Bio-Matrix Scientific Receives Certificate of Compliance for Class 10,000 Processing Laboratory
News Nov 29, 2006
Bio-Matrix Scientific Group Inc. a biotechnology company focused on stem cell cryogenics and disposable stem cell/tissue transfer instruments, has announced it has received its Certificate of Compliance for the new Stem Cell Class 10,000 Processing Laboratory.
The certificate has been granted by the Controlled Environmental Regulatory Testing Service (CERTS) which conducts ISO certification testing.
Bio-Matrix Scientific has completed the calibration and certification of the class 10,000 clean room and has received the ISO 14644 class 7 certificate of compliance.
Bio-Matrix’s stem cell processing laboratory now meets Federal Air Control Regulations to operate as a Class 10,000 Clean Room.
Bio-Matrix intends to utilize closed processing systems to harvest stem cells in its cord blood division by obtaining stem cells from fat tissue, which is a new dimension of stem cell banking.
This processing system requires several procedures that must be carried out under strictly controlled environments to minimize the risk of microbial contamination.
Bio-Matrix Chairman & CEO David Koos stated, "This certificate of compliance, which forms part of our comprehensive cGMP (good manufacturing practices) and cGTP (good tissue practices) systems, will assure our customers that their stem cells are processed and stored under safe, controlled environments."
Bio-Matrix’s new 15,000-sq-ft, laboratory, located in the heart of the San Diego biotechnology corridor, will house Bio-Matrix’s secure Cryogenic Stem Cell Bank; three research laboratories; an aseptic cellular/tissue class 10,000/100 processing laboratory; and hematology, microbiology and flow cytometry laboratories.
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