Original: $100.00
-65%$100.00
$35.00The Story
Biopharmaceutical Production Freeze Dryer – QualiFD™ BP Series
The QualiFD™ BP Series Freeze Dryer is designed for biopharmaceutical manufacturing, enabling sterile, low-temperature drying under deep vacuum. Ideal for GMP-compliant production, the system offers optional CIP and SIP capabilities, along with automation and SCADA-style process management for precise cycle control.
This modular, integrated platform features a one-piece cabinet and welded shelf plates to ensure uniform temperature distribution. Core system modules include the freeze-drying chamber, shelves, condenser, refrigeration, vacuum, circulation, hydraulic, pneumatic, control, CIP, and SIP systems.
Engineered for high-throughput lyophilization in pharmaceutical and biotech environments, the QualiFD™ BP Series emphasizes reliability and ease of maintenance. Patented welded shelf plates enhance heat transfer and consistency across layers, while the condenser incorporates a steam-guided coil design to promote even ice formation. Advanced PLC and SCADA-based controls allow operators to manage complex freeze-drying cycles with consistent, repeatable results.
Applications of the QualiFD™ BP Series Freeze Dryer
Vaccines: Freeze drying helps vaccine formulations maintain stability during storage and transport by achieving low residual moisture without high-temperature stress. Controlled production and batch documentation ensure consistent quality for release criteria.
Pharmaceuticals and Biopharmaceuticals: Injectable and sterile products often rely on lyophilization to extend shelf life and provide cold-chain flexibility. The production Freeze Dryer supports structured cycles for freezing, primary drying, and secondary drying, with optional CIP/SIP integration to meet hygienic changeover requirements between campaigns.
Biochemical Drugs, Biologics, and Probiotics: Sensitive biologic and probiotic materials benefit from moisture reduction while preserving structural integrity. Vacuum levels and shelf temperature setpoints can be adjusted to product-specific limits, and repeatable cycles ensure consistent lot-to-lot performance during scale-up.
Extracts and Nutritional Supplements: Freeze drying plant extracts and nutrition ingredients protects aroma and minimizes degradation caused by water. Controlled drying ensures uniform powder properties for blending and filling, with data logging aiding process troubleshooting in response to raw material variability.
Diagnostic Reagents and Blood Products: Maintaining precise moisture levels supports the stability and long-term storage of diagnostic reagents and related blood products. Freeze drying enables storage-friendly formats, while traceable process data helps investigate deviations in field performance.
Compliance and Standards
The QualiFD™ BP Series Freeze Dryer is designed to align with internationally recognized standards for biopharmaceutical production:
- ISO 13408-3 (Aseptic Processing — Lyophilization): Provides guidance for controlling and validating lyophilization processes in aseptic production environments.
- ISO 13408-4 (Clean-in-Place Technologies): Defines requirements for CIP qualification, validation, operation, and control.
- ISO 13408-5 (Sterilization-in-Place): Covers SIP validation procedures and ongoing operational control.
- ASTM E2500: Offers a risk-based framework for specification, design, verification, and documentation of pharmaceutical and biopharmaceutical manufacturing systems.
These standards ensure the system supports GMP-aligned production, traceable processes, and validated hygienic operations across campaigns.
Key Features – QualiFD™ BP Series Biopharmaceutical Freeze Dryer
- One-Piece Cabinet Design: Reduces leakage risk and simplifies internal geometry for easier cleaning and sterilization.
- Welded Shelf Plates: Patented manufacturing enhances temperature uniformity and heat transfer efficiency across all shelves.
- Condenser Optimization: Steam flow guiding system maximizes effective condenser area, promoting uniform ice formation.
- High-Capacity Vacuum System: Strong exhaust capability improves sublimation efficiency for faster and more consistent drying cycles.
- Closed-Loop Refrigeration: Bitzer refrigeration unit ensures reliable cooling performance and energy efficiency.
- PLC and SCADA Controls: Advanced automation enables precise management of complex freeze-drying cycles and overall system operation.
- Front-End Equipment Integration: Supports optional filling stations and automated material handling to suit facility-specific requirements.
Theory and Method – Freeze Drying Process
The freeze-drying process involves three main stages under controlled vacuum conditions: freezing, primary drying, and secondary drying.
- Freezing: The product is cooled to form ice, establishing an internal structure that governs vapor flow during the drying phases.
- Primary Drying (Sublimation): Ice is removed as vapor, which is captured by the condenser, helping maintain stable chamber pressure and consistent drying conditions.
