- 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 made to order in any size combination from 5×5 mm to 7×7 cm, together with pre-cut discs from 5 mm to 15 mm for ophthalmic use. Our team supports your practice on sizing, handling, storage, and ordering, and can supply the product documentation your records require. Request a quote for a made-to-order size.
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.