Rarefied water, inject uses water (clean vapour) systematic test and verify water of the first section, overview is the dosage in medicaments production the biggest, use a kind of the widest raw material, use at producing the preparation of process and medicaments preparation. Chinese pharmacopoeia (2000 edition) in what receive the pharmacy that carry to use water, the range that uses because of its differs and cent uses water and sterilization inject to use water for rarefied water, inject. The raw water that makes officinal water is the tap water that tap water company supplies or deep well water normally, its quality must accord with GB5749-85 of level of state of People's Republic of China " standard of sanitation of life drinking water " . Raw water cannot use as directly the preparation of preparation or experiment use water. Rarefied water is what law of distill of raw water classics, ion exchange law, reverse osmosis law or other and appropriate honest legal system get to supply officinal water, do not contain any additional agents. Because all sorts of production methods are put in the possibility of different pollution, because this produces device to want special attention to whether have microbial pollution to each, to its each place and effluent water often should be monitored, especially these place out of service when the reuse after a few hours. Rarefied water can use water as the dissolvent that makes up common medicaments preparation to use or experiment, do not get those who be used at injection to make up. Inject is the water of earning of distill of rarefied water classics with water, should accord with requirement of bacterial endotoxin experiment. Inject must be in with water the design that prevents endotoxin generation grows below the condition, store up the outfit that reach cent. Inject can serve as the dissolvent that makes up injection to use with water. Sterilization inject uses water to produce craft preparation gain according to injection for inject with water, basically use at inject to use the thinner of the dissolvent of sterilization powder or inject fluid. Our country " standard " (edited 1998) formulary craft produces the water that uses in craft for medicines and chemical reagents with water, include drinking water, rarefied water, inject to use water. In addition craft still has with water: 1. Drench first water (regulation of GMP of high capacity injection, bacterium colony counts <0.5CFU/ml) ; 2. Drench eventually water (regulation of GMP of high capacity injection, bacterium colony counts <0.1CFU/ml) ; 3. Sterilization boiler refrigeration uses water (regulation of GMP of high capacity injection, bacterium colony counts <0.01CFU/ml) ; 4. The bate water of other utility, refrigeration uses ammonia water to wait. The dimensions of water treatment system depends on the requirement of water consumption of raw water water quality, production and craft to water quality, what water quality of water of its Central Plains and craft decide to make current Cheng to the requirement of water quality is numerous brief, and the size that water consumption decides equipment only. Generally speaking when raw water is tap water, the device of pretreatment is less, and be opposite when craft when the demand of water quality is higher, use at going ionic water, except bacterium and the equipment that remove particle more complete. Change of trends of water treatment system is bigger, raw water several days ago sampling result often is invalid after a few days; And on the other hand, these raw water are used to again however the medicines and chemical reagents with large quantities of extremely high production that measure the land, accordingly Cong Mou is planted degree, water treatment device is fluky, must undertake test and verify beforehand, make be monitored closely daily and be controlled next. The purpose of test and verify of water system all depends on test below a variety of situations that system of this water treatment may produce in future, supply amount and quality ground qualification steadily to use water likely, test and verify means the evidence that should provide sex of this respect character. Want to finish this one job, it is with respect to need inside a longer time, to the system the state below different moving condition has sampling test. The rarefied water that this chapter basically elaborates drug production company to be used generally (Purified Water) , inject uses water (Water For Injection) , include clean vapour (Pure Steam) test and verify. The bate water that as to certain and specific production craft uses (the bate water that uses like boiler) , the refrigeration that high capacity injection uses uses water, drench first a few canto are water, medium after drenching the detailed such as water, ammonia water sees eventually about producing the treatise in craft test and verify. Sterilization inject can regard injection as look upon with water, detailed sees the concerned content of injection test and verify. The technology that the 2nd GMP uses the requirement medicines and chemical reagents of water to produce a business to craft uses water basically is the water that the working procedure place such as the purificatory, catharsis that the working procedure such as bottle, burden and production of raw material drug wash in showing preparation is produced uses. The name of water should avoid and the production process of water is concerned, if go ionic water, remove brine, distilled water such name, namely the production process of water and its name unhook, undertake classified to water according to quality index from chemistry and microbial angle however (if Chinese pharmacopoeia stipulates rarefied water can use 3 kinds of different methods,make, it is better to still can have possibly in the future method) . Inject passes distillation law with rarefied water commonly with water (still have reverse osmosis law and law exceeding filter) make, chemical purity is as high as 99.999% , without heat former. Because process of pure steam preparation and the process that use water with inject of distilled water preparation are same, can use distilled water of same table much effect machine or alone pure vapour generator, reason puts pure vapour in inject to discuss together with water. Drug production technology sees watch 2 with the utility of water - 20. Drinking water of requirement of water quality of utility of water quality category 1, preparation is rarefied the fountainhead of water 2, profess to convinced is washed at the beginning of agent bottle 3, of equipment, container wash first 4, Chinese traditional medicine material, Chinese traditional medicine of prepared herbal medicine in small pieces ready of decoction clean, infiltration and extraction should accord with sanitation of life drinking water
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