Millipore Polygard® CT Cartridge Filter

Overview

The Millipore Polygard® CT Cartridge Filter is a high-performance, gradient-density depth filter engineered for primary clarification of diverse process liquids in life science, biopharmaceutical, food & beverage, and industrial manufacturing environments. Utilizing a proprietary dual-layer melt-blown polypropylene (PP) medium with graded pore structure, the Polygard® CT operates on depth filtration principles—capturing particulates throughout the matrix rather than solely at the surface. This architecture enables superior dirt-holding capacity, low differential pressure development, and extended service life under variable flow and loading conditions. Designed for compatibility with non-aggressive aqueous and organic solvent streams, it serves as a robust first-stage prefilter upstream of membrane-based sterilizing or final filtration units—reducing fouling, extending downstream membrane life, and improving overall process economy.

Key Features

• Gradient-density polypropylene depth medium: Two distinct nominal retention ratings integrated into a single cartridge—optimized for sequential particle capture and high contaminant loading capacity.
• Low-pressure-drop performance: Engineered to maintain ΔP < 0.3 bar at rated flow rates across common viscosities (≤ 10 cP), minimizing energy consumption and system backpressure.
• Broad chemical compatibility: Melt-blown PP construction resists degradation from alcohols, ketones, esters, hydrocarbons, dilute acids/bases (pH 2–12), and aqueous buffers—validated per ASTM D543 and USP cytotoxicity guidelines.
• Batch traceability: Each cartridge bears a laser-etched lot number and manufacturing date for full supply chain accountability and compliance with GMP documentation requirements.
• Pressure-stable integrity: Demonstrated resistance to media migration and fiber shedding under transient pressure spikes up to 4.1 bar (60 psi), supporting reliable operation in dynamic pump-driven systems.
• Scalable configurations: Available in standard 10″, 20″, 30″, and 40″ lengths with diameters of 63 mm and 152 mm—offering filtration areas from 0.25 m² to 9.0 m² per cartridge.

Sample Compatibility & Compliance

The Polygard® CT is validated for use with deionized water, ethanol, isopropanol, acetone, methyl ethyl ketone (MEK), mineral spirits, vegetable oils, beer wort, wine must, soft drink syrups, cosmetic emulsions, papermaking additives, and wastewater effluents containing suspended solids ≤ 500 ppm. It complies with FDA 21 CFR §177.1520 for polypropylene contact with food, meets EU Regulation (EC) No. 1935/2004 for food-contact materials, and conforms to ISO 9001-certified manufacturing protocols. While not intended for sterile-grade filtration (i.e., 0.22 µm or 0.1 µm microbial retention), it supports validation of prefiltration steps per ISO 13408-2 and PDA Technical Report No. 40.

Software & Data Management

As a passive mechanical filtration device, the Polygard® CT requires no embedded firmware, control software, or digital connectivity. However, its performance data—including pressure drop vs. throughput curves, batch-specific retention efficiency reports, and compatibility matrices—are fully integrated into Millipore’s online technical library and supported by electronic documentation packages compliant with 21 CFR Part 11 Annex 11 requirements. Users may download certified test reports, material safety data sheets (MSDS), and validation support kits—including extractables profiles and endotoxin testing summaries—for inclusion in regulatory submissions (e.g., IND, BLA, MAH dossiers).

Applications

• Pretreatment of purified water (PW) and water-for-injection (WFI) systems prior to reverse osmosis or electrodeionization stages.
• Solvent clarification in API synthesis and chromatography mobile phase preparation.
• Removal of yeast, hop residues, and colloidal haze in brewing and winemaking operations.
• Pre-filtration of coating formulations, inks, and pigment dispersions in industrial finishing lines.
• Clarification of fermentation broths and cell culture harvests before tangential flow ultrafiltration (TFF) or depth filtration polishing.
• Treatment of process rinse waters and secondary effluents in pulp & paper mills and electroplating facilities.

FAQ

Is the Polygard® CT suitable for sterile filtration?
No. It is a prefilter designed for particulate removal—not microbial retention. Sterile filtration requires membranes with defined 0.22 µm or 0.1 µm ratings validated per ASTM F838.

Can Polygard® CT cartridges be steam sterilized in place (SIP)?
No. The polypropylene construction has a maximum continuous service temperature of 85°C; autoclaving (121°C) will cause structural deformation and loss of integrity.

What is the recommended maximum operating differential pressure?
4.1 bar (60 psi) at 25°C. Sustained operation above 3.4 bar (50 psi) is not advised without verification of flow stability and particulate release.

How is filter integrity verified post-use?
Integrity testing (e.g., forward flow, bubble point, or diffusion tests) is not applicable to depth filters. End-of-life determination relies on ΔP monitoring, throughput volume thresholds, and visual inspection per SOP-defined acceptance criteria.

Are Polygard® CT cartridges supplied with pre-sterilization or gamma irradiation?
No. They are supplied non-sterile and intended for cleanroom-compatible pre-use sanitization (e.g., hot water flush, solvent rinse) or integration into validated cleaning cycles.