Part of an Overall Transport Validation Plan

Have you got it Covered, Week 4

The new generation, Tyvek® Air Cargo covers from DuPont are a typical low-bulk and lightweight passive protection component. Designed to provide cost-effective off-the-shelf CRT protection for pharmaceuticals, these cargo covers employ a unique triple-action approach to temperature control which renders them a very effective and cost efficient solution to CRT control.

It is this three-stage protection which differentiates Tyvek® from other cargo covers on the market and DuPont has conducted a number of generic and lane-specific validation exercises to demonstrate their superior performance in the field. Thermal testing of Tyvek® covers is a vital element of the overall qualification process and these tests started with a series of operational qualification (OQ) studies. This involved chamber testing to subject the covers to simulated environmental conditions of a sufficiently extreme nature to demonstrate performance under relatively harsh conditions.

These simulation exercises were then replicated to demonstrate repeatability and consistency and the result was a robust data set which confirmed the expected performance boundaries of the Tyvek® product and provided a benchmark for subsequent validation under dynamic field conditions.

Scope of Programme
The scope of the temperature validation plan was to establish proper distribution and product handling requirements, for the purpose of ensuring the maintenance of appropriate product temperature in transit.

Purpose of Programme
The purpose of the Tyvek® temperature validation plan was to use thermal mapping data to provide documented evidence that a cargo pallet protected with a Tyvek® cover provides robust protection against exterior environmental conditions including exposure to both high and low ambient temperatures and the effects of direct solar radiation.

Methodology
The methodology involved assessing the impact of different hazards to enable the degree of risk to be defined. The results were referenced against a selection of contemporary materials currently in widespread use for the passive protection of pharma merchandise.

Click here to view Week 5 – Tyvek® Operational Qualification

 

Route profile test conditions

Route profile test conditions

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