High-purity filter cartridges for drug manufacturing, API purification, sterile filtration, and WFI systems. PTFE and PES membranes rated for pharmaceutical applications.
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0.22 µm sterilization grade. High-temperature resistance up to 260°C. Chemically inert for aggressive solvents. Ideal for API filtration and vent filters.
0.22 and 0.45 µm ratings. Low protein binding for biopharma. High flow rates with low pressure drop. Suitable for sterile filtration and buffer preparation.
1-50 micron pre-filtration. Protects downstream membranes. High dirt-holding capacity. Cost-effective for bulk pharmaceutical water pre-treatment.
| Application | Recommended Cartridge | Micron Rating | Certification |
|---|---|---|---|
| Sterile Filtration | PTFE Membrane | 0.22 µm | USP Class VI |
| API Filtration | PTFE / PES Membrane | 0.45 - 1 µm | FDA 21 CFR |
| WFI Pre-filtration | PP Melt Blown | 5 - 20 µm | USP |
| Buffer Filtration | PES Membrane | 0.45 µm | USP Class VI |
| Vent Filters | PTFE Hydrophobic | 0.22 µm | FDA |
| Compressed Air | PTFE | 0.01 µm | ISO 8573 |
ISO 9001 certified production. Full traceability. Batch testing documentation available.
Custom micron ratings, sizes, and materials. OEM and private label available for pharma OEMs.
Express delivery available. Stock maintained for standard pharma-grade cartridges.
In a pharmaceutical plant the filter is part of the validated process, not a consumable. That changes the selection criteria completely. Instead of asking which cartridge is cheapest per micron, the question becomes which cartridge has documented bacterial retention data, documented extractables and leachables, and documented chemical compatibility with the process stream. USP <87> and <88> biological reactivity testing, USP <788> particulate testing and the relevant FDA guidance on sterile filtration all feed into that.
These are different jobs and should never be conflated. A sterilizing-grade filter carries a 0.22 micron rating validated against a bacterial challenge, typically by the ASTM F838 method, and its job is to produce a sterile filtrate. A pre-filter - usually a polypropylene depth cartridge - has no sterility claim at all. Its job is to remove the bulk particulate load so the sterilizing filter does not blind over after three batches.
Plants that run without adequate pre-filtration do not save money. They replace 0.22 micron membrane cartridges several times more often than necessary, and each of those changes is a validated intervention with documentation attached.
Validation has three components worth separating. Bacterial retention answers whether the filter actually sterilises. Extractables and leachables answer whether the filter gives anything back to the product. Adsorption answers whether the filter takes something out of the product - which matters most with low-dose active ingredients, where a filter can absorb enough of the API to drop a batch out of specification.
All three depend on process conditions, not just the cartridge. Flow rate, temperature, contact time and the solvent system all change the result, so validation data generated under different conditions needs to be re-qualified for your process.
| System | Function | Recommended cartridge | Rating |
|---|---|---|---|
| WFI point-of-use | Sterile filtration | PTFE membrane | 0.22 µm |
| Purified water loop | Bioburden control | PES membrane | 0.22 / 0.45 µm |
| Buffer preparation | Sterile filtration | PES membrane | 0.22 µm |
| API / solvent filtration | Particle and sterile | PTFE pleated | 0.22-1 µm |
| Fermentation inlet air | Sterile vent | PTFE hydrophobic | 0.22 µm |
| Pre-filtration (all systems) | Particulate load | PP depth cartridge | 1-50 µm |
Contact us with your application details. We will recommend the right cartridge and provide a quote within 24 hours.
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