Sunbather
The GMP-ready nanoparticle production system
Jump to GMP nanoparticle production in a jiff
Sunbather takes the precision microfluidic control and flexibility of Sunshine and wraps it in a GMP-ready package, simplifying process transfer and validation. With matching pumps, mixers, and parameters from Sunscreen and Sunshine - plus GMP-ready documentation, software, and a fully replaceable flowpath - Sunbather makes the move to nanoparticle manufacturing seamless. Get brochure.
- Replaceable wetted flowpath: Fully replaceable wetted flowpaths with validated sanitization SOP and supporting extractables, bioburden and endotoxin documentation for every batch.
- Range of mixer types: All of the same high-quality Sunny mixers can be purchased GMP-ready, ensuring the same high-quality particles and direct transferability of a development process into a GMP environment.
- Seamless process transfer: Uses identical pumps and mixers as Sunshine for direct translation of development parameters from pre-clinical to clinical manufacturing.
- Small to mid-size GMP batches: Produces up to 1.8 L/h of nanoparticles - ideal for early-stage clinical trials or small-batch commercial production such as personalized medicines, or saRNA-LNPs. As production needs grow, Sunbathers can be run in parallel to step up throughput without needing to re-optimize.
- GMP-ready design: Manufactured to meet regulatory requirements with IQ/OQ at install and full Unchained Labs QMS backing to ensure full manufacturing traceablity and audit readiness.
- Quality built-in: Electronic records comply with 21 CFR Part 11, ensuring secure, auditable data throughout manufacturing.
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Mix it up big time
Prep one input channel with payloads, the other with lipids or other nanoparticle building blocks, and you’re ready to mix up your nanoparticles with a Sunny. GMP-ready Sunnies have identical mixing designs to those used on Sunscreen and Sunshine, so your nailed down process from development sticks the landing into GMP.
GMP-ready when you are
Sunbather comes available with an installation qualification and operational qualification (IQ/OQ), and comprehensive user training so that you can get up and running as fast as possible. With fully traceable wetted materials, extractables data, and a manufacturing process grounded in by our Quality Management System (QMS), you’ll be ready to dive straight into GMP with Sunbather.
No-nonsense, compliant software
Sunbather’s software serves up Administrator and Operator access levels, a 21 CFR Part 11 compliant audit trail, and password signoff for process critical actions. The software’s simple user interface means fast familiarization, and the touchscreen kiosk keeps things clean and makes setting up a new run a breeze.
The Sunny Suite
The Sunny Suite has a killer solution for every step of your nanoparticle development. Sunscreen automates high-throughput screening of up to 96 formulations, then Sunshine homes in on the perfect mixing process conditions, with both automated experiments and continuous flow modes. When you’re ready for clinical trials, Sunbather dials up your particles in a fully GMP-compliant environment.
Trust the process
With identical fluid delivery and microfluidic mixing at every stage, the Sunny Suite makes for smooth sailing in every transition from formulation screening to process development to GMP production. Whether you’re screening through hundreds of formulations or producing liters of particles for clinical trials, the Sunny Suite’s the total package.
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App Notes
Specifications
| Application | |
|---|---|
| Throughput | 10 mL/min per channel |
| Total flow rate range | 0.1–30 mL/min (configuration dependent) |
| Flow rate ratio (aqueous to organic) range | 1:1 to 10:1 |
| Typical particle size range | 40–200 nm* |
| PDI | <0.2* |
| Encapsulation efficiency | >90%* |
| Instrument | |
|---|---|
| Physical | |
| Weight and dimensions (instrument only) | 19 kg, 29 cm H x 41 cm W x 32 cm D |
| Operating pressure | 0-10 bar |
| Electrical | |
| Voltage Input | 100 V–240 V AC, 50-60 Hz |
| Power consumption (peak/average) | 1A/500 mA |
| Other information | |
| Fluidic port sizes | ¼”-28 threaded nut, luer fitting (male and female) |
| Wetted materials | PEEK, FEP, Glass, PTFE, Silicone |
| Computer | Windows 11 Enterprise Touchscreen PC with Kiosk-mode operation |
| Consumables | |
|---|---|
| GMP Sunnies | GMP-ready glass microfluidic mixing devices of various geometries and channel sizes |
| Available types | Sunny 490 Trident T, Sunny 100 X, Sunny 100 T, Sunny 190 X, Sunny 190 T, Sunny 275 X, Sunny 275 T, Sunny 150 3D, Sunny 50 Micromixer |
| Sunbather 1-Sunny Flowpath Pack | A complete wetted flowpath for use with the Sunbather instrument running a 1-Sunny configuration. |
| Sunbather 2-Sunny Flowpath Pack | A complete wetted flowpath for use with the Sunbather instrument running a 2-Sunny configuration. |
