- FDA RegisteredTissue Establishment · FEI 3017609580
- AATB AccreditedAccreditation No. 00377
- ISO 13485 CertifiedCertificate No. 272926
- Health Canada CTORegistration No. 100270
The AmnioCleanse™ Process
Processed, sterilized, and packaged under a certified quality system.
AmnioCleanse™ is Amnion’s proprietary process for human amniotic membrane recovered from screened donors following scheduled Caesarean-section delivery. Our manufacturing protocols and laboratory operations are validated under a certified quality management system, with testing performed by independent contract laboratories.
Each graft is terminally sterilized by electron-beam (e-beam) irradiation to a validated sterility assurance level, then sealed in packaging validated to support its labeled shelf life.
Every product we manufacture is minimally manipulated and intended for homologous use as a covering.
Contact our team at info@amnion.net for product specifications, sizing, and ordering.
About Amnion
Working With Amnion
Grafts are supplied in eight sizes, from 5×5 mm to 7×7 cm, together with pre-cut discs for ophthalmic use. Our team supports your practice on sizing, handling, storage, and ordering, and can supply the product documentation your records require.
We also work with distributors and health systems outside the United States. To discuss product specifications, samples, or distribution, contact our team at info@amnion.net.
Our Mission
Amnion manufactures human amniotic membrane allografts from birth tissue donated following scheduled Caesarean-section delivery. We exist to make that tissue available to clinicians reliably, at a cost their practices can sustain.
AmnioCleanse™ is at the core of everything we produce — our proprietary processing platform, developed by a team with decades of combined experience in human tissue banking. We manufacture at our own facility in Sterling, Virginia, under a certified quality management system.