Cresco EngineersCommercial GMP Production Freeze Dryers21 CFR Part 11
Model: LyoMega Series
Commercial Scale GMP Pharmaceutical Freeze Dryers
The LyoMega Series encompasses 11 models across 6 shelf sizes, specifically designed for full-scale commercial GMP production. Every unit features AISI 316L mirror-finished product-contact surfaces, sealed radiant shelf plates with internally circulated silicone oil (±1 °C control), independent compressor refrigeration circuits, and oil-sealed rotary pumps reaching 0.1 mbar in ~40 minutes. Full DQ, FAT, IQ, and OQ validation protocol packages are supplied with every system.
Shelf Area Range1.0 – 40.5 m²
Shelf Temperature≥ −55 / +80 °C
Condenser Temp≥ −75 °C
Condenser Capacity27 – 756 kg
AISI 316L Contact ConstructionCIP & SIP Validated21 CFR Part 11 Electronic Signatures & Audit TrailGAMP 5 Validation Documentation Package
Key Features
- 11 models across 6 shelf sizes: 1.0 to 40.5 m² shelf area
- Shelf temperature range: ≥ −55 to +80 °C with silicone oil heat transfer (±1 °C uniformity)
- Condenser temperature: ≥ −75 °C; Condenser capacity: 27 to 756 kg ice
- Refrigeration: two-stage reciprocating compressors up to 10.8 m²; multi-screw compressors from 14.4 m²
- Oil-sealed rotary vacuum pumps (28 to 275 m³/h) with isolation valves and mist filters (0.1 mbar in ~40 min)
- CIP & SIP compatible: chamber and condenser steam sterilization up to 126 °C (130 °C on request)
- Auto Loading Ready: compatible with Auto Loading System (ALU) for direct filling line integration
- Isolator and RABS ready front interface for aseptic vial loading/unloading
Technical Specifications
Commercial Model Table (11 Models)
LyoMega 1.0 m²
Shelf: 400 × 600 mm (4 shelves) | Refrig: 2 × 5 hp | Vac: 1 × 28 m³/h | Condenser: 27 kg
LyoMega 3.2 m²
Shelf: 600 × 900 mm (6 shelves) | Refrig: 2 × 8 hp | Vac: 1 × 40 m³/h | Condenser: 67 kg
LyoMega 5.6 m²
Shelf: 900 × 900 mm (7 shelves) | Refrig: 2 × 12 hp | Vac: 2 × 80 m³/h | Condenser: 107 kg
LyoMega 7.5 m²
Shelf: 900 × 1200 mm (7 shelves) | Refrig: 2 × 16 hp | Vac: 2 × 80 m³/h | Condenser: 148 kg
LyoMega 10.8 m²
Shelf: 900 × 1200 mm (10 shelves) | Refrig: 2 × 20 hp | Vac: 2 × 175 m³/h | Condenser: 218 kg
LyoMega 14.4 m²
Shelf: 1200 × 1200 mm (10 shelves) | Refrig: 2 × 30 hp screw | Vac: 2 × 275 m³/h | Condenser: 294 kg
LyoMega 19.8 m²
Shelf: 1200 × 1500 mm (11 shelves) | Refrig: 3 × 30 hp screw | Vac: 2 × 275 m³/h | Condenser: 398 kg
LyoMega 25.2 m²
Shelf: 1200 × 1500 mm (14 shelves) | Refrig: 3 × 30 hp screw | Vac: 2 × 275 m³/h | Condenser: 532 kg
LyoMega 31.5 m²
Shelf: 1500 × 1500 mm (14 shelves) | Refrig: 3 × 50 hp screw | Vac: 2 × 275 m³/h | Condenser: 644 kg
LyoMega 35.1 m²
Shelf: 1500 × 1800 mm (13 shelves) | Refrig: 3 × 50 hp screw | Vac: 2 × 275 m³/h | Condenser: 756 kg
LyoMega 40.5 m²
Shelf: 1500 × 1800 mm (15 shelves) | Refrig: 4 × 50 hp screw | Vac: 2 × 275 m³/h | Condenser: 756 kg
Standard Equipment & Construction
Chamber Configuration
Rectangular chamber with horizontal or vertical ice condenser; separately mounted control cabinet
Chamber Metallurgy
AISI 316L mirror-finished product-contact surfaces, safety valve, validation flange, drain, illuminated sight glass, nozzles
Chamber Isolation Valve
Mushroom/butterfly type, mirror-finished, with silicone seal and hydraulic actuation
Radiant Shelves
Sealed shelf plates with internally circulated silicone oil for uniform conduction and radiation heating/cooling
Refrigeration System
Two-stage semi-hermetic reciprocating up to 10.8 m²; screw compressors from 14.4 m². Shelf cooling to −55 °C, electronic expansion valves
Vacuum System
Oil-sealed rotary pumps with isolation valves and mist filters, reaching 0.1 mbar in ~40 min with automatic vacuum control
Heat Transfer Circuit
Silicone oil circuit with hermetically sealed pumps and expansion tank; plate heat exchangers; ±1 °C shelf temperature control
Process Valves
