How Our Requalification Process Maintains Material Integrity

Clean and validated cryogenic packing is essential to compliantly ship biological material. But how can you be sure that your supply chain management partner understands the importance of cleanliness in standardized shipping practices? Without preparing shippers for transit with the proper cleaning protocols and industry-compliant solutions, your materials could be put at risk.

To maintain the integrity of your biological material throughout every step of the shipping process, Cryoport Systems has developed a shipper requalification process that sets the industry standard for compliant shipping. Here’s a breakdown of how we requalify every shipper for its impending transit to maintain a therapy’s or a material’s integrity.

1. Cleaning

When you need confidence that your critical therapies are being transported safely, our Advanced Therapy Shipper™ (ATS) product line is your go-to solution. A first-of-its-kind fleet, our ATS shippers are dedicated exclusively to cell and gene supply chain management for both clinical and commercial therapies. Like all our fleets and stainless-steel accessories, ATS shippers are reusable and eco-friendly. Our developed requalification process ensures that each shipper maintains its full integrity during every shipment through our specialized cleaning process.

Before any of our shippers are packed with any material, they undergo our Veri-Clean® process, the industry’s first and only validated cleaning and disinfection procedure. We developed Veri-Clean® to virtually eliminate the risk of cross-contamination between shipments. With support from a third-party accredited laboratory, Veri-Clean’s® disinfectant and cleaning procedure prepares each shipper to safely house your materials by:

• Reducing external contaminants by 99.9999%.
• Eliminating any trace of environmental flora such as bacteria, fungi, and viruses.
• Manually confirming the shipper is free from protein and hemoglobin.

Veri-Clean® is the only process in the industry that upholds ISO 21973, the regulatory guidance for the safe transportation of biological materials. With this assurance, you know that our shippers pose virtually no threat of contamination to your materials or therapies.

2. Thermal Performance Verification

Next, Cryoport Systems confirms the thermal performance of each ATS shipper to ensure that the Nitrogen Evaporation Rate (NER) and liquid nitrogen levels will support your logistics requirements. We use the dry vapor of liquid nitrogen to power our ATS shippers. The use of liquid nitrogen is what maintains the required cryogenic temperatures for the transportation of biological materials. We verify the amount of dry vapor that each ATS shipper can hold prior to every shipment, and we track its capacity and thermal performance during every shipment over the lifetime of each ATS shipper. By confirming the thermal performance of each shipper, we can ensure that our fleet remains in top-performing order.

3. Stocking

Many cold chain transport companies are unable to provide exact hold times for their cryogenic shippers, potentially risking the validity and effectiveness of the sensitive material and therapies inside. However, Cryoport Systems’ stocking process ensures that each of our ATS shippers can maintain the intended, or estimated, shipping duration. This standardization of each unit’s hold time mitigates risk to your shipment and is standard across all of our fleets.

It’s vital that each shipper can maintain a minimum hold time to account for the safety of your shipment if the transit time of the shipper is extended due to logistical reasons outside of our control.

4. Charging and Staging

Once the thermal performance of the shipper has been verified, our units are almost ready for your biological materials and therapies. First, each shipper is fully charged with liquid nitrogen. The shipper is set aside to absorb the liquid nitrogen, and any remaining liquid is emptied from the shipper. This charging process is a vital step as it ensures our shippers maintain cryogenic temperatures while staying complaint with the International Air Transportation Association (IATA). IATA compliance allows our shippers to be transported via aircraft both domestically and internationally.

5. Shipping

Before our ATS shippers can be sent to their receiving destination, our team takes great care to make sure they leave our facility with the proper documentation. We assemble all the components and order materials into a BOM, or a bill of material. A BOM clearly states:

• Handling instructions for your clinical professionals.
• Any loading and unloading instructions.
• Client-specific order details.

With this information, we help ensure that your materials and therapies will be both packaged in the correct shipper and handled compliantly during both the loading and unloading process. This final step completes the requalification process and deems an ATS shipper ready to receive your material from where it’s stored.

These steps in our requalification process ensure that our shippers are uniquely prepared to maintain the integrity of your therapies no matter the shipping destination. For more information on our shipping services, contact us on our website.