Millipore NovAseptic® Magnetic Stirrer

Overview

The Millipore NovAseptic® Magnetic Stirrer is an aseptic-grade, bottom-driven magnetic stirring system engineered for sterile bioprocessing applications in pharmaceutical and biotechnology manufacturing. Unlike conventional top-entry stirrers, the NovAseptic® design integrates a hermetically sealed, magnetically coupled drive mechanism mounted beneath the vessel—enabling true single-use or reusable stainless-steel tank compatibility without penetration of the vessel wall. This architecture eliminates dynamic shaft seals, bearing wear, and associated particulate generation, thereby reducing bioburden risk and supporting compliance with current Good Manufacturing Practice (cGMP) requirements per FDA 21 CFR Part 211 and EU Annex 1. The system operates on the principle of contactless torque transmission via rotating permanent magnets, ensuring consistent mixing performance across varying viscosities (up to 50 cP), volumes (from 1 L to 2,000 L), and temperatures (ambient to 60 °C), while maintaining Class A/B cleanroom suitability when installed with appropriate isolator or RABS integration.

Key Features

• Bottom-mounted magnetic drive with IP67-rated motor housing, enabling installation directly beneath single-use bags or stainless-steel vessels without compromising vessel integrity
• No mechanical seals, shafts, or lubricants—eliminating potential sources of extractables, leachables, and microbial ingress
• Fully compatible with CIP (Clean-in-Place) and SIP (Sterilize-in-Place) protocols using steam (121 °C, 30 min) or chemical agents (e.g., NaOH, hydrogen peroxide vapor)
• Pre-qualified mixing performance data available through Millipore’s global Process Validation Support Center, including residence time distribution (RTD), power input (P/V), and blend time quantification per ASTM E2500-13 guidelines
• Modular control interface supporting analog 4–20 mA output, Profibus DP, or EtherNet/IP connectivity for integration into DCS/SCADA systems and electronic batch records
• Stir bar agitators available in PTFE-coated, PEEK, or USP Class VI-certified elastomer variants for compatibility with sensitive biologics formulations

Sample Compatibility & Compliance

The NovAseptic® Magnetic Stirrer accommodates a broad range of process fluids encountered in upstream and downstream biomanufacturing—including cell culture media, buffer solutions, viral vector suspensions, monoclonal antibody harvest streams, and final formulation buffers. Vessel compatibility extends to standard 316L stainless-steel tanks (ASME BPE-2022 compliant), gamma-sterilized single-use bioreactors (e.g., Sartorius BIOSTAT® STR, Thermo Fisher HyPerforma™), and custom-engineered mixing bags with integrated magnetic coupling plates. All wetted components meet USP <87> and <88> cytotoxicity and systemic injection testing requirements. The system supports full traceability under ALCOA+ principles and includes optional audit trail functionality compliant with FDA 21 CFR Part 11 for electronic signatures and data integrity.

Software & Data Management

Operation is managed via the optional NovAseptic® Control Module—a CE-marked, Windows-based HMI offering real-time monitoring of rotational speed (0–500 rpm, ±1 rpm accuracy), motor current draw, thermal load, and runtime. Historical data is logged in CSV or SQL format with configurable sampling intervals (1 s to 10 min). For regulated environments, the module supports electronic signature workflows, user role-based access control (RBAC), and automatic backup to network-attached storage (NAS) or validated cloud repositories. Data export conforms to ISA-88 and ISA-95 standards, facilitating alignment with MES platforms such as Siemens Opcenter Execution or Rockwell FactoryTalk.

Applications

• Buffer and media preparation in pre-sterile filling suites
• In-line blending of therapeutic proteins prior to ultrafiltration/diafiltration
• Homogenization of lipid nanoparticle (LNP) formulations during mRNA vaccine manufacturing
• pH adjustment and additive incorporation in upstream bioreactor seed train operations
• CIP/SIP cycle verification and validation support for ASME BPE-compliant piping systems
• Process characterization studies under Quality by Design (QbD) frameworks per ICH Q5A(R2) and Q8(R2)

FAQ

Is the NovAseptic® Magnetic Stirrer suitable for use with single-use bioreactors?

Yes—it is specifically designed for integration with gamma-sterilized single-use bags featuring embedded ferromagnetic coupling plates, enabling full aseptic operation without bag modification.
Does Millipore provide IQ/OQ documentation for this system?

Standard Factory Acceptance Test (FAT) reports are included; site-specific Installation Qualification (IQ) and Operational Qualification (OQ) protocols are available upon request and may be executed jointly with Millipore’s Global Validation Services team.
Can the stirrer operate under nitrogen blanket conditions?

Yes—the motor housing and coupling assembly are rated for inert gas environments up to 1.5 bar gauge pressure, supporting anaerobic or oxygen-sensitive processes.
What maintenance is required during routine operation?

No scheduled maintenance is required; periodic visual inspection of coupling alignment and verification of motor cooling airflow are recommended per the Maintenance Logbook (Ref. M-NOV-MAINT-001).
Is remote monitoring supported?

Yes—via optional Ethernet-enabled controllers with Modbus TCP or OPC UA server functionality, allowing integration into centralized process monitoring dashboards.