Qualification / Validation

There are many variables that can influence the temperature of biological samples during the collection, storage, inventorying, packaging and transportation processes. One way to avoid these challenges is to ensure that the software, equipment and processes used are compliant with the products’ requirements throughout the chain of custody. Validated processes and qualified equipment are of critical importance to meet and exceed quality standards.

Whether you need to qualify a shipper or validate a process, we can help evaluate, validate and test your equipment to ensure that your biological materials maintain their integrity and that regulatory requirements are met throughout the chain of custody. The combined components of our qualification and validation services contribute to our superior management of biological material and biospecimens during the collection, storage inventorying, packaging and transportation processes.

Regulatory Compliance

Our protocols are designed and executed to ensure compliance with the US FDA requirements and guidance documents and according to quality standards established by the PDA (Parenteral Drug Association). Additionally, all of our equipment and measuring devices are calibrated according to the NIST standards.

Pack Out Configuration

Our optimal solutions for controlled-temperature pack outs protect the integrity of biological materials. We design pack out configurations based on maximum transit times, shipping routes, payloads, and temperature requirements. Our documentation is accompanied by detailed pack out instructions to ensure temperature uniformity and standardization in your shipments.

Pack Out Qualification

We perform pack out qualification for both physical and thermal testing. For thermal simulation testing, we employ qualified environmental testing chambers, NIST traceable standards, precision-validation equipment, and thoroughly documented protocols. Dry shippers are also tested using mock material loads in different thermal environments. Our team conducts real-time transit studies using mock payloads and provides a comprehensive report of the qualification data in a timely manner.

When is Validation Critical?

  • After purchasing and installing a new unit
  • After relocating a unit that requires shutdown or physical transfer to a different site
  • Before starting a major project which requires a dedicated unit
  • After observing a series of temperature excursions by a unit
  • After experiencing a natural disaster that may have compromised a unit

Additional content


eBook

Defense in Depth: Off-Site Storage for Biological Specimens and Biopharmaceuticals for Risk Mitigation


eBook

Cold Chain Qualification: 5 Questions You Must Ask When Shipping Biologics


Webinar

Qualification and Validation Webinar: How to Manage Cold Chain Qualification When Handling High Value Biologics


eBook

QP Essentials:EU Gateway to Clinical & Commercial Distribution of Cell Therapeutics

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