Large Stoppering R&D Freeze Dryer

Large Stoppering R&D Freeze Dryer

Skip to product information
Large Stoppering R&D Freeze Dryer
  • Large Stoppering R&D Freeze Dryer
Large Stoppering R&D Freeze Dryer
In Stock
SKU:

Large Stoppering R&D Freeze Dryer

The QualiRFD™ 10S is a large stoppering freeze dryer built for pharmaceutical and biotech development batches. This pilot scale system integrates freezing and drying within a single chamber to preserve product integrity. It supports production style handling and precise recipe execution for vial based lyophilization. Its design ensures stable process scale up while maintaining low moisture levels through in chamber sealing.
  • 0.5 Square Meter Drying Area
  • Minus 75 Celsius Cold Trap Temperature
  • 3705 Vials Maximum Batch Capacity
  • 1 Pascal Ultimate Vacuum Level

Get personalized pricing for your specific requirements

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

A large stoppering R&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.

The 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.

The 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.

Applications of the QualiRFD™ 10S Stoppering R&D Freeze Dryer

Lyophilized 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.

Biotech 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.

In 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.

Materials and chemical R&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.

Standards Compliance for the QualiRFD™ 10S Stoppering R&D Freeze Dryer

ISO 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.

ASTM E2500 – Specification, Design, and Verification of Manufacturing Systems: Offers a science- and risk-based framework for pharmaceutical and biopharmaceutical equipment and system validation.

ISO 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.

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

  • Integrated In-Situ Freeze Dryer Workflow: Freezing and drying occur within a single chamber for cleaner handling and consistent cycle performance.
  • Stoppering Function: Seals vial stoppers after drying to maintain low moisture levels and protect product integrity during handling and storage.
  • Transparent Chamber Door: Clear acrylic design allows direct observation of the freeze-drying process without interrupting the run.
  • Optimized Cold Trap Design: Ensures uniform ice collection and efficient vapor capture for reliable drying outcomes.
  • PID-Controlled Shelf Temperature: Minimizes temperature fluctuations to support uniform drying across batches.
  • Advanced Curve Control: Manages pre-freeze cooling rates and staged sublimation/desorption with synchronized vacuum regulation.
  • Recipe-Based Control System: Stores processes with multi-segment temperature programming for development and scale-up work.
  • Real-Time Data Recording & Export: Monitors cold trap temperature, sample temperature, and vacuum trends for analysis and reporting.
  • Flexible Operation Modes: Manual mode for experimentation, automatic mode for routine batch execution once parameters are finalized.
  • Safety & Lab Management: Alarm history, maintenance support, and user access levels for controlled operation in shared laboratory environments.
  • Inert Gas Backfill Connection: Diaphragm-style valve allows post-drying gas backfill when required for product stability.

Theory and Method – QualiRFD™ 10S Stoppering R&D Freeze Dryer

Freeze 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.

The 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.

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

Specification Unit QualiRFD™ 10S
Freeze drying area m² 0.5
Recommended loading capacity kg 5
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 ≥ 10
Number of shelf layers pcs 3 + 1
Material tray size mm 410 × 410
Shelf spacing mm 100
Overall power kW 6.5
Weight kg 800
Dimensions (W × L × H) mm 911 × 1405 × 1983
Loadable materials L/kg 5
Vial capacity (Φ12 mm) pcs 3705
Vial capacity (Φ16 mm) pcs 2058
Vial capacity (Φ22 mm) pcs 1050
Defrost mode — Electric defrost
Safety devices — Audible alarm, emergency stop switch, overpressure protection
Voltage — Single-phase 3-wire, 220 V (110V is also available)

Delivery time varies upon stock availability. Our standard dispatch and shipping times are generally within 1 week, however for some high demand items the delivery may be extended to 2-3 weeks. If you require these items urgently please contact us to check accurate stock availability and to organize faster shipping methods.

🚚

Important Delivery Information

Delivery time varies upon stock availability. Our standard dispatch and shipping times are generally within 1 week, however for some high demand items the delivery may be extended to 2-3 weeks.

Need it urgently? Contact us here to check stock and organize faster shipping.

Orders:
Purchaser acknowledges that when placing an order on the Qualitest:

A. the placing of the order signifies the purchaser's assent to place said order at the Qualitest and that the order will be accepted by the successful processing of the order by Qualitest USA LC.
B. the purchaser typing their name when requested to do so by the Qualitest constitutes a signature to contract
C. the purchaser has the full authority to enter into the contract for such entity, and such grant of authority was indicated by purchaser by placement of the order through the Qualitest.
D. A minimum handling fee will be applied to the shipping total for all orders.

