Our unique ISO-7, Class 10,000, high-demand GMP (clean area)  laboratory was finished in February of 2007 and  was designed to  held to the highest standards by the FDA.

The clean area, which is the production area, has two self-contained tissue processing/manipulation-expansion/culture suites. Many features have been incorporated into the design of this facility to minimize the risk of cross-contamination between products. Some of the specifications of these areas include: unidirectional traffic flow, single-pass HEPA filtered supply air, 100% exhaust from the biological safety cabinets through dedicated ducts, the floor to the entry airlock has a distinct flooring surface to minimize contamination from outside particulate material. The walls, ceilings and floors are coated with a chemically resistant epoxy resin. The entire clean-room facility is cleaned weekly with a viricidal/microbiocidal cleaning agent. Contiguous to the clean area, there is an  ante-room used for gowning and storage of supplies in route to the clean areas, as well as a main lab is used for quality control testing and the receipt and storage of cell culture materials. 

The clean area is equipped with sophisticated tissue culture incubators used during  stem cell expansion and reserved for one-donor/one-chamber use. Thus, cells for individual clients/patients can be processed without risk of cross-contamination. We comply with FDA requirements for the maintenance of equipment, the cleaning of our laboratory setting, and the standardization of equipment. All major equipment is on a remote alarm system that automatically contacts our staff when/if conditions should fall outside the accepted limits.

Lifesource  cryopreservation facility comprises equipment that permits cryopreservation and ultra low temperature maintenance of a diversity of cells and also a healthy return to normal conditions of temperature.  

During cryopreservation liquid water inside cells changes its condition to ice.  To avoid detrimental changes in concentration of salts and other metabolites, cells must be cryopreserved at highly regulated conditions in the presence of cryoprotective agents.    When all these conditions occur, the majority of stored cells will remain viable and unchanged for an indefinite period of time.  For cryopreservation, LifeSource has built a new facility equipped with Controlled Rate Freezing and Liquid Nitrogen (LN2) Storage systems.  The CBS 2100 Controlled Rate Freezing System, a fully computerized instrument, eliminates all variables associated with ultra low freezing to ensure maximum cell viability.

Cells under storage, both for short- term (quarantine) and long-term (for life) periods are preserved in CBS Isothermal freezers which provides ultra low storage temperatures (-190 degree C range) without contact with liquid nitrogen in the sample storage space.  This unique system eliminates the need to submerge samples in liquid nitrogen, thus eliminating the possibility of sample cross contamination.