Small Stoppering R&D Freeze Dryer

Small Stoppering R&D Freeze Dryer – QualiRFD™ 6S

QualiRFD™ 6S Freeze Dryer is a compact pilot R&D unit designed for vial-based lyophilization with integrated stoppering. It enables the development of stable drying cycles and preserves product quality during storage.

This system allows testing and process exploration that mirrors production practices, while keeping batch sizes manageable for development. Freezing and drying occur within the same chamber, minimizing handling and ensuring consistent, repeatable results.

Featuring a dual-chamber design, the QualiRFD™ 6S includes a drying chamber and a cold trap (condenser) that efficiently captures sublimated vapor under controlled vacuum conditions.

The stoppering function seals vials immediately after drying, reducing moisture uptake and lowering the risk of contamination during storage and transport. The control interface supports recipe-driven operation, allowing multi-step temperature programs to be stored and executed for precise cycle development.

Applications

Lyophilized vials for pharmaceutical R&D: Formulation teams use the Freeze Dryer to screen excipient systems, define safe product temperatures, and fine-tune primary and secondary drying steps. Stoppering under controlled conditions supports better post-drying stability when your product must remain sealed until use.

Biotech reagents and sensitive biological samples: Many proteins, enzymes, and biological reagents benefit from low residual moisture and controlled drying curves. Programmable segments and stable temperature control help you run repeatable trials when activity retention and reconstitution behavior matter.

Diagnostics and research kits packaged in vials: Vial-based Freeze Dryer workflows are common for IVD reagents and research kits that need long storage life. The stoppering step helps protect dried material from humidity pickup after the cycle ends.

Specialty materials and chemical R&D: Freeze drying supports porous structures, powders, and other lab-scale materials where controlled ice structure and drying rate affect final morphology. The system is positioned for development work where cycle changes must be tested quickly and compared with consistent data logging.

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Applications of the Small Stoppering R&D Freeze Dryer – QualiRFD™ 6S

Lyophilized vials for pharmaceutical R&D: Ideal for formulation testing, the freeze dryer allows teams to screen excipient systems, determine safe product temperatures, and optimize primary and secondary drying steps. Controlled stoppering enhances post-drying stability for products that must remain sealed until use.

Biotech reagents and sensitive biological samples: Proteins, enzymes, and other biological reagents benefit from low residual moisture and precise drying profiles. Programmable temperature segments and stable control ensure repeatable trials while preserving activity and reconstitution performance.

Diagnostics and research kits in vials: Suitable for IVD reagents and research kits, the vial-based workflow ensures long-term stability. Stoppering immediately after drying protects sensitive materials from humidity and maintains quality during storage.

Specialty materials and chemical R&D: Supports lab-scale development of powders, porous structures, and other materials where ice structure and drying rates impact final morphology. The system enables rapid cycle testing with consistent data logging for reliable comparisons.

Standards Compliance – QualiRFD™ 6S Freeze Dryer

• ISO 13408-3: Provides guidance for controlling and validating lyophilization as an aseptic process, particularly relevant for vial stoppering workflows.
• ASTM E2500: Outlines a science- and risk-based methodology for specifying, designing, and verifying pharmaceutical and biopharmaceutical equipment and systems.
• ISO 14644-1 / ISO 14644-2: Covers cleanroom classification and monitoring, commonly referenced when installing the freeze dryer in controlled environments.

Small Stoppering R&D Freeze Dryer – QualiRFD™ 6S Key Features

• In-situ vacuum operation: Freezing and drying occur in a single chamber, minimizing handling and ensuring consistent results.
• Integrated stoppering mechanism: Seals vial caps immediately after drying to reduce moisture absorption and lower contamination risk.
• Dual-chamber design: Includes a drying chamber and cold trap for efficient vapor capture during sublimation.
• Independent shelf temperature probes: Monitor samples at each shelf level to support development trials and validation runs.
• Precise temperature control: Shelf accuracy ±1 °C with PLC control and PID regulation for stable, repeatable cycles.
• Optimized cooling and heating: Cold trap cooling performance combined with controlled shelf temperature ramps for reliable cycle development.
• Advanced touchscreen interface: Data-rich screens, stored programs, and up to 36 configurable segments per cycle for stepwise operation.
• Flexible cycle adjustments: Edit parameters or skip segments during automatic operation to accelerate development work.
• Nitrogen backfill option: Allows use of inert gas during drying or at the end of the cycle for sensitive products.
• Safety and maintenance features: Alerts, vacuum/refrigeration protections, maintenance reminders, audible alarms, and emergency stop functionality.

Theory and Method – QualiRFD™ 6S Freeze Dryer

Freeze drying (lyophilization) removes solvent through controlled freezing, sublimation, and desorption under reduced pressure. The process begins by freezing the product on temperature-controlled shelves, which defines ice structure and affects mass transfer during drying.

During primary drying, chamber pressure is lowered, allowing ice to sublimate directly into vapor, which is captured by the cold trap at low temperature. Secondary drying follows, reducing bound moisture through controlled shelf temperature holds under vacuum until the target residual moisture is achieved.

The integrated stoppering function adds a closure step at the end of the cycle. Vials can be pre-filled, and the mechanism seals caps after drying to limit rehydration and protect the dried product. This workflow ensures vial-based R&D closely mirrors production practices, supporting reliable and repeatable cycle development.

Small Stoppering R&D Freeze Dryer – QualiRFD™ 6S Technical Specification

Specification	Unit	QualiRFD™ S
Freeze drying area	m²	0.2
Cold trap temperature (no-load)	°C	< -75
Vacuum level (no-load)	Pa	≤ 1
Shelf temperature range (no-load)	°C	-55 to +70
Maximum ice capacity	kg/24h	≥ 6
Number of shelf layers	pcs	2 + 1
Material tray size	mm	400 × 270
Shelf spacing	mm	100
Overall power	kW	4
Weight	kg	300
Dimensions (W × L × H)	mm	1033 × 781 × 1704
Loadable materials	L/kg	2
Loadable vials (Φ12 mm)	pcs	1554
Loadable vials (Φ16 mm)	pcs	868
Loadable vials (Φ22 mm)	pcs	440
Defrost mode	—	Electric defrost
Safety devices	—	Audible alarm, emergency stop, overpressure protection
Voltage	—	Single-phase 3-wire, 220 V (110V is also available)