Sterilization Validation and Routine Operation Handbook (2001)
Sterilization Validation and Routine Operation Handbook (2001)

Author: Anne F Booth

Publisher: CRC Press

Published: 2017-11-22

Total Pages: 155

ISBN-13: 1351357565

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The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes. Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook: Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.

Sterilization Validation and Routine Operation Handbook (2001)
Sterilization Validation and Routine Operation Handbook (2001)

Author: Anne F Booth

Publisher: CRC Press

Published: 2017-11-22

Total Pages: 170

ISBN-13: 1351357573

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The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes. Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook: Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.

Sterile Drug Products
Sterile Drug Products

Author: Michael J. Akers

Publisher: CRC Press

Published: 2016-04-19

Total Pages: 517

ISBN-13: 1420020560

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Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This

Sterilization Validation and Routine Operation Handbook
Sterilization Validation and Routine Operation Handbook

Author: Anne F. Booth

Publisher: CRC Press

Published: 1999-09-01

Total Pages: 142

ISBN-13: 9781566767569

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Stringent regulations require you to validate sterilization processes and step-by-step guidelines are needed to develop and implement a suitable validation program. Sterilization Validation and Routine Operation Handbook: Ethylene Oxide is the best practical guide available for the validation of EtO process. The information provided complies with ANSI/AAMI/ISO 11135: 1994, Medical devices-Validation and routine control of ethylene oxide sterilization which is based on a standard developed by the European Standardization Committee (CEN) entitled EN 550, Sterilization of medical devices- Validation and routine control of ethylene oxide sterilization. The text defines methods to assist you in the interpretation and understanding of the requirements in the standard and offers logical procedures for the validation and routine monitoring of your specific ethylene oxide process.

Pharmaceutical Dosage Forms - Parenteral Medications
Pharmaceutical Dosage Forms - Parenteral Medications

Author: Sandeep Nema

Publisher: CRC Press

Published: 2016-04-19

Total Pages: 420

ISBN-13: 1420086464

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This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the

Veterinary Pharmacology and Therapeutics
Veterinary Pharmacology and Therapeutics

Author: Jim E. Riviere

Publisher: John Wiley & Sons

Published: 2017-11-29

Total Pages: 1552

ISBN-13: 1118855779

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Veterinary Pharmacology and Therapeutics, Tenth Edition is a fully updated and revised version of the gold-standard reference on the use of drug therapy in all major veterinary species. Provides current, detailed information on using drug therapies in all major domestic animal species Organized logically by drug class and treatment indication, with exhaustive information on the rational use of drugs in veterinary medicine Includes extensive tables of pharmacokinetic data, products available, and dosage regimens Adds new chapters on pharmaceutics, ophthalmic pharmacology, food animal pharmacology, and aquatic animal pharmacology Includes access to a companion website with the figures from the book in PowerPoint

Metals for Biomedical Devices
Metals for Biomedical Devices

Author: Mitsuo Niinomi

Publisher: Woodhead Publishing

Published: 2019-05-17

Total Pages: 580

ISBN-13: 0081026676

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Metals for Biomedical Devices, Second Edition, has been fully updated and builds upon the success of its first edition, discussing the latest techniques in metal processing methods and the behavior of this important material. Initial chapters review the current status and selection of metals for biomedical devices. Subsequent chapters cover mechanical behavior, degradation and testing, corrosion, wear testing and biocompatibility, the processing of metals for biomedical applications, including topics such as forging metals and alloys, surface treatment, coatings and sterilization. Chapters in the final section discuss the clinical applications of metals, such as cardiovascular, orthopedic and new generation biomaterials. With its distinguished editor and team of expert contributors, this book is a standard reference for materials scientists, researchers and engineers working in the medical devices industry and academia. - Reviews the latest techniques in metal processing methods, including surface treatment and sterilization - Examines metal selection for biomedical devices, considering the biocompatibility of various metals - Assesses mechanical behavior and the testing of metals, featuring the latest information on corrosion, fatigue and wear - Discusses biodegradable alloys, including a new section on Mg alloys - Includes a new section that discusses the use of additive manufacturing in the production of medical devices

Springer Handbook of Medical Technology
Springer Handbook of Medical Technology

Author: Rüdiger Kramme

Publisher: Springer Science & Business Media

Published: 2011-10-02

Total Pages: 1503

ISBN-13: 3540746587

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This concise, user-oriented and up-to-date desk reference offers a broad introduction to the fascinating world of medical technology, fully considering today’s progress and further development in all relevant fields. The Springer Handbook of Medical Technology is a systemized and well-structured guideline which distinguishes itself through simplification and condensation of complex facts. This book is an indispensable resource for professionals working directly or indirectly with medical systems and appliances every day. It is also meant for graduate and post graduate students in hospital management, medical engineering, and medical physics.

Sterilisation of Biomaterials and Medical Devices
Sterilisation of Biomaterials and Medical Devices

Author: Sophie Lerouge

Publisher: Elsevier

Published: 2012-09-27

Total Pages: 347

ISBN-13: 0857096265

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The effective sterilisation of any material or device to be implanted in or used in close contact with the human body is essential for the elimination of harmful agents such as bacteria. Sterilisation of biomaterials and medical devices reviews established and commonly used technologies alongside new and emerging processes.Following an introduction to the key concepts and challenges involved in sterilisation, the sterilisation of biomaterials and medical devices using steam and dry heat, ionising radiation and ethylene oxide is reviewed. A range of non-traditional sterilisation techniques, such as hydrogen peroxide gas plasma, ozone and steam formaldehyde, is then discussed together with research in sterilisation and decontamination of surfaces by plasma discharges. Sterilisation techniques for polymers, drug-device products and tissue allografts are then reviewed, together with antimicrobial coatings for 'self-sterilisation' and the challenge presented by prions and endotoxins in the sterilisation of reusable medical devices. The book concludes with a discussion of future trends in the sterilisation of biomaterials and medical devices.With its distinguished editors and expert team of international contributors, Sterilisation of biomaterials and medical devices is an essential reference for all materials scientists, engineers and researchers within the medical devices industry. It also provides a thorough overview for academics and clinicians working in this area. - Reviews established and commonly used technologies alongside new and emerging processes - Introduces and reviews the key concepts and challenges involved in sterilisation - Discusses future trends in the sterilisation of biomaterials and medical devices