Sterile Compounding Filters
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International Filter Products is committed to serving sterile compounding pharmacies with our broad range of sterilizing grade filters, including sterilizing grade filters, filter accessories, tubing, Bio-bags, and Bubble Point Stands. We are a stocking distributor with over $300,000 in inventory of standard products used daily to support our compounders. We provide affordable filtration solutions, expert advice, technical support, and complete documentation. We have unique solutions not found elsewhere; capsules and disc filters in different sizes, multiple sterilizing grade membranes, and several options for inlets/outlets. Our filters, whether capsule or disc filter, are factory sterilized, ready to be used out of the package, and include a complete certificate of conformance. Our sterile compounding filters are 100% integrity tested and comply with USP 797 guidelines. Our filters are well known to the FDA inspectors (Saint-Gobain) for their proven quality in the sterile compounding industry. Some of the largest pharmaceutical and drug manufacturer companies have trusted our filters for their final fill over the years.
All sterile compounding products the pharmacist use must comply 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 10993-5 Cytotoxicity, and ASTM Hemolysis testing meet the Human consumption requirement.
Our sterile compounding filter 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. 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. The disc and capsule are available with three (3) different Pharma Grade membranes (PES, PTFE, and PP) to ensure that our products meet the chemical compatibility requirements. See the chemical compatibility chart in the “Filter – Chemical Compatibility” section. Our sterile compounding filters undergo an integrity test using a bubble point stand to comply with the chemical compatibility requirements. A failing result will be yielded in this technique when the product is not chemically compatible or has exceeded its pressure limitation. Please see the “Integrity Testing Filters or Bubble Point” section below for more information on integrity testing. International Filter Products offers filters with low retention rates that reduce the hold-up volume significantly. An estimation for the hold-up volume for different connection types is also mentioned in the section, which helps pharmacists select their best option.
International Filter Products has built a reputation in sterile compounding products filtration and serving major drug and serum producers, 503 (A) and 503 (B) Pharmacies in the United States and overseas.
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D25C Filter Disc Capsules (25 mm diameter) have been designed for the stringent requirements of the Sterile Compounding Industry.
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.
D50C Filter Disc Capsules (50 mm diameter) have been designed for the stringent requirements of the Sterile Compounding Industry.
D65R Filter Disc Capsules (65 mm diameter) have been designed for the stringent requirements of the Sterile Compounding Industry.
D90R Filter Disc Capsules (90 mm diameter) have been designed for the stringent requirements of the Sterile Compounding Industry.
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.
(*) DI water can be substituted by RO water, Purified water or Sterile water.
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.
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.
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.
IFP provides hold-up volume filter capsules that are offered to the electronic processing, pharmaceutical, medical, chemical, food, and beverage markets.
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