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Methods of root cause package failure analysis
Package integrity is critical in maintaining product sterility. As the infection rates in hospitals continue to soar, MDMs continue to strive for reliable sterile barrier packaging. When packaging failures do occur, the causes must be understood and addressed. Find out how to conduct effective package failure analysis and learn more about the anomalies that can cause seal failures.
Avoiding medical packaging material failures
Sterile barrier packaging is the last line of defense between bacteria and the medical device and, as such, plays a critical role in ensuring patient safety. Learn more about the proper measures to take in terms of device design, material and supplier selection, package design, sealing process, and packaging in order to avoid material failures.
Mastering sealing process validation
The validation of the sealing process used to create a medical device package is critical to ensuring product sterility. Learn more about sealing process validation components Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) in this guide to complying with ISO 11607 requirements.
What will TIR 22 do for you? (part two)
AAMI Technical Information Report (TIR) 22:2007 provides the medical device community a roadmap for successful completion of process validation. To find out more about how TIR 22 can help you achieve ISO 11607 compliance, read part two of this article in Pharmaceutical & Medical Packaging News, co-written by Oliver Answer Team member Geoff Pavey.
Choosing a medical packaging supplier
The ideal medical packaging supplier provides exceptional service and expert support, and acts as a partner providing cost savings ideas and technical expertise. Use the checklists in this white paper as a useful guide when evaluating a potential medical packaging partner.
What will TIR 22 do for you?
To find out how AAMI Technical Information Report (TIR) 22:2007 can help you achieve ISO 11607 compliance, read this article in Pharmaceutical & Medical Packaging News, co-written by Oliver Answer Team member Geoff Pavey.
Want to drive costs out medical device packaging?
Read this article in Med-Tech Packaging News, written by Oliver Answer Team member Kevin Zacharias.
ISO 11607 compliance requires strategic planning
For valuable insight into the myths and realities of ISO 11607, read Healthcare Packaging's summary of Randy Troutman's MD&M West conference panel discussion.
How to validate to an existing international standard
Download this HealthPack® 2007 presentation and learn more about FDA, ISO
11607, and QSR validation qualifications.
Consider the basics when developing packaging
Read this article from Medical Device & Diagnostic Industry (MD&DI) magazine, written by Oliver Answer Team member Randy Troutman.
Sterile Barrier System (SBS) validation
Learn more about the necessary steps and stage gates for adequately
validating a package system and the manufacturing processes required to
produce it.
Sterile Barrier System (SBS) expiration dating
Find out why a thorough understanding of ISO 11607, parts 1 and 2, is instrumental in ensuring product efficacy and ultimately, patient safety.
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