Wednesday, 21 September 2016

Bacterial endotoxin contamination and testing limits in ophthalmics


Endotoxin contamination in ophthalmic pharmaceuticals and medical devices presents a risk to users; moreover, endotoxins can cause acute inflammation of the eye following ocular lens replacement surgery.

A new article reviews the risks and requirements for product testing, together with current regulatory guidances. It further analyses recall data relating to ophthalmic pharmaceuticals due to endotoxin contamination. The article concludes by making recommendations for endotoxin control and sets out appropriate endotoxin test limits for finished ophthalmic products.

The article has been written by R. Vijakumar and Tim Sandle. The reference is:

Vijakumar, R. and Sandle, T. (2016) Bacterial endotoxin contamination and testing limits in ophthalmics, European Pharmaceutical Review, 21 (4): 16-18

For further details, please contact Tim Sandle

Posted by Dr. Tim Sandle