Specialized Laboratories for Process and Cryopreservation of Stem Cells and Tissues

StemWay BIOTECH laboratory has official accreditation according to international standards HTA (GMP equivalent. National UK Authority for biotechnology and tissues), JACIE , ISO 9001 and ISO 13485 and have know-how of more than 200,000 samples stored which made it possible to refine a process of conservation of high efficiency. A detailed microbiological control and quality of the sample of cord blood is done in laboratory with the most modern scientific standards that eliminate any risk of contamination.

The advanced technology applied to the microbiological tests carried out, it is not necessary to examine expected after six months from the birth mother’s blood; this examination to be carried out with conservation protocols applied in laboratories with different technology. All this translates into a cryo-preservation of greater safety and quality that ensures the customer a better service and lower costs (the parents are not forced after delivery to make any further expensive analysis).

The separation and storage of stem cells is carried out by trained laboratory personnel, according to a specific protocol that provides for severe conditions of sterilization, meeting the requirements of the sanitary and health regulations and internationally recognized. Access to all areas of handling and processing of the cells is restricted exclusively to laboratory technicians, who wear suits aseptic that completely cover their bodies.

Samples are processed in salt aseptic (sterile rooms of grade B with laminar flow grade A with a positive pressure controlled), standards and procedures that constitute an important know-how of the company. In fact, the “curve of cryo-preservation” used is essential to ensure the viability of the cells even after more than 25 years.

The stem cells of the umbilical cord are placed in two batches of special pockets for cryo-preservation, able to prevent any type of contact with external agents. The cryo-bags are laminated, with multiple compartments, with a second protective bag (the system of the double bag is in agreement with the international guidelines) in order to allow multiple uses and / or at different times of samples contained. A data label with the bar code to identify the customer eliminates any possibility of loss or exchange of your sample.

As a precaution to prevent the possibility of cross-contamination between samples in nitrogen in the liquid phase, the sample is placed in tanks containing nitrogen exclusively in the vapor state (at a temperature of about -190 ° C). The storage temperature is controlled and monitored in a continuous manner over 24 hours per day.

In the unlikely event of prolonged shortages of electrical power or malfunctions of the automatic feed system of the plants, the tanks are equipped with a mechanism for manual operation, usable for long time intervals, which ensures the correct preservation of the sample in the long term. The maintenance of the operating parameters of the structures and storage conditions is monitored 24 hours on 24 for every day of the year by a security system and thanks to the constant presence of control personnel.

All private information is handled, stored and managed in accordance with nationals and European Law. An outside company performs periodic independent quality control laboratories and procedures.