Workshop GMP Freeze Dryer

Workshop GMP Freeze Dryer

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Workshop GMP Freeze Dryer
  • Workshop GMP Freeze Dryer
Workshop GMP Freeze Dryer
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Workshop GMP Freeze Dryer

The QualiWFD™ Series is a specialized freeze dryer built for GMP workshop environments and cleanrooms. It features polished, seamless surfaces to minimize product retention and ensure sterile processing. The platform supports validated workflows with optional CIP and VHP sterilization while maintaining strict cross-contamination control. This system is ideal for pharmaceutical manufacturing where detailed documentation and aseptic conditions are required.
  • 0.2 To 2.25 Square Meter Area
  • Minus 75 Celsius Cold Trap Temperature
  • 1 Pascal Ultimate Vacuum Performance
  • 22.5 Kilogram Maximum Feeding Capacity

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Workshop GMP Freeze Dryer – QualiWFD™ Series

The QualiWFD™ Series Freeze Dryer is designed for GMP workshop environments, offering cleanable product-contact surfaces, precise sealing, and controls ready for documentation. Ideal for production areas and cleanrooms, it ensures cross-contamination control, smooth internal finishes, and optional CIP and VHP functions to support validated processes.

Polished, seamless contact surfaces minimize product retention and simplify cleaning between batches. Optional features such as online CIP cleaning and VHP sterilization help meet stricter hygiene requirements in GMP-controlled spaces.

This GMP-oriented platform is tailored for workshop-scale production and controlled environments. Superior sealing reduces the risk of leakage and limits contamination to the surrounding area.

Internal surfaces are smooth and free from dead zones, reducing microbial buildup and easing maintenance tasks. The QualiWFD™ Series also provides validation-ready documentation for qualification and acceptance testing.

Applications

Pharmaceutical GMP production and pilot manufacturing: GMP workshops often use freeze drying for drug products, vaccines, and biologics to improve stability and extend shelf life. Cleanroom-ready Freeze Dryers support strict cleanliness standards during open product handling and batch changeovers. Built-in documentation support (DQ/IQ/OQ/PQ, FAT/SAT) ensures compliance for regulated deployment and audit preparation.

Biotechnology and life science preservation: Freeze drying enzymes, antibodies, and biological samples helps maintain integrity for storage and later analysis. Cleanroom operation protects sample purity, ensuring reliable comparisons across studies and lots. Advanced probe-based monitoring supports method development and cycle evaluation.

Food processing in controlled environments: Coffee, fruits, and vegetables are freeze-dried to extend shelf life while preserving aroma, texture, and nutritional value. Installation in cleanroom or controlled areas minimizes contamination and microbial exposure, supporting high-quality production and export-ready standards.

Medical device manufacturing and components: Freeze drying certain medical device materials and components removes residual moisture, supporting cleaner handling and reducing variability-related rework. This is particularly beneficial for sensitive assemblies, coatings, and absorbent materials in controlled environments.

Chemical processing and specialty synthesis: Low-temperature freeze drying stabilizes chemical intermediates and specialty compounds that are sensitive to heat. Controlled-environment operation reduces airborne contamination, ensuring product integrity during handling and processing.

Standards

  • ISO 13408-3 (Aseptic Processing — Lyophilization): Provides guidance for equipment design, process control, and validation of freeze drying as an aseptic operation.
  • ISO 14644-1 (Cleanrooms — Air Cleanliness Classification): Commonly referenced for the installation and operation of Freeze Dryers in controlled environments, ensuring consistent air quality.
  • ASTM E2500 (Specification, Design, and Verification of Pharma/Biopharma Systems): Supports a risk-based approach to verification of GMP equipment and automation in pharmaceutical manufacturing.
  • FDA 21 CFR Part 11: Applies to Freeze Dryers using electronic records, audit trails, and electronic signatures, ensuring compliance in regulated workflows.

