Phone:
0086 28 87573647
+86 19150187139
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 purified water are shown in the table.
Project | Chinese Pharmacopoeia (2000 Edition) | European Medicines (2000 Supplement) = 1 * GB3 ① | United States Pharmacopeia (24th Edition) = 2 * GB3 ② |
Source | This product is prepared by distillation, ion exchange, reverse osmosis, or other suitable methods. | It is obtained from drinking water that meets legal standards through distillation, ion exchange or other suitable methods. | Drinking water that meets the legal requirements of the U.S. Environmental Protection Agency, the European Community, or Japan, and is prepared by appropriate methods. |
Properties | Colorless, clear liquid, odorless and tasteless | Colorless, clear liquid, odorless and tasteless | ――― |
pH | Compliant | ――― | ――― |
Ammonia | 0.3μg/ml | ――― | ――― |
Ammonium compounds, sulfates and calcium salts, nitrites, carbon dioxide, non-volatile substances | Compliant | ――― | ――― |
nitrates | 0.06μg/ml | 0.2μg/ml | ――― |
heavy metal | 0.5μg/ml | 0.1μg/ml | ――― |
Aluminum salts | ――― | This item needs to be controlled when used in the production of dialysis fluid. | ――― |
Easily oxidized | Compliant | Compliant | ――― |
Total organic carbon | ――― | 0.5 mg/L | 0.5 mg/L |
electrical conductivity | ――― | 4.3 μS/cm (20℃) | Compliant |
Bacterial endotoxins | ――― | 0.25 EU/ml | ――― |
Aseptic examination | ――― | ――― | Compliant with regulations (controlled when used in the preparation of sterile preparations) |
Microbial contamination correction standard = 3 * GB3 ③ | ――― | 100 cells/ml | 100 cells/ml |
① You may choose to monitor either Total Organic Carbon (TOC) or Easily Oxidizable Species in the European Pharmacopoeia.
②The 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 the fact that when the microbial contamination reaches a certain value, it indicates that the purified water system has deviated from the conditions for normal operation, and corrective measures should be taken to bring the system back to normal operating status.
