{"product_id":"large-stoppering-r-d-freeze-dryer","title":"Large Stoppering R\u0026D Freeze Dryer","description":"\u003ch2\u003eLarge Stoppering R\u0026amp;D Freeze Dryer – QualiRFD™ 10S\u003c\/h2\u003e\n\u003cp\u003eA large stoppering R\u0026amp;D Freeze Dryer supports vial-based cycle development while maintaining product integrity after drying. The QualiRFD™ 10S Freeze Dryer is designed for larger development batches where production-style handling, consistent recipe execution, and clear cycle monitoring are essential. This pilot-scale system is suited for parameter optimization and process scale-up, with stable control across freezing, sublimation, and secondary drying stages.\u003c\/p\u003e\n\u003cp\u003eThe QualiRFD™ 10S operates as an in-situ vacuum Freeze Dryer, integrating a drying chamber with a dedicated cold trap for efficient vapor capture. Its stoppering function seals vials at the end of the cycle, reducing moisture uptake and limiting exposure during post-process handling. A transparent chamber door allows direct visual inspection of product behavior throughout the cycle, making it easier to verify cake structure and identify issues without interrupting the process.\u003c\/p\u003e\n\u003cp\u003eThe control system includes recipe storage, multi-stage temperature programming, and real-time monitoring of cold trap temperature, product temperature, and vacuum levels. Both manual and automatic modes are available, supporting rapid testing during development and consistent performance once process parameters are finalized.\u003c\/p\u003e\n\u003ch2\u003eApplications of the QualiRFD™ 10S Stoppering R\u0026amp;D Freeze Dryer\u003c\/h2\u003e\n\u003cp\u003eLyophilized pharmaceutical vials for development and scale-up: Development teams use stoppering Freeze Dryers to design cycles for injectables and other vial-based products. In-chamber stoppering helps maintain low moisture levels post-cycle, supporting stability testing, packaging transfer, and scale-up decisions.\u003c\/p\u003e\n\u003cp\u003eBiotech and biologics workflows: Sensitive materials such as proteins, enzymes, and antibodies require precise product temperature and stable vacuum conditions. Controlled shelf temperatures and data trending allow formulation comparison and define optimal drying windows that preserve structure and reconstitution quality.\u003c\/p\u003e\n\u003cp\u003eIn vitro diagnostic and research reagents in vials: Diagnostic reagents often need lyophilization in vials to achieve low residual moisture for long-term storage. Stoppering immediately after drying minimizes rehydration risk when vials are handled between development, QC, and packaging areas.\u003c\/p\u003e\n\u003cp\u003eMaterials and chemical R\u0026amp;D: Freeze drying creates porous solids, powders, and structured materials where drying parameters impact final morphology. Recorded vacuum and temperature profiles enable reproducible results and detailed documentation of changes between experiments.\u003c\/p\u003e\n\u003ch3\u003eStandards Compliance for the QualiRFD™ 10S Stoppering R\u0026amp;D Freeze Dryer\u003c\/h3\u003e\n\u003cp\u003eISO 13408-3 – Aseptic Processing of Health Care Products (Lyophilization): Provides guidance for controlling and validating lyophilization as an aseptic process. This standard is widely referenced for vial-based and stoppering workflows.\u003c\/p\u003e\n\u003cp\u003eASTM E2500 – Specification, Design, and Verification of Manufacturing Systems: Offers a science- and risk-based framework for pharmaceutical and biopharmaceutical equipment and system validation.\u003c\/p\u003e\n\u003cp\u003eISO 14644-1 \/ ISO 14644-2 – Cleanroom Classification and Monitoring: Defines cleanroom standards, often applied when Freeze Dryer operation occurs within controlled environments to ensure consistent product quality.\u003c\/p\u003e\n\u003ch2\u003eLarge Stoppering R\u0026amp;D Freeze Dryer – QualiRFD™ 10S Key Features\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eIntegrated In-Situ Freeze Dryer Workflow: Freezing and drying occur within a single chamber for cleaner handling and consistent cycle performance.\u003c\/li\u003e\n\u003cli\u003eStoppering Function: Seals vial stoppers after drying to maintain low moisture levels and protect product integrity during handling and storage.\u003c\/li\u003e\n\u003cli\u003eTransparent Chamber Door: Clear acrylic design allows direct observation of the freeze-drying process without interrupting the run.\u003c\/li\u003e\n\u003cli\u003eOptimized Cold Trap Design: Ensures uniform ice collection and efficient vapor capture for reliable drying outcomes.\u003c\/li\u003e\n\u003cli\u003ePID-Controlled Shelf Temperature: Minimizes temperature fluctuations to support uniform drying across batches.\u003c\/li\u003e\n\u003cli\u003eAdvanced Curve Control: Manages pre-freeze cooling rates and staged sublimation\/desorption with synchronized vacuum regulation.\u003c\/li\u003e\n\u003cli\u003eRecipe-Based Control System: Stores processes with multi-segment temperature programming for development and scale-up work.