Compliance and Regulatory Excellence: Ensuring Uncompromised Quality

At our core, we are committed to exceeding industry standards regarding product testing. The integrity and safety of our offerings remain paramount, and to uphold this commitment, we have meticulously established comprehensive testing guidelines. These guidelines are a testament to our dedication to quality assurance, ensuring that every product that leaves our facility meets the highest standards.

Rigorous Testing Process: Setting New Benchmarks

We engage a third-party laboratory that is a global leader in pharmaceutical, cosmetic, and environmental testing. This strategic partnership empowers us to go beyond the ordinary, employing a rigorous testing process encompassing several vital facets.

Sterility and Purity: Upholding the Gold Standard

Our testing guidelines adhere to the gold standard of sterility, as dictated by the USP 71 Sterility Guidelines. This meticulous approach leaves no room for compromise, encompassing the assessment of fungi, molds, yeasts, and bacteria. In harmony with the tenets set forth by the AATB and FDA, our commitment to sterility reflects our unwavering pledge to product purity.

Thorough Endotoxin Evaluation: Ensuring Absolute Safety

Endotoxins pose a potential threat, one that we address with utmost diligence. Our testing guidelines follow the stringent criteria established by the AATB and FDA, meticulously assessing the presence of endotoxins. Through this process, we demonstrate our commitment to the highest levels of safety and product integrity.

Vigilant Pathogen Detection: A Comprehensive Shield

In a world where pathogen detection is of paramount importance, our testing guidelines leave no stone unturned. In alignment with AATB and FDA guidelines, we subject our products to scrutiny for viruses, bloodborne pathogens, and tissue-borne pathogens. This exhaustive evaluation includes critical markers such as HIV, HBsAg, HCV, and more. Even the likes of the COVID-19 virus are not exempt from our stringent evaluation, showcasing our dedication to safeguarding public health.

Adherence to Regulatory Standards: A Promise to the Public

Regulatory standards stand as the backbone of public safety and product quality. We work in close partnership with reputable regulatory bodies to ensure unwavering compliance. Our adherence to AATB Standards for Tissue Banking, Good Tissue Practices, and Homologous Use is a testament to our commitment to upholding the highest industry benchmarks.

21 CFR PART 1271: A Pillar of Integrity

Navigating the complex landscape of HCT/P regulations, we operate in accordance with 21 CFR PART 1271, a cornerstone that underscores our unwavering dedication to ethical practices and product excellence.

In Closing: A Dedication to Excellence

In a world where quality and safety are paramount, we stand at the forefront, setting new standards through our compliance and regulatory efforts. Each step we take, each guideline we adhere to, is a testament to our commitment to delivering products of uncompromised integrity – products that stand as a beacon of trust and excellence.