Medium Stoppering R&D Freeze Dryer

Medium Stoppering R&D Freeze Dryer

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Medium Stoppering R&D Freeze Dryer
  • Medium Stoppering R&D Freeze Dryer
Medium Stoppering R&D Freeze Dryer
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Medium Stoppering R&D Freeze Dryer

The QualiRFD™ 8S is a medium scale R&D freeze dryer built for precise cycle development and vial stoppering. This in situ system integrates freezing and drying within a single chamber to reduce manual handling steps. It features a dual chamber configuration for efficient vapor capture and stable vacuum control during primary drying. This platform is ideal for pharmaceutical and biotech teams requiring repeatable results for stability studies and process optimization.
  • 0.3 Square Meter Drying Area
  • Minus 75 Celsius Cold Trap Temperature
  • 2187 Vials Per Batch Capacity
  • 1 Pascal Ultimate Vacuum Level

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Medium Stoppering R&D Freeze Dryer – QualiRFD™ 8S

A stoppering R&D Freeze Dryer supports precise cycle development while maintaining product integrity after drying and during storage. The QualiRFD™ 8S is built for medium-scale batches where repeatability and production-style handling are critical. Its in-situ workflow allows freezing and drying within the same chamber, reducing manual transfer steps and improving consistency across development runs.

The QualiRFD™ 8S operates as an in-situ vacuum Freeze Dryer with a dual-chamber configuration that integrates a drying chamber and a condenser (cold trap). The condenser efficiently captures sublimated vapor while stable vacuum conditions are maintained in the chamber, supporting controlled primary drying performance. The integrated stoppering system seals vials at the end of the cycle, helping limit moisture ingress and contamination risks during storage and transport.

The system features recipe-driven control with multi-step programming, allowing users to define and repeat temperature ramps, hold phases, and cycle parameters for process optimization. Shelf-level temperature monitoring provides deeper insight during development, making it easier to manage critical product temperature limits and refine lyophilization cycles with accuracy.

Applications

Lyophilized Pharmaceutical Vials (R&D Use):
Cycle development for injectable formulations requires controlled temperature ramps, stable vacuum levels, and consistent endpoints. In-chamber stoppering within the Freeze Dryer helps maintain cake structure and limits moisture reabsorption after drying, supporting stability studies and smooth transfer to packaging stages.

Biotech and Life Science Reagents:
Proteins, enzymes, and sensitive biological materials require low residual moisture and uniform sublimation conditions. Programmable multi-step cycles and precise shelf temperature control allow teams to evaluate formulations and process windows with high repeatability across runs.

In Vitro Diagnostic (IVD) and Research Kits:
Many IVD and research products are filled into vials prior to lyophilization. Stoppering immediately after drying helps extend shelf life by reducing moisture exposure and minimizing contamination risk during post-process handling and storage.

Specialty Materials and Chemical R&D:
Freeze drying is widely used for developing porous structures, powders, and advanced materials where ice formation and drying parameters affect final morphology. Recorded process data supports validation, comparison of trials, and consistent reproduction of results across experiments.

Standards

ISO 13408-3 (Aseptic Processing — Lyophilization):
Provides guidance for control and validation of lyophilization processes in aseptic environments, aligning with vial-based applications and in-chamber stoppering workflows.

ASTM E2500:
Defines a science- and risk-based framework for specification, design, and verification of pharmaceutical and biopharmaceutical manufacturing systems, supporting structured development and qualification of Freeze Dryers.

ISO 14644-1:
Covers cleanroom air cleanliness classification, often referenced when Freeze Dryer installation and operation are connected to controlled or classified environments.

Medium Stoppering R&D Freeze Dryer – QualiRFD™ 8S Key Features

  • In-situ vacuum Freeze Dryer workflow that integrates freezing and drying within a single chamber, reducing handling steps and improving process consistency.
  • Integrated stoppering system designed to seal vial stoppers at the end of the cycle, helping limit moisture uptake and supporting clean transfer and storage.
  • Dual-chamber configuration combining a drying chamber with a cold trap (condenser) for efficient vapor capture and stable sublimation conditions.
  • Shelf-level independent sample temperature monitoring, providing accurate insight during cycle development and validation runs.
  • Flexible control with stepwise or linear programming for temperature ramps and hold phases across freezing, primary drying, and secondary drying stages.
  • Shelf temperature control accuracy of ±1°C, supported by PLC-based control and PID regulation for stable operation.
  • Cold trap pull-down capability from -20°C to -40°C within ≤20 minutes, helping reduce preparation time between cycles.
  • Nitrogen backfill function available for inert gas use during drying or at the end of the cycle to support product protection.
  • Recipe storage with up to 36 segments per program, with options to adjust parameters and skip steps during automated operation.
  • Built-in maintenance alerts and safety protections, including alarm systems, emergency stop, and overpressure protection for reliable operation.

Theory and Method

Freeze drying removes solvent through three main stages: freezing, sublimation, and desorption under reduced pressure. The product is first frozen on temperature-controlled shelves, which defines the ice structure and influences vapor flow during the drying phase. During primary drying, vacuum conditions allow ice to convert directly into vapor, which is then captured by the cold trap at low temperature to maintain stable chamber conditions.

Secondary drying focuses on reducing bound moisture by maintaining vacuum while adjusting shelf temperature to reach the desired residual moisture level. In a stoppering Freeze Dryer, a final closure step seals vial stoppers at the end of the cycle, helping minimize moisture reabsorption and protecting product quality during storage and handling.

Medium Stoppering R&D Freeze Dryer – QualiRFD™ 8S Technical Specification

Specification Unit QualiRFD™ 8S
Freeze drying area m² 0.3
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 ≥ 8
Number of shelf layers pcs 3 + 1
Material tray size mm 300 × 340
Shelf spacing mm 70
Overall power kW 5.5
Weight kg 400
Dimensions mm 853 × 1272 × 1679
Loadable materials L/kg 3
Vial capacity (Φ12 mm) pcs 2187
Vial capacity (Φ16 mm) pcs 1200
Vial capacity (Φ22 mm) pcs 654
Defrost mode — Electric defrost
Safety devices — Audible alarm, emergency stop, overpressure protection
Voltage — Three-phase 5-wire, 380 V

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.

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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)

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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.

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Information:

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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

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3. Technical measures

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

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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. 

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