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Process water in pharmaceutical manufacturing mainly refers to the water used in bottle washing and ingredient preparation processes during formulation production, as well as in the refining and washing processes during raw material production. The name of the water should avoid being related to its manufacturing process, such as deionized water, demineralized water, or distilled water. That is, the water's manufacturing process should be decoupled from its name, and instead, water should be classified according to quality indicators from a chemical and microbiological perspective (for example, the Chinese Pharmacopoeia specifies that purified water can be obtained by three different methods, and even better methods may be developed in the future).
Water for injection is generally obtained from purified water through distillation (and also reverse osmosis and ultrafiltration), achieving a chemical purity of up to 99.999% and being pyrogen-free. Since the process of preparing pure steam is the same as that of preparing water for injection from distilled water, the same multi-effect distillation machine or a separate pure steam generator can be used; therefore, pure steam is discussed together with water for injection.
The water quality standards for water for injection are shown in the table.
Project | Chinese Pharmacopoeia (2000 Edition) | European Pharmacopoeia (2000 Supplement) ① | United States Pharmacopeia (24th Edition) ② |
Source | This product is purified water obtained through distillation. | It is obtained by distillation of drinking water or purified water that meets legal standards through appropriate methods. | It is obtained by purifying drinking water that meets the legal requirements of the U.S. Environmental Protection Agency, the European Community, or Japan through distillation or reverse osmosis. |
Characteristics | Colorless and clear, odorless and tasteless | Colorless and clear, odorless and tasteless | ――― |
pH | 5.0-7.0 | ――― | ――― |
ammonia | 0.2μg/ml | ――― | ――― |
Chloride, sulfate and calcium salts, nitrite, carbon dioxide, non-volatile substances | Compliant | ――― | ――― |
nitrates | 0.06μg/ml | 0.2μg/ml | ――― |
heavy metal | 0.5μg/ml | 0.1μg/ml | ――― |
Aluminum salts | ――― |
① The European Pharmacopoeia allows for the monitoring of either Total Organic Carbon (TOC) or easily oxidizable substances.
② The United States Pharmacopeia (USP) stipulates: a. For purified water used by the company itself, TOC and inversion rate should be monitored. Commercially used purified water should meet the testing requirements for sterile pure water. The table lists the monitoring items for purified water used by the company itself. b. Purified water must not be used to prepare parenteral preparations.
③ The microbial contamination correction standard refers to a certain value indicating that the purified water system has deviated from normal operating conditions, and corrective measures should be taken to bring the system back to normal operating status.
