Extra Large R&D Freeze Dryer

Extra Large R&D Freeze Dryer – QualiRFD™ 15

Achieving reliable scale-up from lab formulations to pilot batches depends on precise freeze-drying performance. The QualiRFD™ 15 Freeze Dryer is designed for R&D teams requiring consistent cycle development, complete process visibility, and stable control of critical parameters as experiments move toward production scale. Its in-situ workflow allows pre-freezing and drying within a single chamber, minimizing handling steps and supporting cleaner, more uniform results.

This in-situ vacuum Freeze Dryer is ideal for process exploration, formulation testing, and small-batch pilot studies in both regulated and industrial laboratories. The unit integrates a drying chamber with a low-temperature condenser (cold trap) to efficiently capture sublimated vapor while keeping vacuum conditions steady. A transparent chamber door allows live monitoring during freezing, primary drying, and secondary drying, enabling observation of product behavior without interrupting the cycle.

The recipe-driven control system enables stepwise temperature ramps and holds, letting teams create, save, and repeat cycles during optimization. Key parameters such as shelf temperature, product temperature, cold trap temperature, and vacuum are recorded automatically, simplifying trial comparisons and supporting precise process adjustments.

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

Pharmaceutical R&D and Lyophilized Dosage Development:
Ideal for developing and optimizing lyophilization cycles for injectables and other pharmaceutical formulations. Researchers can control freezing rates, define primary drying limits, and verify secondary drying targets to enhance product stability and shelf life.

Biotechnology and Life Science Sample Preservation:
Supports lyophilization of proteins, antibodies, enzymes, and other biomolecules for long-term storage, safe transport, and downstream testing. Precise shelf temperature and vacuum control reduce collapse risk while preserving bioactivity upon reconstitution.

In Vitro Diagnostic and Research Reagents:
Enables development and pilot-scale batches for IVD reagents and similar products, ensuring low residual moisture and stable storage. Consistent cycle performance simplifies method transfer from development to controlled pilot production.

Materials and Chemical Research:
Suitable for preparing porous structures, powders, polymers, coatings, and films. Controlled drying curves minimize deformation and maintain repeatable morphology, supporting reliable comparative studies in materials research.

Environmental Sample Preparation:
Facilitates processing of environmental samples such as soil or water extracts for analytical studies. Recorded cycle data ensures consistent preparation across experiments and over time.

Standards and Compliance

The QualiRFD™ 15 Extra Large R&D Freeze Dryer is designed to align with recognized industry standards, ensuring safe and validated operation in pharmaceutical, biotech, and life science laboratories:

• ISO 13408-3: Provides guidance for control and validation of lyophilization processes in aseptic production of healthcare products.
• ASTM E2500: Supports a risk-based approach for specification, design, and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipment.
• ISO 14644-1 / ISO 14644-2: Covers cleanroom air cleanliness classification and monitoring, essential when freeze-dryer operation is conducted in controlled or GMP environments.

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

• In-Situ Workflow: Freezing and drying occur within the same chamber, reducing handling steps and delivering more consistent results.
• Dual-Chamber Design: Combines a drying chamber and cold trap to capture vapor efficiently during sublimation.
• Transparent Chamber Door: Enables real-time observation of the freeze-drying process without interrupting the run.
• PID Shelf Temperature Control: Maintains precise shelf temperatures to ensure uniform drying across all shelf positions.
• Freeze-Drying Curve Management: Supports stepwise ramps and holds throughout freezing, sublimation, and desorption, aiding process optimization.
• Inert Gas Backfill: Controlled valve allows post-drying backfill to protect sensitive samples.
• Recipe Management: Stores multi-segment temperature programs for repeatable experimentation and small-batch pilot runs.
• Comprehensive Data Trending: Records and exports cold trap, product, and vacuum curves for documentation and cycle development.
• Flexible Operation Modes: Offers manual or automatic modes for hands-on experimentation or consistent batch execution.
• Alarm History and Access Control: Supports troubleshooting, maintenance workflows, and secure operation in regulated environments.

Theory and Method – Extra Large R&D Freeze Dryer – QualiRFD™ 15

Freeze drying removes solvents under vacuum through controlled stages that preserve product integrity:

1. Freezing and Ice Formation
The product is cooled on temperature-controlled shelves until the solvent crystallizes. The freezing rate determines ice crystal size, which directly affects mass transfer during drying.

2. Primary Drying (Sublimation)
Vacuum is applied, and shelf temperature is carefully raised to sublimate ice directly into vapor. The vapor is captured by the cold trap. Controlled temperature ramps and holds prevent product collapse or melt-back, ensuring uniform drying.

3. Secondary Drying (Desorption)
Once most ice has sublimated, shelf temperature is increased to remove residual bound water or solvent. Segmented cycles enable repeatable studies, targeting precise residual moisture levels and predictable reconstitution performance.

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

Item	Unit	QualiRFD™ XL
Freeze-drying area	m²	1.03
Recommended loading capacity	kg	10
Cold trap temperature (no-load)	°C	< -75
Ultimate vacuum level (no-load)	Pa	≤ 1
Shelf temperature range (no-load)	°C	-55 to +70
Maximum ice capacity	kg/24h	≥ 15
Number of shelf layers	pcs	6 + 1
Tray size	mm	480 × 360
Shelf spacing	mm	70
Overall power	kW	6.5
Weight	kg	700
Dimensions	mm	876 × 1190 × 1727