Thermo Scientific HyPerforma DS300 Single-Use Mixer (S.U.M.)

Overview

The Thermo Scientific HyPerforma DS300 Single-Use Mixer (S.U.M.) is a modular, top-driven mechanical mixing platform engineered for sterile, scalable, and process-integrated operations in biopharmaceutical manufacturing. It operates on the principle of controlled rotational agitation via a vertically aligned, torque-regulated drive motor coupled to disposable mixing vessels—specifically single-use bags (S.U.B.s) or liner-equipped rigid containers—mounted within a stainless-steel support station. Unlike magnetic or rocking-based systems, the DS300 delivers consistent shear profiles and predictable power input across volume scales by maintaining precise axial alignment and controlled impeller immersion depth. Its design conforms to current Good Manufacturing Practice (cGMP) requirements for single-use processing, supporting both upstream and downstream unit operations where product contact surfaces must remain non-reusable, validated, and pre-sterilized.

Key Features

• Modular stainless-steel base station with locking casters, height-adjustable ergonomic handle, and integrated vertical lift mechanism featuring digital height indicator for repeatable vessel positioning.
• Motor assembly with precision-engineered gearmotor, configurable speed range (typically 0–120 rpm, depending on load and impeller geometry), and real-time torque monitoring capability.
• Interchangeable drive shafts (three standard lengths) compatible with multiple bag/container configurations—enabling rapid reconfiguration between 50 L and 300 L working volumes without hardware replacement.
• Dual-purpose tool set: calibrated torque wrench and open-end wrench for secure, specification-compliant coupling installation and maintenance.
• Optional motor head tilt adjustment and container centering fixtures to optimize impeller-to-bag geometry for improved mixing uniformity and reduced vortex formation in low-viscosity media.
• Designed for integration with common single-use bioprocess containers (BPCs), including top-discharge, bottom-discharge, and closed-top 3D configurations—each pre-validated for extractables/leachables per USP and ISO 10993-18.

Sample Compatibility & Compliance

The HyPerforma DS300 supports a broad portfolio of commercially available single-use vessels from leading suppliers—including Thermo Scientific HyPerforma bags, Sartorius BPCs, and GE Healthcare Wave bags—provided they meet dimensional and port interface specifications. Compatible configurations include:

• Top-discharge bags: 50 L, 100 L, 200 L, and 300 L volumes.
• Bottom-discharge bags: 50 L, 100 L, and 200 L volumes.
• Closed-top 3D BPCs (dual-port): 50 L, 100 L, and 200 L volumes.

All supported vessels are gamma-irradiated and certified for use in GMP environments. The system architecture enables full traceability of operational parameters (speed, duration, torque, lift position) required for FDA 21 CFR Part 11 compliance when paired with validated electronic record systems. Design documentation aligns with ISO 13485 and ICH Q5A/Q5D for viral clearance and stability studies.

Software & Data Management

While the DS300 operates as a standalone hardware platform with tactile control interface, it is fully compatible with Thermo Scientific’s optional HyPerforma Control Suite—a PC-based application that logs time-stamped operational data, supports user-defined mixing protocols, and exports CSV-formatted reports for audit trail generation. When deployed in regulated environments, the system supports electronic signature workflows, role-based access control, and audit trail review functionality compliant with ALCOA+ principles. Integration with MES/SCADA platforms (e.g., Siemens SIMATIC IT, Rockwell FactoryTalk) is achievable via Modbus TCP or OPC UA interfaces.

Applications

The DS300 serves critical roles across biomanufacturing unit operations requiring gentle yet effective homogenization under aseptic conditions:

• Powder hydration of cell culture media components with minimal foaming and particle agglomeration.
• Dilution of concentrated liquid media formulations prior to bioreactor inoculation.
• Intermediate hold and stabilization of harvested harvest fluid (HCF) prior to chromatography.
• Viral inactivation steps involving pH shift or solvent/detergent addition under controlled agitation.
• Mixing of downstream intermediates—including purified monoclonal antibodies, viral vectors, or plasmid DNA—prior to ultrafiltration/diafiltration.
• Final formulation blending, buffer exchange, and excipient suspension in drug substance and drug product manufacturing.

FAQ

Is the HyPerforma DS300 suitable for high-shear applications such as cell lysis?

No. The DS300 is optimized for low-to-moderate shear mixing; it is not intended for cell disruption or high-energy dispersion tasks.
Can the system be validated for use in commercial GMP manufacturing?

Yes. IQ/OQ documentation packages are available from Thermo Scientific, and the platform supports user-executed PQ protocols aligned with ASTM E2500 and Annex 15.
Does the DS300 require compressed air or external utilities?

No. It operates solely on standard 100–240 VAC power; no pneumatic or hydraulic connections are needed.
Are spare parts and service kits available globally?

Yes. Drive shafts, O-rings, torque-limiting couplings, and calibration tools are stocked through Thermo Fisher’s global distribution network with documented shelf-life and traceability.
How is cleaning and maintenance performed between batches?

As a single-use system, no cleaning-in-place (CIP) or sterilization-in-place (SIP) is required. Post-use disposal follows institutional biohazard protocols; only the stainless-steel station undergoes routine wipe-down with approved disinfectants.