ISO 80369-7 is the newly published standard that replaces the ISO 594 series of standards. The ‘Part 7’ standard is specifically [...]
Amazingly, since the 1990’s the risk of misconnection of fittings for medical device and drug delivery systems has been evident [...]
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.
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
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.
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.
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.
Often in the microbial examination of products, physical issues occur that force adaptations to the sample preparation. Some of these challenges include viscosity, the need for mixing or blending to a