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, -55°C shelf temp, eco-friendly refrigerants, stable & energy-saving.
- Vacuum System: Oil‑free vacuum pumps, ultimate vacuum ≤1.0 Pa, contamination‑free operation, high cleanliness.
- Pneumatic & Hydraulic Systems: Precise control of shelf movement, stoppering, and valve actuation, GMP‑grade reliability.
- Automatic Cleaning & Sterilization System: Fully automatic CIP/SIP, pure steam sterilization, validated to cGMP aseptic standards.
- SCADA Control System: Industrial PLC+SCADA, automated control, real-time monitoring, full audit trail & e-signatures.
- Drying Chamber & Ice Condenser: High-precision shelves (<1mm flatness), -75°C condenser, 1000kg ice capacity, maintains 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 SS chamber & piping, Ra≤0.4μm, dead-leg-free for easy cleaning/sterilization.
- Isolator/RABS Ready: Standard interfaces for seamless integration with isolators, RABS, and automated loading/unloading systems.
- Sustainable Operation: Optimized energy control reduces consumption by ≥15%; oil-free vacuum pump optional.
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 & EU Annex 11, with 3-level access, audit trail, e-records.
- Remote Monitoring & Diagnostics: Remote HMI for real-time status, alerts, remote diagnostics & upgrades; 24/7 global 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: Leverages extensive freeze-drying database to accelerate scale-up from R&D to production.
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
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
- 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