Shipping within the U.S.A.:

All orders will be shipped best way prepaid, via courier for smaller packages or via Freight forwarders for larger crates. A handling fee may be applicable to orders. Title to merchandise transfers to the purchaser upon delivery to the carrier. Loss or damage in transit is the responsibility of the purchaser. Qualitest USA will provide assistance with information needed for processing claims.

Shipping outside of the U.S.A.:

All orders will be shipped best way, via courier for smaller packages or via Freight forwarders for larger crates. A low handling fee may be applicable. Title to merchandise transfers to the purchaser upon delivery to the carrier. Loss or damage in transit is the responsibility of the purchaser. Qualitest USA will provide assistance with information needed for processing claims. Export fees, duties, taxes, and customs clearance are the responsibility of the purchaser.

Shipping insurance is not included, please contact our sales representatives if you need shipping insurance.

Partial shipment: Qualitest USA reserves the right to make partial shipments unless otherwise instructed by the purchaser.

Payment terms: All payments to Qualitest USA are to be made in U.S. Dollars (USD)

A. Credit Card - Qualitest USA will accept Visa, Master Card, AMEX or Discover. Required information from the purchaser is the credit card number, 3 digit security code, expiration date, card holder's name (exactly as it appears on the card), billing address, and valid telephone number for us to use in case of difficulty. Qualitest USA reserves the right to delay shipment pending verification of credit card validity.
B. Wire Transfer - Transfer must be made to Qualitest and confirmed for the full purchase amount (merchandise, handling and shipping) prior to shipment. Please contact us by phone at 1.877.884.TEST (8378)(outside U.S. +1.905.944.9825) or by fax at +1.954.697.8211 for bank information.
C. Open Account - Available to U.S.A. and Canadian customers only. Terms on open accounts are Net 30 days from date of shipment. Qualitest USA reserves the right to refuse shipment of new orders if any unpaid invoices are older than 30 days. Purchasers may apply for an open account by providing:

their bank information
3 credit references from other suppliers
Please allow 5 business days for confirmation of credit and creation of an open account.

Return Policy:

Qualitest USA may accept return of purchased merchandise within North America for refund or credit under the following conditions -

  • There may be an additional restocking fee charged to the transaction if items are already shipped to customer.
  • Goods must be returned to Qualitest USA within 5 days of the date of the receipt of the purchased goods.
  • All freight, duties, customs, and other related shipping charges for the returned merchandise are borne by the purchaser. Shipments made freight collect will be refused.
  • Merchandise must be returned properly packaged in brand new, salable condition, along with original packaging and all documentation, accessories and certificates.
  • Purchaser has confirmed return authorization directly with Qualitest.
  • Merchandise is regular catalog item. Special order items can not be returned.
  • All returned merchandise is subject to inspection by Qualitest. Qualitest reserves the right to refuse return of any merchandise that is used, damaged, or not part of the current published price list. In the case Qualitest does not accept the returned merchandise, reasonable attempts will be made to notify the Buyer and the merchandise will be returned to Buyer as they were received by Qualitest. Damaged merchandise that can be restored to original condition and thus accepted for return will be evaluated on an individual basis. The purchaser will be advised of additional expenses for the repair and restoration of the returned item. After approval, these expenses will be charged to the purchaser in addition to the restocking fee.


Change of Terms:

The acceptance of any order by Qualitest USA is subject to purchaser's assent to all of the terms and conditions set forth herein. Purchaser's assent to these terms and conditions shall be presumed from the purchaser's placement of an order through the Qualitest. Any and all other terms and conditions are expressly rejected, and no addition or modification of terms and conditions shall be binding without the prior agreement of Qualitest USA in writing.

Complete Agreement:

The terms and conditions in the Qualitest web site, incorporated herein by reference, including forms, acknowledgements, quotations, invoices and sales terms and conditions constitute the entire and exclusive agreement between the purchaser and Qualitest USA LC.

Information:

Qualitest USA makes every effort to insure the accuracy of the product information displayed on its web sites, but makes no warranties, expressed or implied, as to the accuracy of the data portrayed on the web sites. Qualitest USA reserves the right to change product information, including pricing information at any time without notice. 

