Specifically Endotoxin contamination of ophthalmic medical devices and intraocular ophthalmic products can cause ‘toxic anterior segment syndrome’ (TASS). This is an acute inflammation of the eye following ocular lens replacement surgery. There are several potential causes of TASS, ranging from particulate contamination to problems with chemical formulation of opthalmics (such as abnormal pH, osmolarity or ionic composition). One cause that is increasing, and of regulatory concern, is contamination of products with bacterial endotoxin.
To examine this important issue, R. Vijayakumar, Mohammad Saleh Al- Aboody1, Wael Alturaiki and Tim Sandle have written a review paper.
The abstract is:
Ophthalmic products are at risk from direct or indirect contamination from Gram-negative bacteria. A by-product of Gram-negative bacteria is the lipopolysaccharide component of the cell wall (commonly known as endotoxin). Bacterial endotoxin is a potent ocular inflammatory agent and causes ‘toxic anterior segment syndrome’. This paper reviews the patient risks from endotoxin and considers the sources of endotoxin in relation to the production of an ophthalmic surgical products. The paper also considers the main product contamination recalls during the past decade. The risks and requirements for testing are then considered in light of current regulatory guidances. We conclude by making recommendations for endotoxin and bioburden control for manufacturing and in setting out appropriate endotoxin test limits for the testing of finished ophthalmic products.
The reference is:
Vijayakumar, R., Al- Aboody, M.S., Alturaiki, W. and Sandle, T. (2017) Review on endotoxin mediated toxic anterior segment syndrome (TASS) in ophthalmic products- Outbreaks, product recall and testing limits, European Journal of Parenteral and Pharmaceutical Science, 22 (1): 20-25
For further details and a copy, please contact Tim Sandle
Posted by Dr. Tim Sandle