Minimizing Risk in Packaging and
Shipping System Qualification
Customizing our services to fulfill your specific needs.
Bringing a new regenerative medicine solution to market is tremendously complex, as is developing innovative animal health solutions or supporting reproductive medicine. Beyond the therapeutic development efforts are the needs of distribution efforts that range in factors impacting the transport of temperature-sensitive materials.
We qualify and protect your valuable samples.
We work with you to develop shipping system qualifications that are focused on your material, your packout, your chosen shipping system, and payload holding system. Cryoport Systems can accomplish your needed shipping systems either using a Cryoport Systems shipping solution or an alternative source.
We can customize every element of our testing to ensure critical acceptance criteria are measured and understood and will result in a report that’s submittable to any regulatory body. We can also work with you to qualify your packaging and primary material to ensure its functionality, thermal integrity, and physical integrity.
Our team can test the packaging our Consulting Services Packaging Engineers have designed for you or even test packaging developed outside of Cryoport Systems.
All qualification work is performed following a quality-driven process. All protocols, studies, and reports are document-controlled in our quality management system.
Shipping System Qualification
Our Consulting Services Team develops customized Shipper System Operational Qualifications to demonstrate confidence in a shipping system’s ability to consistently transport life-saving products at anticipated temperatures and endure any physical stresses encountered during transportation.
The distribution and transport of critical temperature-controlled products is a complex orchestration of transportation, shipping systems, packaging, and the thermal and physical stresses experienced throughout the supply chain for regenerative medicines.
Packaging Qualification
Product integrity and the integrity of all primary, secondary, and tertiary packaging are dependent on the packaging of products.
Cryoport Systems’ Consulting Services will produce comprehensive Packaging Qualifications to verify that packaging integrity and product viability are both maintained via Physical and/or Thermal Performance Testing.
Our team works to develop customized packaging qualification plans to meet the demands of our clients while also supporting regulatory filings.
Cryoport Operational Qualifications
Collaborative
We work collaboratively to construct qualification strategies and associated protocols and reports to qualify shipping systems and packaging to meet product, company, and regulatory needs.
Quality Processes
Cryoport and our clients sign all protocols and reports, which are then assigned a document control number and contained in our quality management system. All our documents can be used to support regulatory filings.
Hands On Testing
We take an active role in ensuring that all test activities, including pre-test preparation, meet our high standards.
Data Driven
Our team focuses on the data and empirical results to drive analysis, actions, and conclusions for any test or qualification performed.
Shipping System & Packaging Agnostic
We collaborate with our clients to qualify non-Cryoport Systems shippers and focus on high-integrity, data-driven testing and outcomes.
Operational Qualifications
The Cryoport Consulting Validation Engineering and Packaging Engineering teams work with you to develop fit-for-purpose customized testing protocols, test execution, data analysis, and comprehensive report creation.
Operational Qualifications can be comprehensive and followed by Performance Qualification (Shipping Qualification) or can be customized to meet your product, shipping system, process, material, and regulatory needs.
Thermal Performance Testing (ISTA 7E/7D)
Verify performance across a range of temperatures representing real-world temperatures faced by shipper and packaging in summer and/or winter months
Physical Performance Testing (ISTA 3A/3B/2A/6/ASTMD4169)
Verify physical integrity and performance (and production integrity) after drop/shock, vibration, stacking, impact, and other physical tests
Thermal Mapping
Map the thermal consistency of the shipper payload area and determine the thermal distribution of the product packout
Custom Testing
Custom fit-for-purpose testing or challenge testing creation
Want to verify the performance of your Shipping System & Packaging?
Contact our Consulting Services Validation Engineers and tell us more about your unique Shipping System and/or Packaging Operational or Comprehensive Qualification needs.
