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Cold Chain Package Testing for Pharmaceuticals

The Cold Chain and related packaging play a vital role in the pharmaceutical industry. Refrigerated pharmaceuticals and biologics requiring temperature control utilize thermal transport packaging and Cold Chain logistics to maintain the low-temperature range. A typical requirement is holding a product temperature of +2⁰C to +8⁰C (+36⁰F to 46⁰F), a target of +5⁰C (+41⁰F), throughout the distribution cycle to package opening by the end-user.

The product’s primary package may be a small, single vaccine vial or a large, palletized bulk pack. The secondary and tertiary package layers may involve an active, refrigerated solution, insulation layers, ice packs, or thermal masses. Temperature indicators, trackers, and recording devices may be used to provide monitoring data during transport.

In addition to maintaining thermal properties, the thermal package system must withstand the distribution environment’s rigors. Accurate testing and validation of the final shipping unit and its sub-systems require the resources, experience, and technical expertise available at WESTPAK.

Typical Procedures/Protocols

ASTM D3103
ASTM D4332
ASTM D6653
ASTM F2825
ISTA 7A
ISTA 7E
IEC 60068-2
ISO 2233

Resources

WESTPAK white papers Ref: Ten Mistakes Companies Make When Specifying and Validating Insulated Cold Chain Shippers

WESTPAK Capabilities

(65) Temperature and Humidity Chambers
(12) Temperature Data Loggers
(1) Thermal Shock Chamber
(3) Temperature and Altitude Chambers