\u003c\/li\u003e\n\u003cli\u003eReal-Time Data Recording \u0026amp; Export: Monitors cold trap temperature, sample temperature, and vacuum trends for analysis and reporting.\u003c\/li\u003e\n\u003cli\u003eFlexible Operation Modes: Manual mode for experimentation, automatic mode for routine batch execution once parameters are finalized.\u003c\/li\u003e\n\u003cli\u003eSafety \u0026amp; Lab Management: Alarm history, maintenance support, and user access levels for controlled operation in shared laboratory environments.\u003c\/li\u003e\n\u003cli\u003eInert Gas Backfill Connection: Diaphragm-style valve allows post-drying gas backfill when required for product stability.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eTheory and Method – QualiRFD™ 10S Stoppering R\u0026amp;D Freeze Dryer\u003c\/h2\u003e\n\u003cp\u003eFreeze drying removes solvents through three controlled phases under vacuum. During freezing, product forms an ice structure on temperature-regulated shelves, which influences vapor flow and mass transfer during drying. Primary drying drives sublimation, where ice transitions directly to vapor and is collected by the cold trap while chamber pressure is precisely maintained. Secondary drying reduces bound moisture through temperature holds under vacuum until the target residual moisture is achieved.\u003c\/p\u003e\n\u003cp\u003eThe stoppering function introduces an in-chamber vial sealing step after drying. This ensures low moisture levels are preserved, protecting product integrity and reducing exposure risks during unloading and transfer.\u003c\/p\u003e\n\u003ch2\u003eLarge Stoppering R\u0026amp;D Freeze Dryer – QualiRFD™ 10S Technical Specification\u003c\/h2\u003e\n\u003ctable class=\"table\" border=\"1\"\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth\u003eSpecification\u003c\/th\u003e\n\u003cth\u003eUnit\u003c\/th\u003e\n\u003cth\u003eQualiRFD™ 10S\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003eFreeze drying area\u003c\/td\u003e\n\u003ctd\u003em²\u003c\/td\u003e\n\u003ctd\u003e0.5\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eRecommended loading capacity\u003c\/td\u003e\n\u003ctd\u003ekg\u003c\/td\u003e\n\u003ctd\u003e5\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eCold trap temperature (no-load)\u003c\/td\u003e\n\u003ctd\u003e°C\u003c\/td\u003e\n\u003ctd\u003e\u0026lt; -75\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eVacuum level (no-load)\u003c\/td\u003e\n\u003ctd\u003ePa\u003c\/td\u003e\n\u003ctd\u003e≤ 1\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eShelf temperature range (no-load)\u003c\/td\u003e\n\u003ctd\u003e°C\u003c\/td\u003e\n\u003ctd\u003e-55 to +70\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eMaximum ice capacity\u003c\/td\u003e\n\u003ctd\u003ekg\/24h\u003c\/td\u003e\n\u003ctd\u003e≥ 10\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eNumber of shelf layers\u003c\/td\u003e\n\u003ctd\u003epcs\u003c\/td\u003e\n\u003ctd\u003e3 + 1\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eMaterial tray size\u003c\/td\u003e\n\u003ctd\u003emm\u003c\/td\u003e\n\u003ctd\u003e410 × 410\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eShelf spacing\u003c\/td\u003e\n\u003ctd\u003emm\u003c\/td\u003e\n\u003ctd\u003e100\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eOverall power\u003c\/td\u003e\n\u003ctd\u003ekW\u003c\/td\u003e\n\u003ctd\u003e6.5\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eWeight\u003c\/td\u003e\n\u003ctd\u003ekg\u003c\/td\u003e\n\u003ctd\u003e800\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eDimensions (W × L × H)\u003c\/td\u003e\n\u003ctd\u003emm\u003c\/td\u003e\n\u003ctd\u003e911 × 1405 × 1983\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eLoadable materials\u003c\/td\u003e\n\u003ctd\u003eL\/kg\u003c\/td\u003e\n\u003ctd\u003e5\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eVial capacity (Φ12 mm)\u003c\/td\u003e\n\u003ctd\u003epcs\u003c\/td\u003e\n\u003ctd\u003e3705\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eVial capacity (Φ16 mm)\u003c\/td\u003e\n\u003ctd\u003epcs\u003c\/td\u003e\n\u003ctd\u003e2058\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eVial capacity (Φ22 mm)\u003c\/td\u003e\n\u003ctd\u003epcs\u003c\/td\u003e\n\u003ctd\u003e1050\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eDefrost mode\u003c\/td\u003e\n\u003ctd\u003e—\u003c\/td\u003e\n\u003ctd\u003eElectric defrost\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eSafety devices\u003c\/td\u003e\n\u003ctd\u003e—\u003c\/td\u003e\n\u003ctd\u003eAudible alarm, emergency stop switch, overpressure protection\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eVoltage\u003c\/td\u003e\n\u003ctd\u003e—\u003c\/td\u003e\n\u003ctd\u003eSingle-phase 3-wire, 220 V (110V is also available)\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e","brand":"Qualitest USA LC","offers":[{"title":"Default Title","offer_id":51846101500215,"sku":null,"price":100.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0786\/1859\/1543\/files\/large-stoppering-rd-freeze-dryer1509020422.webp?v=1775028822","url":"https:\/\/qualitest.us\/es\/products\/large-stoppering-r-d-freeze-dryer","provider":"Qualitest USA LC","version":"1.0","type":"link"}