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Refrigeration System
Secop compressor (international brand) with hybrid refrigeration technology, ensuring low-temperature stability and environmental compliance.
Control Interface
7-inch color LCD touchscreen with user-friendly HMI, lock screen function, and optional remote control via PC/mobile.
Operating System
Industrial-grade embedded OS with isolated power supply design (strong/weak current separation) for enhanced safety.
Data Management
Auto-save function for freeze-drying parameters, supporting data review, export (USB), deletion, and anti-loss protection.
Drying Chamber
Transparent high-pressure corrosion-resistant PE chamber (460mm height, one-piece injection molding) for real-time material observation.
Vacuum System
Stainless steel vacuum line with KF25 quick-connect clamp; corrosion and low-temperature resistant.
Vacuum pump delay start (activates below set temperature) to extend lifespan.
Monitoring & Recording
Real-time display of vacuum level, cold trap/material temperatures, and freeze-drying curves; supports multi-curve storage and USB data extraction.
Safety & Protection
Vacuum alarm, power-off auto-inflation (prevents moisture ingress), and inert gas filling port.
One-click auxiliary heating/defrost for rapid recovery.
Mechanical Design
Axial cooling fan with dual-ball imported bearings for ultra-stable operation and extended durability.
Magnetic maintenance panel for easy cleaning and dust management.
Smart Maintenance
Automated reminders for pump oil replacement and system upkeep based on operational hours.
| Model | FD-12A | FD-12B | FD-12C | FD-12D | FD-12BM | |
|---|---|---|---|---|---|---|
| Type | Standard Chamber | Manual Capping | Multi-manifold | Multi-manifold Capping | T-frame | |
| Freeze-dried Area | 0.12㎡ | 0.08㎡ | 0.12㎡ | 0.08㎡ | / | |
| Amount of vials of cillin | Φ12mm | 920 | 560 | 920 | 560 | / |
| Φ16mm | 480 | 285 | 480 | 285 | / | |
| Φ22mm | 260 | 165 | 260 | 165 | / | |
| Cold Trap Temperature | -60℃ (Optional-80℃) | |||||
| Water Capture KG/batch | 4 | |||||
| Standard Vacuum Degree | ≦5Pa | |||||
| Ultimate Vacuum Degree | 2PA | |||||
| Material Tray | 200mm 4 layers | 180mm 3 layers | 200mm 4 layers | 180mm 3 layers | / | |
| Consumption | 680W Optional-80℃ 1300W | |||||
| Main Unit Weight | 70kg (Optional-80℃: 80KG) | |||||
| External Size | 600x510x760mm | |||||
| Power Supply | AC 220 V, 50 HZ | |||||
| Applicable Environment | Ambient temperature ≤30℃ | |||||
| Noise | ≤ 55dB | |||||
| Accessories | Vacuum pump, 2 KF25 clamps, 1 KF vacuum hose | |||||
Whether a pharmaceutical product is suitable for freeze-drying depends on its heat sensitivity and stability requirements. The following pharmaceutical products are generally well-suited for freeze-drying:
Biologics: Vaccines, antibodies, proteins, peptides, enzymes, hormones, and other highly temperature-sensitive active substances—freeze-drying is the gold standard process for maintaining their long-term activity.
Antibiotics: Such as penicillins and cephalosporins, which can address the issue of potency decline in humid and hot environments.
Diagnostic reagents: Products that require the preservation of activity, such as enzyme-linked immunosorbent assay (ELISA) kits and nucleic acid detection kits.
Freeze-drying stabilizes drugs at the molecular level through a dual mechanism of water removal and low-temperature processing:
Inhibiting hydrolysis reactions: Water serves as both a medium and a reactant in many degradation reactions. Freeze-drying reduces water content to 1%–3%, physically blocking chemical degradation pathways such as hydrolysis and oxidation, thereby preserving the drug’s chemical integrity.
Inhibits microbial growth: Extremely low water activity creates an environment where microorganisms cannot survive, preventing biological spoilage.
Protects heat-sensitive molecular structures: Processing at low temperatures throughout (typically below -40°C) prevents structural damage—such as protein denaturation and antibody inactivation—caused by high temperatures.
Forms a stable physical form: Freeze-drying produces a loose, porous, sponge-like “cake” with a large specific surface area and stable physicochemical properties, capable of maintaining efficacy for several years at room temperature.
Rapid Rehydration: The porous structure allows for complete rehydration within seconds upon contact with a solvent, restoring the original therapeutic efficacy.
When selecting a freeze-drying service provider, a comprehensive evaluation should be conducted across the following seven key dimensions:
Technical Capabilities and Experience: Does the provider have experience in developing freeze-drying processes tailored to your specific material type (e.g., proteins, vaccines, diagnostic reagents)? Can they provide technical support such as eutectic point testing and freeze-drying curve optimization?
Equipment Performance and Compliance: Do core parameters—such as cold trap temperature, shelf uniformity (temperature difference ≤ ±1°C), and vacuum level—meet standards? In the pharmaceutical sector, confirm that IQ/OQ/PQ validation documents are provided and comply with GMP/FDA requirements.
Production Capacity and Scalability: Does the single-batch processing capacity meet your needs? Do they have the capability for seamless scale-up from laboratory pilot testing to pilot production and then to industrial-scale production?
Quality Management System: Are they certified to ISO 9001, ISO 13485, or similar standards? Do they have a comprehensive system for batch records and data traceability?
Customized Services: Can they customize freeze-drying solutions and equipment configurations based on material characteristics and production capacity requirements? Do they offer custom design capabilities?
After-Sales Service: Coverage of the after-sales service network, response time to malfunctions (recommended within 24 hours), spare parts lead time, and the continuity of process support.
Long-Term Costs: Consider the total cost of equipment acquisition, operating energy consumption, maintenance frequency, and service life comprehensively, rather than focusing solely on the initial quote.