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State of the Art Processing

Stability Biologics is committed to cutting-edge product development and the provision of high quality, safe and effective products in the marketplace. We maintain full compliance with FDA, State, and AATB standards and we are devoted to being good stewards of the Gift of Life to further benefit of patients.


Stability utilizes a 21,000 sq. ft, state-of-the-art Manufacturing & Distribution facility in San Antonio, TX to manufacture and process under strict aseptic techniques to ensure maximum control, sterility and safety of every product. Processing is performed in fully validated, certified and classified Processing Cleanrooms to ISO Class 5, Class 6 and Class 8. All cleaning activities, manufacturing steps, materials, packaging, monitoring and processes are fully validated, and all products are terminally sterilized and validated to ensure a Sterility Assurance Level (SAL) of 10-6.

State of the Art Processing and Distribution
ꔷMultiple Processing Cleanrooms
ꔷResearch & Development Lab
ꔷQuality & Compliance
ꔷStorage
ꔷDistribution

 

Stability is registered with the U.S. FDA CBER for Allograft (HCT/P) manufacturing, accredited by the American Association of Tissue Banks (AATB) and licensed for tissue banking by California, New York, Florida, Maryland and registered in all applicable states. All products are processed from donated human tissue that has been recovered, screened, tested for infectious disease, and determined suitable for transplantation by a licensed Medical Director according to applicable FDA, AATB, and state requirements for donor eligibility and infectious disease testing.

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