Monday, 6 October 2014

Sterile Ophthalmic Preparations and Contamination Control

Ophthalmic preparations (eye preparations) are sterile liquid, semi-solid, or solid preparations that may contain one or more active pharmaceutical ingredients. Ophthalmic products are intended for application to the conjunctiva, the conjunctival sac, or the eyelids. The course of treatment may extend during several days. Although eye preparations contain a preservative, there is a probability of microbial contamination after the package sterility seal has been broken during the period of use.

In a new paper for the Journal of GXP Compliance, Tim Sandle considers the key elements relating to the manufacture of ophthalmic products from the perspective of microbial contamination control. Its focus is upon the aseptic dispensing of the products and environmental and technological requirements including blow-fill-seal filling and container sealing systems.

The reference is:

Sandle, T.  (2014) Sterile Ophthalmic Preparations and Contamination Control, Journal of GXP Compliance, 18 (3): 1-5

Posted by Tim Sandle