Sartorius Reusable Needle Filter Holder with 13 mm Membrane

Overview

The Sartorius Reusable Needle Filter Holder (Cat. No. 16574) is a precision-engineered filtration component designed for high-integrity sample preparation in analytical, pharmaceutical, and biotechnological laboratories. Unlike single-use syringe filters, this system implements a modular architecture based on the principle of mechanical membrane retention: a chemically inert PTFE filter holder securely clamps standard 13 mm disc membranes—enabling full reusability of the housing after thorough cleaning and sterilization. Its operation relies on positive-pressure filtration driven by manual or automated syringe actuation, with performance governed by Darcy’s law under controlled differential pressure (up to 5 bar). The design prioritizes minimal sample loss (< 0.03 mL residual volume), chemical resilience across aggressive solvents (e.g., acetonitrile, THF, chloroform), and compatibility with stringent regulatory environments where extractables and leachables must be rigorously controlled.

Key Features

• PTFE construction ensures broad chemical compatibility—resistant to strong acids, bases, halogenated solvents, and polar aprotic media without swelling, degradation, or extractable release.
• Self-locking, seal-free clamping mechanism eliminates reliance on O-rings or gaskets, preventing membrane damage during installation and ensuring consistent sealing integrity across repeated cycles.
• Optimized fluid path geometry minimizes dead volume and enhances recovery of precious samples—critical for HPLC, UHPLC, LC-MS, and small-volume bioprocess filtrations.
• Rated for sustained operation at 5 bar (500 kPa), supporting rapid filtration even with viscous or particulate-laden solutions when paired with appropriate membrane pore ratings (0.2 µm or 0.45 µm).
• Autoclavable at 121 °C (30 min) or 134 °C (3–5 min), or dry-heat sterilizable at 180 °C—fully compliant with ISO 11140-1 and EN 285 for steam sterilization validation.
• Lightweight (13 g), ergonomic profile facilitates one-handed operation and integration into automated liquid handling workflows.

Sample Compatibility & Compliance

This holder accommodates all commercially available 13 mm disc membranes—including PTFE, nylon, PVDF, cellulose acetate, and polyethersulfone—allowing method flexibility across aqueous, organic, and mixed-phase applications. Its inert surface and absence of adhesives or binders ensure non-interference with UV-sensitive analytes, low-protein-binding assays, and trace-metal analysis. The system supports compliance with pharmacopeial standards including USP (particulate matter), USP (bacterial endotoxins), and ISO 8573-1 (compressed air purity). When used with certified low-extractables membranes, it meets ICH Q5A/Q5D requirements for biopharmaceutical process intermediates and final container closure systems.

Software & Data Management

As a passive, non-electronic filtration component, the holder requires no embedded firmware or software interface. However, its reusability supports full traceability within electronic lab notebook (ELN) and laboratory information management systems (LIMS). Each unit can be assigned a unique asset ID; sterilization cycles, membrane lot numbers, and usage logs are recorded per GLP/GMP documentation protocols. Audit trails for cleaning validation (e.g., TOC rinse testing) and sterilization cycle parameters (F₀, temperature, duration) align with FDA 21 CFR Part 11 requirements when integrated into validated workflows.

Applications

• HPLC/UHPLC mobile phase and sample filtration prior to injection—reducing column fouling and extending lifetime.
• Pre-filtration of cell culture supernatants, viral vectors, and monoclonal antibody harvests in upstream/downstream bioprocessing.
• Purification of synthetic reaction mixtures in medicinal chemistry, especially where solvent compatibility precludes nylon or cellulose-based filters.
• Environmental analysis of hydrophobic pollutants (e.g., PAHs, PCBs) from water extracts using PTFE membranes.
• Gas chromatography sample cleanup involving volatile organic compounds (VOCs) and derivatized metabolites.

FAQ

Can this holder be used with membranes other than PTFE?
Yes—it accepts any standard 13 mm disc membrane, provided the membrane material is compatible with the sample matrix and intended downstream analysis.
What is the recommended cleaning protocol between uses?
Rinse thoroughly with ≥95% ethanol or isopropanol, followed by ultrapure water; sonicate for 5 min in each solvent; dry under nitrogen or in a Class A laminar flow hood.
Is the holder suitable for sterile filtration of cell culture media?
Only when paired with a 0.2 µm sterilizing-grade membrane and validated through bacterial challenge testing (e.g., Brevundimonas diminuta ATCC 19146); autoclave the assembled unit post-use.
Does residual volume include both inlet and outlet dead space?
Yes—the < 0.03 mL value represents total retained volume across the Luer Lock inlet channel, filter chamber, and Luer Slip outlet taper, measured gravimetrically with water at 20 °C.
How many reuse cycles are supported under GMP conditions?
Lifecycle depends on cleaning validation data; typical qualification supports ≥50 cycles with documented integrity testing (bubble point or diffusion test) before retirement.