Validating Medical Packaging
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Validating Medical Packaging
Author | : Ronald Pilchik |
Publsiher | : CRC Press |
Total Pages | : 160 |
Release | : 2002-09-27 |
Genre | : Medical |
ISBN | : 9781420014945 |
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According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution." As specific as this statement is, the FDA does not provide instruc
Medical Device Packaging
Author | : Ron Pilchik |
Publsiher | : Unknown |
Total Pages | : 380 |
Release | : 1996 |
Genre | : Medical instruments and apparatus |
ISBN | : 1566764696 |
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Medical Device Packaging
Author | : Ron Pilchik,Technomic Publishing Company. Program Division |
Publsiher | : Unknown |
Total Pages | : 135 |
Release | : 1994 |
Genre | : Medical instruments and apparatus |
ISBN | : OCLC:43266205 |
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Medical Device Packaging Handbook Second Edition Revised and Expanded
Author | : Max Sherman |
Publsiher | : CRC Press |
Total Pages | : 416 |
Release | : 1998-08-25 |
Genre | : Medical |
ISBN | : 0824701992 |
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This volume details current developments in industry practices and standards relating to medical device packaging. This edition offers entirely new as well as revised chapters on packaging materials, package validation and methods and integrity testing, bar-coding technology, environmentally sound packaging and disposal procedures, storage autoclave sytems, international standards, customer needs, regulatory aspects, and more.
Pharmaceutical Packaging Validation
Author | : Institute of Quality Assurance |
Publsiher | : Unknown |
Total Pages | : 134 |
Release | : 1998 |
Genre | : Drugs |
ISBN | : 0906810582 |
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Guidelines for packaging engineering professionals.
Medical Device Packaging Handbook Second Edition Revised and Expanded
Author | : Max Sherman |
Publsiher | : Unknown |
Total Pages | : 135 |
Release | : 1998 |
Genre | : Biomedical engineering |
ISBN | : 0429074697 |
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"This volume details current developments in industry practices and standards relating to medical device packaging. This edition offers entirely new as well as revised chapters on packaging materials, package validation and methods and integrity testing, bar-coding technology, environmentally sound packaging and disposal procedures, storage autoclave sytems, international standards, customer needs, regulatory aspects, and more."--Provided by publisher.
Packaging for Terminally Sterilized Medical Devices Validation Requirements for Forming Sealing and Assembly Processes
Author | : British Standards Institute Staff |
Publsiher | : Unknown |
Total Pages | : 20 |
Release | : 2006-05-31 |
Genre | : Electronic Book |
ISBN | : 0580770672 |
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Packaging materials, Packaging, Medical equipment, Medical instruments, Sterilization (hygiene), Sterile equipment, Packages, Wrapping, Seals, Packaging processes, Sealing processes, Quality, Acceptance (approval), Quality assurance systems, Verification, Performance, Performance testing
Packaging for Terminally Sterilized Medical Devices
Author | : Anonim |
Publsiher | : Unknown |
Total Pages | : 0 |
Release | : 2022 |
Genre | : Electronic Book |
ISBN | : 053923169X |
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BS EN ISO 11607-2:2020 specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.