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    Home > Active Ingredient News > Drugs Articles > Discussion on the purification of water and gas in clean room

    Discussion on the purification of water and gas in clean room

    • Last Update: 2018-05-18
    • Source: Internet
    • Author: User
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    1 Water purification: the process water for pharmaceutical industry includes drinking water, softened water, pure water (i.e deionized water, distilled water) and injection water The water for preparation production starts from tap water, and further uses pure water (including deionized water and distilled water) and water for injection More importantly, it also specifies the cooling water for sterilization pots and products Generally, the industrial raw water is tap water, which is obtained by coagulation, sedimentation and chlorination of natural water in the water plant However, according to the industrial standard, there are still many impurities, mainly including dissolved inorganic and organic matters, fine particles, colloids and microorganisms Dissolved inorganic substances are one of the main objects of pure water treatment: they are equal equivalent to cation and anion Cations such as Na + Ca + + Anions such as SO4, Cl, NO3 And so on Dissolved organic matters, such as oil hydrocarbons, industrial organic wastewater, detergents and metabolites of microorganisms, are characterized by being uncharged but extremely fine Fine particles include all kinds of suspended or precipitated solid particles, which are not only numerous in raw water, but also produce falling off substances in various parts of water treatment equipment and distribution system Colloids include some compounds of sol, such as silicic acid, iron and aluminum, and some high molecular compounds such as humic colloids Their particle size is much smaller than that of fine particles Microorganisms include bacteria, plankton and algae Especially bacteria, which are difficult to deal with in the preparation of pure water, including viruses and pyrogens, have particle sizes of μ m and nm And when the conditions are right, they will breed in ion exchange resin, activated carbon, water storage tank and various valves and pipelines at high speed Bacteria itself has all the characteristics of particles The bacteria often contain metal ions and organic matters, so comprehensive measures should be taken to deal with them The specific indicators of "pure water" or "ultra pure water" should be determined according to different purposes of use When used in the pharmaceutical industry, the main indicators are resistivity, bacteria and pyrogens; the "purity" of industrial water is relatively speaking, usually in addition to softened water, desalted water, pure water and high-purity water cages are collectively referred to as pure water In the pharmaceutical industry, pure water also includes distilled water Its resistivity (25 ℃) is between 0.1-1.0'106-1.0'107 Ω / cm, and the remaining salt content is below 1-5mg / l-0.1mg/l, with a quite wide range In fact, the ideal "pure water" is not available, because it has high solubility and instability, and it is easy to be polluted by other substances and reduce the purity Drinking water must be tap water or well water with good quality as the water source, deionized water must be drinking water as the water source, and prepared by ion exchange Distilled water can be prepared by distillation of drinking water, but pure water still cannot remove pyrogen, so pure water prepared by the above method must be further prepared by distillation Pure water preparation is based on raw water as raw material, and the water quality is purified step by step to meet the production requirements There is no fixed mode in the pure water preparation system It is necessary to weigh many factors and combine them flexibly according to the characteristics of various purification methods It should not only be restricted by the nature of raw water, water standard and water consumption, but also consider the level of water production efficiency, 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 pure water quality, it should be circulated continuously in the system after being made, so as to achieve the purpose of "water does not decay" Even if it is not used temporarily, it should still return to the storage tank for purification and purification, and then circulate, without stagnation The materials and installation measures that meet the requirements of hygiene must be adopted for the preparation of purified water and the preparation of purified water and the pipeline of purified water 2 Gas purification: the industrial gas used by pharmaceutical manufacturers mainly refers to compressed air and nitrogen used as protective gas The compressed air in contact with the medicine and the compressed air for bottle washing, subpackage and filtration shall be purified by oil and water removal The first is purity, the second is the number of dust particles and bacteria in the gas For all kinds of bottled nitrogen sold on the market, the dust content in the air is 1140-265 grains / L (0.3 μ m) The dust content in the gas output from the gas generation station is more than 600 particles / L (≥ 0.3 μ m) Generally, the dust content of gas for production is not more than 3.5 particles / L (≥ 0.5 μ m) Therefore, dust filter shall be installed For the gas used in the pharmaceutical industry, the filter used at the end of the pipeline mostly adopts microporous filter membrane The pore diameter of the filter membrane is different, including 0.22 μ m, 0.45 μ m, 1 μ m, 3 μ m, 5 μ m, etc., so the purification degree is also different The air filter can reach 100 levels for the dust with particle size ≥ 0.3 μ m, which is currently the main means used as the terminal purification The air filter has flat plate type, cylinder type and folding type, and it can be divided into several models according to the different gas flow 3 Drainage in clean area: drainage system in clean area refers to indoor drainage system The task of the indoor drainage system is to rapidly discharge the sewage discharged from washing and sanitary appliances and production equipment, as well as the rainwater and snow water falling on the roof to the outdoor drainage pipe At the same time, the cleaning requirements of the pharmaceutical production need to prevent the harmful gas, odor and harmful insect lamp in the outdoor drainage pipe from entering the room, producing microbial pollution, and for the treatment and comprehensive benefit of the outdoor sewage Therefore, the drainage system of clean area is also very important There are three types of sewage produced by the pharmaceutical industry: (1) domestic sewage includes the sewage discharged from sanitary wares, hand washing facilities and shower facilities; (2) production wastewater is the sewage and wastewater produced in the production process, including equipment and container washing water, cooling water, etc.; and (3) rainwater includes roof rainwater and melted snow water The indoor drainage system generally adopts the split system Besides the code for design of domestic sewage and drainage (tj13-74), relevant GMP regulations must also be observed The main measures are as follows: (1) the level 100 clean room should not be equipped with water buckets and floor drains, the level 10000 clean room should avoid the installation of water buckets and floor drains, and the number of water buckets and floor drains should be reduced to Zui low level in other levels of clean rooms (2) water trap or water sealing device must be set below the discharge outlet of equipment, cleaning appliances and drainage equipment connected with the sewer in the clean room (3) the floor drain in the clean room shall be made of materials that are not easy to corrode (the inner surface shall be bright and clean, such as stainless steel material), not easy to scale, with a sealing cover, easy to open, and can prevent waste water and waste gas from pouring back It is allowed to open the cover temporarily when washing the ground, or cover up when not in use If necessary, it shall be sterilized with disinfectant according to the product process requirements, so as to better prevent pollution( At present, a new type of special clean floor drain for the pharmaceutical industry has been developed in China; (4) the quality supervision department and the acid and alkali waste water produced in production should also be provided with special pipes, and PVC (plastic pipe or ABS engineering plastic pipe, acid and alkali treatment device should be used Shanghai Sujing Industry Co., Ltd if you have any need, you can pass with us at any time Thank you very much for your support and look forward to cooperating with you Thank you & bestragard! Suing Jinghua
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