The two main sources of clean room pollution are water and gas. Water is the necessary carrier for production and life. In the process of producing water, the volatilization and use of water can produce more pollution. The pollution carried by gas is the largest in clean room. The source of pollution, through the gas, can be spread to any corner of the clean room. Therefore, in the design and use of clean rooms, strict management is usually required. 1. Purification of water: The pharmaceutical industry process water is divided into drinking water, demineralized water, pure water (ie deionized water, distilled water) and water for injection. Formulation production water, from the beginning of the application of tap water, further the use of pure water (including deionized water and distilled water) and water for injection, more importantly, the cooling water for the sterilization pot and sterilization products. Usually, the raw water for industrial use is tap water. It is obtained by coagulation precipitation and chlorination treatment with natural water in a water plant, but it is still measured by industrial standards and still contains many impurities, mainly including dissolved inorganic substances and organic substances, fine particles. , colloids and microorganisms. Dissolved inorganics are one of the main targets of pure water treatment: they exhibit equivalent amounts of cations and anions. A cation such as Na+Ca++, etc., an anion such as SO4, Cl, NO3, etc. Dissolved organic matter, such as oil and fat hydrocarbons, industrial organic wastewater, detergents, and metabolites of microorganisms, are characterized by being uncharged but extremely fine. The fine particles include various suspended or precipitated solid particles, which are not only abundant in the raw water, but also continuously generate exfoliation in various parts such as water treatment equipment and distribution systems. Colloids include sols, such as certain compounds of silicic acid, iron, aluminum, as well as some high molecular compounds such as hummus colloids. Their particle size is much smaller than that of fine particles. Microorganisms include bacteria, plankton and algae. Among them, bacteria, in particular, is an aspect that is difficult to deal with in the preparation of pure water, including viruses and pyrogens, and the particle size is in the order of μm and Nm. And when conditions are appropriate they will multiply at high speed in ion exchange resins, activated carbon, water storage tanks, and various valves and piping. Bacteria themselves have all the characteristics of particles, and they often contain metal ions and organic substances, and comprehensive measures are needed. The specific indicators of “pure water†or “ultra-pure water†are determined according to different purposes of use. The main indicators used in the pharmaceutical industry are resistivity and bacteria and pyrogens; the “purity†of industrial water is relatively speaking. Usually, in addition to softening water, more desalted water, pure water and high-purity water are collectively referred to as pure water. In the pharmaceutical industry, pure water also includes distilled water, the resistivity (25 ° C) is between 0.1 ~ 1.0 Ì 106 ~ 1.0 Ì 107 Ω / cm, the remaining salt content is below 1 ~ 5mg / L ~ 0.1mg / L, There is a fairly wide interval. In fact, the ideal "pure water" is not available because it has extremely high solubility and instability, and is highly susceptible to contamination by other substances to reduce purity. Drinking water: tap water or well water with good water quality should be used as the water source. Deionized water must be prepared by using ionized water as drinking water. Distilled water can be prepared by distillation of drinking water. Pure water still cannot remove pyrogens. The water for injection must be prepared by further purifying by the pure water obtained by the above method. The preparation of pure water is based on raw water, and the water quality is purified step by step to meet the production requirements. The pure water preparation system does not have a fixed mode, and it is necessary to comprehensively balance various factors and flexibly combine and apply according to the characteristics of various purification means. It is subject to the nature of raw water, water standards and water consumption, but also the efficiency of water production, the size of energy consumption, the complexity of equipment, the difficulty of management and maintenance, and the cost of products. In order to ensure the stability of the pure water quality, it should be circulated continuously in the system after the production, in order to achieve the purpose of "flowing water is not rot", even if it is not used for a while, it must be returned to the storage tank for re-purification and purification, and then circulated without stagnation. Purification of water preparation and piping Preparation of purified water and pipelines for the installation of purified water must be carried out in accordance with hygienic requirements of materials and installation measures. 2. Purification of gases: The industrial gases used by pharmaceutical manufacturers mainly refer to compressed air and nitrogen used as protective gases. The compressed air in contact with the drug and the compressed gas for washing, dispensing and filtering should be purified by degreasing and dewatering. The index for evaluating the cleanliness of industrial gases is purity, and the number of dust particles and bacteria entrained in the gas. Commercially available various bottles of nitrogen, the dust content in the air is 1140 ~ 265 / L (0.3 μm). The dust output from the gas output from the gas generation station is greater than 600 particles/L (≥0.3 μm). The dust content generally required for the production gas is not more than 3.5 particles/L (≥0.5 μm). Therefore, a dust filter must be installed. For the gas used in the pharmaceutical industry, the filter used at the end of the pipe mostly uses a microporous membrane. The pore size of the membrane is different, and there are 0.22 μm, 0.45 μm, 1 μm, 3 μm, 5 μm, etc., so that the degree of purification is also different, and the air filtration is high. The dust can reach 100 grades for dust with a particle size of ≥0.3μm, which is currently used as the main means of terminal purification. High-efficiency air filters are available in flat, barrel and folding styles and are divided into several models depending on the gas flow rate. 3. Drainage in clean areas: The clean area drainage system refers to the indoor drainage system. The task of the indoor drainage system is to quickly discharge the sewage that has been removed from the washing and sanitary appliances and production equipment, as well as the rainwater and snow water that has landed on the roof, into the outdoor drainage pipe, and the cleanliness requirements of the pharmaceutical production need to be prevented in the outdoor drainage pipe. Harmful gases, odors, and harmful insect lamps enter the room, cause microbial contamination, and provide convenient conditions for the treatment and comprehensive utilization of outdoor sewage. Therefore, the drainage system in the clean area is also extremely important. There are three types of sewage generated by the pharmaceutical industry: (1) Domestic sewage includes sewage discharged from sanitary ware, hand washing facilities, shower facilities, etc.; (2) The production wastewater is the sewage and wastewater generated during the production process, including equipment and container washing water, cooling water, etc.; (3) Rainwater includes rain on the roof and melted snow. The indoor drainage system generally adopts the diversion system, and the domestic sewage and drainage design code (TJ13-74) must also comply with the relevant regulations of GMP. The main measures taken are: (1) It is not advisable to install water buckets and floor drains in Class 100 clean rooms. Water tanks and floor drains should be avoided in Class 10,000 clean rooms. The number of water buckets and floor drains should be reduced to a minimum in other clean rooms. (2) The water bend or water seal device must be installed in the following parts of the equipment for the connection between the clean room and the sewer pipe, cleaning appliances and drainage equipment; (3) The floor drain provided in the clean room requires that the material is not easy to corrode (the inner surface is smooth, such as stainless steel), it is not easy to scale, there is a sealing cover, it is convenient to open, it can prevent the waste water from flowing back, and it is allowed to temporarily open the cover when flushing the ground. At the same time, the cover will be covered and, if necessary, disinfected and disinfected according to the product process requirements, so that the pollution can be better prevented (the new special clean floor drain of the pharmaceutical industry has been developed in China); (4) The quality supervision department and the acid-base wastewater generated in production should also be provided with special pipelines, and PVC (plastic pipe or ABS engineering plastic pipe should be used to lead to the acid-base treatment device. The clean area should avoid installing water buckets and sewers as much as possible. The aseptic operation area should be absolutely avoided. If it is installed, the design should consider its location for easy maintenance and cleaning, so as to minimize microbial contamination. Anesthetic Cream,Eye Anesthetic Cream,Topical Anesthetic Cream,Anesthetic Numbing Cream Shijiazhuang Asa Technology Co., Ltd. , https://www.asaantiwrinkle.com
Purification of water and gas during clean room design and use