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Achieving SBS Validation
Validating a Sterile Barrier System package in accordance with ISO 11607 calls for close communication with key departments including, but not limited to, Quality Assurance, Marketing, Operations and Purchasing says Kevin Zacharias, Engineering Program Manager,Oliver-Tolas Healthcare Packaging. Read more by reading Oliver-Tolas whitepaper, Sterile Barrier System Validation, published in
Medical Design Technology(MedicalDesign.com).
Communicate packaging criteria to avoid risk
Customer and supplier synergy are key to a successful product launch, according to Lora Keena, Oliver-Tolas Answer Team member, in her address to the MD&M West 2009 packaging conference. Find out more by reading a summary or viewing an excerpt of the speech at Pharmaceutical & Medical Packaging News (PMPNews.com).
Implications of material selection on the design of packaging machinery
Material selection can impact the design—and cost—of HFFS machinery. Find out how to avoid unnecessary costs, machine redesigns, and project delays in this article written by John Merritt, Oliver-Tolas International Managing Director, and published in Medical Device Technology.
The benefits of standardized test methods for medical packaging
When choosing a test method, packaging engineers need to consider a variety of factors including material type; size and type of package; process being evaluated; and more. By being sure to choose a standardized test method, medical packaging engineers benefit from expert review by knowledgeable industry members and, ultimately, uniform evaluation of materials and products.
Reducing risk through packaging
Medical device packaging engineers have questions about how to comply with ISO 11607; you'll learn the answers in this article written by members of the Sterilization Packaging Manufacturers Council (SPMC)—including Oliver-Tolas Answer Team member Geoff Pavey—and published in Pharmaceutical & Medical Packaging News.
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 failures in sterile barrier systems
As hospital infection rates soar, medical device manufacturers continue to strive for reliable sterile barrier packaging. Download this Med-Tech Packaging News article, written by Oliver-Tolas Answer Team member Kevin Zacharias, to learn more about how to avoid packaging 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-Tolas 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-Tolas Answer Team member Geoff Pavey.
Want to drive costs out medical device packaging?
Read this article in Med-Tech Packaging News, written by Oliver-Tolas 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 the February, 2007 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
Learn more about how to adequately prove the efficacy of the sterile barrier system (SBS) in this article from Medical Device & Diagnostic Industry (MD&DI) magazine.
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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