Chemical Compatibility for Sterile Compounding

When it comes to sterile filtering of aqueous, oil, or medication solutions, the foremost priority is choosing a filter that is chemically compatible with the solution being filtered. At International Filter Products Inc., we emphasize that even the most advanced techniques and state-of-the-art facilities can fall short if the filter materials are not chemically compatible with the solution or medication. Incompatibility often leads to compromised membranes or seals, resulting in a non-sterile product and lower bubble points in post-use integrity testing.

Chemical compatibility charts are crucial in determining the suitability of different filter materials for specific chemical solutions. These charts guide the selection of the most appropriate filter material, evaluating its resistance to chemical attack, swelling, and degradation. By consulting a chemical compatibility chart, you can confirm that your chosen filter materials will not only be compatible with the chemicals in your process but also maintain the integrity and effectiveness of your filtration system.

While the table provided below is not exhaustive for all solutions used in sterile compounding pharmacies, it serves as an invaluable guide. We continuously update this list to ensure its relevance and utility. Should you require information about a compound or solution not listed, our team is equipped to assist. Utilizing our extensive network, chemical compatibility charts for plastics used in filters, and a range of filters with varying materials, we are committed to finding the correct solution for your needs.

In Appendix A of our chemical compatibility chart, we detail the most commonly used filter materials in sterile compounding filtration applications. These include PES (polyether sulfone), PTFE (polytetrafluoroethylene), PP (polypropylene), PVDF (polyvinylidene fluoride), and NYL (nylon), ensuring a broad spectrum of options to meet the diverse needs of our clients in sterile compounding.

