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Biotechnology: Quality Assurance and Validation provides a
practical, detailed discussion of what issues Quality Assurance and
Quality Control need to identify for effective control in the
preparation of biotechnology products. The book presents a series
of topics that define some of the unique challenges facing
biotechnology companies in producing biopharmaceutical products.
The topics selected address quality and validation issues, starting
with the cryopreservation of cell lines through the filling and
finishing of the product. It includes a validation guide, a clear
presentation of how to use filtration effectively, a synoptic view
of cleaning procedures, and much more.
Completely updated and enlarged to three volumes (originally
published as two volumes), the Second Edition of Pharmaceutical
Dosage Forms: Parenteral Medications examines every important
aspect of sterile drug products. This volume (3) offers
comprehensive coverage of medical devices, quality assurance and
regulatory issues.;This in-depth reference and text: discusses
regulatory requirements in record-keeping based on the US Food and
Drug Administration's (FDA) Current Good Manufacturing Practices;
places special emphasis on methods of detecting, counting and
sizing particles; offers new perspectives on contemporary
validation concepts and how they affect the validation process;
explains current FDA enforcement activities, the voluntary
compliance policy, select court cases, and how these relate to
parenterals; provides recent materials on the use of audits as a
means of verifying the efficacy of manufacturing control systems;
highlights new US regulations for medical devices; and examines
quality assurance, including new information on biological control
tests for medical device materials.;With the contributions of
leading experts, volume 3 of Pharmaceutical Dosage Forms:
Parenteral Medications is intended as a day-to-day reference for
pharmacists, medical device manufacturers, quality control and
regulatory personnel, chemists and drug patent and litigation
attorneys, as well as a text for upper-level undergraduate,
graduate and continuing-education students in the pharmaceutical
sciences.
This book covers the principles of cryopreservation as they relate
the preservation of viable cells and cell materials being developed
for biopharmaceutical applications. Topics include: the principles
of freezing and thawing cells, physiochemical phenomena, process
and system design options, method selection considerations,
preservation procedures, cryoprotectant additives, freeze-drying
human live virus vaccines, and transport system selection criteria.
Contributions from well-known experts such as Steven S. Lee, Thomas
C. Pringle, William H. Siegel, Richard Wisniewski, and Fangdong Yin
make this the single most important study available.
Includes a guide for troubleshooting of film-coated products Lists
trademarked ingredients and equipment for film coating Presents a
checklist for a QC coating-defect reporting program This book is a
complete, authoritative resource on the coating of tablets,
capsules, and other solid dosage forms of therapeutic agents.
Fourteen authors cover the industry's technologies. The book begins
with a full discussion of the primary processes -- sugar coating,
film coating, and microencapsulation -- as well as the rationale
for coating, methodologies, formulations, processing methods, and
equipment and cleaning. Then it explores automation of the coating
process, including hardware and software requirements. Finally, the
book examines major stability and quality control issues.
Regulations underlie all discussions.
In this unique book, experts describe practices applicable to the
large-scale processing of biotechnological products. Beginning with
processing and bulk storage preservation techniques, the book
provides strategies for improving efficiency of process campaigns
of multiple products and manufacturing facilities for such
processing techniques. Large-scale chromatography for the
purification of biomolecules in manufacturing and lyophilization of
protein pharmaceuticals are discussed. Includes a case study on
blow-fill-seal processing technology and a chapter on economic and
cost factors for bioprocess engineering.
Sterile Pharmaceutical Products: Process Engineering Applications
addresses the key concepts and applications of the sterile
pharmaceutical manufacturing industry. It covers elements of the
design, installation, validation, and usage of critical processes
associated with sterile product manufacture. From water systems to
clean-in-place systems, to sterile powder handling and robotic
applications in sterile production environments, this book
addresses the issues of system implementation, integration, and
operations. Written by recognized experts and peer reviewed for
accuracy, all chapters include references to supplemental resources
and numerous illustrations.
Completey revised and updated, this second edition requires three
volumes to accommodate the many changes in the science and
technology associated with these products. Volume 1 covers
formulation and product development, with chapters on the dosage
form and its historical development. Volume 2 discusses the
principles, characteristics, and operations of the processing
functions of sterile drug products. Volume 3 offers comprehensive
coverage of medical devices, quality assurance, and regulatory
issues and explains current FDA enforcement activities, the
voluntary compliance policy, select court cases, and how these
relate to parenterals.
This book covers the principles of cryopreservation as they relate
the preservation of viable cells and cell materials being developed
for biopharmaceutical applications. Topics include: the principles
of freezing and thawing cells, physiochemical phenomena, process
and system design options, method selection considerations,
preservation procedures, cryoprotectant additives, freeze-drying
human live virus vaccines, and transport system selection criteria.
Contributions from well-known experts such as Steven S. Lee, Thomas
C. Pringle, William H. Siegel, Richard Wisniewski, and Fangdong Yin
make this the single most important study available.
This book is a complete, authoritative resource on the coating of
tablets, capsules, and other solid dosage forms of therapeutic
agents. Fourteen authors cover the industry's technologies. The
book begins with a full discussion of the primary processes --
sugar coating, film coating, and microencapsulation -- as well as
the rationale for coating, methodologies, formulations, processing
methods, and equipment and cleaning. Then it explores automation of
the coating process, including hardware and software requirements.
Finally, the book examines major stability and quality control
issues. Regulations underlie all discussions.
Biotechnology: Quality Assurance and Validation provides a
practical, detailed discussion of what issues Quality Assurance and
Quality Control need to identify for effective control in the
preparation of biotechnology products. The book presents a series
of topics that define some of the unique challenges facing
biotechnology companies in producing biopharmaceutical products.
The topics selected address quality and validation issues, starting
with the cryopreservation of cell lines through the filling and
finishing of the product. It includes a validation guide, a clear
presentation of how to use filtration effectively, a synoptic view
of cleaning procedures, and much more.
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