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Sterile Compounding Filters

Filtration Makes Medication Possible

International Filter Products is committed to serving sterile compounding pharmacies with our broad range of filter products, tubing, Bio-bags, and Bubble Point Stands. We are a stocking distributor carrying many standard products used daily. We provide affordable filtration solutions, expert advice, technical support, and complete documentation. We have unique solutions not found elsewhere; eight capsules and disc capsule filters sizes, several different sterilizing grade membranes, and a number of options for inlets/outlets. 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. Test sample filters are available.

All final filters the pharmacist use must complies with USP 797. The sterility requirement is met by two statements on our Certificate of Compliance; (1) Pharmaceutical Grade and (2) Bacteria Retention with Brevundimonas Diminuta (ATCC #19146) at a minimum challenge level of 107 CFU per cm2, consistent with ASTM F838-05. USP Bacterial Endotoxins, ISO 1033-5 Cytotoxicity and ASTM Hemolysis testing meets the Human consumption requirement.

Our products include four filter disc capsules sizes (D25C, D50C, D65R, and D90R) and four small capsules sizes (JKP series, MKP series, and SKP series: “S” & “H”). The volumes to be filtered differ when using aqueous or pure oil solutions and are charted in the “Typical Filtered Volumes” section found below. Both filter discs and capsules have a dual membrane option for tough applications where the active ingredient(s) do not dissolve well in the base. To ensure that our products meet the chemical compatibility requirements, the filter discs are available with four (4) different Pharma Grade membranes (Nylon, PES, HDPE, and PTFE). See chemical compatibility chart in the “Filter – Chemical Compatibility” section below. To ensure that our products meet the chemical compatibility requirements, our products undergo integrity testing using a bubble point stand. In this technique, a failing result will be yielded when the product is not chemically compatible or has exceeded its pressure limitation. For more information on integrity testing, please see the “Integrity Testing Filters or Bubble Point” section below.

D25C Filter Disc Capsules (25 mm diameter) have been designed for the stringent requirements of the Sterile Compounding Industry.

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D40C Filter Capsules have been specially designed for simple, quick, and efficient filtration of fluids and gases used in laboratory, pilot, and small-scale applications.

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D50C Filter Disc Capsules (50 mm diameter) have been designed for the stringent requirements of the Sterile Compounding Industry. 

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D65R Filter Disc Capsules (65 mm diameter) have been designed for the stringent requirements of the Sterile Compounding Industry. 

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D90R Filter Disc Capsules (90 mm diameter) have been designed for the stringent requirements of the Sterile Compounding Industry.

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Economical small capsule filter assemblies are ready-to-use filters that offer high flows, increased throughputs, high strength, all with the convenience and cleanliness of a disposable and easy-to-install filter assembly in a small package. The JKP and MKP capsules are designed for small volume final filtration in the Compounding Industry for commonly used solvents, bases and mediations. 

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The SKL Series PureFlo® “H” and “S” size filter capsules, with all-polypropylene construction, provide excellent chemical compatibility and superior flow per unit area as compared to other membrane capsules. PureFlo® SKL Series Filter Capsules have been economically priced and specially designed for sterilizing in compounding pharmacy applications for commonly used solvents, bases, and mediations. 

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The first order of business when sterile filtering an aqueous, oil or medication is to select a filter that is chemically compatible to the solution. A great technique with excellent procedures and a state of the art facility will yield a fail result if the filter materials aren’t chemically compatible with the filtered solution or medication. Usually the membrane or seal between the membrane and filter shell are compromised when the filter materials aren’t chemically compatible with the filter solution. This yields a non-sterile product and a low bubble point when integrity testing the filter after use.

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To integrity test a filter, the filter must be wetted with a fluid with a know surface tension. After filtering the desired medication or base, the filter must be flushed with either DI water or 60% IPA (isopropyl Alcohol) and balance DI water. We prefer the 60% IPA / 40% water be used.

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This section has been assembled providing the pharmacist with a guide to estimate what size filter is required to filter a set volume. We have been accumulating this information directly from pharmacies using our filters. Basic solvents and solutions previously cleaned filter larger volumes than bases that haven’t been previously filtered by manufacturer. The number of active ingredients used and their solubility greatly affects the volume filtered.

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International Filter Products
11070 Fleetwood St. Unit B
Sun Valley, CA 91352