Millipore Express® SHF 0.2 µm Hydrophilic Sterile-Grade Filter Cartridge
| Brand | Millipore |
|---|---|
| Origin | USA |
| Filter Membrane | Hydrophilic Polyethersulfone (PES) |
| Pore Size | 0.2 µm |
| Sterility Assurance Level (SAL) | ≤10⁻⁶ |
| pH Compatibility | 1–14 |
| Chemical Compatibility | Broad (including aqueous buffers, saline, alcohols, and mild organics) |
| Integrity Test Method | Forward Flow or Bubble Point |
| Sterilization Options | Steam-in-Place (SIP), Gamma Irradiation, Ethylene Oxide (EtO) |
| Regulatory Compliance | Meets USP <788>, ISO 13408-2, ASTM F838-22, and FDA 21 CFR Part 11 requirements for electronic records in validated environments |
Overview
The Millipore Express® SHF 0.2 µm Hydrophilic Sterile-Grade Filter Cartridge is an engineered solution for high-throughput, sterile filtration of biopharmaceutical buffers and process liquids. Designed around a hydrophilic polyethersulfone (PES) membrane with a nominal pore size of 0.2 µm, this filter delivers robust microbial retention—validated per ASTM F838-22 using Brevundimonas diminuta—while maintaining exceptional flow rates across broad pH (1–14) and chemical compatibility profiles. Its surface-modified PES architecture eliminates pre-wetting requirements and ensures immediate, consistent wetting with low protein binding, making it ideal for critical downstream purification steps where extractables, leachables, and residual volume must be minimized. Unlike conventional hydrophobic membranes, the SHF’s intrinsic hydrophilicity supports rapid equilibration and stable performance under variable temperature and pressure conditions typical of large-scale buffer preparation systems.
Key Features
- Hydrophilic PES membrane with proven 0.2 µm sterilizing-grade retention (log reduction value ≥7 for B. diminuta)
- Flow rates up to 2× higher than competitive sterile-grade filters under identical process conditions
- Low extractables profile verified per USP and EP 3.2.1; certified non-pyrogenic (<0.03 EU/mL)
- No fiber shedding or particulate release—validated via light obscuration and membrane integrity testing
- Full compatibility with SIP cycles (up to 121°C, 30 min, 20+ cycles) and gamma irradiation (25–50 kGy)
- Manufactured under ISO 9001 and ISO 13485-certified facilities; each unit undergoes 100% post-sterilization integrity testing (forward flow or bubble point)
Sample Compatibility & Compliance
The SHF filter demonstrates consistent performance across diverse bioprocessing fluids—including Tris, phosphate, acetate, citrate, and histidine-based buffers—as well as saline solutions, ethanol/water mixtures (≤30%), and low-concentration surfactants (e.g., polysorbate 20/80). It meets the material safety and biological reactivity requirements outlined in ISO 10993-5 and USP /. All configurations comply with ICH Q5A(R2) guidelines for viral clearance validation support and are qualified for use in GMP-compliant manufacturing environments. Documentation packages include Certificate of Conformance, Certificate of Sterility, Extractables Study Summary, and Validation Support Dossier aligned with FDA Process Validation Guidance (2011) and EMA Annex 15.
Software & Data Management
While the SHF cartridge itself is a passive filtration component, its integration into automated buffer management systems enables full traceability within compliant digital workflows. When used with MilliporeSigma’s Process Analytics Suite or third-party SCADA/DCS platforms, filter lot numbers, integrity test results, cycle logs, and batch-associated metadata can be captured and archived in accordance with 21 CFR Part 11 requirements. Electronic signatures, audit trails, and role-based access control are supported through validated LIMS or MES interfaces. Each SHF unit ships with a unique serialized QR code linking to digital Certificates of Analysis and regulatory dossiers accessible via MilliporeSigma’s secure customer portal.
Applications
- Final sterile filtration of formulation buffers prior to drug substance filling
- Pre-filtration of cell culture media and harvest intermediates in upstream processing
- In-line polishing of chromatography eluents and diafiltration buffers
- Single-use system (SUS) integration for modular biomanufacturing platforms
- Process development studies requiring rapid scalability from OptiScale® (3.5 cm²) to Opticap® XLT (1.71 m²) formats
- Regulatory filing submissions supporting comparability protocols during tech transfer
FAQ
What is the maximum recommended operating pressure for the SHF cartridge?
The SHF is rated for continuous operation up to 5.5 bar (80 psi) at 25°C; pressure limits decrease linearly above 40°C per manufacturer specifications.
Can the SHF filter be reused after steam sterilization?
No—SHF cartridges are designed for single-use applications in GMP environments; repeated SIP cycles may compromise membrane integrity and invalidate regulatory qualification.
Is the SHF compatible with high-salinity solutions such as 2 M NaCl?
Yes; the hydrophilic PES membrane maintains structural stability and flux performance in ionic strengths up to 3 M, with no measurable increase in extractables or particle generation.
How is filter integrity confirmed prior to use?
Each unit undergoes automated forward flow testing post-sterilization; users perform final pre-use bubble point or diffusion tests per SOPs aligned with ASTM F838-22 and EU Annex 1.
Does MilliporeSigma provide validation support documentation?
Yes—full validation toolkits including IQ/OQ templates, risk assessments (FMEA), and extractables/leachables data are available upon request for qualified customers under NDA.
