleanness.
III. key points for cleanliness control of water supply and drainage
1. Dead angle and blind pipe shall be avoided in the design of pharmaceutical solution, injection water and purified compressed air pipes. The structure of its preparation, storage and distribution equipment shall prevent the growth and pollution of microorganisms. Quick release connection shall be adopted for pipeline connection, and filter shall be set at the terminal.
2. The floor drain shall be provided with a sealing cover and there shall be no blind pipe on the ground.
IV. key points of cleanliness control of mechanical equipment
1. The surface of the equipment shall be clean and easy to clean. The equipment with materials shall be sealed as much as possible. The inner wall in direct contact with the materials shall be smooth and flat to avoid dead angle. Low carbon stainless steel shall be used for sterile pharmaceutical equipment and containers.
2. The transmission parts of the equipment shall be well sealed to prevent the leakage of lubricating oil from polluting the drugs, containers and materials.
3. For the equipment that will produce a large amount of dust in the production process of the preparation, it is necessary to strengthen the dust prevention, dust collection and dust collection devices. The discharged gas shall be filtered to prevent air from pouring back.
4. There shall be purification device for dry air, compressed air and inert gas for workshop production.
5. The packaging machinery shall be easy to operate without mistakes, and shall have functional display
6. Matched parts: such as lighting, valve, electrical switch, frequency converter, worktable, etc. shall be of high quality and durable products to prevent maintenance personnel from frequent access to production workshop and ceiling area due to quality failure.
As a powerful purification engineering company in China, Shandong ed purification Engineering Co., Ltd. has a special project department responsible for the design, production, installation and commissioning of dust-free workshop purification, cosmetics workshop purification, printing and packaging workshop purification, and electronic dust-free workshop purification. The company integrates professional scheme design team, complete supporting product channels, professional system construction team and perfect after-sales service. With the relevant construction qualification issued by the national construction department; with an experienced engineering technology research and development team; with years of professional accumulation in the field of purification, combined with the construction management practice of many domestic projects, to provide comprehensive and high-quality overall purification system technical support for domestic customers. If you want to know more about the clean construction of the dust-free workshop, you are welcome to have a detailed communication with the engineering personnel of the project department. For more knowledge of medical purification industry, please pay attention to WeChat public address: Aide-188 (Ed purify oxygen supply).