一次性顶式搅拌配液系统

Overview

The Applitech Single-Use Overhead Stirring Liquid Preparation System is an engineered solution for controlled, scalable mixing of biopharmaceutical process fluids—including cell culture media, buffer solutions, and formulation diluents—in open-container configurations. Unlike magnetic stirrers, this system employs a precision-controlled, brushless DC motor mounted above the vessel, driving a vertically oriented shaft and impeller assembly through a sealed top port. It operates on the principle of mechanical shear-driven fluid dynamics, ensuring homogeneous blending with minimal foaming, particle attrition, or heat generation—critical for protein stability and excipient integrity. Designed specifically for single-use bioprocessing workflows, the system integrates seamlessly with flexible, gamma-sterilized Haimore-series polyethylene (PE) or multi-layer film bags housed in stainless steel or PE support vessels (50–1000 L). Its architecture complies with core requirements of ISO 13485, ICH Q5D, and USP for ancillary equipment used in biomanufacturing.

Key Features

• Brushless DC motor with digital speed control (0–300 rpm, ±1 rpm repeatability), enabling precise shear profile selection across viscosity ranges from 1 to 10,000 cP
• Modular overhead drive unit with dual-section coupling design—facilitating rapid disassembly without tools for cleaning-in-place (CIP) validation or bag changeover
• Integrated bag presence detection via load-cell-based weight verification and proximity sensing—preventing operation unless a certified Haimore bag is correctly seated and tensioned
• Touchscreen HMI (7″ resistive LCD) with multilingual UI (English, Chinese, Spanish), supporting role-based access control (admin, operator, QA reviewer)
• Seamless welded stainless-steel support frame with recessed electrical cabinet—designed for ISO Class 7 cleanroom compatibility and ease of wipe-down decontamination
• Interchangeable impeller kits (Rushton turbine, pitched-blade, hydrofoil) optimized for low-shear suspension vs. high-shear dispersion applications

Sample Compatibility & Compliance

The system is validated for use with single-use bags conforming to ASTM F2739 (polyolefin film integrity) and USP (plastic packaging systems). It supports open-bag mixing under laminar airflow hoods or isolator environments. All wetted components—including shaft seals, impeller hubs, and bag clamping rings—are constructed from USP Class VI-certified materials (e.g., EPDM gaskets, 316L SS shafts). The software architecture adheres to FDA 21 CFR Part 11 requirements, delivering electronic signatures, time-stamped audit trails, and immutable data logs exportable in CSV or PDF format. Optional modules meet ISO 27001-compliant cybersecurity protocols for networked deployment.

Software & Data Management

The embedded control software (v3.2+) provides full lifecycle data governance: recipe creation with parameter locking (e.g., max RPM, duration, temperature setpoint), real-time sensor trending (pH, conductivity, temperature), and automated calibration logging for connected transmitters. All events—including user logins, parameter changes, alarm triggers, and bag installation—are timestamped and cryptographically signed. Data archives are retained for ≥30 days onboard and can be exported via USB or Ethernet to LIMS or MES platforms. Audit trail reports include WHO-issued user IDs, action timestamps (UTC), and before/after values—fully traceable during regulatory inspections.

Applications

• Preparation of serum-free and chemically defined cell culture media for upstream bioreactor inoculation
• Buffer blending and pH adjustment prior to chromatography column equilibration
• Dilution and homogenization of monoclonal antibody (mAb) drug substance intermediates
• Final formulation mixing under aseptic conditions using closed bag-to-bag transfer pathways
• QC batch release testing support—ensuring compositional uniformity per ICH Q5A(R2) comparability criteria

FAQ

Is this system compatible with non-Haimore single-use bags?

Yes—provided the bag’s top flange geometry, port layout, and material thickness meet Applitech’s mechanical interface specifications (available upon NDA). Custom adapter plates are available for select third-party bag systems.

Can the system operate in a Grade A environment?

It is rated for use in Grade B background environments; operation within Grade A requires integration with an isolator or RABS and validation of particulate shedding per ISO 14644-1 Class 5 protocols.

What validation documentation is supplied?

Factory acceptance test (FAT) reports, IQ/OQ protocols (user-executable), and material certificates (EN 10204 3.1) for all wetted parts are included. PQ support packages are available as a service option.

Does the system support remote monitoring?

Yes—via optional OPC UA server module compliant with ISA-95 standards, enabling integration with SCADA and manufacturing execution systems (MES).

How is speed calibration verified?

Speed accuracy is confirmed using a traceable optical tachometer during FAT; recalibration is performed annually or after motor replacement, with certificate issued per ISO/IEC 17025.