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Large Stoppering R&D Freeze Dryer

Large Stoppering R&D Freeze Dryer
Parent Product
R&D Freeze Dryer
Standards
ASTM E2500
ISO 13408-3
ISO 14644-1
ISO 14644-2
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Large Stoppering R&D Freeze Dryer – QualiRFD™ 10S

A Freeze Dryer with stoppering helps R&D teams run vial-based cycles that stay protected after drying. The QualiRFD™ 10S Freeze Dryer is built for larger development batches where production-like handling, repeatable recipes, and cycle visibility matter. This pilot-scale platform is positioned for parameter optimization and process scale-up work that needs stable control across freezing, sublimation, and secondary drying.

QualiRFD™ 10S is an in-situ vacuum Freeze Dryer that combines a drying chamber with a dedicated cold trap for vapor capture. Stoppering capability seals vials at the end of the cycle to reduce moisture pickup and limit exposure during post-process handling. A transparent chamber door supports direct observation of product behavior across stages, which helps teams confirm cake appearance and detect issues without breaking the run.

The control platform supports recipe storage, multi-segment temperature programs, and real-time trend display for cold trap temperature, product temperature, and vacuum. Manual and automatic modes allow quick experimentation during development, then consistent execution once parameters are locked.

Large Stoppering R&D Freeze Dryer – QualiRFD™ 10S Applications

  • Lyophilized pharmaceutical vials for development and scale-up: Formulation teams use a stoppering Freeze Dryer to build cycles for injectables and other vial-filled products. Stoppering inside the chamber helps maintain dryness after the cycle ends, which supports stability studies, packaging transfer, and process scale-up decisions.
  • Biotech and biologics workflows: Proteins, enzymes, antibodies, and other sensitive materials often need controlled product temperature and steady vacuum behavior. Shelf temperature control and data trending help compare formulations and define a drying window that protects structure and reconstitution performance.
  • In vitro diagnostic and research reagents in vials: Many diagnostic reagents are filled into vials before lyophilization and require low residual moisture for storage life. Stoppering after drying reduces rehydration risk when vials move between development, QC, and packaging areas.
  • Materials and chemical R&D: Freeze drying is used to create porous solids, powders, and structured materials where drying conditions affect final morphology. Logged vacuum and temperature curves help teams reproduce outcomes and document changes between trials.
Large Stoppering R&D Freeze Dryer

Standards

  • ISO 13408-3 (Aseptic processing of health care products — Lyophilization): guidance for control and validation of lyophilization as an aseptic process, commonly referenced for vial-based and stoppering workflows.
  • ASTM E2500: science- and risk-based approach for specification, design, and verification of pharmaceutical/biopharmaceutical manufacturing systems and equipment.
  • ISO 14644-1 / ISO 14644-2: cleanroom classification and monitoring, often used when freeze dryer operation is tied to controlled environments.

Large Stoppering R&D Freeze Dryer – QualiRFD™ 10S Key Features

  • In-situ vacuum Freeze Dryer workflow that keeps freezing and drying inside one chamber for cleaner handling and repeatable cycles.
  • Stoppering function for sealing vial stoppers after drying to help protect product dryness during handling and storage.
  • Clear acrylic chamber door for live viewing of the freeze-drying process without interrupting the run.
  • Cold trap capture design intended to promote uniform ice collection and strong vapor capture performance.
  • Shelf temperature control based on PID regulation to reduce temperature deviation and support consistent drying behavior.
  • Curve control for pre-freeze cooling rate plus staged control during sublimation and desorption with vacuum coordination.
  • Recipe-based control system with stored processes and multi-segment temperature programming for development work.
  • Real-time data recording and export of cold trap temperature, sample temperature, and vacuum curves for analysis and reporting.
  • Flexible manual and automatic modes for experimentation, then routine batch execution once parameters are finalized.
  • Alarm history, maintenance support functions, and user access levels for controlled operation in shared labs.
  • Inert gas backfill connection through a diaphragm-style valve for post-drying backfill when required by the product.

Theory and Method

Freeze drying removes solvent through three controlled phases under vacuum. Freezing forms ice structure on temperature-controlled shelves, which influences mass transfer during drying. Primary drying then drives sublimation, where ice turns directly into vapor and is captured by the cold trap at low temperature while chamber pressure stays controlled. Secondary drying follows to reduce bound moisture, using temperature holds under vacuum to reach the target residual moisture level.

A stoppering Freeze Dryer adds a closure step after drying. Vials can be sealed inside the chamber to limit moisture reabsorption and reduce exposure risk during unloading and transfer.

Large Stoppering R&D Freeze Dryer – QualiRFD™ 10S Technical Specification

SpecificationUnitQualiRFD™ 10S
Freeze drying aream²0.5
Recommended loading capacitykg5
Cold trap temperature (no-load)°C< -75
Vacuum level (no-load)Pa≤ 1
Shelf temperature range (no-load)°C-55 to +70
Maximum ice capacitykg/24h≥ 10
Number of shelf layerspcs3 + 1
Material tray sizemm410 × 410
Shelf spacingmm100
Overall powerkW6.5
Weightkg800
Dimensions (W × L × H)mm911 × 1405 × 1983
Loadable materialsL/kg5
Vial capacity (Φ12 mm)pcs3705
Vial capacity (Φ16 mm)pcs2058
Vial capacity (Φ22 mm)pcs1050
Defrost mode—Electric defrost
Safety devices—Audible alarm, emergency stop switch, overpressure protection
Voltage—Single-phase 3-wire, 220 V (110V is also available)

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R&D Freeze Dryer