Millipore Millidisk® Cartridge Filter
| Brand | Millipore |
|---|---|
| Origin | USA |
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model | Millidisk® |
| Pricing | Available Upon Request |
| Membrane Material | Hydrophilic/Hydrophobic Durapore® PVDF |
| Sterility | Pre-sterilized Options Available |
| Membrane Area | 500–2000 cm² |
| Pore Sizes | 0.1 µm, 0.22 µm, 0.45 µm, 5.0 µm (hydrophilic) |
| Residual Volume | Minimized via Unsupported Disc Stack Architecture |
| Protein Binding | Ultra-low |
| Chemical Compatibility | Broad (compatible with aqueous and low-polarity solvents) |
Overview
The Millipore Millidisk® Cartridge Filter is a sterile-grade, unsupported disc-stack depth filtration device engineered for high-integrity particulate and microbial removal from critical bioprocess liquids and gases. Unlike conventional pleated or membrane-cartridge filters, the Millidisk® employs a unique layered disc architecture—comprising stacked, non-woven support-free Durapore® polyvinylidene fluoride (PVDF) membranes—designed to eliminate fiber shedding, minimize hold-up volume (< 1.5 mL typical for 500 cm² configuration), and ensure consistent flow dynamics across scale-up transitions. Its operation relies on surface retention combined with controlled depth filtration, enabling robust bacterial retention (≥ log4 reduction of Brevundimonas diminuta per ASTM F838-22 at rated pore size) while maintaining high throughput and low pressure drop. The filter is validated for use in aseptic processing environments compliant with ISO 13408-1, USP , and EU Annex 1 requirements for sterile filtration.
Key Features
- Unsupported disc-stack design eliminates backing mesh or support layers—reducing extractables, minimizing residual volume, and preventing particulate release during installation or operation.
- Durapore® PVDF membrane offers ultra-low protein binding (< 5 ng/cm² for IgG), broad chemical compatibility (including alcohols, acetone, ethyl acetate, and buffered aqueous solutions), and intrinsic hydrophilicity without surfactant leaching.
- Pre-sterilized configurations available via gamma irradiation (25–40 kGy) or steam-in-place (SIP)-compatible housing options—fully traceable with individual lot-specific CoA and bioburden data.
- Integrated QR code on each unit enables real-time access to full validation documentation, including retention testing reports, extractables profiles (per USP ), and endotoxin limits (< 0.25 EU/mL).
- Scalable format: standardized 25 mm, 47 mm, and 90 mm outer diameters; membrane area range from 500 cm² to 2000 cm² supports lab-scale process development through clinical and commercial manufacturing.
Sample Compatibility & Compliance
The Millidisk® filter is qualified for use with biological therapeutics (monoclonal antibodies, vaccines, viral vectors), diagnostic reagents, cell culture media, buffers, and purified water (PW/UPW). It meets ISO 9001 and ISO 13485 quality system requirements and is supported by comprehensive regulatory documentation packages—including Design History File (DHF) excerpts, risk assessments per ISO 14971, and compatibility matrices aligned with ICH Q5A(R2) and Q5D guidelines. All pre-sterilized units are manufactured under cGMP conditions and comply with FDA 21 CFR Part 11 for electronic records when paired with validated data acquisition systems.
Software & Data Management
While the Millidisk® cartridge itself is a passive filtration component, its integration into automated bioprocessing workflows is supported via compatibility with industry-standard SCADA and MES platforms (e.g., DeltaV, Siemens Desigo, Rockwell FactoryTalk). Batch records generated during filter integrity testing (forward flow, water intrusion, or bubble point) can be electronically captured and archived with audit trail functionality meeting ALCOA+ principles. Full technical datasheets—including flow vs. pressure curves, particle challenge data, and sterilization cycle validation summaries—are accessible via secure portal download using the embedded QR code.
Applications
- Sterile filtration of injectables, ophthalmic solutions, and parenteral nutrition formulations prior to final fill.
- Clarification and sterile polishing of upstream harvest streams and downstream purification intermediates (e.g., post-protein A eluate, virus removal filtrate).
- Gaseous stream sterilization (compressed air, nitrogen, CO₂) in bioreactor headspaces and filling line environments.
- Final-point filtration of purified water and clean steam condensate in pharmaceutical water systems.
- Non-aqueous solvent filtration (e.g., ethanol-based formulations, lipid nanoparticle suspensions) where low adsorption and chemical stability are critical.
FAQ
What integrity test methods are recommended for Millidisk® filters?
Forward flow, bubble point, and water intrusion tests are all supported—method selection depends on membrane hydrophilicity/hydrophobicity and process fluid properties. Validation protocols follow ASTM F316-22 and PDA Technical Report No. 26.
Can Millidisk® filters be used in continuous processing trains?
Yes—mechanical stability under cyclic pressure (up to 5 bar operating pressure) and validated reuse potential (with appropriate cleaning and integrity retesting) enable integration into continuous biomanufacturing architectures.
Is extractables data available for regulatory submissions?
Yes—full extractables profiling per USP and ICH Q3D is included in the Certificate of Analysis and Regulatory Support Dossier.
How does the unsupported disc design affect scalability from lab to production?
Geometric similarity across sizes ensures linear scale-up of flux and differential pressure—validated across 500 cm² (R&D), 1000 cm² (pilot), and 2000 cm² (commercial) configurations per ISPE Baseline Guide Vol. 4.
Are Millidisk® filters compatible with single-use bioprocessing systems?
Yes—standardized port configurations (1/4″ NPT, Tri-Clamp® 1.5″) and housing materials (316L SS, polypropylene, or polycarbonate) allow seamless integration with single-use manifolds and connectors.
