1. Clean area In the layout design of the gmp clean workshop of the pharmaceutical factory, to meet the corresponding cleanliness requirements, the general clean area can be divided into four levels: Class A: It is a high-risk operation area. In the sterile assembly or connection operation area, it is necessary to use a one-way flow operation table to maintain the environmental state of the place. The one-way flow system wind speed control, only in a closed isolation operation area, or gloves In the box, lower wind speed can be used; Class B: generally refers to the background area where the Class A clean area is located for high-risk operations such as aseptic preparation and filling. Classes C and D: generally refer to the clean areas of less critical steps in the production of sterile drug products. 2. Production area Aiming at the pollution problem of the gmp clean workshop of the pharmaceutical factory, it is necessary to carry out a formal and reasonable design and layout of the clean workshop according to the properties of the drug, the technological process and the cleanliness requirements. 1. According to the properties, process, use, production facilities and equipment of the drug, determine the workshop and make corresponding assessments; 2. For the production of special drugs, special or independent workshops, production facilities and equipment should be used, and reasonable purification treatment should be adopted for the exhaust gas, and attention should be paid to the exhaust vents, which should be kept away from the air inlets of other air purification systems; 3. The production of certain amide structure drugs or hormone products requires special facilities and equipment, and is strictly separated from other drug production areas; 4. In the production of cytotoxic and highly active chemicals, special facilities and equipment should be used. In special cases, protective measures should be taken and necessary verifications should be carried out. Such pharmaceutical preparations can be produced in stages and share the same production facilities and equipment; 5. The pharmaceutical gmp factory shall not be used for the production of non-medical products that have a bad influence on the quality of the medicines. 3. Storage area 1. The storage area of the pharmaceutical gmp factory shall have sufficient space to ensure the orderly storage of various materials and products such as raw and auxiliary materials, packaging materials, intermediate products, products to be packaged and finished products that are pending inspection, qualified, unqualified, returned or recalled. 2. The storage area should be able to meet the storage conditions of materials or products (such as temperature and humidity, avoid light) and the requirements for safe storage, and be inspected and monitored. Storage areas should be designed and constructed to ensure good storage conditions, with ventilation and lighting. 3. The layout and facilities of the receiving ...
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The laboratory purification project is a systematic project that applies air cleaning technology to control the living and living environment to meet the requirements of the cleanliness level of the indoor environment. It mainly includes two parts: air purification system and air supply and exhaust system. This entry is reviewed by the "Science China" Science Encyclopedia Encyclopedia Entry Compilation and Application Work Project. Introduction Laboratory purification engineering is a system engineering that uses air cleaning technology to control the living and living environment to meet the requirements of the cleanliness level of the indoor environment. It mainly includes two parts, the air purification system and the air supply and exhaust system Classification Laboratory purification projects can be divided into the following three categories according to their uses and scope of application: (1) sterile laboratory purification; (2) air purification of biological safety cabinets (biological safety cabinets); (3) high-purity electronic industry use Gas and special gas treatment Scope of application 1. Medical industry: surgical ICU ward, etc. 2. Pharmaceutical industry: GMP car drug inspection institute 3. Food processing industry 4. Cosmetics manufacturing 5. Precision machinery manufacturing 6. Scientific research and teaching 7. Other places that need to be purified
1. Market prospects When it comes to the market prospects of the domestic purification engineering industry, its market demand has broad prospects. This is because domestic industries such as biomedicine, electronic information, precision instruments, food and chemical industries are developing continuously, which has also driven the development of the purification engineering industry. It can be said that the domestic purification engineering industry is ushering in a new period of development. What needs to be pointed out here is that with the implementation of domestic medical reform and the release of GMP-2010, the demand for purification engineering in the biomedicine, food and chemical industries has been greatly promoted, and the large-scale expansion of the entire purification engineering industry has been driven. Due to the positive impact of these policies, the strong demand for purification projects in the domestic market will remain for a long time. 2. Market competition When it comes to market competition in the domestic purification engineering industry, it is mainly from price competition to value competition. Taking the purification workshop of electronic products as an example, these products are currently changing to integration, precision, miniaturization, and functionalization, so there are strict requirements on the reliability of components, and the requirements for purification workshops are becoming more and more strict. . For precision electronic components, a small amount of dust or static electricity is enough to cause a significant reduction in the yield rate, which in turn affects the company's benefits. Taking the static voltage threshold of the hard disk head as an example, it is currently within 3V, and the packaging environment is required to reach the level of Class 10 or even Class 1. To achieve integration, precision, miniaturization, and functionalization, the cost price will naturally increase, so price competition is obviously no longer applicable, but it must be turned to value competition. In short, for companies in the purification engineering industry, only with technology research and development and independent innovation capabilities can they continue to develop and not be overwhelmed by the trend of the times. Committed to cleanroom wall systems、clean room partitions and clean room windows etc.
