【序号】：ISBN-10: 1574910272 【作者】： Collentro, William V. 【题名】：Pharmaceutical Water: System Design, Operation, and Validation 【期刊】：Informa Healthcare 【年、卷、期、起止页码】： 694 pages 15 December 2010 【全文链接】： http://informahealthcare.com/doi/book/10.3109/9781420077834
By: Collentro, William V. Published By: Informa Healthcare Published Date: 15 December 2010 Edition: 2 PDF for Digital Editions : US$ 300.00 Read Online (what's this?)
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A major new work on all aspects of water, the most used raw material ingredient in the pharmaceutical and biotechnology industriesa "used as an excipient in pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent.
Drawing on the authora (TM)s extensive field experience with more than 400 pharmaceutical and related water purification systems, the texta (TM)s numerous case studies illuminate the best and worst of water system design and operation.
The expanded Second Edition also includes new chapters that discuss:
passivation and electropolishing rouging ozone systems and accessories USP purified water and water for injection individual component process and instrumentation diagram (PIDs) with control interface documentation and specification requirements systems installation, start-up, and commissioning
Preface Chapter Opening | Online Chapter | Chapter PDF (53 KB) | PDF Plus (53 KB) Chapter 1 Introduction Water and steam used in the pharmaceutical industry and related disciplines are classified by various pharmacopeias. The U.S. Pharmacopeia (USP) classifies compendial waters as follows:Water for InjectionBacteriostatic Water for InjectionSterile Water ... Chapter Opening | Online Chapter | Chapter PDF (101 KB) | PDF Plus (101 KB) Chapter 2 Impurities in raw water It would be inappropriate to discuss the various unit operations configured in a water purification system without discussing the impurities present in raw water. The nature, type, and concentration of various impurities should define the water ... Chapter Opening | Online Chapter | Chapter PDF (185 KB) | PDF Plus (185 KB) Chapter 3 Pretreatment techniques Numerous water purification unit operations are employed as pretreatments to an ion removal technique. The selection of a pretreatment scheme is a function of several variables, including the nature of the feed water supply, the ion removal technique, the ... Chapter Opening | Online Chapter | Chapter PDF (848 KB) | PDF Plus (849 KB) Chapter 4A Ion removal techniques—reverse osmosis Ion removal is discussed in Chapters 4A, 4B and 4C. This chapter (4A) discusses primary ion removal by reverse osmosis. Chapter 4B discusses primary ion removal by ion exchange. Chapter 4C discusses post–reverse osmosis polishing ion removal techniques. Chapter Opening | Online Chapter | Chapter PDF (622 KB) | PDF Plus (623 KB) Chapter 4B Ion removal techniques—ion exchange Ion exchange, as an ion removal technique, has historically played a very important part in the production of pharmaceutical grades of water. While the use of reverse osmosis as a primary ion removal technique has increased dramatically over the last 20 ... Chapter Opening | Online Chapter | Chapter PDF (432 KB) | PDF Plus (432 KB) Chapter 4C Additional ion removal techniques The final section of this chapter discusses ion removal techniques other than classical ion exchange and reverse osmosis. The primary focus of this section is continuous electrodeionization (CEDI). Two ion removal techniques employing principles leading ... Chapter Opening | Online Chapter | Chapter PDF (562 KB) | PDF Plus (563 KB) Chapter 5 Distillation and pure steam generation Distillation is the primary process used for the production of USP Water for Injection for pharmaceutical applications. It is the only process allowed for the production of EP Water for Injection. USP essentially states that Water for Injection may be ... Chapter Opening | Online Chapter | Chapter PDF (880 KB) | PDF Plus (881 KB) Chapter 6 Storage systems and accessories There are many technical reasons for including storage systems in pharmaceutical water systems. In less complex distribution systems, a storage tank may simply provide a convenient method of repressurizing compendial water prior to a distribution loop. ... Chapter Opening | Online Chapter | Chapter PDF (844 KB) | PDF Plus (844 KB) Chapter 7 Ozone systems and accessories Ozone, an unstable powerful oxidant, may be dissolved in water and used as a very effective disinfecting agent in Purified Water systems. Ozone is injected into the Purified Water storage tank as a gas or dissolved in water on the basis of the method of ... Chapter Opening | Online Chapter | Chapter PDF (624 KB) | PDF Plus (624 KB) Chapter 8 Polishing components This chapter discusses various unit operations that could be positioned downstream of a storage system as “polishing” components. With the exception of distribution pumps, polishing components do not apply to USP Water for Injection systems. Chapter Opening | Online Chapter | Chapter PDF (564 KB) | PDF Plus (565 KB) Chapter 9 Distribution systems—design, installation, and material selection This chapter discusses distribution systems—an important part of any pharmaceutical water system. The materials of loop construction are one of the important considerations. Certainly, 316L stainless steel should be used for all Water for Injection ... Chapter Opening | Online Chapter | Chapter PDF (882 KB) | PDF Plus (885 KB) Chapter 10 Controls and instrumentation There are numerous texts available that discuss controls and instrumentation. The purpose of this chapter is to provide a general overview of controls and instrumentation for pharmaceutical water systems. Chapters 11 and 13 will discuss specification ... Chapter Opening | Online Chapter | Chapter PDF (633 KB) | PDF Plus (633 KB) Chapter 11 System design and specification guidelines It is inappropriate to discuss the design, installation, validation, operation, and maintenance of pharmaceutical water purification systems without providing examples of required specifications and associated documentation. Specifications are an ... Chapter Opening | Online Chapter | Chapter PDF (244 KB) | PDF Plus (245 KB) Chapter 12 System installation, start-up, and commissioning System installation, start-up, and commissioning are important to the successful long term operation of a pharmaceutical water purification system. Throughout this text, emphasis has been placed on proper component design, component and system ... Chapter Opening | Online Chapter | Chapter PDF (119 KB) | PDF Plus (120 KB) Chapter 13 System validation Validation is a requirement for USP/EP/JP Purified Water and Water for Injection systems. Many pharmaceutical water purification systems have also established internal “qualification” programs, with the same general structure as a validation program. ... Chapter Opening | Online Chapter | Chapter PDF (246 KB) | PDF Plus (247 KB)
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