Protecting the Integrity of Biological Samples
Choosing an experienced and reliable storage provider for your cellular products is a critical decision that can affect downstream therapeutic success. HemaCare integrates cold chain management with temperature-controlled storage to provide customers with a comprehensive solution for managing their cellular material. HemaCare’s biorepository can store samples at -70°C to -93°C (ultra low), -150°C and below (vapor phase LN2), and -196°C (LN2) to suit your short -or long-term storage needs. HemaCare is committed to meeting the specific biorepository requirements of every customer.
Exceeding the Quality Standard
The number of cell therapies advancing toward clinical adoption necessitates the most stringent quality control measures to ensure sample integrity and patient safety. HemaCare’s facility is FDA-registered (FDA CFR 21 Part 1271), is managed by comprehensive quality systems that exceed industry standards, follows cGMP guidelines, and adheres to governing bodies.
Temperature Control and Safeguards
The recovery and downstream utility of stored samples is directly correlated to temperature management. HemaCare’s storage units are monitored 24/7 for temperature and humidity. With a comprehensive backup power strategy and call out alarm monitoring system to notify on-call staff 24/7 of any deviation in temperature, customers can rest assured that their sample integrity is protected while in our care.
Traceability and tracking of biological samples stored within HemaCare’s biorepository are fully validated and managed by standard operating procedures (SOPs) and HemaCare’s quality system, ensuring the integrity of all samples. Samples are managed by a comprehensive inventory system providing tracking of sample and aliquot lineage for effective traceability of cell therapy and blood products offering customers complete chain-of-custody for every sample.
HemaCare’s facility is secured by card-controlled access and around-the-clock surveillance. Our biorepository is controlled by access cards that admit only trained and certified staff. All storage units within the biorepository are equipped with a temperature monitoring system and call out alarm monitoring system. In the event of a power outage, HemaCare’s facility is equipped with a LN2 bulk tank and a comprehensive back-up generator system.