Trusted CRYOstorage

The Trusted CRYOstorage advance process is based on usage of Controlled Rate Freezing and an environment of Vaporized Liquid Nitrogen (LN2) maintained at -196 o C for CRYOstorage of stem cells, irrespective of the duration.

The medically accepted standard for best CRYOstorage is under an environment of Vaporized Liquid Nitrogen (LN2) which is maintained at -196 o C. It is important to note that at this stage the stem cells are at normal room temperature and if they are directly taken to an extremely sub-freezing temperature, most of them will die and become ineffective for any use when required. To mitigate this situation, medically TRUSTED process of Controlled Rate Freezing is used to gradually take the stem cells, extracted at normal room temperature, down in steps to the extreme sub-freezing temperature of -196 o C required for effective CRYOstorage. It requires addition of appropriate cryoprotectant, a substance used to protect biological tissue from freezing damage, in a “Specific” mix depending upon the type and condition of the stem cells to be CRYOstored. As is evident that this part of the process is highly critical for the long- term survivability of the stem cells

Hospitals in India tend to use “DUMP” storage instead of Trusted CRYOstorage. DUMP storage, by the name itself, suggests that it is a temporary solution as it neither has the provision of Controlled Rate Freezing and maintains a temperature of -80 o C only. It implies that 10-50% of the stem cells stored in DUMP facility are no longer viable for effective use as the change in temperature from room level to -80 o C is a sheer drop and not easy for stem cells to withstand in one step.

There is also no provision for DUMP storage setup to monitor the change in temperature during the period of storage. The hospitals and practitioners compromise by using DUMP storage for short durations, few days to 3 months, as it is less expensive and does not require them to invest in specialized resources and tools to manage the processes. Consequently, they are LIMITED to managing specific diseases such as transplantation process of some of the blood cancers.

DUMP storage cannot be of use for mid to long term storage and to manage confirmed vitality levels of stem cells stored in them.

HEMATOCRYO fully complies with the TRUSTED CRYOstorage norms.

HEMATOCRYO process has three distinct sections. In the first section stem cells are prepared for CRYOstorage and its starts with a Quality Check to know the vitality level as only those cells with near 100% vitality are preferred to be CRYOstored. Post QC, the process involves extraction of stem cells from the sample for CRYOstorage and making them ready for CRYOstorage by addition of cryoprotectant. HEMATOCRYO uses clinical grade cryoprotective agents to ensure that the gradual freezing and thawing are crucially done in handling these precious cells. At HEMATO, there are restricted access CRYOstorage facilities that use V series or Isothermal models which contain liquid nitrogen inside the vessels. It is made sure that stored samples never come in contact with Liquid Nitrogen. Automatic controller helps in setting the Liquid Nitrogen levels in the vessel and it helps in maintaining the temperatures without manual interventions. This feature of CRYOstorage with HEMATOCRYO helps in maintaining temperatures at -196 o C. After the samples are processed, they are first transferred to controlled rate freezer to avoid rapid cooling effect. Under the guidance of the trained professionals and expertise the temperature of the processed
samples is brought down and then shifted to CRYOstorage vessels. CRYOstored samples are then barcoded and identified using cryolabels which are designed to withstand low temperatures and remain intact even under minus degrees. What is CRYOstored.

The second section covers the periodic monitoring of CRYOstored samples. Additionally, facilities of storage are backed up with multiple power sources and make sure the CRYOstorage vessels are run without interruptions. Frequent check-ups of the CRYOstorage temperatures and levels of the liquid Nitrogen are done by expert technicians present at the facility. It is again a specialized task performed by specialists to ensure the environment is fully controlled to sustain the temperature levels of -196 o C essential for maintaining >90% vitality levels.

The third section is for the period when all or part of the CRYOstored sample has to be prepared for use for any treatment. The stem cells have to be made ready by removing the cryoprotectant, managing the change on temperature and then delivering them to the point of application, such that it can be used at as required by the practitioner.