Abstract
This chapter discusses the preservation and sterility of ophthalmic preparations and devices. The most important issue with respect to ophthalmic preparations is to reduce the risk of microbial contamination as far as possible. In doing so, one must distinguish between the risk of contamination. There is the least risk of contamination if it is possible to sterilize ophthalmic solutions in the closed final containers in the autoclave for 30 min at 121°C. This is the most reliable method for all products which, because of their use in ophthalmic surgery (ophthalmic solutions for surgical use and introduced into the anterior chamber of the eye) must be free of preservatives. The risk of contamination is far greater in the manufacture and filling of ophthalmic preparations under aseptic conditions. In view of this fact, a large number of pharmacopoeias stipulate that such products be protected in addition by including a suitable preservative (antimicrobial agent).
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