Validating medical device moisture barrier integrity

Application Note

Verifying medical device package moisture barrier integrity

NOTICE: As of February 2011, Veriteq's Low Humidity data loggers (2000-LRH) are discontinued.

For customers who already have this product, we will continue to support the loggers up to December 2014.

Please review Vaisala's line of Low Humidity transmitters for measurement applications of industrial low dew point measurements below 10% (RH). The Vaisala DRYCAP® transmitters have optional data logging and (W)LAN interface.

 

Application:

A large medical device manufacturer is using the VL-2000-LRH Low Relative Humidity Logger to test the moisture barrier properties of their product packaging.

According to the company, the loggers are placed in the product packages after they have been vacuum packed and purged with nitrogen. This process creates the totally moisture free environment (approximately 0% RH) necessary to ensure product quality. The packages are then placed in a one month high temperature, high humidity environment for an accelerated study.

Following the study, the loggers are examined to determine the level of moisture ingress. Increases in moisture can be determined by examining the collected data for increases in dewpoint temperature or relative humidity.

The above tests are designed to test the integrity of the company's packaging methods and to maintain the highest possible levels of product quality.