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Plastic Packaging: Interactions with Food and Pharmaceuticals

Plastics are the most important class of packaging materials. This successful handbook, now in its second edition, covers all important aspects of plastic packaging and the interdisciplinary knowledge needed by food chemists, pharmaceutical chemists, food technologists, materials scientists, process engineers, and product developers alike.

This is an indispensable resource in the search for the optimal plastic packaging. Materials characteristics, additives and their effects, mass transport phenomena, quality assurance, and recent regulatory requirements from FDA and European Commission are covered in detail with ample data.

Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164

Covering the recently passed 45 CFR, and the parallel CFR 21 Part 11 and HIPAA regulations 160, 162, and 164, this book provides guidance for purchasing, installing, validating, and managing commercial off-the-shelf software data for collection and retention. Addressing the interface between these regulations and how to be in compliance with them, the authors cover audit trails, validation, documentation, training, and how to establish and maintain security and accountability. They discuss what the regulations mean in terms of industry standard, explain the audit function for facilities that are subject to the newer HIPAA regulations, and present the standards for documentation.

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Filtration and Purification in the Biopharmaceutical Industry, Second Edition

Expanded to include extensive new material on the critical role of purification and detailing the significant advances in filtration science and technology, this Second Edition of a classic reference provides state-of-the-science information on all aspects of filtration and purification, including current methods, processes, technologies, equipment, and the latest industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries.

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Physical Characterization of Pharmaceutical Solids

This unique reference provides the first systematic coverage available in a single-source volume on the application of materials science techniques to the pharmaceutical field-offering a comprehensive program for the physical characterization of raw materials, drug substances, and formulated products.

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Methods in Enzymology, Volume 391: Liposomes, Part E

Liposomes are cellular structures made up of lipid molecules. Important as a cellular model in the study of basic biology, liposomes are also used in clinical applications such as drug delivery and virus studies. Liposomes Part E is a continuation of previous MIE Liposome volumes A, B, C and D.
* One of the most highly respected publications in the field of biochemistry since 1955
* Frequently consulted, and praised by researchers and reviewers alike
* Truly an essential publication for anyone in any field of the life sciences

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Handbook of Preformulation: Chemical, Biological, and Botanical Drugs

Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct phase of new drug development. Entirely focused on preformulation principles, this handbook provides detailed descriptions of preformulation methodologies, gives a state-of-the-art description of each technique, and lists the currently available tools useful in providing a comprehensive characterization of a new drug entity.

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ORA Quality Manual, January 2007

The ORA Quality Manual contains the required policy elements to structure the Office of Regulatory Affairs (ORA) Quality Management System (QMS). The anticipated audience for this manual includes those in the public, regulated industry, counterpart agencies, and FDA who wish to understand the ORA QMS. Use of this manual presumes some understanding of quality system principles and standards.

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Packaging Closures and Sealing Systems (Sheffield Packaging Technology)

Packaging closures have undergone much evolution and development in recent years, and their functions have grown beyond simply allowing easy access and reclosing, This volume examines the technologies relevant to packaging closures and sealing systems. It features chapters contributed by top professionals in the packaging industry. To date, this is the only book dedicated to this important area. It is organized according to the various types of packagingmetal, glass, plastics, flexible, and composite containers. One chapter explores child resistant mechanisms, tamper evidence, and openability; the book also includes a chapter on quality assessment.