Sterile Filtration For Opthalmic
Sterile Filtration For Opthalmic
Sterile Filtration For Opthalmic
Ophthalmic Solutions
Abstract
Liquid ophthalmic products include a wide variety of formulations for cleaning
and storing contact lens, eye washes and drops, as well as many therapeutic
treatments. All ophthalmic products must meet a number of requirements for
E Sterile filtration is a preferred safety and efficacy that include certification of sterility. Sterility is defined as the
method to achieve sterility of absence of viable microbial contamination which, if present in such formulations,
opththalmic preparations
could result in infections of the eye with possible serious consequences.
E Millipore Express SHF filters The preferred method to achieve sterility of ophthalmic preparations is sterile
provide sterilizing grade
performance with superior filtration. By this method, the finished preparation is passed through a sterilizing-
economy and efficiency grade membrane during fill of the final (presterilized) product container. The
E Millipore Express SHF
membrane filter in this application must not only meet established regulatory
N O T E
membrane for high flux, requirements for bacterial retention, but must also satisfy industry specifications
low inherent preservative for cleanliness (extractables, pyrogenicity), chemical compatibility, reliability, and
binding process efficiency.
E Up to 2-1/2 times the flow
rate of competitive filters
A P P L I C A T I O N
Conclusion
The combined benefits of low inherent
preservative binding and high through-
put per unit area make Millipore
Express SHF filters the ideal choice for
the sterile filtration of ophthalmic
solutions. Assuming a minimum performance requirement of 95% BAK passage, the nearest
competitor would require more than 10% additional flush volume or lost product.
For most other competitive membranes, product losses could be more than double
that of Millipore Express SHF membrane.
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