一次性底部磁力搅拌系统

Overview

The Applitech Single-Use Bottom-Driven Magnetic Stirring System is an engineered solution for aseptic liquid handling in biopharmaceutical manufacturing. Designed around contactless magnetic torque transmission, the system employs a hermetically sealed, bottom-mounted permanent magnet assembly coupled with an external servo-driven rotating field—eliminating mechanical shafts, dynamic seals, and associated contamination risks. Unlike conventional top-driven agitators or overhead stirrers, this configuration ensures full compatibility with single-use bioprocess bags (e.g., Haimore series), enabling homogeneous mixing of cell culture media, process buffers, purification intermediates, and vaccine adjuvants under Grade A/ISO 5 conditions. The system operates on the principle of eddy-current-free magnetic coupling—optimized for low-shear, high-reproducibility agitation across viscosities up to 100 mPa·s and volumes ranging from 50 L to 3,000 L. Its architecture supports both modular integration into larger fluid management platforms and standalone operation in cleanroom environments.

Key Features

• Bottom-driven magnetic coupling: Eliminates shaft penetration, seal leakage, and cleaning validation requirements—fully compliant with single-use processing paradigms.
• Integrated servo motor control: Enables precise speed regulation (0–600 rpm typical range), programmable ramp profiles, and real-time torque monitoring for process consistency.
• Hygienic design: Fully enclosed drive unit with smooth, crevice-free stainless steel housing; IP65-rated electronics; no exposed cables—supports WFI rinsing and vaporized hydrogen peroxide (VHP) decontamination.
• Modular functional expansion: Optional integration of load cells (±0.1% FS accuracy), pH and conductivity sensors (ASTM D1125-compliant calibration), temperature probes (Pt100, ±0.2 °C), and thermal jackets (±0.5 °C control).
• Flexible configuration: Available in both integrated (drive + base frame) and split-mount (drive unit mounted separately beneath floor or platform) variants to accommodate facility layout constraints.
• Compliance-ready software interface: Supports user role-based access control (RBAC), electronic signatures, audit trail generation per FDA 21 CFR Part 11, and GMP-aligned alarm management (e.g., over-torque, sensor fault, bag misalignment).

Sample Compatibility & Compliance

The system is validated for use with standard gamma-irradiated, USP Class VI-certified single-use bags—including Applitech’s Haimore series—featuring ethylene vinyl acetate (EVA) or multi-layer polyolefin films. It meets ISO 13485:2016 design control requirements and supports compliance with ICH Q5A(R2), Q5D, and EU Annex 1 (2022) for aseptic processing. All wetted components are non-leachable and extractables-tested per USP and . The absence of CIP/SIP cycles reduces water-for-injection (WFI) consumption by >90% compared to reusable stirred-tank reactors, aligning with sustainability targets in modern biomanufacturing facilities.

Software & Data Management

The embedded HMI runs Applitech’s ProcessLogic™ v3.2 firmware, offering intuitive touch-based navigation with multilingual support (English, German, Chinese). Core capabilities include recipe-driven batch execution, configurable parameter logging (≥10 Hz sampling), CSV/Excel export with time-stamped metadata, and automated report generation (PDF/HTML). All data entries—including operator actions, sensor readings, and alarm events—are timestamped, digitally signed, and immutable within the audit trail. System validation documentation (IQ/OQ/PQ protocols, risk assessments per ISO 14971) is provided to support regulatory submissions and internal quality audits.

Applications

• Aseptic preparation of cell culture media and process buffers (e.g., PBS, Tris-HCl, MOPS) at commercial scale.
• Mixing of chromatography eluents and formulation buffers during downstream purification.
• Homogenization of vaccine adjuvants (e.g., aluminum hydroxide suspensions) and virus inactivation solutions (e.g., Triton X-100, β-propiolactone dilutions).
• Blending of final drug substance intermediates prior to sterile filtration or fill-finish.
• Buffer exchange and diafiltration hold steps in continuous bioprocessing workflows.

FAQ

Is the system compatible with third-party single-use bags?
Yes—mechanical and magnetic coupling dimensions adhere to ISPE Baseline Guide v3.0 standards for bottom-agitated bags; compatibility testing with major suppliers (Sartorius, Thermo Fisher, Danaher) is available upon request.
What is the maximum allowable viscosity for effective mixing?
The system achieves uniform dispersion up to 100 mPa·s at 50% fill level in 3,000 L configurations; higher viscosities require application-specific evaluation using shear-rate profiling.
Does the system support 21 CFR Part 11 compliance out-of-the-box?
Yes—audit trail, electronic signature, and role-based access are enabled by default; full Part 11 validation package (including URS, FRS, and test scripts) is included with purchase.
Can the drive unit be installed in a Grade A isolator environment?
The drive module is rated IP65 and designed for external mounting beneath the isolator floor; only the magnetic coupling penetrates the barrier—no electrical components enter the critical zone.
Is remote monitoring supported?
OPC UA server integration is available as an optional add-on, enabling connection to MES/SCADA systems (e.g., Siemens SIMATIC IT, Rockwell FactoryTalk) for centralized process oversight.