Original: $100.00
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$35.00The Story
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 | ||||||
Description
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 | ||||||
