Sterile Filter (PES 0.22µm)

Description

1. Product Overview

The Sterile Filter (PES 0.22µm) is a high-throughput, membrane-based filtration device engineered for the critical removal of microorganisms and particulates from biopharmaceutical, laboratory, and industrial fluids. Its primary industrial use lies in sterilizing heat-sensitive solutions—such as cell culture media, buffers, and biological reagents—where absolute sterility must be maintained without compromising protein passage or flow rate. With its low protein binding and high flow consistency, this filter delivers a strategically vital balance of sterility assurance and yield integrity, reducing batch failures and operational downtime in regulated production environments.

2. Key Specifications & Technical Characteristics

• Chemical Composition: Polyethersulfone (PES) hydrophilic membrane; polypropylene or polysulfone housing and support layers

• Purity Grade: USP Class VI tested; non-cytotoxic; low extractables (<1.5 mg per 10 cm²)

• Physical Characteristics: Asymmetric membrane pore structure; 0.22µm nominal pore size; sterile white disk/cartridge; thickness 110–150 µm; bubble point ≥3.2 bar (with 70% IPA)

• Packaging Options: Double-bagged gamma-irradiated; individually sealed in peel pouches; available in 25 mm, 47 mm, 90 mm discs, or cartridge formats (5” to 40”)

• Shelf Life: 3 years from sterilization date when stored in original, unopened packaging at 4–30°C, away from solvents and UV

3. Core Industrial Applications

• Biopharmaceutical Manufacturing: Terminal sterilization of protein solutions, monoclonal antibodies, and vaccines prior to filling. Outperforms cellulose-based filters by achieving faster flow decay resistance, reducing filtration time per batch by up to 35%.

• In-Vitro Diagnostics (IVD) Production: Sterilization of aqueous reagents and diluents. PES’s low protein adsorption ensures diagnostic sensitivity remains intact—unlike nylon or PVDF, which can bind critical detection antibodies.

• Food & Beverage QC Labs: Sterile filtration of beverages, enzymes, or flavor extracts for microbial limit testing. The 0.22µm absolute rating ensures removal of Brevundimonas diminuta at ≥10⁷ CFU/cm², exceeding ISO 13408-2 requirements.

• Cell Culture Media Prep: Direct sterilization of serum-free or animal-component-free media. Non-cytotoxic construction eliminates the need for pre-rinsing, saving 15–20 minutes per filtration setup.

4. Competitive Advantages

• Quality Consistency: Every batch integrity-tested via bubble point and pressure hold; lot-specific certificates of analysis (CoA) available for ISO 13485:2016 traceability.

• Supply Reliability: Dual manufacturing sites (Asia and EU) with 12-month rolling capacity forecast; <2% historical backlog incidence over 8 years.

• Logistics Capability: Temperature-controlled warehousing in 6 global hubs; lead time 5–7 days for standard packs, 15 days for bulk cartridges.

• Price Competitiveness: Tiered pricing delivering 18–22% cost savings vs. leading EU/US brands for equivalent PES media and sterility assurance level (SAL 10⁻⁶).

• Sustainability & Support: Housing made with 30% post-industrial recycled polymer; full technical dossier (validation guide, extractables profile) provided with initial order.

5. Commercial & Supply Information

• Minimum Order Quantity (MOQ): 500 units (mix-and-match discs/cartridges) for first order; 250 units for repeat orders

• BULK 20MT Loading Capacity: Not applicable for finished filters (volume-dense, not mass-dense). Instead: 20FT container holds up to 240,000 units (47mm disc pack) or 4,800 units (10” cartridges) – weight ≤2.5MT.

• Note: For bulk membrane sheet rolls (unsterilized PES 0.22µm): 20MT loading capacity requires 20 dry containers; typical roll MOQ = 1 pallet (~150 kg). Contact supply team for reel-grade pricing.