Sterile Compounding Filters




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.

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D25C Filter Caps

D25C Filter Disc Capsules (25 mm diameter) have been designed for the stringent requirements of the Sterile Compounding Industry. The filter discs are available with four (4) different Pharma Grade membranes (Nylon, PES, HDPE, and PTFE) and three (3) component materials (Nylon, HDPE, and Polypropylene) ensuring that our products meet the chemical compatibility requirements for a wide range of medications produced by the Sterile Compounding Industry. Dual layer membranes are available for the tough applications where the active ingredient(s) doesn’t dissolve well in the base. This increases the volume filtered 35% to 2X more for a minimal cost increase. There are eleven (11) different connections for the Inlet / Outlet to choose from. The most popular fittings are Luer Female Inlet and Luer Male Outlet. The filters 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 class V1, USP 797 guidelines, etc. Test samples are immediately available for most applications. The effective filter is 4.6 cm2.


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D50C Filter Caps

D50C Filter Disc Capsules (50 mm diameter) have been designed for the stringent requirements of the Sterile Compounding Industry. The filter discs are available with four (4) different Pharma Grade membranes (Nylon, PES, HDPE, and PTFE) and three (3) component materials (Nylon, HDPE, and Polypropylene) ensuring that our products meet the chemical compatibility requirements for a wide range of medications produced by the Sterile Compounding Industry. Dual layer membranes are available for the tough applications where the active ingredient(s) doesn’t dissolve well in the base. This increases the volume filtered 35% to 2X more for a minimal cost increase. There are eleven (11) different connections for the Inlet / Outlet to choose from. The most popular fittings are Luer Female Inlet and Luer Male Outlet. The filters 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 class V1, USP 797 guidelines, etc. Test samples are immediately available for most applications. The effective filter is 15.9 cm2.


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D65R

D65R Filter Disc Capsules (65 mm diameter) have been designed for the stringent requirements of the Sterile Compounding Industry. The filter discs are available with four (4) different Pharma Grade membranes (Nylon, PES, HDPE, and PTFE) and three (3) component materials (Nylon, HDPE, and Polypropylene) ensuring that our products meet the chemical compatibility requirements for a wide range of medications produced by the Sterile Compounding Industry. The larger diameter is excellent when filtering oil base medications. Dual layer membranes are available for the tough applications where the active ingredient(s) doesn’t dissolve well in the base. This increases the volume filtered 35% to 2X more for a minimal cost increase. There are eighteen (18) different connections for the Inlet / Outlet to choose from. The most popular fittings are Luer Female Inlet and Luer Male Outlet. The filters 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 class V1, USP 797 guidelines, etc. Test samples are immediately available for most applications. The effective filter is 26 cm2. This filter disc size is larger and not available elsewhere.


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D90R Filter Caps

D90R Filter Disc Capsules (90 mm diameter) have been designed for the stringent requirements of the Sterile Compounding Industry. The filter discs are available with four (4) different Pharma Grade membranes (Nylon, PES, HDPE, and PTFE) and three (3) component materials (Nylon, HDPE, and Polypropylene) ensuring that our products meet the chemical compatibility requirements for a wide range of medications produced by the Sterile Compounding Industry. The larger diameter is excellent when filtering oil base medications. Dual layer membranes are available for the tough applications where the active ingredient(s) doesn’t dissolve well in the base. This increases the volume filtered 35% to 2X more for a minimal cost increase. There are eleven (11) different connections for the Inlet / Outlet to choose from. The most popular fittings are Luer Female Inlet and Luer Male Outlet. The filters 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 class V1, USP 797 guidelines, etc. Test samples are immediately available for most applications. The effective filter is 60 cm2. This filter disc size is unique and not available elsewhere.

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Small Capsules

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 (aqueous & oils) and mediations. PureFlo® Junior and miniature capsule assemblies are available with a wide range of hydrophilic and hydrophobic filter membranes with sterile filtration capability per USP 797 for liquid and oil applications. For the convenience of the pharmacist, female Luer loc inlet and male Luer loc connections are available as well as 13 other fitting options. We have more fittings available than any other filter manufacturer. Dual layer membranes are available providing the option thus increasing the filtered volume 35% to 200% with only a small cost increase of approximately 15%. All capsules are 100% integrity tested, factory sterilized, have a Certificate of Conformity and comply with USP 797.


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Medium Capsules

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 (aqueous & oils) and mediations. The capsules are available with a wide range of hydrophilic and hydrophobic membranes. For the convenience of the pharmacist, female Luer loc inlet connection is available as well as 25 other fitting options. All capsules are 100% integrity tested, factory sterilized, have a Certificate of Conformity and comply with USP 797.


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Chemical Compatibility

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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Typical Filtered Volumes

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. There are a number of strategies which can be employed to increase the volume filtered. With an aqueous solution, the options are to increase the filter size, use a dual layer filter or both. A dual layer filter simply has two (2) membrane layers; the first is a pre-filter, 0.8 um, 0.65 or 0,45 over the final filter 0.2 um. The pre-filter removes the larger particles and protects the downstream 0.2 um final filter. The dual layer membrane strategy usually increases the volume filtered 35% to 200% from a single layer membrane filter and only costs 15 to 20% more. When filtering oils, you have three options, you can employ the two options above and or heat the oil to 90 or 100 F. The heating of the oil reduces its viscosity thus making it much easier to flow and filter. The lower viscosity lowers the pressure drop across the filter allowing it to collect more contamination prior to reaching terminal pressure or final filtered volume. The expected filtered volumes are shown under the , see details tab.


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Integrity Testing Filters or Bubble Point

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. This solution is easier to wet the capsule and the acceptable bubble point values are much lower; see the acceptable bubble point values in the table below. 18 Psi is a much safer pressure to operate at than 50 psi. This is important when the chemical compatibility is unknown and the capsule may not be structurally sound.


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