Thermo Scientific Sorvall™ BIOS 16/A Series Large-Capacity Floor-Standing Centrifuge

Overview

The Thermo Scientific Sorvall™ BIOS 16/A Series is a floor-standing, high-speed large-capacity centrifuge engineered for robust, repeatable performance in biopharmaceutical manufacturing and upstream/downstream processing environments. Designed around the principles of hydrodynamic separation under controlled gravitational fields, this series operates on fixed-angle and horizontal rotor configurations to achieve precise sedimentation of mammalian cells, microbial cultures, viral vectors, clarified harvests, and intermediate bioprocess streams. With a maximum RCF of 8,500 × g and rotational speeds exceeding 30,000 rpm, the BIOS 16/A platform supports scalable batch processing—enabling efficient clarification, concentration, and purification steps without compromising sterility or process integrity. Its compact footprint (1015 × 816 × 900 mm) allows integration into GMP-compliant cleanrooms and ISO Class 5–7 production suites while maintaining accessibility for routine maintenance and rotor exchange.

Key Features

• Engineered for bioprocess continuity: Sealed rotor chambers with integrated condensate management and HEPA-filtered air purge options support closed-system operation compatible with single-use bioreactor workflows.
• Intelligent rotor recognition: Automatic detection of certified horizontal rotors—including the 6×1000 mL and 4×2000 mL configurations—ensures speed/RCF limits are enforced per ISO 21501-4 and IEC 61010-2-020 safety standards.
• Enhanced thermal stability: Active refrigeration system maintains sample temperature between –9 °C and +40 °C with ±0.5 °C uniformity across the rotor chamber, critical for thermolabile monoclonal antibodies and plasmid DNA intermediates.
• GMP-aligned user interface: Touchscreen control panel with audit-trail-enabled log generation, password-protected method storage, and electronic signature capability compliant with FDA 21 CFR Part 11 requirements.
• Structural durability: Reinforced stainless-steel chassis and vibration-dampening suspension system ensure long-term mechanical stability under continuous 24/7 operation at rated capacity.

Sample Compatibility & Compliance

The Sorvall™ BIOS 16/A Series accommodates standard bioprocessing vessels including 500–2000 mL disposable bags (with adapter kits), glass and polycarbonate bottles (up to 2 L), and sealed centrifuge tubes (e.g., 500 mL conical). All rotor assemblies are validated per ASTM F2118 for fatigue life and undergo third-party certification to ISO 13485:2016 for medical device quality systems. The instrument meets electromagnetic compatibility (EMC) requirements per EN 61326-1 and carries CE marking for in vitro diagnostic (IVD) use in EU regulatory frameworks. Optional validation packages include IQ/OQ documentation aligned with WHO TRS 986 Annex 4 and EU GMP Annex 15 guidelines.

Software & Data Management

CentriLog™ software (v3.2+) provides centralized control, real-time parameter monitoring, and automated report generation. It supports secure network deployment via Ethernet/IP or OPC UA protocols, enabling integration into MES/SCADA environments. All run logs—including rotor ID, speed profile, temperature history, imbalance alerts, and door cycle events—are timestamped and cryptographically signed. Data export formats include CSV, PDF, and XML, with optional cloud backup to Thermo Fisher Connect™ (validated for HIPAA and GDPR compliance). Electronic records retain full traceability for GLP/GMP audits and regulatory submissions.

Applications

• Clarification of CHO and HEK293 cell culture harvests prior to depth filtration or TFF
• Concentration and buffer exchange of AAV and lentiviral vectors
• Harvesting of bacterial inclusion bodies for downstream refolding
• Separation of lipid nanoparticles (LNPs) during mRNA vaccine formulation
• Processing of plasma-derived therapeutics including coagulation factors and immunoglobulins
• Stability testing of biologics under accelerated centrifugation stress conditions (per ICH Q5C)

FAQ

What rotor configurations are certified for the BIOS 16/A Series?

The system supports horizontal rotors with capacities up to 4 × 2000 mL or 6 × 1000 mL, all pre-validated for maximum RCF of 8,500 × g at 16,000 rpm.
Is remote diagnostics supported?

Yes—CentriLog™ enables secure remote access for firmware updates, error log retrieval, and predictive maintenance alerts via Thermo Fisher Connect™.
Can the centrifuge be integrated into a fully automated bioprocessing line?

Absolutely—the BIOS 16/A features digital I/O ports, Modbus TCP support, and configurable PLC handshake signals for synchronized start/stop and interlock signaling.
Does it comply with FDA 21 CFR Part 11 for electronic records?

Yes—audit trail, electronic signatures, and role-based access control are natively implemented and documented in the system validation package.
What is the recommended preventive maintenance interval?

Thermo Scientific recommends quarterly calibration verification and annual full service by certified field engineers, with rotor lifetime tracking embedded in CentriLog™.