Diaphragm, butterfly, and ball valves with AISI 316L product-contact surfaces, pneumatically actuated
CIP Spray System
Clean-in-place spray system with dedicated recirculation pump and controls
Instrumentation
PT100 temperature sensors for product, heat-transfer fluid, and each condenser circuit
Control System
PLC with PC-based graphical interface, printer, and recorder (Manual, semi-automatic, automatic modes)
Validation Package
DQ / FAT / IQ / OQ protocol package supplied with every unit
Optional Commercial Extras
Steam-In-Place (SIP)
Steam sterilization up to 126 °C (130 °C on request) with post-sterilisation drying by water-ring pump
Sterile Vent Filter
Sterile vent filter housings, single or dual in series, with manual in-situ integrity test ports
Loading Trays & Fences
AISI 316L loading trays and product fences in a range of sizes
Hydraulic Shelf Movement
Hydraulic shelf movement for easier loading of larger models
Hydraulic Stoppering
Hydraulic stoppering with bellows-sealed piston rods and bellows integrity monitoring
Variable Frequency Drive (VFD)
VFD for screw compressors reducing mechanical wear and energy use
Refrigeration Redundancy
Back-up compressors for fail-safe refrigeration
Vacuum Redundancy & Boosters
Back-up (dual) vacuum pump plus Roots booster pump for shorter pump-down times
Dry Vacuum Pump
Oil-free vacuum pump eliminating risk of oil vapour entering process
Capacitance Manometer
Heated capacitance manometer (MKS-type) with modulated vacuum control
UPS Back-up
Uninterruptible power supply for control system (minimum 10 minutes runtime)
Compliance Software
21 CFR Part 11 compliant electronic signatures and GAMP 4/5 control system documentation
Auto Loading System (ALU)
ALU integration for automated vial loading and unloading
Isolator / RABS Interface
Chamber front and loading door designed for sealed integration with an isolator or RABS
Controlled Nucleation
Uniform ice crystal structure for batch repeatability and reduced primary drying duration
Available Models & Configurations
| Model | Description |
|---|---|
| LyoMega-1.0 | 1.0 m² commercial freeze dryer, 4 shelves (400 × 600 mm), 27 kg condenser |
| LyoMega-3.2 | 3.2 m² commercial freeze dryer, 6 shelves (600 × 900 mm), 67 kg condenser |
| LyoMega-5.6 | 5.6 m² commercial freeze dryer, 7 shelves (900 × 900 mm), 107 kg condenser |
| LyoMega-7.5 | 7.5 m² commercial freeze dryer, 7 shelves (900 × 1200 mm), 148 kg condenser |
| LyoMega-10.8 | 10.8 m² commercial freeze dryer, 10 shelves (900 × 1200 mm), 218 kg condenser |
| LyoMega-14.4 | 14.4 m² screw compressor freeze dryer, 10 shelves (1200 × 1200 mm), 294 kg condenser |
| LyoMega-19.8 | 19.8 m² screw compressor freeze dryer, 11 shelves (1200 × 1500 mm), 398 kg condenser |
| LyoMega-25.2 | 25.2 m² screw compressor freeze dryer, 14 shelves (1200 × 1500 mm), 532 kg condenser |
| LyoMega-31.5 | 31.5 m² high-capacity freeze dryer, 14 shelves (1500 × 1500 mm), 644 kg condenser |
| LyoMega-35.1 | 35.1 m² high-capacity freeze dryer, 13 shelves (1500 × 1800 mm), 756 kg condenser |
| LyoMega-40.5 | 40.5 m² industrial freeze dryer, 15 shelves (1500 × 1800 mm), 756 kg condenser |
Request for Quotation & Engineering Data
Inquire About LyoMega Series
Need pricing, validation documentation (IQ/OQ), or custom application sizing? Contact our bioprocess engineering team.
Applications
- Full-scale commercial GMP injectable manufacturing
- Sterile vial lyophilization with automated ALU loading
- Aseptic manufacturing under Isolator or RABS barriers
- Biologics, vaccines, and high-value lyophilized pharmaceutical products
Calibration & Validation
ISO/IEC 17025 factory calibration certificates and IQ/OQ documentation packages are available on request.
Include in enquiryDocumentation
Technical datasheets and user manuals are available from our engineering team upon request.
Request DocumentationRelated Products
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