Workshop GMP Freeze Dryer – QualiWFD™ Series Key Features

  • GMP-focused internal surfaces: Smooth, polished, and free of dead zones to simplify cleaning and reduce microbial buildup.
  • Advanced sealing design: Minimizes sample leakage and limits contamination to the surrounding production environment.
  • Cross-contamination control: Supports multi-batch operation while maintaining product integrity.
  • Optional CIP and VHP functions: Online cleaning and vapor-phase sterilization enhance hygiene standards and reduce downtime.
  • Regulated operation controls: Program settings, user authorization, temperature curve management, and data recording/storage for compliance.
  • Process development tools: Optional features include endpoint determination, vacuum fine-tuning, pressure rise experiments, and eutectic point testing.
  • Remote monitoring and control: View equipment status via PC or mobile without being on-site.
  • Validation documentation package: Includes DQ, IQ, OQ, PQ, FAT, SAT, manuals, and P&ID for seamless regulatory deployment.

Theory and Method

Freeze drying, or lyophilization, removes water by first freezing the product, then reducing chamber pressure to enable sublimation during primary drying. The condenser (cold trap) captures vapor as ice, stabilizing the vacuum and protecting the vacuum pump. Secondary drying uses controlled shelf temperature holds to reduce residual moisture to the target level. Consistent results depend on precise shelf temperature control, stable chamber pressure, and accurate product temperature feedback throughout the cycle.

For GMP workshop operation, hygienic design and repeatable cleaning are critical. Smooth internal surfaces minimize residue accumulation, while optional CIP and VHP functions enable faster, consistent batch changeovers. Validation documentation, including DQ, IQ, OQ, PQ, and FAT/SAT, supports commissioning and ensures readiness for regulatory audits.

Workshop GMP Freeze Dryer – QualiWFD™ Series Technical Specification

System-Level Technical Parameters (Series Range)

  • Freeze-drying area: 0.2 m² to 2.25 m²
  • Feeding capacity: 2 kg to 22.5 kg
  • Cold trap temperature: ≤ −75°C
  • Vacuum degree: ≤ 1 Pa
  • Shelf temperature range: −55°C to +70°C
  • Heating/cooling rate: 1°C/min

Model Table

Specification Unit QualiWFD™ 300 QualiWFD™ 400 QualiWFD™ 600 QualiWFD™ 700 QualiWFD™ 1200 QualiWFD™ 340 QualiWFD™ 400 QualiWFD™ 800 QualiWFD™ 1000 QualiWFD™ 1500
Configuration — Standard Stoppering
Freeze-drying area m² 0.3 0.4 0.7 1.03 2.25 0.2 0.3 0.5 1.15 2.2
Cold trap temperature (no-load) °C ≤-75 / ≤-85 / ≤-110
Vacuum degree (no-load) Pa < 1
Min shelf temperature °C -55 / -65 / -75 / -100
Max shelf temperature °C 70 / 80
Ice capacity kg/24h > 6 > 8 > 10 > 15 > 30 > 6 > 8 > 10 > 15 > 30
Number of shelves Layer 3 + 1 4 + 1 6 + 1 5 + 1 2 + 1 3 + 1 4 + 1
Shelf dimensions mm 400 × 270 340 × 300 480 × 360 480 × 360 900 × 500 400 × 270 300 × 340 410 × 410 480 × 600 610 × 910
Shelf spacing mm 70 80 100 70 100
Power kW 3 4.5 5.5 6.5 13.5 4 5.5 6.5 7.5 14.5
Main unit weight kg 300 400 600 700 1200 340 400 800 1000 1500
Dimensions (W×L×H) mm 1390 × 815 × 1631 1422 × 780 × 1570 1620 × 930 × 1450 1750 × 930 × 1632 2000 × 1180 × 1730 1390 × 815 × 1920 1687 × 780 × 1673 1730 × 950 × 1885 1823 × 1144 × 2014 2198 × 1472 × 2310
Vial capacity (Ø12/Ø16/Ø22) pcs — — — — — 1554 / 888 / 440 2187 / 1200 / 654 3705 / 2058 / 1050 8624 / 4788 / 2460 13400 / 7600 / 3888
Material capacity (10 mm thickness) L 3 4 7 10 22.5 2 3 5 11 22
Sealing method (stoppering) — Hydraulic, ~10 kgf/cm²
Vacuum control — Electromagnetic valve + fine adjustment valve
Defrosting mode — Independent cold trap, electric defrosting
Safety devices — Audible alarm, emergency stop, overpressure protection
Voltage — Single-phase 3-wire , 220V 50Hz (110V is also available) Three-phase 5-wire, 380V 50Hz Single-phase 3-wire, 220V 50Hz (110V is also available) Three-phase 5-wire, 380V 50Hz

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)

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. 

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