Chemical	PES	PTFE	PP	PVDF	Nylon
Acetic Acid (Glacial) Acid, Organic	Excellent	Excellent	Excellent	Excellent	Not Recommended
Acetone Ketone	Not Recommended	Excellent	Excellent	Not Recommended	Excellent
Acetonitrile (ACN) Nitrile	Not Recommended	Excellent	Not Recommended	Limited	Excellent
Aminolite	Excellent	Not Recommended	Testing Required	Excellent	Testing Required
Ammonium Hydroxide Caustic	Not Recommended	Excellent	Testing Required	Excellent	Testing Required
Ammonium Sulfate (Saturated) Salt, Aqueous Solution	Testing Required	Excellent	Excellent	Not Recommended	Excellent
Amyl Acetate Ester	Excellent	Excellent	Testing Required	Excellent	Testing Required
Amyl Alcohol	Excellent	Excellent	Excellent	Excellent	Testing Required
Ascorbic Acid	Excellent	Excellent	Excellent	Testing Required	Testing Required
Benzene HC, Aromatic	Not Recommended	Excellent	Not Recommended	Excellent	Excellent
Benzyl Alcohol HC Aromatic/Alcohol	Testing Required	Excellent	Excellent	Excellent	Testing Required
Benzal Chloride	Testing Required	Excellent	Excellent @ 10% Solution	Excellent	Excellent
Benzal Conium Chloride	Testing Required	Excellent	Excellent @ 10% Solution	Excellent	Excellent
Benzyl Alcohol	Excellent	Excellent	Excellent	Testing Required	Testing Required
Benzyl Benzoate	Not Recommended	Excellent	Excellent	Testing Required	Testing Required
Boric Acid (Aqueous Solution)	Excellent	Excellent	Excellent	Testing Required	Excellent
Butyl Acetate Ester	Not Recommended	Excellent	Testing Required	Testing Required	Excellent
Butyl Alcohol	Excellent	Excellent	Excellent	Excellent	Excellent
Carbon Tetrachloride HC, Halogenated	Not Recommended	Excellent	Testing Required	Excellent	Testing Required
Caprylic/Capric Triglyceride	Not Recommended	Excellent	Excellent	Testing Required	Excellent @ 70˚F
Cellosolve (Ethyl) Glycol Ether	Excellent	Excellent	Excellent	Testing Required	Excellent
CHAPS (Aqueous Solution) Surfactant / Detergent	Testing Required	Testing Required	Testing Required	Testing Required	Testing Required
Chlorobutanol up to 2%	Excellent	Excellent	Excellent	Testing Required	Testing Required
Chloroform HC, Halogenated	Not Recommended	Excellent	Testing Required	Excellent	Not Recommended
Corn Oil	Excellent	Excellent	Excellent	Testing Required	Testing Required
Cottonseed Oil	Excellent	Excellent	Excellent	Testing Required	Testing Required
Cyclohexanone Ketone	Not Recommended	Excellent	Excellent	Not Recommended	Excellent
Cyclosprorine	Excellent	Excellent	Excellent	Testing Required	Testing Required
Cyclosprorine Ophthalmic Sof’n	Not Recommended	Excellent	Excellent	Testing Required	Testing Required
Dextrose	Excellent	Excellent	Excellent	Testing Required	Testing Required
Dimethylacetamide Low Concentration	Excellent	Excellent	Excellent	Testing Required	Testing Required
Diethyl Pyrocarbonate, 0.2% Carboxylic Anhydride	Testing Required	Testing Required	Testing Required	Testing Required	Testing Required
Dimethyl Sulfoxide (DMSO), Sulfoxide	Not Recommended	Excellent	Excellent	Not Recommended	Excellent
Dimethylformamide Amide	Testing Required	Excellent	Excellent	Not Recommended	Excellent
Dioxane Ether	Testing Required	Not Recommended	Excellent	Excellent	Excellent
Ethanol Alcohol / Ethyl Alcohol	Not Recommended	Excellent	Excellent	Testing Required	Testing Required
Ethers Ether	Testing Required	Testing Required	Not Recommended	Excellent	Excellent
Ethyl Acetate Ester	Not Recommended	Testing Required	Testing Required	Excellent	Excellent
Ethyl Alcohol	Excellent	Excellent	Excellent	Excellent	Testing Required
Ethylene Glycol	Excellent	Excellent	Excellent	Excellent	Excellent
Formaldehyde	Excellent @ 40% Solution	Excellent	Excellent	Excellent	Excellent @ 37% Solution
Formaldehyde Aldehyde	Testing Required	Excellent	Excellent	Excellent	Excellent
Formic Acid, 50% Acid, Organic	Testing Required	Excellent	Excellent	Excellent	Not Recommended
Freon® (TF Or PCA) HC, Halogenated	Testing Required	Excellent	Excellent	Excellent	Excellent
Gasoline HC	Excellent	Excellent	Not Recommended	Excellent	Excellent
Giycerin	Excellent	Excellent	Excellent	Excellent	Excellent
Glycerol	Excellent	Excellent	Excellent	Excellent	Excellent
Glycol	Excellent	Excellent	Excellent	Testing Required	Testing Required
Glycerine (Glycerol) Glycol	Excellent	Excellent	Excellent	Excellent	Excellent
Grape Seed	Excellent	Excellent	Excellent	Testing Required	Testing Required
Guaifenesin	Excellent	Excellent	Excellent	Testing Required	Testing Required
Helium Gas	Testing Required	Excellent	Excellent	Testing Required	Excellent
Hexane HC, Aliphatic	Excellent	Excellent	Not Recommended	Excellent	Excellent
HCI	Excellent	Excellent	Excellent	Testing Required	Testing Required
Hydrochloric Acid, 1 N (HCL) Acid, Inorganic	Excellent	Excellent	Excellent	Excellent	Excellent
Hydrochloric Acid, 6 N (HCL) Acid, Inorganic	Excellent	Excellent	Testing Required	Testing Required	Testing Required
