Medical device packaging is subjected to prescribed temperature and humidity levels in preparation for distribution testing (i.e., compression, drop/impact, vibration). The environmental conditioning is necessary because paper-based materials, which are used in most packaging systems, experience changes in physical properties as temperature and humidity change. Most plastic components change strength in direct proportion to changes in temperature.
Exposure is conducted via a dedicated environmental chamber designed to maintain tight controls over both temperature and humidity as well as the rates at which these quantities are changed. The test levels chosen and rates of change between these levels are documented in the customer’s test report and encompass what might be encountered during the actual distribution cycle.
Typical Procedures/Protocols
ASTM D4332
ASTM F2825
IEC 60068-2
ISTA Series (all)
ISO 2233
MIL STD 810G
WESTPAK Capabilities
(65) Temperature and Humidity Chambers
(1) Thermal Shock Chamber
(4) Temperature and Altitude Chambers
Typical Sample Size
Typical sample size quantity ranges from 30 to 60.