Extra Large R&D Freeze Dryer – QualiRFD™ 15S

Extra Large R&D Freeze Dryer – QualiRFD™ 15S

Kickstart your food freeze-drying projects in R&D with the QualiRFD™ 15S, designed for precise, repeatable lyophilization cycles before scaling up. This R&D Freeze Dryer features a stoppering configuration ideal for vial-based drying and small-batch development.

The QualiRFD™ 15S is suited for bioproduct research, in-vitro diagnostic reagents, and laboratory-to-pilot workflows. It also accommodates bulk materials, including liquids, pastes, and solids, depending on process requirements. Stoppering after drying minimizes moisture reabsorption, ensuring long-term product stability.

Built with a dual-chamber design, the system integrates a drying chamber and cold trap to enable automated freeze-drying runs. Its PLC-based controller with PID temperature regulation ensures consistent shelf performance.

Each shelf includes independent temperature probes for accurate product monitoring during development. A nitrogen backfill feature provides inert-gas handling at cycle completion. The intuitive control system includes a large touchscreen with multi-segment temperature programming and storage for multiple freeze-drying recipes.

Extra Large R&D Freeze Dryer – QualiRFD™ 15S Applications

Vial-Based R&D and Small-Scale Production:
Formulation teams can portion products into vials, run a programmed freeze-drying cycle, and stopper for secure storage and transport. This workflow minimizes moisture uptake and reduces the risk of post-drying contamination. It also enables consistent comparison across batches when optimizing cycle parameters.

Bioproducts and IVD Reagent Development:
The QualiRFD™ 15S supports research on bioproducts and in-vitro diagnostic reagents. Stable temperature control and programmable recipe storage allow repeatable cycle execution for screening, verification, and pilot studies. Clear vial capacity listings help plan efficient batch loading from bench-scale to pilot-scale workflows.

Bulk Materials in Multiple Forms:
Beyond vial-based drying, this system accommodates bulk liquids, pastes, and solids. Its versatility allows evaluation of drying performance across different container formats and sample types. Stoppering remains available when vials are used for final product packaging, ensuring stability and protection.

Compliance and Standards

• ISO 13408-3 – Aseptic Processing & Lyophilization: Provides guidance for freeze-drying operations within aseptic environments, ensuring product integrity and safety.
• ASTM E2500 – System Design and Verification: Defines a risk- and science-based approach for validating pharmaceutical and biopharmaceutical equipment and systems.
• ISO 14644-1 / ISO 14644-2 – Cleanroom Standards: Establishes classification, monitoring, and control requirements for cleanrooms used in filling, loading, and critical handling areas.
• 21 CFR Part 11 – Electronic Records & Signatures: Ensures compliance when managing electronic data, audit trails, and e-signatures within regulated R&D and manufacturing workflows.

Extra Large R&D Freeze Dryer – QualiRFD™ 15S Key Features

• Stoppering Workflow: Seals vials immediately after drying to minimize moisture absorption and maintain product stability during handling and storage.
• Dual-Chamber Design: Separates the drying chamber from the cold trap, ensuring stable vapor capture and precise cycle control.
• Independent Temperature Monitoring: Each shelf layer includes probes to track product temperature, supporting development work and cycle optimization.
• Precision Shelf Control: PLC-based system with PID temperature regulation delivers ±1 °C accuracy for repeatable ramps and hold periods.
• Nitrogen Backfill: Provides inert-gas handling at the end of a cycle when required for sensitive products.
• Advanced Touchscreen Control: Stores multiple recipes and supports multi-segment programs, with options to adjust or skip segments during runs.
• Safety and Reliability: Features alarms, emergency stop, overpressure protection, and maintenance reminders to ensure safe and continuous operation.

Theory and Method

Freeze drying begins by freezing the product, forming ice within the material matrix. During primary drying, a vacuum is applied, allowing the ice to sublimate directly into vapor. This vapor is captured by the cold trap, maintaining stable chamber conditions throughout the process.

Secondary drying removes residual bound moisture by using controlled shelf temperature steps. The system supports both stepwise and linear ramp control, with a sublimation-curve switch for precise optimization of drying cycles.

Extra Large R&D Freeze Dryer – QualiRFD™ 15S Technical Specification

Specification	QualiRFD™ 15S
Freeze-drying area	1.15 m²
Cold trap temperature	< -75 °C (no-load)
Vacuum level	≤ 1 Pa (no-load)
Shelf temperature range	-55 to +70 °C (no-load)
Maximum ice capacity	≥ 15 kg / 24 h
Shelf layers	4 + 1
Material tray	480 × 600 mm
Shelf spacing	100 mm
Loadable materials	11
Loadable vials	Φ12 mm: 8624 pcs; Φ16 mm: 4788 pcs; Φ22 mm: 2460 pcs
Defrost mode	Electric defrost
Safety devices	Audible alarm, emergency stop switch, overpressure protection
Power	7.5 kW
Voltage	Three-phase 5-wire, 380 V
Weight	1000 kg
Dimensions	1823 × 1144 × 2014 mm