Clean and validated cryogenic packing is essential to compliantly ship reproductive material. But how can you be sure that your logistics provider understands the importance of cleanliness in their standardized shipping practices? Without preparing the packaging for transit with the proper cleaning protocols and industry-compliant solutions, your reproductive materials could be put at risk.
Cryoport Systems knows that your reproductive materials are precious and irreplaceable. To maintain the integrity of your reproductive material throughout every step of the shipping process, we’ve developed a requalification process for our Cryoport Express® shippers that sets the industry standard for regulatory compliant shipping. Here’s a breakdown of how Cryoport Systems requalifies every Cryoport Express® shipper for its impending journey to maintain reproductive material integrity.
Cryoport Systems’ signature Cryoport Express® dry vapor shippers are the most advanced storage and shipping containers on the market and can maintain the cryogenic temperatures needed to safely ship reproductive materials. Our shippers and stainless-steel accessories are reusable, eco-friendly, and our requalification process ensures that each shipper maintains its full integrity during every shipment.
Before any of our shippers are packed with reproductive material, they undergo our Veri-Clean® process – the industry’s first and only validated cleaning and disinfection procedure. Our proprietary cleaning methodology, Veri-Clean®, virtually eliminates the risk of contamination potentially accumulated during the shipping process. With support from a third-party accredited laboratory, Veri-Clean’s® disinfectant and cleaning procedure prepares each shipper to safely house your reproductive materials by:
- Reducing external contaminants by 99.9999%.
- Eliminating environmental flora such as bacteria, fungi, and viruses.
- Visual confirmation that the unit is free from contamination.
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 can be confident that your reproductive materials will be transported in a safe and secure environment.
2. Thermal Performance Verification
Next, Cryoport Systems confirms the thermal performance of each Cryoport Express® 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 Cryoport Express® 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 Cryoport Express® shipper can hold prior to every shipment, and we track its capacity and thermal performance during every shipment over the lifetime of each Cryoport Express® shipper. By confirming the thermal performance of each shipper, we can ensure that our fleet remains in top-performing order.
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 inside. However, Cryoport Systems’ stocking process ensures that each of our Cryoport Express® shippers can maintain the intended, or estimated, shipping duration. This standardization of each unit’s hold time mitigates risk to your biological materials 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 materials 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 reproductive materials. 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.
Before our shippers can be sent to their receiving destination, our team takes great care to make sure it leaves 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 will be both packaged in the correct Cryoport Express® shipper and handled compliantly during both the loading and unloading process. This final step completes the requalification process and deems a Cryoport Express® shipper is ready to be sent to your clinical facility for the packaging of your reproductive material.
These steps in our requalification process ensure that our shippers are uniquely prepared to maintain the integrity of your reproductive materials no matter the shipping destination. For more information on our reproductive shipping services, contact our dedicated team.