Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1: 2006) PDF Download
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Author:
Publisher:
ISBN: 9788325105785
Category :
Languages : en
Pages : 40
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Author:
Publisher:
ISBN: 9788325105785
Category :
Languages : en
Pages : 40
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Book Description
Author: Standards Australia (Organization)
Publisher:
ISBN: 9780733779176
Category : Medical instruments and apparatus
Languages : en
Pages : 38
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Author: British Standards Institution
Publisher:
ISBN:
Category :
Languages : en
Pages : 0
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Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 38
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Author: Malaysia. Jabatan Standard
Publisher:
ISBN:
Category : Biological decontamination
Languages : en
Pages : 41
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Book Description
Author: Anne F Booth
Publisher: CRC Press
ISBN: 1351357565
Category : Medical
Languages : en
Pages : 155
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Book Description
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.
Author: Standards South Africa
Publisher:
ISBN: 9780626196905
Category :
Languages : en
Pages : 37
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Author: South African Bureau of Standards
Publisher:
ISBN: 9780626360290
Category :
Languages : en
Pages : 37
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Author: Stephen P. Denyer
Publisher: CRC Press
ISBN: 1420021621
Category : Science
Languages : en
Pages : 500
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Book Description
Microbiological matters continue to exercise considerable influence on product quality. In both the pharmaceutical and medical device industries, products of greater sophistication, along with evolving regulatory requirements, are elevating the challenges related to maintaining microbiological integrity. Updated to reflect technological and regulatory changes, the Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition covers thoseprincipal aspects of microbiology that arerelevant to the preformulation, formulation, manufacturing, and license application stages involved with the production of pharmaceuticals and medical devices. In recognition of the diverse disciplines involved in pharmaceutical and medical device production, this work provides a brief introduction to microbiology geared towards the nonmicrobiologist. Covering good manufacturing practice in the control of contamination, the text explores quality control, the preservation of formulations, and principles of sterilization, including microbiological-specific considerations for biotechnological products and other medical devices. It also provides additional materials on package integrity and contamination risks in clean rooms. The editors have produced a companion text, the Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices (see reverse), which when paired with the Guide offers a complete theoretical and practical treatment of microbiological control. This book provides a comprehensive distillation of information concerning methodology and regulations that would otherwise remain scattered throughout the literature. It allows scientists from many fields to address potential problems in advance and implement suitable strategies at the earliest stages of development.
Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages :
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