QUALITY SAFETY ETHICS

QUALITY ASSURANCE

At One Biologics, quality is essential to us because we value our customers' reputations and, above all else, their patients' safety. With our AATB® Certified Tissue Bank Specialist Medical Director, FDA registered and cGTP compliant lab, we strive to provide products and services which not only meet but exceed, Current Good Tissue Practice requirements.

SAFETY ASSURANCE

One Biologics follows rigorous written policies and standard operating procedures in all its activities. We regularly update our policies and procedures to ensure compliance with all relevant standards and regulations. Additionally, we conduct quality assurance audits on all internal and external processes on a routine basis to maintain high standards of quality.

ETHICS ASSURANCE

You can be confident that the 361 HCT/P Tissue Allografts you receive from One Biologics are ethically sourced (Donated), carefully processed, and thoroughly tested for safety and effectiveness.

Our team of experts stays current with the latest advancements in tissue processing and transplantation to provide patients with the best possible outcomes.

AMERICAN ASSOCIATION OF TISSUE BANKS®

CERTIFIED TISSUE BANK SPECIALIST MEDICAL DIRECTOR

The American Association of Tissue Banks® is the organization that sets standards, inspects facilities, and accredits tissue banks in North America. The AATB® trains and certifies tissue banking specialists. In crafting new federal regulations for tissue banking, the FDA has relied heavily on the expertise of the AATB®.

TISSUE RECOVERY AND PROCESSING

  • Microbiological cultures are collected from every tissue to ensure no microorganisms are present.

  • To maintain biological integrity, we process all tissue by using aseptic techniques in ISO 5 and ISO 7 environments

  • Selected 361 Tissue Allografts products are terminally sterilized by electron beam radiation

  • All 361 Tissue Allografts undergo multiple quality assurance checks before release to ensure utmost safety and quality.

  • We ensure traceability for all tissues, starting from the point of recovery and continuing through testing, processing, packaging, distribution, and implantation.

DONOR SELECTION & SCREENING FULL REQUIREMENTS