What types of cartridge filters can be used in the pharmaceutical industry?

The Cartridge filters with PTFE filter elements and 316L stainless steel housing is widely used in the pharmaceutical industry, especially suitable for critical process links with high cleanliness, strong corrosiveness or high-temperature sterilization requirements. Its advantages and application methods are as follows.

Core Advantages

1. Extreme chemical inertness.

• PTFE (polytetrafluoroethylene): Resistant to virtually all organic solvents, strong acids, strong bases, and strong oxidizers, eliminating the risk of leachables.
• 316L stainless steel: Ultra-low carbon content prevents intergranular corrosion, and the passivated surface provides a smooth, superior corrosion resistance to 304 stainless steel.

2. Ultra-high cleanliness assurance.

• PTFE membranes are additive-free, have low protein adsorption, and meet USP Class VI biosafety standards.
• 316L housings are electropolished to reduce microbial retention.

3. High-temperature tolerance.

• PTFE filter elements: Continuous operating temperature ≤ 260°C, steam sterilizable up to 140°C.
• 316L housing: withstands high-temperature steam sterilization and dry heat sterilization.

Typical Pharmaceutical Applications

1. Critical Filtration for Aseptic Processes.

• Final Filtration of Water for Injection: Removes microorganisms and endotoxins. Filter elements typically have a pore size of 0.22 μm or 0.1 μm.
• Drug Sterilization Filtration: Terminal sterilization of large-molecule biologics and filtration of highly corrosive drug solutions.
• Gas Sterilization: Terminal sterilization of compressed air and nitrogen (requires a hydrophobic PTFE filter element with a pore size of 0.22 μm).

2. High-Purity Solvent/Raw Material Filtration.

• Organic Solvent Refining: Filters particulate matter from strong solvents such as DMF (pore size 1 to 5 μm).
• Strong Acid/Base Filtration: Purification of concentrated nitric acid and sodium hydroxide solutions (to prevent fiber shedding and contamination).

PTFE+316L cartridge filters are ideal for highly corrosive, high-temperature sterilization processes in the pharmaceutical industry. Their extreme inertness ensures pharmaceutical purity, while their stringent material and design standards meet GMP sterility requirements. When selecting a filter, it is important to verify the filter element's sterilization performance, the cleanability of the housing, and a full set of compliance documents to ensure the reliability of the entire process from filtration to sterilization.