Hydrochloric Acid, Conc. (HCL) Acid, Inorganic	Testing Required	Excellent	Not Recommended	Not Recommended	Not Recommended
Hydrofluoric Acid, Inorganic	Not Recommended	Excellent	Not Recommended	Not Recommended	Not Recommended
Hydrogen Gas	Testing Required	Excellent	Excellent	Excellent	Excellent
Hydrogen Peroxide, 3% Peroxide	Testing Required	Excellent	Excellent	Excellent	Excellent
Hydrogen Peroxide, 30% Peroxide	Testing Required	Excellent	Testing Required	Excellent	Testing Required
Hydrogen Peroxide, 90% Peroxide	Testing Required	Excellent	Excellent	Excellent	Not Recommended
HYPO (Aqueous Solution) Salt, Aqueous Solution	Testing Required	Excellent	Excellent	Excellent	Excellent
Isobutyl Alcohol	Excellent	Excellent	Excellent	Excellent	Testing Required
Isopropyl Acetate Ester	Not Recommended	Excellent	Testing Required	Excellent	Excellent
Isopropyl Alcohol	Excellent	Excellent	Excellent	Excellent	Testing Required
Ketoprofen	Excellent	Excellent	Excellent	Excellent	Testing Required
Kerosene HC	Excellent	Limited	Testing Required	Excellent	Excellent
Lactanase	Excellent	Not Recommended	Testing Required	Excellent	Testing Required
Lactic Acid, 50% Acid, Organic/Alcohol	Testing Required	Excellent	Excellent	Testing Required	Testing Required
Lodine	Testing Required	Excellent	Excellent	Testing Required	Testing Required
Linseed Oil	Excellent	Excellent	Excellent	Excellent	Excellent
Methyl Ethyl Ketone (MEK) Ketone	Not Recommended	Excellent	Excellent	Not Recommended	Excellent
Methyl Acetate Ester	Not Recommended	Excellent	Testing Required	Not Recommended	Excellent
Methyl Alcohol	Excellent	Excellent	Excellent	Excellent	Testing Required
Methylene Chloride HC, Halogenated	Not Recommended	Excellent	Not Recommended	Not Recommended	Testing Required
Methyl Isobutyl Ketone	Not Recommended	Excellent	Not Recommended	Not Recommended	Excellent
Mineral Spirits HC	Excellent	Excellent	Not Recommended	Excellent	Excellent
NaOH	Excellent	Excellent	Excellent	Testing Required	Testing Required
Nitric Acid, 6 N Acid, Inorganic	Excellent	Excellent	Testing Required	Excellent	Not Recommended
Nitric Acid (Concentrated) Acid, Inorganic	Testing Required	Testing Required	Not Recommended	Not Recommended	Not Recommended
Nitrobenzene HC, Aromatic	Testing Required	Excellent	Not Recommended	Excellent	Excellent
Nitrogen Gas	Testing Required	Excellent	Testing Required	Excellent	Excellent
Ozone Gas	Testing Required	Excellent	Not Recommended	Excellent	Not Recommended
Paraldehyde Aldehyde	Testing Required	Excellent	Testing Required	Testing Required	Excellent
Peanut Oil	Excellent	Excellent	Excellent	Testing Required	Testing Required
Pentane HC, Aliphatic	Excellent	Excellent	Not Recommended	Excellent	Excellent
Petroleum Ether	Testing Required	Excellent	Not Recommended	Excellent	Excellent
Phenol	Not Recommended	Excellent	Excellent	Excellent	Not Recommended
Phenol (Aqueous Solution) Phenol	Testing Required	Excellent	Not Recommended	Excellent	Not Recommended
Potassium Hydroxide, 3 N Caustic	Testing Required	Excellent	Excellent	Excellent	Excellent
Progesterone	Testing Required	Excellent	Excellent	Testing Required	Testing Required
Propylparaben up to 2%	Excellent	Excellent	Excellent	Testing Required	Testing Required
Pyridine Amine	Not Recommended	Excellent	Excellent	Not Recommended	Testing Required
Sarracenea	Excellent	Not Recommended	Testing Required	Excellent	Testing Required
Sesame Oil	Not Recommended	Excellent	Excellent up to 70˚F	Excellent	Excellent up to 70˚F
Silicone Oils	Testing Required	Excellent	Excellent	Excellent	Excellent
Sodium Carbonate (Aqueous Solution) Salt, Aqueous Solution	Testing Required	Excellent	Excellent	Excellent	Testing Required
Water (Brine) Salt, Aqueous Solution	Testing Required	Excellent	Excellent	Excellent	Excellent
Sodium Chloride (Aqueous Solution) Salt, Aqueous Solution	Testing Required	Excellent	Excellent	Excellent	Excellent
Sodium Hydroxide, 3 N Caustic	Excellent	Excellent	Excellent	Excellent	Excellent
Sodium Hydroxide (Concentrate) Caustic	Excellent	Excellent	Excellent	Excellent	Not Recommended
Sulfuric Acid (Concentrated) Acid, Inorganic	Not Recommended	Excellent	Not Recommended	Testing Required	Not Recommended
Tetrahydrofuran (THF) Ether	Testing Required	Excellent	Not Recommended	Not Recommended	Excellent
Testosterone	Testing Required	Excellent	Excellent	Testing Required	Testing Required
Toluene HC, Aromatic	Excellent	Excellent	Not Recommended	Excellent	Excellent
TCA (Aqueous Solution) Acid, Organic	Testing Required	Excellent	Excellent	Excellent	Testing Required
Trichloroethylene HC, Halogenated	Not Recommended	Excellent	Not Recommended	Testing Required	Testing Required
Urea, 8 M Salt, Aqueous Solution	Testing Required	Excellent	Excellent	Excellent	Excellent
Xylene HC, Aromatic	Testing Required	Excellent	Not Recommended	Excellent	Excellent

