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Glycerol Preservation and Bio-safety
Glycerol has been used to preserve allografts for ophthalmic surgeries since the 1960’s,
with the longest clinical experience available for sclera as patch grafts or as covering for
ocular prostheses (e.g., [1, 2]). Global Sight Network continues that tradition. We use
only glycerol made without any animal-derived products, eliminating risk for
transmission of agents derived from that source. Through a validated process, we ensure
that preparation of vials containing glycerol, as well the process of transferring from
intermediate-term storage to glycerol, are performed aseptically and under a certified ISO
5 Laminar flow hood. Our quarantine protocol is based on available peer-review
literature [3], as well as our eye banking colleagues with ample experience in these
methods for their collaborating surgeons. Additional treatments of glycerol preserved
tissue with radiation or caustic agents do not enhance safety, at least in animal models
[4]. Global Sight Network adheres to all guidelines and regulations for the Eye Bank
Association of America, the U.S. Food and Drug Administration, and the Occupational
Health and Safety Administration. Global Sight Network performs microbiological
surveillance on all batches of sterilized vials to ensure absence of organism growth.
Although the cornea itself is not sterilized, every precaution is taken to ensure that the
tissue is safe for transplantation.
1
Freedman J. Scleral patch grafts with Molteno setons. Ophthalmic Surg. 1987
Jul;18(7):532-4. PMID 3627691
2
Oh JH, Kim JC. Repair of scleromalacia using preserved scleral graft with
amniotic membrane transplantation. Cornea. 2003 May;22(4):288-93. PMID 12792468
3
Dailey JR, Rosenwasser GO. Viability of bacteria in glycerin and ethanol
preserved sclera. Journal of refractive and corneal surgery. 1994 Jan-Feb;10(1):38-40.
PMID 7517780
4
Fernandes JB, Matayoshi S, Osaka JT, et al. [Comparative analysis between
sclera treated with glycerin and sclera treated with gamma irradiation, alkali and glycerin
in the reconstruction of anophthalmic socket: experimental study in rabbits]. Arquivos
brasileiros de oftalmologia. 2007 Jul-Aug;70(4):639-47. PMID 17906761