Millipore Express® SPG Hydrophobic Filter Cartridge

Overview

The Millipore Express® SPG Hydrophobic Filter Cartridge is an engineered, gamma-irradiated, pre-sterilized gas filtration solution designed for critical biopharmaceutical manufacturing processes. Built upon a hydrophobized 0.2 µm polyethersulfone (PES) membrane, it delivers robust microbial retention (validated per ISO 13408-2 and ASTM F838-22 for Brevundimonas diminuta challenge), high flow rates, and low protein binding—making it ideal for sterile venting of bioreactors, buffer tanks, and single-use systems. Its asymmetric membrane architecture minimizes pressure drop while maintaining consistent bubble point integrity (>35 psi for air at 23°C), ensuring reliable performance across variable gas composition and humidity conditions. Unlike standard hydrophobic filters, the SPG variant undergoes proprietary surface modification to enhance resistance to surfactant-induced wetting and extend service life in demanding upstream and downstream unit operations.

Key Features

• Hydrophobized 0.2 µm PES membrane with asymmetric pore structure for high throughput and low differential pressure
• Pre-sterilized via validated gamma irradiation (25–40 kGy), compliant with ISO 11137-1 and USP <1229> Sterilization of Pharmaceutical Products
• Validated bacterial retention per ISO 13408-2 and ASTM F838-22 using Brevundimonas diminuta (ATCC 19146)
• Low extractables profile, certified per USP <661.1> and EP 3.2.1, suitable for GMP-compliant environments
• Compatible with standard 10-inch and 20-inch sanitary housing configurations (e.g., Sartorius, Pall, Merck housings)
• Integrated into Mobius® single-use platforms as a factory-installed, ready-to-use component with full traceability (batch-specific CoA and CoC)
• Opticap® XL 50 and Opticap® XL 300 housing compatibility confirmed per manufacturer specifications

Sample Compatibility & Compliance

The Millipore Express® SPG filter is qualified for use with compressed air, nitrogen, CO₂, and other process gases across pH 3–10 and temperatures up to 50°C (continuous). It exhibits no detectable leachables under ICH Q5C stability conditions and passes endotoxin testing (<0.25 EU/mL per USP <85>). Regulatory documentation includes full validation dossiers supporting compliance with FDA 21 CFR Parts 210/211, EU Annex 1 (2022), and WHO TRS 986 Annex 2. All units are supplied with lot-specific Certificates of Analysis (CoA), Certificates of Conformance (CoC), and sterilization validation reports aligned with ISO 13485:2016 quality management system requirements.

Software & Data Management

While the SPG filter itself is a passive hardware component, its integration into digital bioprocessing workflows is supported through Merck’s Bio4C™ Process Analytics Suite. When deployed in conjunction with Mobius® sensors and controllers, filter usage history—including installation timestamp, cumulative runtime, and pressure decay trends—is automatically logged and archived. Audit trails comply with FDA 21 CFR Part 11 requirements for electronic records and signatures. Batch-level filter data can be exported in CSV or XML format for inclusion in electronic batch records (EBRs) and regulatory submissions.

Applications

• Sterile venting of stainless-steel and single-use bioreactors during fed-batch and perfusion cultures
• Gas sparging and headspace blanketing in upstream purification vessels
• Final fill line environmental control (e.g., isolator purge gas filtration)
• Integrity testing support via forward flow and water intrusion methods (WIT)
• Critical utility gas lines supplying cleanrooms and aseptic processing suites
• Integration into closed-system transfer devices (CSTDs) and fluid management platforms requiring validated hydrophobic barriers

FAQ

Is the Millipore Express® SPG filter compatible with steam-in-place (SIP) cycles?
No—this cartridge is gamma-irradiated and not rated for repeated autoclave or SIP exposure. It is intended for single-use, pre-sterilized applications only.
What integrity test methods are validated for this filter?
Forward Flow (FF) and Water Intrusion Test (WIT) are fully validated per ASTM F3154-18 and referenced in the product’s Technical Data Sheet.
Can the SPG filter be used for liquid filtration?
No—it is strictly designed for gas-phase applications. Its hydrophobic nature prevents wetting by aqueous solutions and does not guarantee retention in liquid streams.
Does Merck provide installation qualification (IQ) and operational qualification (OQ) documentation?
Yes—custom IQ/OQ protocols and executed reports are available upon request, aligned with ASTM E2500-13 and ISPE Baseline Guide Vol. 4.
How is lot traceability maintained throughout the supply chain?
Each filter carries a unique 2D data matrix code linked to Merck’s global ERP system, enabling real-time access to CoA, CoC, sterilization logs, and raw material certifications.