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:
Posted by Tim Sandle
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