Please note that these compatibility recommendations may vary depending on the specific formulation or concentration of the chemical being used. It's always important to consult the manufacturer's recommendations.

Appendix A

PES (Hydrophilic) Membrane is a versatile filter media that is widely used in the pharmaceutical and biotech industries due to its excellent flow rates and retention capabilities. This membrane is hydrophilic, meaning it has a strong affinity for water and other polar solvents. This makes PES ideal for applications where the filtration of aqueous solutions is required, such as sterile filtration of culture media, buffers, and vaccines.

PTFE (Hydrophobic) Membrane is a highly resistant filter media that repels water and other polar solvents. This membrane is ideal for applications where oils, ketones & organic solvents, or gases are required, such as viscous oil base solutions, filtration of aggressive solvents, compressed air, or venting of tanks.

PES and PTFE membranes are available in a 0.2um sterilizing grade, commonly used in sterile compounding applications. These filters are designed to quantitatively retain bacteria, such as Brevundimonas diminuta (ATCC #19146), at a minimum challenge level of 10⁷ CFU per cm² of filtration area, consistent with ASTM F838-05. This ensures that the filtered product is free from bacterial contamination and meets the highest safety and quality standards.

Polypropylene (PP) is a widely used filter material due to its low cost, high chemical resistance, and excellent mechanical properties. It is compatible with a wide range of acids, bases, and solvents, including hydrochloric acid, sulfuric acid, sodium hydroxide, acetone, and methanol. However, it is not recommended for use with strong oxidizing agents, such as nitric acid and hydrogen peroxide, as they can cause the degradation of the polymer.

Polyvinylidene fluoride (PVDF) is a high-performance filter material that offers excellent chemical resistance and thermal stability. It is compatible with a wide range of acids, bases, and solvents, including hydrochloric acid, sulfuric acid, sodium hydroxide, acetone, and ethanol. It is also resistant to most organic solvents, including chlorinated solvents and aromatic hydrocarbons. However, PVDF is not recommended for use with strong oxidizing agents, such as nitric acid and hydrogen peroxide.

Nylon is a versatile filter material widely used to filtrate aqueous and organic solvents. Nylon can endure higher temperatures and is compatible with a wide range of chemicals, including most acids, bases, and solvents. However, it is not recommended for use with strong oxidizing agents, such as nitric acid and hydrogen peroxide, as they can cause the degradation of the polymer.

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Chemical Compatibility for Sterile Compounding

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