The Neomem® Xac manufacturing processThe process to manufacture Neomem® Xac is centered on tightly controlled procedures focused on:
- Best in class procedure, driven by internal research and peer reviewed studies
- Minimal manipulation to retain optimal regenerative capacity native to tissue
- Exhaustive post-processing rinsing to effectively eliminate processing reagents
Placental membranes are recovered from cesarean section procedures and shipped to the manufacturer overnight in validated coolers. The membranes are processed fresh upon receipt and never frozen. The membrane is subjected to a proprietary series of mild aqueous rinses to disinfect and clean the tissue in ISO Class 6 clean rooms without the use of harsh chemicals. Once rinsed, the tissue is dehydrated, cut to size, packaged in foil and tyvek pouches. Finished grafts are evaluated by dedicated quality control technicians and subjected to terminal sterilization via low dose e-beam irradiation to a sterility assurance level of 10-6.
Every step of the process is completed in accordance with current Good Tissue Practices (cGTP), AATB standards and AORN aseptic technique. All processes are validated against appropriate ISO standards.
Finally, a comprehensive review of the infectious disease testing, processing records, labeling documentation, and medical records are completed by a dedicated quality associate prior to the tissue being released for distribution.