1. Advanced System Technologies
LYOPHARMA is built on six core subsystems that work in synergy to deliver efficient, compliant, and continuous production:
- Refrigeration System: High‑efficiency screw compressors, shelf temperature as low as -55°C, eco‑friendly refrigerants, stable and energy‑saving.
- Vacuum System: Oil‑free vacuum pumps, ultimate vacuum ≤1.0 Pa, contamination‑free operation, high cleanliness.
- Pneumatic and Hydraulic Systems: Precise control of shelf movement, stoppering, and valve actuation, GMP‑grade reliability.
- Automatic Cleaning and Sterilization System: Fully automatic CIP/SIP cycles, pure steam sterilization capability, validated to cGMP aseptic standards.
- SCADA Control System: Industrial PLC + SCADA architecture, fully automated process control, real‑time data monitoring, complete audit trail and electronic signatures.
- Drying Chamber and Ice Condenser: High‑precision shelves (flatness <1 mm), condenser temperature as low as -75°C, ice capacity up to 1000 kg, maintaining system vacuum.
2. Design Features
- Superior Temperature Uniformity: Dual‑circulation silicone oil system, shelf temperature uniformity ≤ ±1°C, consistent batch drying.
- Full cGMP Compliance: Designed to cGMP, FDA, and EU standards, complete validation documentation package (FAT/SAT/IQ/OQ).
- Modular Layout: Available in integral or split configuration to flexibly adapt to facility space and capacity needs.
- High‑Quality Materials: 316L stainless steel chamber and piping, internal surface roughness Ra≤0.4μm, dead‑leg‑free design for easy cleaning and sterilization.
- Isolator/RABS Ready: Standard interfaces for seamless integration with isolators, RABS, and automated loading/unloading systems.
- Sustainable Operation: Optimized energy control reduces energy consumption by ≥15% compared to conventional designs; oil‑free vacuum pump option available.
3. Intelligent Solutions
- Fully Automated Process Control: SCADA system stores thousands of freeze‑drying recipes, one‑touch recall, unattended operation.
- Data Integrity & Compliance: Meets FDA 21 CFR Part 11 and EU Annex 11 requirements, including three‑level user access, audit trail, and electronic records.
- Remote Monitoring & Diagnostics: Remote HMI for real‑time status monitoring, fault alerts, remote diagnostics, and software upgrades, 24/7 global technical support.
- Lifecycle Validation Services: Complete support from URS, DQ, FAT, SAT to IQ/OQ, on‑site CSV assistance to ensure compliant handover.
- Process Scale‑Up Support: Leveraging an extensive freeze‑drying process database to help customers rapidly transfer and scale up from R&D to production batches.
4. Optional Configurations
Users can select the following modules based on process needs:
- External CIP water tank
- Hydraulic stoppering system
- Mushroom valve isolation device
- Oil‑free vacuum pump system / Rotary vane vacuum pump
- Screw compressor (for higher cooling capacity)
- SIP system extension unit
- Sub‑door (pizza door) system
5. Automatic Loading/Unloading System
LYOPHARMA can be integrated with the following automated loading/unloading systems to enable sterile, continuous, unattended production:
- Fully Automatic Fixed Row‑by‑Row (RBR) System: Automatically connects the filler to the freeze dryer’s pizza door, pushes/pulls vials row by row, and transfers to the capper after unloading. Speed up to 300 vpm (based on 2 ml vials). Optional sterile isolator or RABS, no manual intervention.
- Fixed Tray Loading System / Mobile AGV System: Suitable for sterile APIs or bulk materials. Trays move row by row into and out of the freeze dryer. No change parts required, compatible with multiple container sizes. Supports fully or semi‑automatic operation for flexible production needs.
6. Technical Specifications (Range)
The LYOPHARMA series covers drying capacities (ice capacity) from 40 L to 1000 L, with typical parameters:
Shelf area: 2 m² to 50 m²
Number of usable shelves: 4 to 15
Shelf temperature: -55°C (lower optional)
Condenser temperature: -75°C
Ultimate vacuum: ≤1.0 Pa
2 ml vial loading capacity: approx. 17,000 to 200,000 vials
Installation: integral or split design
For detailed model specifications (LyoPharma‑2 to LyoPharma‑50), please refer to the data sheet.
2. Design Features
