主题：【已应助】求助英文书Pharmaceutical Water: System Design, Operation, and Validation

【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
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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
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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 ...
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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 ...
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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 ...
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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.
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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 ...
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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 ...
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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 ...
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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. ...
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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 ...
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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.
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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 ...
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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 ...
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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 ...
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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 ...
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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. ...
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