Millipore Express® SHC Hydrophilic Sterile-Grade Filter Cartridge

Overview

The Millipore Express® SHC Hydrophilic Sterile-Grade Filter Cartridge is an engineered solution for robust, high-throughput sterile filtration in biopharmaceutical manufacturing and upstream/downstream processing. Based on a dual-layer polyethersulfone (PES) membrane architecture—comprising a graded prefilter layer over a validated 0.22 µm sterile-grade final membrane—the Express® SHC delivers consistent log reduction of microorganisms while maintaining high flux and extended service life. Its hydrophilic surface eliminates the need for alcohol pre-wetting, enabling rapid, reliable wetting with aqueous solutions including cell culture media, protein formulations, and low-surface-tension buffers. The filter operates under standard tangential or normal-flow conditions and is designed for integration into single-use or stainless-steel systems compliant with current Good Manufacturing Practice (cGMP) requirements.

Key Features

• Dual-layer PES membrane structure: A coarse prefilter layer captures particulates and aggregates, protecting the downstream sterile membrane and delaying pore fouling.
• High-capacity design: Achieves up to 3× higher throughput than conventional single-layer 0.22 µm filters when processing viscous or particle-laden streams such as clarified harvests or concentrated monoclonal antibody solutions.
• Chemical resilience: Stable across pH 1–14; compatible with common CIP agents (e.g., NaOH, phosphoric acid), sanitizers (e.g., peracetic acid), and formulation excipients including polysorbates and amino acids.
• Rapid wetting & integrity assurance: Hydrophilicity ensures complete, uniform membrane hydration within seconds using water or process-relevant fluids—facilitating straightforward forward flow or bubble point testing per ASTM F838-22 and ISO 13408-2.
• Regulatory-ready construction: Manufactured under ISO 13485-certified processes; supplied with full Certificate of Conformance, extractables data (per USP and ), and bacterial retention validation reports aligned with PDA TR26 and ISO 13408-1.

Sample Compatibility & Compliance

The Express® SHC filter demonstrates proven compatibility with a broad spectrum of bioprocess streams, including serum-free and chemically defined cell culture media, insulin or growth factor supplements, low-conductivity buffers (e.g., Tris-HCl, acetate), high-solids harvests post-centrifugation or depth filtration, and aggressive cleaning solutions used in multi-campaign facilities. It meets the microbial retention performance criteria specified in FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing (2004) and EMA’s Annex 1 (2022). All configurations support audit-ready documentation packages required for FDA 21 CFR Part 11-compliant electronic records and EU Annex 11 validation protocols.

Software & Data Management

While the Express® SHC is a passive filtration device, its qualification and lifecycle management are fully supported through MilliporeSigma’s Filter Selector Tool and Validation Support Portal. Users can access digital validation dossiers—including microbial challenge data, extractables profiles, and compatibility matrices—for seamless integration into electronic validation master plans (VMPs). Batch-specific Certificates of Analysis (CoA) and Certificates of Conformance (CoC) are available via QR-coded labels and integrated ERP interfaces. For facilities implementing MES or LIMS systems, structured metadata (e.g., lot number, membrane area, sterilization method) is provided in CSV and XML formats compliant with ISA-88 and ISA-95 standards.

Applications

• Sterile filtration of mammalian and microbial cell culture media prior to bioreactor inoculation
• Pre-filtration protection for chromatography columns (e.g., Protein A, ion exchange, SEC)
• Final sterile filtration of therapeutic proteins, vaccines, and viral vectors
• Clarification and polishing of cell lysates and harvest supernatants after depth filtration
• Filtration of aggressive cleaning-in-place (CIP) and steam-in-place (SIP) solutions without membrane degradation
• Buffer and titrant preparation in analytical QC labs operating under GLP conditions

FAQ

Is the Express® SHC filter suitable for use with organic solvents?
No. While chemically resistant to aqueous extremes (pH 1–14), it is not rated for prolonged exposure to acetone, acetonitrile, DMSO, or other non-aqueous solvents.
Can Express® SHC filters be reused after steam sterilization?
No. These are single-use, disposable devices intended for one campaign only—even when SIP-sterilized—to ensure sterility assurance level (SAL) compliance and avoid cross-contamination risks.
What integrity test method is recommended for routine release?
Forward flow testing is preferred for high-area cartridges (>0.5 m²); bubble point is suitable for smaller formats (<0.2 m²). Water intrusion testing applies only to hydrophobic variants—not the SHC series.
Does MilliporeSigma provide installation qualification (IQ) and operational qualification (OQ) templates?
Yes. Standardized IQ/OQ protocols—aligned with ASTM E2500 and ISPE Baseline Guide Vol. 4—are available upon request through technical support or the Validation Resource Center.
How does Express® SHC compare to the previous Millipore Express® SHF platform?
The SHC introduces enhanced prefilter grading and optimized pore interconnectivity, resulting in ~25% higher throughput for high-viscosity feeds and improved resistance to irreversible fouling from aggregated proteins.