Charles River Endosafe® PRS 3 Photometric Microplate Reader for Bacterial Endotoxin Testing

Overview

The Charles River Endosafe® PRS 3 is a dedicated photometric microplate reader engineered specifically for quantitative bacterial endotoxin testing using the Limulus Amebocyte Lysate (LAL) assay principle. It operates on absorbance-based detection in 96-well microplates and is fully validated for dynamic turbidimetric (KTA/KTA2), kinetic chromogenic (KCA), and recombinant Cascade Reagent (Trillium® rCR) methodologies. Unlike general-purpose plate readers, the PRS 3 integrates optical architecture, thermal control, and kinetic measurement algorithms optimized for endotoxin quantification across pharmaceutical, biotechnology, and medical device manufacturing environments. Its design adheres to the core regulatory expectations outlined in USP <85>, EP 2.6.14, JP 4.03, and FDA Guidance for Industry on Pyrogen Testing — ensuring alignment with Good Manufacturing Practice (GMP) and quality control workflows requiring traceable, auditable, and reproducible results.

Key Features

• High-stability xenon flash lamp with >10-year operational lifetime—eliminates routine halogen bulb replacement and associated calibration drift.
• Single monochromator system covering 200–999 nm UV-Vis range—enables full spectral flexibility without mechanical filter wheels or external filter sets.
• Onboard self-diagnostic startup sequence generating printable instrument health reports via EndoScan-V software.
• Thermally stabilized microplate carrier maintaining ±0.5 °C uniformity across all wells during kinetic assays.
• Optimized optical path geometry minimizing well-to-well crosstalk and edge effects critical for low-endotoxin-level quantification (e.g., ≤0.005 EU/mL).
• Designed for seamless reagent interoperability—supports Charles River’s KTA, KTA2, KCA, and Trillium® rCR kits without hardware modification or recalibration.

Sample Compatibility & Compliance

The PRS 3 is validated for use with all commercially available LAL and rCR reagents compliant with USP <85> and EP 2.6.14 specifications. It accommodates standard 96-well clear-bottom microplates (including low-binding and sterile formats) and supports both single- and multi-point calibration curves. The system meets ISO/IEC 17025 requirements for method validation when used within a qualified laboratory environment. All firmware and hardware configurations are documented per ICH Q5C and Q9 principles, supporting risk-based qualification strategies including IQ/OQ/PQ protocols aligned with FDA and EMA expectations for regulated biopharmaceutical testing.

Software & Data Management

EndoScan-V Software v6.2+ provides full 21 CFR Part 11 compliance, including role-based user access control, electronic signatures, audit trail generation (with immutable timestamps, operator ID, and action type), and export of raw absorbance data in CSV and PDF formats. Audit trails are searchable by date range, user, assay type, or sample ID. The software supports custom report templates compliant with internal SOPs and external regulatory submissions. Data integrity safeguards include automatic backup, version-controlled method files, and cryptographic hashing of raw datasets. Integration with LIMS systems is supported via ASTM E1578-compliant export modules.

Applications

• Quantitative endotoxin testing of parenteral drug products, vaccines, and biologics per USP <85>.
• Raw material screening (e.g., water for injection, excipients, cell culture media).
• Process intermediate monitoring during aseptic manufacturing.
• Medical device extractables testing under ISO 10993-11.
• Comparative studies between LAL and rCR reagents to support sustainability-driven assay transitions.
• Supporting validation of depyrogenation cycles and cleaning processes in GMP facilities.

FAQ

Is the PRS 3 compatible with non-Charles River LAL reagents?
Yes—the instrument accepts any commercially available LAL or rCR reagent meeting USP <85> performance criteria; however, only Charles River reagents are pre-qualified in EndoScan-V method templates.
Does the PRS 3 require annual recalibration?
No scheduled recalibration is required; instead, users perform periodic verification using NIST-traceable calibration plates (optional accessory), with results documented in EndoScan-V audit trails.
Can the PRS 3 replace an existing BioTek ELx808 in endotoxin testing?
Yes—Charles River has completed formal equivalence studies confirming analytical comparability between ELx808 and PRS 3 when used with EndoScan-V and validated LAL/rCR reagents.
What temperature control options are available?
The PRS 3 maintains ambient temperature operation (20–25 °C) with active plate-carrier stabilization; no integrated incubation or cooling is provided—external environmental control is recommended for temperature-sensitive assays.
Is remote monitoring or cloud-based data storage supported?
EndoScan-V stores data locally on Windows-based workstations; networked deployment is permitted within secure intranets, but cloud upload or SaaS hosting is not enabled to preserve data sovereignty and regulatory compliance.