Sterile Filtration For Opthalmic

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Sterile Filtration of

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

E Lowest BAK binding of Introduction To ensure the proper amount of


comparable test membranes preservative is maintained in the final
Ophthalmic solutions of many types
are packaged in multiple dose product, some initial portion of the
containers, and a bacteriostatic filtered product is typically discarded
preservative agent is generally added until the membrane filter is conditioned
to reduce the risk of inadvertent or saturated with the preservative.
bacterial contamination with repeat Therefore to maximize production
open-air exposure. Common preser- yields, sterilizing-grade filters must
vatives used include benzalkonium minimize membrane-specific adsorp-
chloride (BAK), paraben, potassium tive losses of these preservatives as
sorbate, chlorhexidine acetate, well as maximize throughput per
chloroscresol and polyhexamine surface area.
gluconate.
These preservatives will, to varying Millipore Express SHF for
degrees, bind or be adsorbed onto Superior Efficiency and
many common membrane filter Economy
materials. The degree of adsorption Millipore Corp.(Billerica, MA) has
depends on both the preservative and recently introduced a new line of
the chemical composition of the filter microporous sterilizing-grade filter
(membrane polymer, surface chemistry, products for cost-effective aseptic
support materials, etc.). The uptake of processing of aqueous-based
preservative by the filter is highest at pharmaceuticals. Millipore Express®
the start of filtration and diminishes SHF filters are based on a patented,
with time according to the volume of composite, asymmetric polyethersulfone
product processed relative to the (PES) membrane that provides both high
membrane area. flux rates and sterility assurance for

 superior filtration economy and efficiency.


Experimental Conditions Figure 1.
and Results
The high flux rate of Millipore Express Contact Lens Solution Competitive Sterile Filtration
SHF membrane can mean substantial
savings in sterile filtration costs for
Tests: 0.2 Micron Membranes
manufacturers of ophthalmic products.
In a competitive comparison (Figure 1)
Millipore Express SHF (PES) Membrane
Millipore Express SHF membranes
achieved up to 2-∞ times the
throughput of competitive filters.
In addition, a series of filtration tests
were conducted to evaluate the pre-
servative binding of various sterilizing-
grade membranes. Eye wash product
containing 0.01% Benzalkonium
chloride (BAK) was chosen as a
model test solution.
The test membranes were all 0.2 µm
sterilizing-grade, and composed of
either PES or polyvinylidenedifluoride
(PVDF). Aliquots of the filtered eye
wash were collected at several Figure 2.
incremental process volumes and
analyzed for BAK content. BAK Concentration in Filtrate of Millipore Express
The test results (Figure 2) show that SHF and Competitive PES Filters
of the membranes tested, Millipore
Express SHF membrane demonstrated
the lowest BAK binding. Millipore
Express SHF membrane produced the
highest initial BAK content and most
rapidly reached a process point of
minimal BAK removal.

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.

Millipore Corporation 290 Concord Road Billerica, MA 01821 U.S.A.


1-800-MILLIPORE (645-5476) www.millipore.com

Millipore and Millipore Express are registered trademarks of Millipore Corporation.

 Lit. No. AN1575EN00 Rev. - 10/04 Printed in U.S.A. 04-278


© 2004 Millipore Corporation, Billerica, MA 01821 U.S.A. All rights reserved.

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