Water can be divided into two main categories, batch water and sterilized water. Batch water is for immediate production and immediate use of water, while sterilized water is for production, packaging and sterilization, which can maintain microbial quality during the packaging shelf life. There are several specific types of sterilized water with different end-use, packaging requirements and other quality requirements.
Purified water can be used as an excipient in the manufacture of non-parenteral products. Other uses include cleaning certain equipment and contact parts of non-parenteral products. Unless otherwise specified, purified water is to be used for all tests and content determination (see General Rules and Requirements). Regardless of the spelling of the font and case, the water shall comply with the text of the purified water variety.
The water shall meet the requirements of ion and organic chemical purity inspection and shall be able to prevent microbial contamination. The minimum standard of raw water for producing purified water is that of drinking water. Raw water can be purified by unit operations, including deionization, distillation, ion exchange, reverse dialysis, filtration or other appropriate purification methods. Pharmaceutical purified water systems should be proven to reliably and consistently produce and deliver chemical and microbiological quality water. Purified water systems operating at room temperature are particularly affected by microbial membranes, which are a source of live microorganisms or endotoxins in effluent water. Therefore, the water system should be frequently disinfected, and monitoring of microorganisms, to ensure that the quality of microorganisms at the site of water use meets the requirements.
The purified water variety body is also available commercially in large packages. In contrast to sterile purified water, large package purified water is not required to be sterile. Large packages of unsterilized water are susceptible to microbial contamination or other quality changes. Such packaged water shall be prepared and stored in such a way as to limit microbial growth and/or immediate use before microbial growth makes it unsuitable for use. There is also the issue of packaging materials, which can get dissolved into the water. Although this variety is required to meet the same chemical purity requirements as batch water, the package leavers can make the package water less pure than batch water. It is the user's responsibility to ensure that the packaged water is fit for purpose when it is used for manufacturing, clinical or analytical purposes.
Water for injection is used in the manufacture of parenteral preparations and other preparations requiring the control of bacterial endotoxins. Other pharmaceutical uses include cleaning parts of certain equipment that come into contact with parenteral preparations. Raw water is pretreated for subsequent distillation. The finished water for injection should meet all the chemical quality requirements of purified water, and also meet the requirements of bacterial endotoxin examination. Because endotoxins are produced by certain bacteria and exist in water, the equipment and methods used in the purification, storage and distribution system for water for injection should reduce or prevent microbial contamination and remove endotoxins introduced into the initial water. Water for injection system should be certified for reliable and continuous production and distribution of quality water.
The body also includes large packages of water for injection for commercial use. In contrast to sterilized water for injection, large packaging water for injection is not required to be sterile. However, to prevent significant changes in microbial and endotoxin levels during storage, water for injection of the dosage form should be prepared and stored in an environment that limits microbial growth, and/or used before microbial proliferation renders it unfit for its intended use. And depending on the packaging material used, there may be packaging leachate into the water. Although this variety is required to meet the same chemical purity requirements as batch water, the package leavers can make the package water less pure than batch water. The nature of these impurities may render the water unsuitable for certain uses. Water for injection in large packages should be sterile to avoid quality changes caused by microbial contamination. Leavers from packaging materials may render the water unsuitable for some uses. Large packs of water for injection are used for manufacturing, clinical or analytical purposes, and it is the user's responsibility to ensure that such higher purity packs are fit for purpose.
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