- Secondary Drying (Desorption): Bound moisture is removed by holding shelves at controlled temperatures under vacuum to achieve the target residual moisture level.
The QualiFD™ BP Series supports automated operation, allowing operators to set tray temperature, cycle time, and vacuum level before initiating a fully automated freeze-drying cycle, ensuring repeatable and consistent results.
Biopharmaceutical Production Freeze Dryer – QualiFD™ BP Series Technical Specification
| Model / Specification | QualiFD™ BP 20 | QualiFD™ BP 40 | QualiFD™ BP 60 | QualiFD™ BP 100 | QualiFD™ BP 200 | QualiFD™ BP 400 | QualiFD™ BP 600 | QualiFD™ BP 800 |
|---|---|---|---|---|---|---|---|---|
| Freeze Drying Area (m²) | 1.15 | 2.2 | 3.3 | 5.25 | 10.5 | 20.2 | 30 | 41 |
| Vacuum Level (Pa) | ≤1 | |||||||
| Cold Trap Temp (°C) | -75 | |||||||
| Max Ice Capacity (kg/batch) | >20 | >40 | >60 | >100 | >200 | >400 | >600 | >800 |
| Shelf Temp Range (°C) | -50 to +70 | |||||||
| Material Tray (mm) | 480 × 600 | 610 × 910 | 610 × 910 | 750 × 1000 | 990 × 1520 | 1210 × 1520 | 1520 × 1800 | 1520 × 1800 |
| Shelf Layers (pcs) | 4+1 | 4+1 | 6+1 | 7+1 | 7+1 | 11+1 | 11+1 | 15+1 |
| Loadable Materials (φ16 2 mL vials) | 4,788 | 9,216 | 13,824 | 22,540 | 45,360 | 84,942 | 131,967 | 179,955 |
| Dimensions (mm) | 1640 × 1100 × 1830 | 2500 × 1560 × 2020 | 2500 × 1560 × 2300 | 4000 × 1360 × 2800 | 5500 × 1670 × 2800 | 6500 × 1980 × 2800 | 7500 × 2280 × 2900 | 7500 × 2280 × 3300 |
| Overall Power (kW) | 7.5 | 12 | 15 | 24 | 46 | 85 | 160 | 180 |
Description
Biopharmaceutical Production Freeze Dryer – QualiFD™ BP Series
The QualiFD™ BP Series Freeze Dryer is designed for biopharmaceutical manufacturing, enabling sterile, low-temperature drying under deep vacuum. Ideal for GMP-compliant production, the system offers optional CIP and SIP capabilities, along with automation and SCADA-style process management for precise cycle control.
This modular, integrated platform features a one-piece cabinet and welded shelf plates to ensure uniform temperature distribution. Core system modules include the freeze-drying chamber, shelves, condenser, refrigeration, vacuum, circulation, hydraulic, pneumatic, control, CIP, and SIP systems.
Engineered for high-throughput lyophilization in pharmaceutical and biotech environments, the QualiFD™ BP Series emphasizes reliability and ease of maintenance. Patented welded shelf plates enhance heat transfer and consistency across layers, while the condenser incorporates a steam-guided coil design to promote even ice formation. Advanced PLC and SCADA-based controls allow operators to manage complex freeze-drying cycles with consistent, repeatable results.
Applications of the QualiFD™ BP Series Freeze Dryer
Vaccines: Freeze drying helps vaccine formulations maintain stability during storage and transport by achieving low residual moisture without high-temperature stress. Controlled production and batch documentation ensure consistent quality for release criteria.
Pharmaceuticals and Biopharmaceuticals: Injectable and sterile products often rely on lyophilization to extend shelf life and provide cold-chain flexibility. The production Freeze Dryer supports structured cycles for freezing, primary drying, and secondary drying, with optional CIP/SIP integration to meet hygienic changeover requirements between campaigns.
Biochemical Drugs, Biologics, and Probiotics: Sensitive biologic and probiotic materials benefit from moisture reduction while preserving structural integrity. Vacuum levels and shelf temperature setpoints can be adjusted to product-specific limits, and repeatable cycles ensure consistent lot-to-lot performance during scale-up.
Extracts and Nutritional Supplements: Freeze drying plant extracts and nutrition ingredients protects aroma and minimizes degradation caused by water. Controlled drying ensures uniform powder properties for blending and filling, with data logging aiding process troubleshooting in response to raw material variability.
