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Water is used as the basic raw material for drug production, the amount used in the process of drug production is very large, generally used for raw material cleaning, drug production process and preparation process of pharmaceutical preparations, pharmaceutical water is the lifeline of the pharmaceutical industry, so purified water equipment has become an important water supply system
.
Water demand in the pharmaceutical industry Water for pharmaceutical production: Process water (purified water and water for injection) for the production of pharmaceutical products is essential to the production process of pharmaceutical products, at least to meet the water quality standards
specified in the pharmacopoeia.
According to the scope of its use, the Chinese Pharmacopoeia divides pharmaceutical water into drinking water, purified water, water for injection and water for sterilization and injection
.
And clearly stipulate that the raw water of pharmaceutical process water must meet the drinking water sanitation standards
specified in GB5749.
Internationally, raw water that meets drinking water standards is usually used, purified water or water for injection obtained through certain procedures, which is used to participate in the process
of drug production.
Drinking water: Usually not directly involved in the pharmaceutical process, but in some Chinese medicine factories, it is commonly used as rinsing of medicinal materials, rough washing of tools, leaching of certain packaging materials and cooling water
of some pharmaceutical equipment.
Purified water: The electrolytes in the water are almost completely removed, and the insoluble colloidal substances and microbial particles, dissolved gases, organic matter, etc.
in the water have also been removed to a very low degree
.
Purified water is raw water that meets drinking water standards and is prepared by distillation, ion exchange, reverse osmosis or other suitable methods for medicinal purposes, without any additives
.
It may be used as a solvent or test water for the preparation of general pharmaceutical preparations, but may not be used in the preparation
of injections.
Generally, the remaining salt content in purified water should be controlled below 0.
1mg/L, and when the water temperature is 25 °C, its conductivity should be 0.
1 μs/cm, and above 25 °C, it is generally close to 0.
1 s/cm
.
Water for injection: The purity of water is similar to that of purified water, and the main difference with purified water is that the water does not contain microorganisms and pyrogen substances, and is obtained
by distillation of purified water.
It is required to monitor all preparation links at any time, and regularly clean and disinfect the equipment for the preparation and delivery of water for injection
.
Generally stored above 80 °C, warm cycle above 65 °C or sterile state below 4 °C, and used
within 12 hours of preparation.
The Chinese Pharmacopoeia stipulates that the water used for injection is the water prepared by distillation of purified water; Should comply with bacterial pyrogen test requirements; Water for injection must be produced, stored and distributed
under conditions that prevent the generation of pyrogens.
There are two methods for preparing water for injection in the United States Pharmacopeia, namely distillation and reverse osmosis
.
Water for injection can be used as a solvent or diluent for the preparation of sterilization preparations such as injections and eye drops; Cleaning
of containers for injection.
Sterilized water for injection, refers to the preparation of water for injection according to the production process of injection, is the water prepared by sterilization of water for injection, is sterile, pyrogen-free water, can be considered as a preparation
.