Why ISO 21973 Matters for Reproductive Transport: Setting the Standard for Safety
When reproductive materials leave the controlled environment of a clinic, the conditions they encounter can be unpredictable. A shipment might sit on a tarmac in extreme heat, pass through multiple couriers, or face delays at customs. Each of these moments introduces risk. And for patients, the stakes couldn’t be higher.
That’s why standards like ISO 21973 matter. They provide a framework for how biological materials should be managed during transport, reducing variability during material handoff and protecting integrity throughout the journey. When logistics partners are certified to ISO 21973, clinics gain greater confidence that what happens outside their walls reflects the same discipline applied inside them.
What Is ISO 21973 & What It Means for Your Patients
Published in 2020, ISO 21973 establishes transport and handling requirements for human cells intended for therapeutic use. ISO 21973’s principles span the entire transport process to safeguard biological material from risks during shipment, from packaging requirements and equipment requalification to shipment traceability and communication procedures. While the standard outlines requirements specifically for the human biopharma industry, its principles apply directly to handling gametes and embryos, which face the same vulnerabilities such as temperature excursions and documentation gaps.
Cryoport Systems’ subject matter experts played a key role in the Standards Coordinating Body working group responsible for creating this standard. ISO 21973 directly draws from our proprietary Chain of Compliance® framework, which was established years before ISO 21973, to outline how best to manage risk and track chain of custody, chain of identity, and chain of condition across transport.
Today, Cryoport Systems is the only supply chain management provider certified to ISO 21973. This certification ensures that we apply the same rigorous requirements to every reproductive shipment we manage. Our rigorous compliance standards reduce variability and give both you and your patients confidence that their precious materials stayed secure from origin to destination.
The Systems That Keep Reproductive Materials Safe in Transit
When Cryoport Systems manages a shipment, each touchpoint follows defined, ISO-compliant protocols, introducing a level of control that reduces the variables that can delay procedures or put viability at risk. That discipline is reinforced by systems and processes specifically engineered to support safe, compliant transport of reproductive materials.
Our Cryoport Express® Cryogenic Standard Shipping Systems are proprietary, custom-engineered shippers designed specifically for transporting sensitive reproductive materials at cryogenic temperatures. These dry vapor systems maintain cryogenic hold times at or below -150°C throughout transit and contain an integrated monitoring system for tracking physical conditions. Every shipping system is fully requalified before each use, meaning that it is thoroughly tested and inspected to ensure hold time, temperature stability, and structural integrity. It also undergoes our Veri-Clean® validated cleaning process to remove 99.9999% of contaminants like bacteria, viruses, and fungi. We are the only provider in the industry to apply this level of rigor to every shipping system, every time, providing you and your patients with confidence that the shipping system will perform as expected throughout the journey.
From the moment a shipment is loaded into the shipping system to the moment it’s unloaded at the receiving clinic, our Smartpak™ condition monitoring system is continuously tracking temperature, location, orientation, and shock events. These data points are captured and stored in our Cryoportal® logistics management platform, giving you complete visibility into every shipment. And should anything unexpected occur, our 24/7/365 team of logistics experts is notified and can intervene quickly with established risk-mitigation processes to ensure the safety of the shipment.
The documentation doesn’t stop after delivery. The Chain of Compliance framework captures chain of custody, chain of identity, and chain of condition records for the full shipment journey. Clinics can use these historic records to support internal quality programs and external audits with confidence, providing verifiable evidence of how materials were handled (and under what conditions) from origin to destination.
A Trusted Extension of Your Clinical Practice
Our ISO 21973-backed transport processes bring more predictability to your team’s day-to-day workflows. We track your patients’ materials from delivery to destination, maintaining clear, documented visibility across every step of the transportation process. This prevents you from having to chase status updates to verify integrity or rush to receive materials if they show up outside of delivery windows. You’ll know exactly when materials will arrive and the specific conditions they’ll arrive in.
The level of care matches that of your existing processes. Working with an ISO 21973-certified logistics provider ensures that what happens outside the clinic aligns with the care and precision you apply within. The result is a partnership built on matching expectations and a mutual commitment to your patients’ outcomes.
Cryoport Systems brings ISO-certified transportation, validated systems, and proven expertise to every shipment. By embedding ISO 21973 principles into our operations, we help ensure consistency continues when materials leave and enter your lab. With our support, you’ll have greater capacity for patient care so you can help more patients achieve their fertility goals and build the families they are working toward.
