SQ Endotoxin-Removal Terminal Filter

Overview

The SQ Endotoxin-Removal Terminal Filter is a high-integrity, single-use filtration device engineered for the final purification step in ultra-pure water (UPW) systems used in pharmaceutical, biotechnology, and analytical laboratories. Designed to operate as a terminal filter—installed immediately upstream of point-of-use outlets—the unit removes residual endotoxins (lipopolysaccharides, LPS) from water streams that have already undergone primary purification via reverse osmosis, deionization, and ultraviolet oxidation. Its performance is based on proprietary adsorptive membrane technology combined with precisely controlled pore architecture, enabling efficient capture of endotoxin aggregates while maintaining low protein binding and negligible leachables. This filter complies with ISO 8573-1 (compressed air purity classes) and USP guidelines for water for injection (WFI) distribution system integrity, and is validated for use in environments requiring adherence to GMP and GLP principles.

Key Features

• Endotoxin reduction capacity ≥ 4-log₁₀ (≥99.99%) per unit, verified per USP bacterial endotoxin test methodology using Limulus Amebocyte Lysate (LAL) assay
• Hydrophilic polyethersulfone (PES) membrane with surface-modified chemistry to minimize nonspecific adsorption of biomolecules
• Integrity-testable design compatible with forward flow and bubble point testing per ASTM F838-22 and ISO 13408-2
• Pre-sterilized via gamma irradiation (25–35 kGy); certified sterile, non-pyrogenic, and DNase/RNase-free
• Compact, modular housing with 1/4″ NPT or sanitary tri-clamp (ISO 2852) inlet/outlet options for seamless integration into UPW loops
• No internal wetting agents or surfactants; extractables profile compliant with USP and EP 3.2.1

Sample Compatibility & Compliance

The SQ filter is intended exclusively for aqueous streams with conductivity ≤ 1 µS/cm and total organic carbon (TOC) 5 ppm free chlorine), or solutions containing >0.1% surfactants. Validation data support its use in WFI, purified water (PW), and clean steam condensate applications per EU Annex 1, FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing (2004), and WHO TRS No. 977. Each batch is supplied with a Certificate of Conformance (CoC) and Certificate of Analysis (CoA), including lot-specific endotoxin challenge test results, membrane surface area, and pre-use integrity test limits.

Software & Data Management

As a passive, single-use hardware component, the SQ Endotoxin-Removal Terminal Filter does not incorporate embedded electronics or firmware. However, it is fully compatible with digital water system monitoring platforms (e.g., Siemens Desigo CC, Emerson DeltaV, or custom SCADA architectures) via external pressure differential transducers and flow meters installed upstream/downstream. Audit trail functionality—including filter installation timestamp, usage duration, and post-installation integrity test records—is maintained within the facility’s validated electronic quality management system (eQMS) in accordance with FDA 21 CFR Part 11 requirements. Batch-level traceability is ensured through laser-etched serial numbers and QR-coded labels aligned with GS1 standards.

Applications

• Final polishing of ultra-pure water for cell culture media preparation and monoclonal antibody manufacturing
• Point-of-use protection for HPLC mobile phase preparation, ICP-MS calibration standards, and ELISA reagent formulation
• Critical rinse water in aseptic filling lines for parenteral drug products
• Feedwater conditioning for quartz crystal microbalance (QCM) and surface plasmon resonance (SPR) biosensors
• Compliance-driven upgrades to legacy UPW systems lacking validated endotoxin control at the outlet

FAQ

What is the recommended maximum service life under continuous operation?
Typical service life is 720 hours or 30 days—whichever occurs first—under nominal flow rates of 0.5–2.0 L/min at 25°C. Extended use requires documented risk assessment and revalidation.
Can this filter be autoclaved or steam sterilized in place (SIP)?
No. The unit is gamma-sterilized prior to packaging and is not rated for repeated thermal exposure. In-line steam sterilization will degrade membrane integrity and compromise endotoxin removal efficiency.
Is compatibility data available for integration with specific ultra-pure water system brands (e.g., ELGA, Veolia, Sartorius)?
Yes. Deepflow provides application notes and mechanical interface drawings for leading UPW platforms; contact technical support for system-specific validation protocols.
Does the filter require pre-flushing before first use?
Yes. A minimum 30-minute flush with ≥5 L of UPW at operating pressure is required to remove process-related particulates and stabilize hydraulic resistance. Post-flush integrity testing is mandatory prior to commissioning.