The Accumulative Effect Of The Transport Environment

Vibration is a force in nature that is difficult to control and reduce.  It is inevitable that packages and their contents will be exposed to vibration forces and may be the cause of critical damage to products; such as loss of product sterility.  However, other dynamic forces such as shock and compression are present in distribution as well.  Therefore, it is paramount that the medical device manufacturers assess the ability of both the product and the packaged product to withstand all of these forces.

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.  This regimen is interchangeably called ‘distribution’, ‘transport ‘, or ‘shipping’ simulation performance testing.  In ISO 11607-1 (first published in 1997) the requirement to evaluate the performance of the package design for these forces is called out in Clause 6, section 6.3.5; “The packaging system shall provide adequate protection to the product through the hazards of handling, distribution and storage”

The dynamic transportation forces are cumulative and may cause damage that might never occur with only one ‘hazard’ assessed.  And so for sterile medical devices, it is vital that the sterile barrier system (SBS) be capable of withstanding these forces without losing its sterile barrier integrity.   In addition, FDA requires that all processes be validated; “(the manufacturer) …must ensure the product and package system combine to create a total product which performs efficiently, safely, and effectively in the hands of the user”

There are several published simulation standards available for compliance to ISO 11607-1 Clause 6.  These include the ISTA 3 Series of simulation standards, and the ASTM D 4169 test standard.  These are approved standards and appear in the FDA’s Guidance for Industry and FDA Staff:  Recognition and Use of Consensus Standards.    The test engineer and package engineer should choose the best simulation test for the risk level they are willing to sustain.  Whitehouse Labs works with the client to develop a protocol for package validation that meets the objectives for regulatory compliance.

Vibration forces, and other dynamic forces, do cause damage to sterile barrier systems and is very often the hidden origin.  Don’t ignore this nebulous transport threat and design your sterile barrier system with this in mind.  Whitehouse Labs is uniquely equipped from a technical expertise and test equipment standpoint to assess all of these forces, with the ultimate goal of ensuring that product sterility will be maintained on its journey from manufacturer to final end user.