Committee F02 develops consensus standards for flexible barrier packaging, including barrier materials, their properties, and package design, development and production. Typical flexible barrier materials include papers, nonwovens, plastic films and metal foils.
Diane Trinsey, ASTM International: ASTM Mechanics and Overview
Abstract: An overview of the products and services ASTM offers, including the benefits of being an ASTM member with a focus on Committee F02 and their recent standards activity.
Franz Sturm, Lippke: Future Trends in Permeation Measurements
Abstract: Trends in permeation measurements have always been driven by industries with quality relevant permeation concerns. The paper will address new permeation concerns arising from trends to more sustainable, eco-friendly materials and also from new ultra high barrier materials. How will these concerns drive the future developments in permeation measurement, will be the subsequent focus of the presentation.
Thierry Wagner, DuPont Medical & Pharmaceutical Protection: Microbial Barrier Test Methods for Porous Sterile Barrier Materials
Abstract: The international standard EN ISO 11607 "Packaging for terminally sterilized medical devices" states that "porous materials shall provide an adequate microbial barrier to microorganisms in order to provide integrity of the sterile barrier system and product safety." At the same time, the standard notes that there is no universally accepted method of demonstrating microbial barrier properties.
The presentation will provide the background to the key questions above, it will give an overview of available test methods working with aerosols of spores as well as a summary of research and current developments of the new test method ASTM-F2638 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
Henk Blom, Rollprint Packaging Products:Towards a Package Durability Predictive Model
Abstract: Current industry sustainability trends toward minimizing packaging materials and packaging costs have led to thinner and less expensive flexible packaging materials being proposed to replace thicker and more expensive structures. Existing methods for determining package durability are at best expensive and time-consuming, and at worst counter-predictive of field performance. More advanced tools are required to enable ranking of material candidates and prediction of package performance. This paper will explore the use of basic material properties of films and laminates (such as tensile strength, puncture force, abrasion resistance, etc.) to predict the performance of a package in the field.
Wendy Mach, Nelson Laboratories: "Package Integrity: Methods of Detection"
Hal Miller, PACE Solutions, LLC: Use of Design Guide F2097 and U.S. FDA Recognition
Abstract: Do you ever ponder which or what test method is best for my product or package? What is the significance of consensusstandards that are recognized by the United States Food and DrugAdministration (FDA)? ASTM F2097 is a standard guide that lists the test methods commonly used toevaluate flexible medical packaging. It is not only applicable to medical packaging, but any flexible barrier package. Each test method, whether ASTM or not, is organized by category, thumbnail description and applicability to provide the user a guide to selection. Additionally, finding and using the U.S. FDA recognized consensus standards website will be demonstrated.
Pat Weixel, U.S. FDA: U.S. FDA Perspective: The use of standards in premarket submissions and auditing the medical device packaging process
Abstract: Patrick Weixel a Consumer Safety Officer of the United States Food and Drug Administration, Center for Devices and Radiological Health, and member of the ASTM F02 Flexible Barrier Packaging Committee, will give a presentation that addresses FDA's recognition of consensus standards to satisfy certain premarket notification regulatory requirements. The presentation will also address auditing the packaging process for medical devices and identify recent inspectional observations and medical device recalls due to packaging problems.
Pat Nolan, DDL: Sterile Medical Device Package Performance Testing and the Nebulous Effect of Vibration in Transit
Abstract: Medical packaging needs to survive all sorts of potential problems to keep the contents intact and unharmed. This presentation will explain the effects of transport vibration forces on medical device packages, and the standards that should be complied to in order to negate the effects of vibration on medical device products and to maintain their efficacy.
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