Our facility has decades of experience keeping your frozen tissues safe.

How is tissue stored?

The operation of all freezers is actively monitored, and the temperature of each storage unit is recorded. All freezers have alarms that notify personnel in the event that expected temperature ranges are exceeded. All freezer units relay temperature readings via thermocouple sensors to a centralized server and are managed with our environmental monitoring software.

  • LN2 back-up systems on all ultra-low freezers, critical emergency SOPs, and emergency contracts with liquid nitrogen vendors
  • Diesel back-up power system
  • Secure-access facility and laboratories
  • Labeling system in compliance with cGTPs to allow label tracking with our products
  • Regulatory compliance through leading industry and association certifications
  • In addition to fully automated alarms and fill systems, all of our cryostorage units are routinely checked by visual inspection of nitrogen levels and temperature to ensure the highest in quality control.

How is tissue accessed?

Your physician’s office is the best place to start to understand what options may exist for transferring and using your tissue sample. They can also help you understand and comply with the applicable regulatory requirements. In accordance with regulations and our policy, only a physician or qualified storage facility may receive your banked tissue sample. As the owner of your tissue sample, you may request access to or transfer of those tissue samples at any time. If you expect to transfer your tissue sample, please have your physician’s office or storage facility contact us so we may begin coordinating the effort.

Transfer of banked tissue samples is considered a regulated activity under current federal law (CFR-Code of Federal Regulations Title 21 Part 1271). The time it takes to release your tissue sample depends on several factors including: certification of the receiving party, geographic location, intended usage for the tissue samples, and/or appropriate regulatory clearances. The transfer of tissue is unique to each client and may take weeks to even months.

We are prohibited by Federal law from offering advice on usage or clinical application of your banked tissue samples. For advice, please contact your physician’s office. To learn more about how banked tissue samples are being used in current clinical trials, visit www.clinicaltrials.gov.
 

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