ASTM D 4169-14 is the current FDA approved consensus standard. The typical test regimen for medical device package testing is distribution cycle 13 (DC 13). The test intensity levels are most co
Significant product and package responses and interactions during shipment can be severe and may lead to package or product failure. Identification of critical frequencies and the nature of package stresses can aid in minimizing the effect of these occurrences.
Highlights of Proposed Revisions to ISO 11607 Adapted from HealthPack 2017 presentation, “The Next generation of ISO 11607”, by Nick [...]
The Potential Impact on Medical Device Performance Testing Adapted from HealthPack 2017 presentation, “The Next generation of ISO 11607”, by [...]
In package performance protocols, these vibration forces are incorporated into a regimen of other transport hazards such as handling (shock), compression, and environmental temperature and humidity extremes.
Consolidating Your Vendor Network: Why It Is Important To Work With A Laboratory That Offers A Range Of Servicesadmin 2018-05-10T07:13:26+00:00
Whitehouse Laboratories is one such location that provides all of the testing and validation services that any medical or pharmaceutical manufacturer needs to ensure the efficacy of their products, and the safe delivery to their end use.
The debate in the industry is which standard to use for compliance with the ISO 11607 standard.
Is critical in the package development and design process to assess the ability of the sterile barrier system to resist the vibratory forces in the transport environment
The nebulous aspect of vibration is that most of the damage caused by vibration forces is not known to have occurred until the product is delivered and about to be used for its intended use.
Let's take a moment to go into detail of one of the most widely used distribution simulation test methods, ASTM D4169 – Standard Practice for Performance Testing of Shipping Containers and Systems.