Standardizing Shipments of Companion Animal Pharmaceuticals

Cryoport Systems understands the importance of the bond that humans share with their companion animals. We work to protect this bond, which means that we place high importance on our ability to compliantly ship companion animal pharmaceuticals anywhere in the world to keep pets healthy and happy.  

Our supply chain expertise supports the delivery of sensitive materials like veterinary medicines to veterinarians and animal clinics around the globe. To ensure that safety is at the forefront of every shipment’s journey, Cryoport Systems upholds the highest standards to maintain transport consistency and viability from pickup to final destination. Through three key compliance processes and standards, Cryoport Systems can maintain transport certainty for every shipment of companion animal pharmaceuticals 

1. ISO 21973’s Support of Standardization

   In 2020, ISO/TC 276 Biotechnology Technical Committee defined a new standard that pertained to the transportation of cells. ISO 21973, otherwise known as the general requirements for transportation of cells for therapeutic use, outlined six key sections of standards to strengthen the supply chain, including:  

   1. Cell Transportation Specification
   2. Shipping Container & Labeling 
   3. Operation 
   4. Organization 
   5. Storage 
   6. Documentation 

   Cryoport Systems’ expansive industry expertise was integral to the development of ISO 21973, and our experts personally contributed to outlining the necessary protocols to form this compliance standard. Ever since its inception, Cryoport Systems has implemented ISO 21973 into our supply chain processes to ensure that every commodity is stored and transported to the highest industry standards no matter if it’s for therapeutic use or not. 

2. Establishing Consistency through Requalification

   Shippers are qualified by the manufacturer as they leave the factory before their first use. With other providers, that initial inspection is the only qualification process a shipper will likely undergo. Cryoport Systems utilizes shippers and stainless-steel accessories that are reusable, eco-friendly, and able to be qualified after each shipment. We developed the industry’s only requalification process to ensure that each of our shippers maintain its full integrity throughout its journey.  

   The need for continued recertification after every shipment is paramount to mitigating risk. Cryoport Systems’ requalification process adheres to ISO 21973 and includes: 

   • Veri-Clean® – the industry’s first and only validated cleaning and disinfection process. 
   • Physical suitability tests – a visual inspection of the internal and external conditions of the equipment to guarantee it’s suitable for continued use. 
   • LN2 capacity checks – tests the shipper’s capacity for maintaining the proper liquid nitrogen levels throughout transit. 
   • Minimum required hold time threshold – ensures that our shippers can maintain a 10-day dynamic hold time. 

   With this assurance, receiving clinics and vets can be sure that the transported pharmaceuticals were shipped in fully qualified, decontaminated shippers. 

3. Accessing Traceability with Chain of Compliance®

   Cryoport Systems’ Chain of Compliance® precision process allows for full traceability throughout the entire supply chain by establishing complete identification of the equipment and processes used in managing the environmental control of transported commodities, including:    

   • Identification of equipment performance 
   • Requalification history 
   • Commodity history 
   • Courier handling and performance history 
   • Calibration history 
   • Correlation competencies  

   The Chain of Compliance® allows our team of professionals to better understand variability and actively mitigate risk throughout the entire transport process. Chain of Compliance® ensures that sensitive materials such as pet vaccinations are handled with care and delivered with integrity intact. 

For more information on how Cryoport Systems compliantly transports sensitive materials for the animal health industry, connect with Cryoport Systems’ animal health expert, Tony Thomas at tthomas@cryoport.com.