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Table of Contents

Table of Contents

Clinical

Comparison of Endothelial Cell Measurements by Two Eye Bank Specular Microscopes

Transitioning from PK to DMEK in a Public Hospital in Southern Brazil: First Series of 24 Consecutive Cases

Editorial

Letter from the Editor

Featured Article

EBAA Major Guidance and Standards Changes

Proceedings

EBAA Major Guidance and Standards Changes

HCT/P Case Presentations: Adverse Reactions and Product Deviations

Terminal Sterilization: One Eye Bank’s Experience

Manufacturing Arrangements: Industry Compliance

Terminal Sterilization: One Eye Bank’s Experience

Authors

Christopher G. Stoeger, MBA, CEBT, CTBS

Abstract

Microorganisms are frequently referred to as “bugs”. Terminal sterilization is a method of inactivating any microorganisms on a given object. Corneal tissue is not considered sterile and, by definition, harbors microorganisms. While infections related to corneal transplants are rare, they do happen. For some types of corneal transplants, cellular viability is not required. Examples of this are tectonic grafts and glaucoma shunt covers. For these non-viable grafts, eye banks may wish to consider a sterilization protocol in order to reduce the already low likelihood of graft related infections. Additionally, sterilization of corneal tissue makes shelf-stability easier to achieve as bioburden growth will no longer compromise the tissue once sterilized. Making a sterility claim is not to be taken lightly. Please use this information in careful consultation of experts in the field of tissue sterilization.

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