Lyomac offer all pilot scale lyophilization solution
(Capacity ranging : 20~ 150 Liters)
✓ More capacity for your requirement
✓ Better efficiency and performance
✓ GMP & FDA compliance
Lyomac offers highly customizable freeze-drying solutions tailored to your specific product types, production capacities（range from 20-150 Liters）, and customerize design for your facility layouts. Whether you need special performance for your process, GMP-compliant systems for vials or API materials, our diverse range of process options and specialized configurations ensures optimal performance. For more details on capacity scaling and customized solutions, please review the information below.
Expert on commercial production for API and vial lyophilization
As a professional manufacturer of commercial freeze dryers, we have successfully delivered over 300 projects globally in the past two decades. These installations, primarily dedicated to the production of APIs, sterile raw materials, and injectable vials, fully comply with FDA and cGMP standards.
We offer extensive customization options, backed by comprehensive local support and long-term maintenance services. Contact us today to select the ideal equipment for your needs, including our range of advanced electronic solutions.
Models and specifications for your needs:
The pilot model freeze dryer with drying capacity up to 150 Liters,cover most demand for vial or other material commercial production,compliance with cGMP and FDA. More optional systems available, main features are:
◆Automatic shelf stoppering under vacuum
◆Automatic control for freeze drying,SIP,CIP and De-icing system
◆Auto dosing system for API liquid / Auto loading for vials
◆Scada control system comliance with GAMP regulation and save up to thousand recipes
◆Shelf flatness less than 1.0mm,temperature uniformity less than 1C.
◆Energy saving control system by control compressor and vacuum pump
◆Oil or dry vacuum pump
◆Flexible arrangement design,suit user’s plant layout,thus space saved
LYOMAC pilot lyophilizers bridge laboratory R&D and commercial manufacturing. Optimized for process development, cycle validation and medium batch production for CDMOs, biotech startups and 503B outsourcing facilities. Radiant shelf heating eliminates local overheating and improves batch repeatability. Process parameters can be directly scaled up to industrial production freeze dryers.
Standard Specifications
- Shelf Area Range: 1.0~ 7.5 ㎡
- Shelf Temperature Range: -55 ℃ ~ +80 ℃
- Shelf Temperature Uniformity: ≤ ±1.0 ℃
- Condenser Temperature: ≤ -75 ℃
- Ultimate Vacuum: ≤ 1Pa
- Heating Method: Conductive shelf heating
- Wetted Parts: 316L stainless steel
- Control: SCADA system, audit trail, electronic batch record with 21CFR compliance
- Standard Door: Stainless steel hinged door or sub door for auto loader connection
Optional Configuration
- Automatic vial stoppering under vacuum
- CIP (Clean-in-Place)
- SIP (Sterilize-in-Place)
- Online eutectic point detection
- Inverter energy-saving control
- Isolator / RABS interface for aseptic operation
Typical Applications
- Peptide process validation, sterile injectable API trials, 503B compounding production, biologic formulation, probiotic pilot production, food & nutraceutical testing.
- Regenerative & Aesthetic Peptide Lyophilization
- 503A / 503B Compounding Pharmacy Solutions
Model List：
| Parameter | LYOPRO-1.0 | LYOPRO-2.0 | LYOPRO-3.0 | LYOPRO-5.0 | LYOPRO-7.5 |
|---|---|---|---|---|---|
| Drying Capacity (Liter) | 20 | 40 | 60 | 100 | 150 |
| Shelf Size (mm) | 600×450×20 | 900×600×20 | 900×600×20 | 1200×900×20 | 1200×900×20 |
| Useful Shelf No | 4 | 4 | 6 | 5 | 7 |
| Vial Loading Quantity φ16 | 4400 | 9000 | 14000 | 20000 | 32000 |
| Vial Loading Quantity φ22 | 2200 | 4500 | 7500 | 10000 | 16000 |
| Inter-Shelf Distance (mm) | 90 | 90 | 90 | 90 | 90 |
| Shelf Ultimate Cooling Temp (°C) | -55 | -55 | -55 | -55 | -55 |
| Condenser Ultimate Cooling Temp (°C) | -75 | -75 | -75 | -75 | -75 |
| Ultimate Vacuum (Pa) | ≤1 | ≤1 | ≤1 | ≤1 | ≤1 |
| Installation Dimension (mm) | 3000×1400×2200 | 3200×1500×2200 | 4000×1500×2200 | 4500×1750×2200 | 5000×1750×2400 |
| Weight (Kgs) | 2000 | 3500 | 4500 | 7500 | 8500 |
| Power (KW) | 18.0 | 22.0 | 28.0 | 40.0 | 52.0 |
