The INS-FD-400 SIP/CIP Pharmaceutical Freeze Dryer is a high-performance vacuum freeze-drying system designed for pharmaceutical, biotechnology, and sterile production environments. Built with full SIP (Sterilization-in-Place) and CIP (Cleaning-in-Place) compliance, it meets GMP, cGMP, FDA, and EU regulatory standards.
The drying chamber is constructed from AISI 316L stainless steel with a rectangular design and ultra-smooth surface finish (Ra ≤ 0.4 µm), ensuring excellent cleanliness and contamination control. The system provides an effective drying area of ≥ 5.4 m² and supports stable, uniform shelf temperature control using silicone oil heat transfer technology.
Equipped with dual BITZER (Germany) compressors and R404A refrigerant, the freeze dryer delivers reliable refrigeration performance with coil temperatures reaching ≤ -70°C. Rapid cooling performance allows shelves to cool to -40°C within 60 minutes and the condenser within 30 minutes. The condenser supports up to 100 kg of ice per batch, ensuring efficient moisture capture during freeze-drying cycles.
Vacuum performance is optimized with an ultimate vacuum of ≤ 2.6 Pa, achieving atmospheric pressure down to 10 Pa within 30 minutes. The DN300 mm hydraulic mushroom valve, made from AISI 316L stainless steel, provides leak-proof operation with feedback control for enhanced process safety.
The system is controlled by a Mitsubishi PLC with touchscreen HMI and integrated industrial PC, supporting both automatic and manual operation modes. Process data can be stored for up to 10 years, ensuring full traceability and compliance with pharmaceutical documentation requirements.
Key Technical Parameters:
- Drying Chamber: AISI 316L stainless steel, rectangular, Ra ≤ 0.4 µm
- Effective Shelf / Plate Area: ≥ 5.4 m²
- Shelf Temperature Range: -50°C to +80°C
- Temperature Uniformity: ±1°C
- Heating Rate: ≥ 1°C/min (silicone oil heat transfer)
- Condenser Capacity: 100 kg ice per batch
- Vacuum Performance: Ultimate vacuum ≤ 2.6 Pa
- Refrigeration System: BITZER (Germany) compressors ×2, R404A refrigerant
- Cooling Performance:
- Shelf to -40°C ≤ 60 minutes
- Condenser to -40°C ≤ 30 minutes
- Control System: Mitsubishi PLC, touchscreen HMI, industrial PC
- Mushroom Valve: DN300 mm hydraulic, AISI 316L, leak-proof with feedback control
- Overall Dimensions (Approx.): 4500 × 1500 × 3500 mm (L × W × H)
- Power Consumption: 33.5 kW
- Weight: Approx. 6 tons
- Compliance: GMP / cGMP, FDA & EU compliant
Application:
Ideal for pharmaceutical, biotech, and sterile production processes requiring high-precision freeze-drying with full SIP and CIP compliance.