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Lab

Lab

Hearten Biotech Human Medicine division is equipped with an area of sterilization, a laboratory of common use and a sterile biosafe area, this last one complying with the regulations for level 3 security. During the production process the samples, the operator and the product are protected, by injecting permanently recirculating filtered air at positive pressure, ensuring a sterile atmosphere.

In addition, all procedures involving the manipulation of the samples are performed within biological safety cabinets that ensure the quality and sterility of the product.

The laboratory has controlled atmosphere incubators for cell growth, advanced microscopy systems and an electronic cell counter that by dual fluorescence, reports the growth and viability of the cells.


The laboratories meet standards of:

Good Manufacturing Practices (GMP) and Good Laboratory Practice (GLP), which include monitoring the process through a centralized bar code system. Operators strictly comply with standard operating procedures (SOPs) regulated by the authorities of Hearten Biotech.


Quality control

 Quality control is supervised by qualified personnel of Hearten Biotech.
 Permanent quality control.
 The control procedures are performed on site and, if necessary, by outsourcing.