ISO 21973: Aligning our Standards for Compliant Animal Health Shipments
In June 2020, the ISO/TC 276 Biotechnology Technical Committee defined a revolutionary standard for the transportation of cells for therapeutic use. ISO 21973 details how transportation shipment providers can achieve complete traceability of the equipment, processes, and logistics used in managing the environmental control of the materials while in transit. While this standard is specific to advanced therapies, its support of a compliant supply chain is universal to the animal health industry.
Cryoport Systems’ team of experts and years of supply chain excellence helped develop the necessary protocols to form ISO 21973 alongside its forming committee. As industry leaders in maintaining compliance, we built our platform of supply chain solutions to uphold the strict specifications of this standard for all commodity types. To showcase how our processes align, we’re highlighting some of ISO 21973’s requirements and the processes we use to meet and exceed them.
Requirement:
“The shipping containers must be suitable to meet the temperature requirement of the product, ensuring the container will remain at temperature for the duration of the transportation.”
Solution: An Inclusive Network of Shipper Fleets
Cryoport Systems elevates our supply chain support by utilizing our own diverse shipper fleets, Cryoport Elite™ and Cryoport Express®, to transport client commodities. The combination of these shipper lines supports the consistent temperatures from standard room through cryogenic, meaning that there is a shipper system to support all animal health material types and temperature ranges. These systems additionally meet International Air Transport Association (IATA) requirements for transport, including Class 6.2 infectious substances, are International Safe Transit Association (ISTA) “Transit Tested” certified, and carry the CE (Conformité Européenne) mark.
Requirement:
“The records of all processes in transportation should be retained, including the time of collection and delivery plus the signatures of consignor, consignee, and transportation personnel.”
Solution: Chain of Compliance’s® End-to-end Traceability
Our own Chain of Compliance® precision process promotes full traceability throughout the entire animal health supply chain. The Chain of Compliance® maintains the complete identification of the equipment and processes used in managing the environmental control of the commodity throughout the supply chain. This information includes identification of equipment performance, requalification history, commodity history, courier handling and performance history, calibration history, and correlation competencies that can link in-field events to equipment performance. With the Chain of Compliance®, animal health professionals have access to the records of their material’s viability throughout its shipment process.
Requirement:
“For reusable shipping containers, records should be maintained relating to the equipment’s performance, commodity, cleaning, and maintenance.”
Solution: Total Decontamination with Veri-Clean®
Unlike our competitors, we are the only provider who requalifies all shippers after every shipment. Each shipper undergoes our Veri-Clean® cleaning and disinfection process once returned to our facility. This validated cleaning process encompasses a series of steps that work together to virtually eliminate the risk of cross-contamination before the shipper is reused. Veri-Clean® is unmatched within the animal health industry and achieves a 99.9999% reduction in external contaminants, bringing peace of mind to clients that the integrity of their materials is never at risk when placed in a Cryoport Systems’ shipper.
Requirement:
“The transportation service provider should establish optimal shipping routes and methods to reduce risk and time in transit while taking into consideration that airline schedules may change and that regulations may differ between countries.”
Solution: Active Mitigation through Shipping Risk Assessments
The ability to actively mitigate risk is of the highest importance to our animal health clients, and our Consulting Services team can mitigate risk before a shipment has left our facilities. Our shipping risk assessments compile a detailed analysis of cross-carrier data on 800,000+ tracked shipments across various temperature bands, shipper types, and global lanes. This service is supported by the knowledge gained from previous regulatory submissions that we have conducted throughout all stages of clinical and commercial development. These assessments are paramount to helping select the best logistical choices in transporting sensitive animal health commodities, thus reducing risk before it can befall a shipment.
When it comes to the animal health market, Cryoport Systems is the industry leader in exceeding compliance standards to Enable the Outcome™ for our clients. For more information on ISO 21973 and how our platform of solutions upholds this standard, read our white paper, ISO 21973: How to Ensure Full Compliance Throughout Every Step of the Journey.