SUMMARY TO DATE

For years, pharmacists (community, hospital, veterinary, nuclear, etc.) have used sterile filtration for sterilizing various volumes of compounded sterile preparations. There is a diversity of compounded preparations, techniques, and technology utilized in these compounding processes and locations. The currently official United States Pharmacopeia (USP) <797> chapter that went into effect June 1, 2008 has the following statement regarding filters:

STERILIZATION OF HIGH-RISK LEVEL CSPs BY FILTRATION

Commercially available sterile filters shall be approved for human-use applications in sterilizing pharmaceutical fluids.

It is unclear what is meant by "approved for human-use applications" and what are the standards/specifications for that to occur. It is assumed this is done by the FDA, but, if that is the case, the sterilizing filters for human use should be labeled as such. However, it is somewhat difficult to comply with this statement as sterilizing filter companies do not prominently place such a statement on their packaging. They may, however, label these sterilizing filters "For laboratory use" and provide certification documents, etc. as to their effectiveness/quality and sterility.

So then, what is required to be confident of purchasing sterilizing filters approved for human-use?

A summary of the companies that appear to be supplying sterilizing filters for human-use applications follows. The documentation for the process occurring over the past few months is available as a free download at:

CompoundingToday.com
Click on "USP Compliance"

NOTE: IF ANYTHING IN THE FOLLOWING LIST IS INCORRECT, PLEASE LET US KNOW SO IT CAN BE CORRECTED

YES, THESE CAN BE USED

INTERNATIONAL FILTER PRODUCTS
Our filters, whether a capsule or a filter disc capsule, are factory sterilized, ready to be used out of the package, and include a complete certificate of conformance. Our filters are 100% integrity tested and comply with USP <797> guidelines, etc.

MILLIPORE
Millipore has stated that Millex filters are cleared for use in humans to filter drug solutions and render them sterile.

The following table is provided.

NO, THESE CANNOT BE USED

Baxter
Pall
Sartorius

UNCLEAR IF THESE CAN BE USED

Gelman
https://www.accessdata.fda.gov/scripts/cdrh/Cfdocs/cfPMN/pmn.cfm?ID=K941589

Thanks to the following for all their efforts in this process:

Michael Akers, PhD; Lisa D. Ashworth, BS, RPh; Melanie A. Jordan, PhD; Willis C. Triplett, PharmD.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

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Critically evaluate members of regulatory and standards-setting entities to confirm they are "knowledgeable and practical." Simply occupying a responsible position does not guarantee an appropriate knowledge and experience data base; too many are involved in administrative functions and not familiar with "where the rubber hits the road." As appropriate, GET INVOLVED!

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