水处理技术的改善对于制药企业意味着什么？

What Water Treatment Advancements Mean For Pharma

水处理技术的改善对于制药企业意味着什么？

By Mike Henley,Ultrapure Water Journal and Industrial Water Treatment

Pharmaceuticalwater is key to the production of pharmaceutical drug products, many of whichrequire high-purity water. This is water purified according to guidelines asdefined by the USP or other pharmacopeias.

医药用水是药品生产的关键,其中许多需要高纯度的水。这是根据USP或其他药典作为指南而被定义的纯化水。

There have beena number of technological advancements in high-purity pharmaceutical-gradewater. Unlike other industries, however, changes in the use of high-puritywater systems have often been in response to compendial and regulatory changesrather than a desire to innovate.

虽然高纯度的医药用水在技术层面已经取得了许多进步。但是医药行业与其他行业不同，高纯度水系统的技术革新往往是对药典和监管变化的回应，而不是来自对创新的愿望。

To start, it’suseful to provide some context about pharmaceutical water’s place in the largerwater world. The category known as ultrapure water (UPW) itself is used by endusers in four main industries: life sciences, microelectronics, powergeneration, and specialty applications. Each industry’s definition of UPW isunique and their methods to produce this water, and requirements for materialsof construction (piping, valves, storage tanks, etc.), vary. Treated UPW thatmeets requirements for a power station would be unacceptable for apharmaceutical plant. And purified water meeting pharma plant quality standardsdoes not meet the stricter requirements found in the microelectronics industry.

首先，提供一些医药用水的背景（在水世界的地位）是有用的。超纯水被用于四个主要行业：生命科学，微电子，发电和专业应用。每个行业对超纯水的定义都是独一无二的并且它们对生产这种水的方法和与之接触的管道，阀门，储罐等建筑材料的要求各不相同。经过处理的超纯水能够满足发电站要求，但是对于制药厂来说是不可接受的。而符合制药厂质量标准的纯水却不达不到微电子行业更严格的要求。

For pharma, the water treatment guidelines are based around pharmacopeias,of which the USP, European Pharmacopeia (EP), and Japanese Pharmacopeia (JP)are among the most influential. The Indian Pharmacopeia and ChinesePharmacopeia are also growing in importance. Of course, facilities providingproducts to other regions follow the pharmacopeias applicable for those marketsthey sell into. For example, an Indian plant supplying the European marketfollows EP guidelines when purifying water used to make products sold in thatmarket.

对于制药公司而言，水处理指南以药典为基础，其中USP，欧洲药典（EP）和日本药典（JP）是最具影响力的药典。印度药典和中国药典也越来越重要。当然向其他地区提供产品的（水）设备遵循并适用于他们销售市场的药典。例如当印度工厂生产的药品供应欧洲市场时，用于生产药品的纯化水须遵循EP指南。

On theregulatory side, the U.S. FDA administers the USP treatment guidelines throughinspections to validate system performance, as well as by taking enforcementaction when problems are found. Because pharma is a global industry, the FDA sendsits staff internationally to nations like India to inspect and validate atreatment system when the plant’s products are sold into the U.S. market.

在监管方面，美国FDA通过检查来验证（水）系统性能并在发现问题时采取强制措施来管理USP治疗指南。由于制药行业是一个全球性的行业，因此FDA将其工作人员派往印度等国家，以便在厂的药品销往美国市场时检查和验证其水处理系统。

Water FlowsThroughout Pharma

Pharmaceuticalwater falls under several classifications, based on the final application.Examples include bacteriostatic water for injection, purified water, sterilepurified water, and water for injection (WFI). Other examples are listedin Table 1, which also provides an overview of the concernsand uses for pharmaceutical-grade waters. Outside of being used as aningredient, pharmaceutical water has multiple other applications, includingcontainer and equipment cleaning, intravenous fluids, product contact ofingredient, product contact of medical device (cleaning), and reagent orsolvent in drug manufacturing (but not in final product).

根据最终应用，医药用水分为几类，包括注射用的抑菌水，纯净水，无菌净化水和注射用水。表1列出了一些示例，其中还包括了医药用水和用途的概述。在用作成分之外，医药用水还有其他多种应用，包括容器和设备清洁，静脉注射液，成分的产品接触，医疗器械的产品接触（清洁）以及药物制造中的试剂或溶剂（但不是最终的产品）。

Table 1 Overviewof Pharmaceutical Water and Concerns

Specific water treatment concerns within pharma includechemical/microbial/ endotoxin contamination and case-specific controls forcertain types of pharmaceutical water (i.e., aluminum for water forhemodialysis). Life science facilities, including pharma plants, are requiredto use feedwater that meets drinking water standards as set forth by the U.S.EPA, similar agencies in the country the plant is located, or WHO. Sinceincoming water is already clean, water pretreatment generally focuses aroundchlorine removal to protect reverse osmosis (RO) membranes. Common technologiesmay be activated carbon or metabisulfite.

制药行业一直关注着特定的水处理问题，包括化学/微生物/内毒素污染和某种类型的医药用水（即用于血液透析的水的铝）的特定控制。生命科学设施(包括制药厂)必须使用符合美国 EPA、工厂所在国家的类似机构或世界卫生组织规定的饮用水标准的给水。由于进水已经是干净的,水的预处理通常围绕着除去氯离子展开工作，目的是保护反渗透 (RO) 膜。常见的技术也许是活性炭吸附或亚硫化物还原技术。

The main treatment system may includeion exchange (IX), electrodeionization (EDI), RO, distillation, ultrafiltration(UF), microfiltration (MF), ultraviolet (UV), and ozone. The most commonmaterial of construction for distribution systems and storage tanks isstainless steel, which can be heat sanitized and carry hot water. Commoninstruments used to measure water quality are total organic carbon (TOC) andconductivity.

主要的水处理系统可能包括离子交换（IX），电去离子（EDI），RO，蒸馏，超滤（UF），微滤（MF），紫外（UV）和臭氧。输送系统和储存罐所使用的最常见的结构材料是不锈钢，它能够被热消毒并且可以携带热水。总有机碳（TOC）和电导率是最常见用于衡量水质的指标。

What’s DrivingNew Water Treatments?

One key factorthat drives the choice of water treatment technologies among pharma companiesis regulation and changes in the USP guidelines over time. So, unlike otherusers of UPW, pharma companies tend to move slowly and carefully when adoptingnew treatment technologies. Many times, innovation in pharmaceutical watersystems is driven because of changes in the USP chapters, not because it is thebest available technology for a particular need.

推动制药公司选择水处理技术的一个关键因素是USP指南的监管和变化。因此，与UPW的其他使用者不同，制药公司在采用新的治疗技术时往往比较迟缓且行动谨慎。很多时候，制药水系统的创新是由USP章节的变化而驱动的，而不是因为它是满足特定需求的最佳可用技术。