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Complying with ISO 11607: What Will TIR 22 Do for You? Part II

Published in Pharmaceutical & Medical Packaging News | 11. 09. 2007

In part two of a two-part series, the Sterilization Packaging Manufacturers Council offers guidance on designing and evaluating a packaging system for a medical device, keeping ISO 11607 and the AAMI TIR 22 close at hand. Full story ›

Complying with ISO 11607: What Will TIR 22 Do for You? Part I

Published in Pharmaceutical & Medical Packaging News | 10. 05. 2007

In part one of a two-part series, the Sterilization Packaging Manufacturers Council offers advice on designing and evaluating a packaging system for a medical device, keeping ISO 11607 and AAMI TIR 22 close at hand. Full story ›

Six Myths about ISO 11607

Published in _Pharmaceutical & Medical Packaging News_ | 05. 29. 2007

The contributors to ISO 11607:2006, Parts I and II, address some misconceptions about the new document. Full story ›

Guidance on the New Packaging Standard

Published in European Medical Device Technology | 11. 01. 2006

Some of the important points of the revised ISO 11607, Packaging for Terminally Sterilised Medical Devices, are reviewed here. In addition, the contents of a Technical Information Report (TIR), which is scheduled to be approved and published in early 2007, are described. This TIR will provide in-depth guidance on how to comply with the requirements of the standard. Full story ›

Sterile Packaging: The Facts of Shelf Life

Published in Medical Device Network | 03. 01. 2006

Ageing and humidity both compromise the integrity of sterile packaging. However, according to the Sterilization Packaging Manufacturers Council, these effects can be simulated, allowing medical device packagers to assign an accurate shelf life to each sterile medical device. Full story ›

A Round Robin Approach to Seal Strength

Published in Pharmaceutical & Packaging News | 01. 09. 2006

After conducting hundreds of peel tests, users of the tensile machine testing method probably don’t often think about the group of people who 37 years ago created a standard for flexible-package seal-strength testing, F88. The F02 committee on flexible barrier materials of the American Society for Testing and Materials (ASTM) created the standard to determine the seal strength of flexible barrier materials. Today, it is the cornerstone for physical package testing. Millions of seal-strength measurements are used globally to qualify materials, validate equipment, control processes, and accept shipments during incoming inspection. Full story ›

Testing Bags and Pouches

Published in Pharmaceutical & Medical Packaging News | 02. 01. 2004

The Sterilization Packaging Manufacturers Council sets standards to educate and increase awareness. In the precise world of medical packaging, clarification is a never-ending process. And the Sterilization Packaging Manufacturers Council (SPMC; Linthicum, MD) considers that an important part of its mission. Full story ›

Material Selection Made Easier

Published in Pharmaceutical & Medical Packaging News | 12. 01. 2000

Choosing the right packaging material for a medical or pharmaceutical product involves detailed planning and analysis. Companies must assess the benefits of using one material over another, which material works best with a given product going through its sterilization process, and how quality and performance can be maintained in the many lots that are produced over time. With so many things to consider, who has time to cast about for the right test method? Full story ›

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