Bespoke Systems

Built around
your process.

Standard systems force your process to adapt to the equipment. We start with your process constraints — flow behaviour, pressure sensitivity, viscosity, scale — and engineer a system that fits.

Alphinity bespoke bioprocessing system

How we deliver

Process first. Quality always.

Every system follows a circular delivery model — starting and ending with your process. Four layers build on each other, while qualification runs as a continuous parallel thread from day one. Not bolted on at the end.

The four layers

1. Process

Everything starts here. Your URS, your constraints, your product. We define the flow paths, pressure profiles, and control strategies that your process demands — before a single component is selected.

2. Single-Use Flowpath

The disposable fluid path — PIXER® pump heads, VannX™ valve bodies, tubing, bags, and sensors. Modular, pre-assembled, gamma-compatible. Configured from your process definition.

3. Hardware

The permanent platform — drive units, actuators, frame, panel, sensors, electrical. Designed to host the single-use flowpath and last for the lifetime of the system.

4. Automation

ConSynSys™ ties it all together — closed-loop control, recipe management, data logging, and operator interface. The automation layer circles back to the process: monitoring, controlling, and optimising in real time.

The loop closes. Automation feeds process data back to where it started — your process understanding. Every batch makes the next one better.

Qualification runs in parallel

Most projects stall because qualification is treated as a hurdle at the end. We run it as a continuous thread alongside every layer — full traceability from concept to commissioning, designed to move projects forward, not slow them down.

DQ — Design Qualification

Runs alongside layers 1–2. Verifies the design meets your URS before anything is built. P&IDs, risk assessments, component selections — all documented and traceable.

IQ — Installation Qualification

Runs alongside layer 3. Confirms every component is installed correctly, matches the design, and has documented material traceability. FAT at our facility, SAT at yours.

OQ — Operational Qualification

Runs alongside layer 4. Proves the system operates within specified parameters. Control loops, alarm responses, safety interlocks — all tested and documented.

PQ — Performance Qualification

Proves the system performs consistently with your actual process under production conditions. The final confirmation that the loop from process to automation delivers what was promised.

Designed to penetrate bureaucracy. Full traceability from URS through commissioning means your quality team isn't blocking the project — they're running alongside it. Every decision documented, every component traceable, every test protocol ready before it's needed.

Where we focus

The processes others can't support

We engage where standard equipment fails — fragile modalities, viscous formulations, pressure-sensitive operations, and intensified processes that demand precision at every point in the flow path.

Fragile Modalities

Viral vectors, exosomes, LNPs, cell therapy

Standard processing loses 20–40% of AAV titer to pump-induced damage. The PIXER® diaphragm pump delivers 4.4× better filterability — preserving product integrity that conventional equipment destroys.

Viscous Formulations

Up to 3,000 cP

High-concentration mAbs, dense buffers, and viscous intermediates that peristaltic pumps cannot move reliably. The PIXER® diaphragm pump handles them natively — no output loss, no workarounds.

Pressure-Sensitive Processes

±0.3 PSI continuously adjustable control

Operations where pressure transients cause yield loss, membrane damage, or product degradation. The VannX™ motorized valve's continuously adjustable electric actuation eliminates pressure spikes at the source.

System Examples

What we build

Flagship system

TFFi™ — Tangential Flow Filtration

Our standard single-use TFF platform. 30 mL to 10 L. Ultra-low shear PIXER® pumps, VannX™ valve control, and ConSynSys™ automation — fully integrated and qualification-ready. 4.4× better filterability than the low-shear benchmark.

  • UF/DF for concentration, buffer exchange, and formulation
  • Two vessel sizes: 30 mL–2 L and 1–10 L
  • USP Class VI · gamma-validated · GMP-compatible
Explore the TFFi™ system →
TFFi™ tangential flow filtration system — full system render

Plexus™ Process System

Multi-unit operation platform. Multiple process steps coordinated through ConSynSys™ cloud. Centralised recipe and data management.

Viral Inactivation & Filtration

Precision pH control and mixing with the PIXER® pump's low-shear performance and internal mixing capability. Consistent hold times and gentle product handling.

Buffer Dilution

Inline buffer preparation with accurate, repeatable mixing. PIXER®'s internal injection port mixing combined with VannX™ continuously adjustable valve control for precise dilution ratios.

Chromatography Support

Precise gradient control and column loading with pulsation-free flow. Stable pressure profiles for consistent separations.

Custom Unit Operations

Tell us about your process challenge. If precision flow control is the answer, we can build it. Start the conversation →

Let's Build

Tell us about your process

We solve the problems others can't. Whether it's a single component or a complete system, the conversation starts with your process.

Speak to an engineer Tell us about your process

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