Diagnostic Reagents and Blood Products: Maintaining precise moisture levels supports the stability and long-term storage of diagnostic reagents and related blood products. Freeze drying enables storage-friendly formats, while traceable process data helps investigate deviations in field performance.
Compliance and Standards
The QualiFD™ BP Series Freeze Dryer is designed to align with internationally recognized standards for biopharmaceutical production:
- ISO 13408-3 (Aseptic Processing — Lyophilization): Provides guidance for controlling and validating lyophilization processes in aseptic production environments.
- ISO 13408-4 (Clean-in-Place Technologies): Defines requirements for CIP qualification, validation, operation, and control.
- ISO 13408-5 (Sterilization-in-Place): Covers SIP validation procedures and ongoing operational control.
- ASTM E2500: Offers a risk-based framework for specification, design, verification, and documentation of pharmaceutical and biopharmaceutical manufacturing systems.
These standards ensure the system supports GMP-aligned production, traceable processes, and validated hygienic operations across campaigns.
Key Features – QualiFD™ BP Series Biopharmaceutical Freeze Dryer
- One-Piece Cabinet Design: Reduces leakage risk and simplifies internal geometry for easier cleaning and sterilization.
- Welded Shelf Plates: Patented manufacturing enhances temperature uniformity and heat transfer efficiency across all shelves.
- Condenser Optimization: Steam flow guiding system maximizes effective condenser area, promoting uniform ice formation.
- High-Capacity Vacuum System: Strong exhaust capability improves sublimation efficiency for faster and more consistent drying cycles.
- Closed-Loop Refrigeration: Bitzer refrigeration unit ensures reliable cooling performance and energy efficiency.
- PLC and SCADA Controls: Advanced automation enables precise management of complex freeze-drying cycles and overall system operation.
- Front-End Equipment Integration: Supports optional filling stations and automated material handling to suit facility-specific requirements.
Theory and Method – Freeze Drying Process
The freeze-drying process involves three main stages under controlled vacuum conditions: freezing, primary drying, and secondary drying.
- Freezing: The product is cooled to form ice, establishing an internal structure that governs vapor flow during the drying phases.
- Primary Drying (Sublimation): Ice is removed as vapor, which is captured by the condenser, helping maintain stable chamber pressure and consistent drying conditions.
- Secondary Drying (Desorption): Bound moisture is removed by holding shelves at controlled temperatures under vacuum to achieve the target residual moisture level.
The QualiFD™ BP Series supports automated operation, allowing operators to set tray temperature, cycle time, and vacuum level before initiating a fully automated freeze-drying cycle, ensuring repeatable and consistent results.
Biopharmaceutical Production Freeze Dryer – QualiFD™ BP Series Technical Specification
| Model / Specification | QualiFD™ BP 20 | QualiFD™ BP 40 | QualiFD™ BP 60 | QualiFD™ BP 100 | QualiFD™ BP 200 | QualiFD™ BP 400 | QualiFD™ BP 600 | QualiFD™ BP 800 |
|---|---|---|---|---|---|---|---|---|
| Freeze Drying Area (m²) | 1.15 | 2.2 | 3.3 | 5.25 | 10.5 | 20.2 | 30 | 41 |
| Vacuum Level (Pa) | ≤1 | |||||||
| Cold Trap Temp (°C) | -75 | |||||||
| Max Ice Capacity (kg/batch) | >20 | >40 | >60 | >100 | >200 | >400 | >600 | >800 |
| Shelf Temp Range (°C) | -50 to +70 | |||||||
| Material Tray (mm) | 480 × 600 | 610 × 910 | 610 × 910 | 750 × 1000 | 990 × 1520 | 1210 × 1520 | 1520 × 1800 | 1520 × 1800 |
| Shelf Layers (pcs) | 4+1 | 4+1 | 6+1 | 7+1 | 7+1 | 11+1 | 11+1 | 15+1 |
| Loadable Materials (φ16 2 mL vials) | 4,788 | 9,216 | 13,824 | 22,540 | 45,360 | 84,942 | 131,967 | 179,955 |
| Dimensions (mm) | 1640 × 1100 × 1830 | 2500 × 1560 × 2020 | 2500 × 1560 × 2300 | 4000 × 1360 × 2800 | 5500 × 1670 × 2800 | 6500 × 1980 × 2800 | 7500 × 2280 × 2900 | 7500 × 2280 × 3300 |
| Overall Power (kW) | 7.5 | 12 | 15 | 24 | 46 | 85 | 160 | 180 |
