Pharmaceutical water is almost present in every aspect of drug and related product production, making it the "lifeline" of drug and related product production. As an important raw material, water directly affects the quality of pharmaceutical products. Therefore, it must meet the quality standards specified in the pharmacopoeia, just like other raw and auxiliary materials used in drug production.

    Production of large infusion, injection, oral liquid and other preparations

    Extraction, washing, injection, and capsule production of active pharmaceutical ingredients

    Production of eye drops and care solutions

    Hospital blood induction room, biochemical analysis room, and operating room sterile water

    Multi effect distilled water machine raw water, bottle washing water

    Cosmetics process water, detergent water

    Biochemical drug products, diagnostic reagents

 

    1) Potable Water: usually tap water or deep well water supplied by water companies, also known as raw water, whose quality must comply with the national standard GB5749-85 "Sanitary Standards for Drinking Water". According to the 2000 Chinese Pharmacopoeia, drinking water cannot be directly used as preparation or testing water for formulations.

    2) Purified Water: Pharmaceutical grade water produced from raw water through distillation, ion exchange, reverse osmosis, or other suitable methods, without any additives. Purified water can be used as a solvent or experimental water for preparing ordinary pharmaceutical preparations, and should not be used for the preparation of injections. Purified water prepared by non heat treatment methods such as ion exchange, reverse osmosis, ultrafiltration, etc. is generally also known as deionized water. Purified water prepared by distillation using a specially designed distiller is generally referred to as distilled water.

    3) Water for Injection: Purified water is used as raw water, distilled in a specially designed distiller, condensed and cooled, and then prepared by membrane filtration. Injection water can be used as a solvent for preparing injections.

    4) Sterile Water for Injection: Water prepared for injection according to the injection production process. Sterilized injection water is used as a solvent for sterilizing powders or as a diluent for injection solutions.

 

    According to the GMP (1998 revision) definition issued by the FDA, "Purified water is water prepared for medicinal use by distillation, ion exchange, reverse osmosis, or other suitable methods, without any additives

    The appendix of the Chinese Pharmacopoeia (2010 edition) defines: "Purified water is pharmaceutical water prepared from drinking water by distillation, ion exchange, reverse osmosis, or other suitable methods. Its quality should comply with the regulations under the purified water item in Part II of the Chinese Pharmacopoeia. Purified water does not contain any additives." It also stipulates: "Each production process should be strictly monitored to prevent microbial contamination

    Article 34 of GMP (1998 Revision) stipulates: "The preparation, storage, and distribution of purified water and injection water should prevent the growth and contamination of microorganisms. The materials used in storage tanks and pipelines should be non-toxic and corrosion-resistant. The design and installation of pipelines should avoid dead corners and blind pipes. Storage tanks and pipelines should have cleaning and sterilization cycles specified

    The General Provisions of the Appendix of GMP (1998 Revision) clearly stipulate that "the validation content of the drug production process must include the process water system".

    1) Overview of Purified Water Treatment System

    There is no fixed mode for the purified water preparation system. The commonly used procedure is: using drinking water as raw water, the first step is pre-treatment (pretreatment) to remove suspended solids, organic matter, colloids, bacteria and other impurities, and remove residual chlorine, so as to reduce the turbidity of the water to below 1 degree; The second step is desalination, which removes inorganic substances and oxygen in the form of ions from water; The third step is post-processing (refinement) to further remove extremely fine particles, bacteria, and killed bacterial remnants.

    2) Principles for selecting system equipment combinations:

    Meet the quality requirements for purified water;

    Meet the requirements of water production efficiency;

    Minimize energy consumption as much as possible;

    Convenient for maintenance and management.

 

    1) Drinking water: It should comply with the national standard of the People's Republic of China, "Sanitary Standards for Drinking Water" (GB5749-2008)

    2) Purified water: It should comply with the purified water standards listed in the 2010 Chinese Pharmacopoeia. In the water production process, online detection of the electrical resistivity value of purified water is usually used to reflect the concentration of various ions in the water. The electrical resistivity of purified water in the pharmaceutical industry should usually be ≥ 0.5M Ω At CM/25 ℃, the electrical resistivity of purified water used for flushing injection and eye drop containers should be ≥ 1M Ω CM/25 ℃.

    3) Injection water: It should comply with the injection water standards listed in the 2010 Chinese Pharmacopoeia.