Pall PES Folded Cartridge Filter Element
| Origin | Shanghai, China |
|---|---|
| Manufacturer Type | Authorized Distributor |
| Product Origin | Domestic (China) |
| Model | PES |
| Price Range | USD 140 – 1,400 (FOB) |
| Filtration Ratings | 0.1 µm, 0.22 µm, 0.45 µm, 0.65 µm |
| Filter Area | 0.60 m² |
| Bubble Point (Water) | 0.42 MPa @ 0.1 µm |
| Water Flow Rate (ΔP = 0.01 MPa, 1 cP) | ≥5 L/min @ 0.1 µm |
| Max Operating Pressure | 0.42 MPa (forward), 0.21 MPa (reverse) |
| Sterilization | Steam-in-place (SIP) at 121°C, 0.1 MPa, 30 min × 30 cycles |
| Max Temp | 65°C (standard), 95°C (high-temp grade, 0.1 MPa) |
| Housing Material | Polypropylene (PP) or PVDF |
| Core Support | Imported polyester nonwoven |
| Seal Material | Silicone or FKM (Viton®) |
| Chemical Compatibility | Broad—refer to certified compatibility chart |
Overview
The Pall PES Folded Cartridge Filter Element is a high-performance, single-use depth and surface filtration device engineered for sterile-grade liquid processing in regulated life science and biopharmaceutical manufacturing environments. Constructed with hydrophilic polyethersulfone (PES) membrane as the primary filtration layer, this cartridge operates on the principle of size-exclusion and surface adsorption minimization—enabling robust retention of microorganisms (≥10⁷ CFU/cm²), particulates, and endotoxin aggregates while preserving labile biomolecules. Unlike hydrophobic membranes requiring pre-wetting agents, the intrinsic hydrophilicity of PES eliminates the need for surfactants or wetting additives, thereby reducing extractables and ensuring compatibility with protein therapeutics, monoclonal antibodies, vaccines, and other sensitive biologics. Its folded pleated geometry maximizes active filtration area within compact dimensions (standard 10-inch length), delivering high flux and extended service life under controlled differential pressure conditions.
Key Features
- Hydrophilic PES membrane with no added surfactants or wetting agents—minimizing leachables and eliminating pre-flush requirements
- High porosity (>80%) and optimized pore geometry for uniform flow distribution and enhanced particle capture efficiency
- Low protein binding characteristics—validated per ASTM F838-22 using BSA challenge tests; ideal for high-value bioprocess streams
- Pre-certified integrity tested per ISO 13408-2 and ASTM F316-21 using water bubble point methodology prior to release
- Rinsed with ultra-pure water (UPW) to meet USP and EP 2.6.27 specifications for extractables control
- Chemically resistant construction: compatible with alcohols, organic solvents, acids, bases, and oxidizers—verified against industry-standard chemical compatibility matrices
Sample Compatibility & Compliance
This filter element is validated for use across critical unit operations including pre-filtration of cell culture harvests, final sterile filtration of parenterals (large-volume IV solutions, ampoules), and point-of-use polishing of purified water and WFI. It complies with ISO 13408-1 (sterile filtration of pharmaceutical products), ISO 8536-4 (infusion containers), and supports adherence to FDA 21 CFR Part 11, EU Annex 1, and WHO TRS 961 requirements for filter qualification. All lots undergo full documentation traceability—including Certificate of Conformance, Certificate of Integrity Test, and Extractables Summary Report—aligned with ICH Q5A(R2) and Q5D guidelines for biologics manufacturing.
Software & Data Management
While the PES cartridge itself is a passive hardware component, its integration into automated process systems (e.g., Skid-mounted bioreactor trains, CIP/SIP skids, or PLC-controlled filling lines) enables digital record linkage via electronic batch records (EBR). When used with integrity test instruments such as the Pall Integrity Tester i5 or Sartorius Biotest, real-time bubble point or diffusion test data can be exported in CSV/Excel format and archived within compliant LIMS or MES platforms supporting 21 CFR Part 11 audit trails. Filter usage logs—including cycle count, SIP exposure history, and delta-P trending—are programmatically captured to support preventive maintenance scheduling and regulatory review.
Applications
- Sterile filtration of large-volume parenterals (LVPs), small-volume parenterals (SVPs), and ophthalmic solutions
- Final clarification and sterilizing filtration of recombinant proteins, vaccines, viral vectors, and mRNA-LNPs
- Polishing filtration of wine, fruit juices, functional beverages, and dairy-based formulations
- Point-of-use (POU) and final barrier filtration for purified water (PW), water for injection (WFI), and clean steam condensate
- Pre-filtration upstream of tangential flow filtration (TFF) cassettes or chromatography columns to protect downstream equipment
FAQ
Is this cartridge suitable for steam-in-place (SIP) sterilization?
Yes—validated for up to 30 cycles of SIP at 121°C and 0.1 MPa for 30 minutes per cycle. High-temperature variants support intermittent exposure up to 95°C at reduced pressure.
What integrity test methods are recommended?
Bubble point testing is standard for 0.1–0.65 µm ratings; forward flow (diffusion) testing may be applied where low surface tension liquids are involved.
Can it be used in GMP manufacturing environments?
Affirmative—manufactured under ISO 13485-certified quality management systems; supplied with full validation support packages including PQ, IQ/OQ documentation templates.
How does it compare to PVDF or nylon membranes in protein applications?
PES demonstrates significantly lower nonspecific binding than PVDF or nylon in comparative ELISA and HPLC recovery studies—particularly for IgG, interferons, and albumin.
Are custom configurations available?
Yes—custom lengths (5″, 20″, 30″), end-cap configurations (222, 226, flat-bottom), and material substitutions (e.g., 316L SS core, FKM seals) are offered under OEM agreements.
