3.3.1 Bulk purified water (BPW) should be prepared from a drinking-water source as a minimum-quality feed-water. It should meet the relevant pharmacopoeial specifications for chemical and microbiological purity with appropriate action and alert limits. It should also be protected from recontamination and microbial proliferation. BPW may be prepared by a
combination of reverse osmosis (RO) RO/electro-deionization (EDI) and vapour compression (VC). Alert levels for the water system should be determined from knowledge of the system and are not specified in the pharmacopoeias.
散装纯化水（BPW）应采用饮用水源作为最低质量源水来制备。它应该符合相关的药典质量标准中化学和微生物纯度，并制订有适当的行动和警戒限。它还应该保护不受再次污染和微生物滋生。BPW可以采用RO，RO/EDI和蒸汽压缩方式制备。水系统的警戒限应从对系统的了解来制订，在药典中并未指定。 3.4 Bulk highly purified water 散装高纯水
3.4.1 Bulk highly purified water (BHPW) should be prepared from drinking water as a
minimum-quality feed-water. BHPW is a unique specification for water found only in the European Pharmacopoeia. This grade of water must meet the same quality standard as water for injections (WFI), including the limit for endotoxins, but the water-treatment process used may be different. Current production methods include, for example, double-pass RO coupled with other suitable techniques such as ultrafiltration and deionization.
散装高纯水（BHPW）源水最低应为饮用水。BHPW质量标准仅在欧洲药典中提出。该级别水必须符合注射用水（WFI）相同的质量标准，包括内毒素限度，但制水工艺可以是不同的。目前的制水方法包括，例如，两次反渗透配合其它适当的技术，如超滤和去离子。 BHPW may be prepared by a combination of different methods such as RO, ultrafiltration and deionization.
BHPW可能需要采用不同方法联合制备，如RO、超滤和去离子。
3.4.2 BHPW should also be protected from recontamination and microbial proliferation. BHPW也需要保护不受再污染和微生物滋生。
3.4.3 BHPW and WFI have identical microbiological requirements. BHPW和WFI有相同的微生物要求。 3.5 Bulk water for injections 注册用散装水
3.5.1 Bulk water for injections (BWFI) should be prepared from drinking-water (usually with further treatment) or purified water as a minimum-quality feedwater. BWFI is not sterile water and is not a final dosage form. It is an intermediate bulk product and suitable to be used as an ingredient during formulation. BWFI is the highest quality of pharmacopoeial WPU.
散装注射用水（BWFI）应采用饮用水（一般会进一步处理）或纯化水作为最低原水质量来制备。BWFI不是无菌水，不是最终的剂型。它是一个中间散装产品，可以在配方中作为一种成分加入。BWFI是药典WPU中质量最高的水。
3.5.2 Certain pharmacopoeias place constraints upon the permitted purification techniques as part of the specification of the BWFI. The International Pharmacopoeia and the European Pharmacopoeia, for example, allow only distillation as the final purification step.
某些药典对纯化方法作为BWFI质量标准的一部分进行了限制。国际药典和欧洲药典，例如，仅允许将蒸馏作为最终纯化步骤。
3.5.3 BWFI should meet the relevant pharmacopoeial specifications for chemical and microbiological purity (including endotoxin) with appropriate action and alert limits.
BWFI应符合相关的药典质量标准中化学和微生物纯度（包括内毒素），并制订有适当的行动限和警戒限。
3.5.4 BWFI should also be protected from recontamination and microbial proliferation. BWFI还应保持免受再污染和微生物滋生。 3.6 Other grades of water 其它级别水
3.6.1 When a specific process requires a special non-pharmacopoeial grade of water, its
specification must be documented within the company quality system. As a minimum it must meet the pharmacopoeial requirements relating to the grade of WPU required for the type of dosage form or process step.
如果特定的工艺要求特殊的非药典级别水，其质量标准必须记录在公司的质量体系中。水的质量至少必须满足该类型剂型或工艺步骤的WPU级别相关的药典要求.
4. Application of specific types of water to processes and dosage forms 特定类型的水在工艺和剂型中的用途
4.1 Product licensing authorities specify the minimum grade of WPU that must be used during the manufacture of the different dosage forms or for different stages in washing, preparation, synthesis, manufacturing or formulation.
产品许可批准中指定了在不同剂型，或清洁、制备、合成、生产或配方时所必须使用的最低级别的WPU。
4.2 The grade of water used should take into account the nature and intended use of the intermediate or finished product and the stage in the manufacturing process at which the water is used. 使用何级别的水，应考虑中间体或成品的特性及使用目的，和生产工艺中使用水的步骤。 4.3 BHPW can be used in the preparation of products when water of high quality (i.e. very low in microorganisms and endotoxins) is needed, but the process stage or product requirement does not include the constraint on the production method defined in some of the pharmacopoeial monographs for BWFI.
BHPW可以用于需要更高质量的水（即低的微生物和内毒素），但工艺步骤或产品要求对水的制备方法在某些药典中对BWFI没有严格限制的情况下药品生产。
4.4 BWFI should be used in the manufacture of injectable products for dissolving or diluting substances or preparations during the manufacturing of parenterals, and for manufacture of sterile water for preparation of injections.
BWFI应用于注射级产品生产中的物质的溶解或稀释，或在注射剂生产过程中制备，以及注射制剂用无菌水的生产。
BWFI should also be used for the final rinse after cleaning of equipment and components that come into contact with injectable products as well as for the final rinse in a washing process in which no subsequent thermal or chemical depyrogenization process is applied.
BWFI还应用于注射级产品生产设备的清洁后淋洗，以及与注射级产品接触的部件表面的清洁后淋洗，以及无热力学或化学去热源工艺中洗涤工艺的最终淋洗。
4.5 When steam comes into contact with an injectable product in its final container or with equipment for preparing injectable products, it should conform to the specification for BWFI when condensed. 如果蒸汽会与注射级产品在最终包装容器中有接触，或与制备注射级产品的设备有接触，则其冷凝水应满足BWFI的质量标准。 5. Water purification systems 水纯化系统
5.1 General considerations 一般考虑
5.1.1 The specifications for WPU found in compendia (e.g. pharmacopoeias) do not define the permissible water purification methods apart from for BWFI (refer to section 3.5). 除BWFI外（参见3.5部分），药典中的WPU质量标准并未指定允许的纯化方法。 5.1.2 The chosen water purification method or sequence of purification steps must be appropriate to the application in question. The following should be considered when selecting the water treatment method:
选择的水纯化方法，或一系列的纯化步骤，必须适用于所要求的目的。以下是在选择水处理方法时应考虑的内容：
— the final water quality specification; — 最终水质量标准
— the quantity of water required by the user; — 使用者所需的水量
— the available feed-water quality and the variation over time (seasonal changes); — 可以得到的进水质量，随时间的变动性（季节性变化）
— the availability of suitable support facilities for system connection (raw water, electricity,
heating steam, chilled water, compressed air, sewage system, exhaust air);
— 适当的支持性系统连接设施可获得性（原水、电、加热蒸汽、冷却水、压缩空气、排水
系统、排气）
— the sanitization strategy; — 消毒策略
— the availability of water-treatment equipment on the market; — 水处理设备在市面上是否可获得
— the reliability and robustness of the water-treatment equipment in operation; — 水处理设备操作中可靠性和耐用性
— the yield or efficiency of the purification system; — 纯化系统的产水率和效率
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