Disc Centrifuge

Our GMP-grade disc stack centrifuge constitutes a core unit operation platform for biomanufacturing downstream workflows. Rooted in thorough demand mapping of the biopharma sector and sustained proprietary R&D, this internally developed centrifuge platform is engineered to satisfy stringent pharmaceutical CIP a……

Disc Centrifuge

Our GMP-grade disc stack centrifuge constitutes a core unit operation platform for biomanufacturing downstream workflows. Rooted in thorough demand mapping of the biopharma sector and sustained proprietary R&D, this internally developed centrifuge platform is engineered to satisfy stringent pharmaceutical CIP and SIP requirements. The platform addresses long-standing market reliance on imported separation equipment and delivers a high-performance domestic alternative for aseptic bioprocess clarification and primary separation. It is widely deployed across vaccine manufacturing, fermentation broth clarification for APIs, intracellular enzyme harvesting, and monoclonal antibody production, where it reliably separates cell debris, inclusion bodies, host cell proteins and particulate impurities while preserving the biological activity of target biomolecules.

The centrifuge is built with a suite of hygienic, process-optimized design features tailored to sensitive biological feed streams. It adopts a fully enclosed automated feed system fitted with high-precision modulating valves and continuous flow monitoring to deliver steady, low-shear material transfer, minimizing shear-induced damage to delicate biomolecules and maximizing product recovery. Its high-precision laser-welded disc stack is hydraulically optimized to establish stable laminar flow conditions; under high-speed rotation, solid contaminants such as cell debris and inclusion bodies are rapidly sedimented, delivering superior clarification efficiency and mechanical stability. Additional built-in design provisions include an integrated purified water reservoir that maintains stable pressure feed for mechanical seal cooling and lubrication, offering emergency water buffering against unexpected water supply loss to avert seal dry-run failure. A standard aseptic isolation vessel forms a positive barrier against ingress of ambient airborne microorganisms via sludge discharge overflow, sustaining closed aseptic conditions for high-grade applications such as vaccines and insulin production.

The platform integrates comprehensive process control, monitoring and sterilization functions to support compliant aseptic campaigns. An embedded SIP subsystem enables fully verifiable in-place sterilization cycles pre- and post-batch, maintaining equipment internal sterility and aligning with global GMP expectations for continuous aseptic manufacturing. Multiple distributed temperature sensors provide closed-loop real-time thermal monitoring across feed, separation and discharge streams, keeping thermolabile active constituents within defined process envelopes and safeguarding batch consistency and product safety. A dedicated aseptic sampling port permits in-process representative sampling during operation, allowing operators to assess stream clarity, impurity loading and other critical quality attributes, and enact agile parameter adjustment to stabilize separation performance throughout the run.

We deliver a full lifecycle validation package underpinned by risk-based quality principles and formal change control governance spanning design, fabrication, commissioning and routine operation. The complete documentation deliverable encompasses validation plan, criticality assessment, FMEA, DQ, IQ, OQ, PQ and validation summary report. This structured validation framework ensures robust process control, immutable and traceable process records, and facilitates streamlined regulatory review, enabling our biomanufacturing partners to accelerate market access for their biological products on both domestic and international markets.

Applications of Disc Centrifuge

Vaccine Preparation
Efficiently separate viral particles from cell debris to guarantee the purity and activity of vaccines.
API Clarification
Effectively remove bacterial cells and impurities from fermentation broth, improving product purity and yield.
Enzyme Extraction
Gently separate intracellular enzymes from cell debris while maintaining enzyme activity and recovery efficiency.
Antibody Production
Accurately recover target antibodies and eliminate host proteins and contaminants to enhance product yield.

Product Features

Automatic Feeding Control

Adopts a fully closed automatic feeding design. Equipped with high-precision regulating valves and real-time flow monitoring, it realizes stable material conveying, effectively protects active substances such as cells and proteins, and increases product yield. It is ideal for separation and purification of sensitive materials including biological products and fermentation broth.

Precision Drum Assembly

High-precision disc stack with full laser welding. The disc gaps are optimized based on fluid dynamics to form stable laminar flow. During high-speed rotation, inclusion bodies, cell debris and other contaminants are rapidly separated from the clarified liquid, boosting overall separation efficiency and operational stability.

Purified Water Supply Guarantee

Equipped with a standard built-in purified water storage tank to provide cooling water and lubrication with stable pressure for mechanical seals continuously. It can maintain water supply for a certain period even under sudden water cutoff conditions, preventing dry friction of mechanical seals, extending equipment service life and ensuring production safety.

Aseptic Isolation Protection

Comes with a standard aseptic isolation tank. The overflow water from slag discharge effectively isolates ambient air and prevents microbial contamination from entering the separation system, maintaining an aseptic production environment throughout the process. It is applicable to high-standard aseptic production such as vaccines and insulin.

Integrated SIP Module & Aseptic Maintenance

The centrifuge is integrated with an SIP sterilization system to perform comprehensive and verifiable online cleaning and sterilization before and after production. It maintains internal sterility of the equipment, complies with GMP regulations, and supports continuous aseptic production.

Real-time Temperature Monitoring

Multiple temperature sensors are installed to monitor and feedback the temperature of feeding, separation and discharging processes in real time. This ensures materials are always kept within the optimal temperature range, avoids damage to active ingredients, and improves product consistency and safety.

On-site Real-time Sampling & Testing

The equipment supports aseptic sampling during production. Operators can monitor key indicators such as material status, clarity and bacterial concentration in real time, and adjust process parameters timely to stabilize product quality.

Complete GMP Validation Documentation

Adopting a risk-oriented philosophy, we implement validation and change management throughout design, manufacturing, commissioning and operation. A full set of validation documents including VP, CA, FMEA, DQ, IQ, OQ, PQ and VSR are provided to ensure controllable process performance, authentic, complete and traceable data. This enables products to enter the international market faster and more steadily.

 

As a leading process-oriented engineering company, Sino Bioengineering delivers professional bioengineering solutions and comprehensive technical services to clients worldwide.

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