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.

International Filter Products have supplied innovative, high-performance polymer products for the most demanding applications. Our corporation has been built with the single purpose of serving the customer and a commitment to quality. IFP combines our material expertise and application knowledge with Saint-Gobain’s superior single-use bioprocess containers and other products to offer a wide array of custom and configurable fluid management solutions. Saint-Gobain’s tubing portfolio encompasses a range of material types to meet the needs of the bioprocessing industries. Offered in standard and custom sizes, our biocompatible tubes are supported by Validation Guides and technical expertise. Combine these tubing solutions with pure-fit fittings, Saint-Gobain single-use bioprocess bags, and filters to create single-use systems that protect your most critical bioprocessing fluids. Place your trust in our industry-leading quality systems, technical support, and validation services to find the optimum answers to your most complex fluid management challenges.

To serve the bioprocessing industry, International Filter Products provides a wide range of components and assemblies. We provide products made by Saint-Gobain here in the USA, a leader in the industry. In response to your requirements and consumption rates, we will stock for you and eliminate your shortages. We have divided our products into five categories: bioprocessing bags, single-use tubing, Pure-fit fittings, filters, and tank liners. As a result of the complexity of filter documentation and technologies, we have divided them into separate sections.