Trademarks and Copyrights:

The WorldofTest.com Qualitest contains trademarked product names. Product names are not to be reproduced or used in any fashion by any party other than Qualitest without the express written consent of Qualitest International Inc.. All pictures, descriptions, and other content of this web site are copyrighted by Qualitest USA and may not be used without the express written permission of Qualitest USA. Purchaser acknowledges that they have no right, title, or interest in the trademarks or copyrights in the products, and purchaser covenants that it will take no action to register or otherwise interfere with such rights. Please contact us with any requests for permission or questions about our trademarks. 

Warranty Disclaimer:

No warranty or affirmation of fact, express or implied, other than expressly set forth herein is made or authorized by Qualitest USA. Qualitest USA disclaims any and all liability for product defect claims. Qualitest USA does not express or imply a warranty that any product on the web site(s) is fit for a particular purpose. Qualitest USA honors the product warranty as published and made available by Qualitest USA. Warranty claims for products not manufactured by Qualitest are the responsibility of the manufacturer. Qualitest USA will always make its best good faith effort to resolve warranty claims. 


Force Majeure:

Qualitest USA shall not be liable for any delay in or impairment of performance resulting in whole or in part from Acts of God, service interruptions, labor disruptions, insurrections, governmental decrees or controls, war risks, severe weather, supplies or raw materials, inability to procure or ship products, inability to obtain permits and/or licenses, or any other circumstances or causes beyond the control of Qualitest USA in the conduct of its business. 

Qualitest USA Privacy Policy 

I. What legal provisions govern our data processing practices? How and from where (internal/external sources) is personal data acquired? What are the rights of the user (web site visitor/registered customer)? 

1. General
As a general principle, no personal details need to be provided when visiting our Internet site. Data made available to us by you is treated in strict confidence and in accordance with the provisions of the Federal Data Protection Act. With a few exceptions (see point 2 below), our web server only registers non-personal (anonymous) data concerning the use of our site. Specifically, the log files of our web server, as a general rule, only contain the user's IP address, the last page visited by the user, the browser used, date, time and the file requested. This anonymous data, however, does not permit conclusions to be drawn about the individual users, and merely serves to prepare statistics on the use of our Internet site for the purpose of its improvement. At the same time, great importance is placed on ensuring that usage data is not linked with personal data. 

2. Personal data

Person-related data (personal data) is only used if the newsletter is ordered (by email), product(s) is (are) ordered, or to supply product information. We undertake to use the personal data entrusted to us only for the purposes stated. Purchase history is retained for assistance with future customer needs. 

II. What security measures are used to protect personal data? What are the user's options for processing personal data? 

3. Technical measures

Databases are optimally protected against third party access, loss, misuse and falsification through the use of appropriate technical means. In order to determine the popularity of individual topic areas, cookies are used in those sections. These text files are stored on your hard disk and facilitate your use of our Internet site. Thanks to these cookies, there is no need for specific registration each time you visit a section requiring registration, and we can supply you with the personalized contents you request. 

It is for you to decide whether you want to work with cookies and, if so, which kind (permanently stored on the hard disk or only placed for the time of the browser activity). However, we draw your attention to the fact that access to fields requiring registration is only possible with activated cookies. 

III. What data is communicated to third parties and for what purposes? 

4. Communication of personal data

Personal data entrusted to us by you is not communicated, leased or sold to third parties. 

IV. Which department answers questions about the processing of personal data? 

5. Contact

In the light of the rapid technical developments in connection with the Internet, we make every effort to constantly improve our Internet site and technical precautions, including those connected with data protection. We will keep you suitably informed about such measures. Any changes will be published here. Further information is available at any time by contacting Qualitest USA.

Disclaimer of liability Qualitest USA shall not be liable for direct, indirect or consequential losses resulting from or in connection with access to, use of or queries to the Qualitest web site or its links with other web sites, even if Qualitest USA has previously been informed of the possibility of such losses. No guarantee is provided as to the accuracy of the information disseminated via the Qualitest USA web site. In addition, Qualitest USA guarantees neither the reliability nor the completeness of the information contained on its web site. The information made available on the Qualitest and WorldofTest.com web site may be amended at any time without prior notice. In particular, Qualitest USA shall not be liable for losses caused by transmission errors, technical faults and interruptions, breakdowns or an unlawful interference with the user's data processing system or the generally accessible systems and transmission networks. Nor shall Qualitest USA be liable for losses resulting from breakdowns, interruptions or overloads occurring to any data processing systems. If certain links are activated on the Qualitest and WorldofTest.com web site, the user may under certain circumstances leave the Qualitest web site. Qualitest USA assumes no responsibility for the contents, products or services offered or other information or offers contained on these linked web sites. 

Related Products