Millipore Milligard® PES Sterile-Grade Prefilter System
| Brand | Millipore |
|---|---|
| Origin | USA |
| Manufacturer Type | Authorized Distributor |
| Import Status | Imported |
| Model | Milligard® |
| Pricing | Available Upon Request |
Overview
The Millipore Milligard® PES Prefilter System is a single-use, polyethersulfone (PES)-based depth and surface filtration platform engineered for bioprocess fluid conditioning prior to sterile-grade final filtration. Designed specifically for non-sterilizing prefiltration applications, it delivers validated bioburden reduction—certified for 1.2/0.2 µm (nominal) and 1.2/0.45 µm dual-layer configurations—thereby extending the service life and throughput of downstream sterilizing-grade filters (e.g., 0.22 µm PVDF or PES membranes). Its hydrophilic PES membrane architecture ensures low protein binding, high flow rates under low differential pressure, and compatibility with aqueous and mild organic solvent streams common in upstream and downstream biomanufacturing. The system operates on a robust depth-filtration principle, combining graded porosity layers to capture particulates, aggregates, and microorganisms across a broad size distribution while maintaining consistent flux and minimal fouling.
Key Features
- Validated bioburden reduction performance per ISO 13408-2 and ASTM F838-22 standards for 1.2/0.2 µm and 1.2/0.45 µm configurations
- High-flow, low-pressure-drop design enabled by asymmetric PES membrane structure and optimized pleat geometry
- Fully scalable architecture—from benchtop process development (OptiScale® 25) to commercial manufacturing (cylindrical cartridges)
- Gamma-irradiated, ready-to-use configuration; compatible with in-line steam-in-place (SIP) at ≤121°C for up to 60 minutes (Opticap® XL and cylindrical formats)
- Chemical resistance profile validated against common CIP agents (0.5–1.0 N NaOH, 0.1–0.5% phosphoric acid) and sanitants (70% IPA, 0.5% hydrogen peroxide)
- Leachables and extractables profile compliant with USP , USP , and USP ; endotoxin levels <0.25 EU/mL per filter unit
Sample Compatibility & Compliance
The Milligard® PES system is qualified for use with mammalian cell culture harvests, clarified monoclonal antibody (mAb) and recombinant protein streams, viral vector preparations, and vaccine intermediates. It meets biocompatibility requirements per ISO 10993-5 and ISO 10993-12. All configurations are manufactured under ISO 13485-certified conditions and support full traceability via unique serial numbering. Filter integrity testing (forward flow and bubble point) is fully supported per ASTM F316-22 and EU Annex 1 (2022), with documented validation protocols available for GMP environments. The system supports audit readiness for FDA 21 CFR Part 11-compliant electronic records when integrated with validated SCADA or MES platforms.
Software & Data Management
While the Milligard® PES filters themselves are passive hardware components, their integration into automated bioprocessing systems enables full digital lifecycle management. When used with MilliporeSigma’s Process Solutions digital ecosystem—including the BioCharge™ monitoring platform and Integrity® Test Suite—users can log batch-specific integrity test results, SIP cycle parameters, and usage history. Audit trails include operator ID, timestamp, test method, pass/fail status, and raw data export (CSV/PDF). All documentation aligns with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) for GLP/GMP-regulated workflows.
Applications
- Prefiltration of clarified CHO cell culture harvests to reduce load on 0.22 µm sterilizing filters
- Clarification of lentiviral and AAV vector preparations prior to ultrafiltration/diafiltration
- Polishing step in plasmid DNA purification workflows
- Pre-treatment of buffer and media solutions before sterile filtration in fill-finish operations
- Scale-down modeling for tech transfer using OptiScale® 25 capsules in DOE-driven filter screening studies
- Single-use skid-integrated filtration in continuous bioprocessing trains
FAQ
Is the Milligard® PES filter suitable for sterile filtration?
No—it is explicitly designed as a prefilter to reduce bioburden and particulate load ahead of a certified sterilizing-grade filter (e.g., 0.22 µm). It does not meet the microbial retention requirements of ISO 13408-1 for sterile filtration.
Can Opticap® XL capsules be autoclaved?
Yes—Opticap® XL capsules are rated for repeated steam-in-place (SIP) cycles at 121°C for up to 60 minutes; however, gamma irradiation is the standard terminal sterilization method.
What is the maximum operating temperature for Milligard® PES filters?
Continuous operation up to 45°C; short-term exposure up to 60°C for cleaning-in-place (CIP); validated SIP up to 121°C for defined durations.
Are extractables data available for regulatory submissions?
Yes—comprehensive extractables reports (per USP and ICH Q5C) are included in the Certificate of Analysis and Technical Dossier provided with each lot.
How is scalability demonstrated between OptiScale® 25 and production-scale cylindrical cartridges?
Scalability is based on constant specific throughput (L/m²/h) and identical membrane chemistry, pore structure, and housing materials—validated through side-by-side challenge testing per ASTM E2654-21.