Purification workshop engineering, also known as clean room or clean room. It is the foundation of pollution control. Without a clean room, mass production of contamination-sensitive parts is impossible. In fed-std-2, a cleanroom is defined as a room with air filtration, distribution, optimization, construction materials and devices, where specific regular operating procedures are used to control airborne particulate concentrations to achieve an appropriate level of particulate cleanliness . In order to obtain a good cleaning effect in the purification workshop project, not only should we focus on taking reasonable air-conditioning purification measures, but also require corresponding measures in technology, architecture and other professions: not only reasonable design, but also careful construction that conforms to specifications Installation, as well as the correct use of clean rooms and scientific maintenance management. In order to obtain a good effect in the clean room, many domestic and foreign literatures have expounded it from different angles. In fact, it is difficult to achieve ideal cooperation between different professions, and it is difficult for designers to grasp the quality of construction and installation, as well as the use and management, especially the latter. As far as clean room purification measures are concerned, many designers, or construction parties, often do not pay enough attention to its necessary conditions, resulting in unsatisfactory cleaning effects. 1. Within a certain space, remove the pollutants such as particulates, harmful air and bacteria in the air, and control the indoor temperature, cleanliness, pressure, airflow speed and airflow distribution, noise and vibration, lighting, and static electricity within a certain requirement. Engineering disciplines in scope. The room specially designed by the purification project has the performance of maintaining the cleanliness, temperature, humidity and pressure of the original set requirements no matter how the external air conditions change. two, 1. Negative ion purification: Negative ions are a kind of negatively charged gas ions in the air, which adsorb the suspended particles with positively charged ions, neutralize them into non-charged particles and settle down to purify the air. It can be said that the purification of air by negative ions is to reduce the concentration of suspended particulate matter in the air, but it cannot kill bacteria, viruses, or decompose pollutants. Air is made up of countless atoms and molecules. When molecules or atoms in the air lose or gain electrons, they form charged particles called ions; those with positive charges are called positive ions, and those with negative charges are called negative ions. 2. Photocatalytic air purification technology: The central air-conditioning photocatalytic air purification and sterilizer module manufactured by this technology is composed of coated titanium dioxide fine wire filter, primary and ...
A clean room refers to a well-sealed space in which air cleanliness, temperature, humidity, pressure, noise and other parameters are controlled as required. 1. Maintain the positive pressure value of the air-conditioned room. If the room has negative pressure or the positive pressure value is lower than that of the adjacent room, the air in the outdoor and surrounding rooms will infiltrate through the cracks in the doors and windows. Especially in the purifying air conditioning system, the positive pressure value of the higher purification level is higher than the positive pressure value of other rooms. The cleanliness of the medical design is greater than 10 Pa at least than the non-clean area, and the cleanliness between different cleanliness is greater than 10 Pa. 2. To ensure the reasonableness of airflow in the air-conditioned room. If the airflow is destroyed, not only the indoor temperature distribution will be affected, but also because of the excessive vortex, the unclean airflow near the corners and the ground will spread to the indoor working area. Therefore, the layout of workbenches and equipment in air-conditioned rooms should take into account the rationality of airflow. The equipment cannot block the return air vent, and the return air louver is strictly prohibited to move indiscriminately. 3. To clean the room, you must ensure that there are three levels of filtration: coarse, medium, and high-efficiency filtration. It is necessary to strengthen the management of purification air-conditioning. The staff should abide by the system and operating procedures to ensure that the indoor hygiene meets the purification requirements. 4. Clean and replace the air filter frequently or regularly, and clean the medium and coarse-efficiency and medium-efficiency foam filters with fresh air. When the final resistance of the medium-efficiency filter is twice the initial resistance or the limit value, it should be cleaned. When the resistance of the high efficiency filter is too large, it should be replaced. After the foam filter is cleaned, it should be measured. 5. Keep the air conditioning processing equipment and the air conditioning room clean. 6. Regularly measure the dust content and positive pressure value in the room. Welcome to inquiry cleanroom wall systems、clean room partition panels and clean room ceilings etc.