Sartorius, OCTET-RH16-GXP, Octet® RH16, 16-Channel High Throughput Protein Analysis System with GxP Package

Top Features of Octet® R16, 16-Channel High Throughput Protein Analysis System with GxP Package Analyze up to 16 samples simultaneously Streamline workflows with automation Available as a complete GxP package with 21 CFR Part 11 software and IQOQ/PQ kits, manufacturer-derived protocols, and services for regulatory compliance. The Octet RH16 GxP package system offers a comprehensive suite of products, software, and services for GxP compliance. It is an ideal choice for regulated quality control labs involved in biopharmaceutical development and manufacturing. The Octet RH16 GxP package includes various tools to develop validated assay methods on the Octet® BLI platform. These tools simplify operations for analytical development and regulated quality control labs. The package is tailored for lot release and in-process testing for ligand binding, concentration, and impurity analysis in upstream and downstream processes. Key product highlights and services includes; Comprehensive Installation and Operational Qualification: The Octet® instrument package includes an IQ/OQ kit and services that offer comprehensive documentation and verification. This ensures that the instrument and its accessories are installed and operating accurately. The kit guarantees that critical components, such as the optical system, plate temperature, system alignment, lamp performance, and shaker speed, meet the manufacturer's specified standards Performance Qualification Kits and Software Validation: Performance Qualification (PQ) kits are available for quickly verifying the performance of the Octet RH16 system. These kits include the PQ-Kinetics and Quantitation assays that ensure the accuracy and precision of the assays are within manufacturer specifications. They use a well-characterized model system pair to assess the system's performance. Octet® 21 CFR Part 11 Software: This software is designed to assist in meeting FDA regulations by providing essential technical and administrative features. It offers controlled access with multiple user levels and a structured set of permissions that cater to different laboratory roles and privileges. This helps to ensure secure, compliant, and efficient management of laboratory data, making it an indispensable tool for regulated environments. Software Validation Package: The Octet® Software Validation Package is designed for researchers working in GLP (Good Laboratory Practice) or GMP (Good Manufacturing Practice) laboratories. It offers the most comprehensive set of documentation and tools for validating the features and functions of the Octet® GxP Server Monitor and Octet® CFR Software. This package ensures that the software adheres to industry standards and regulatory requirements, making it an essential component for laboratories seeking to maintain the highest level of compliance and data integrity The Octet RH16 GxP package includes: The Octet® RH16 system for biomolecular detection using label-free analysis Latest Octet® 21 CFR Part 11 Software Software Validation Package IQ/OQ Kit, and Manual, PQ-Quantitation and PQ-Kinetics Kits and Manual, IQ/OQ Service PQ Services PM/OQ Service Specifications Features: Operation: Automated Plate Compatibility: 96 Well; 384 Well Sample Plate Capacity: 2 General Specifications: Affinity Range: 1 mM to 10 pM Analysis time per 96 samples (Concentration): 14 min Analysis time per 96 samples (Kinetics): 1.4 hr Analyte MW Range: > 150 Da Association rate: 10¹ to 10⁷ M⁻¹ s⁻¹ Channels: 16 Crude sample compatibility: Yes Dissociation rate: 10⁻⁶ to 0.1 s⁻¹ External Automation: Yes Orbital Flow Capacity: Static or 1000 – 2600 RPM Temperature Range: 4 C above ambient to 40 C Operating Conditions: Minimum Operating Volume: 40 µL