Pilot Vacuum Freeze Dryer

Pilot Vacuum Freeze Dryer

 

Pilot vacuum freeze dryers engineered for laboratory-scale process optimization, formulation research, and small-batch trial production. These systems feature precise shelf temperature control, independent refrigeration circuits, and 316L stainless steel sanitary chambers to establish exact freezing and drying curves before scaling to industrial lines.

 

 
 
Key Specifications & Quick Decision Guide

 

Model Range

Available in FD-05P (benchtop, 0.12 - 0.25 m² shelf area), FD-10P (floor-standing, 0.50 - 1.00 m²), and FD-30P (production pilot, 1.50 - 3.00 m²) series.

01

Temperature & Condenser

Condenser temperatures reach <= -55°C or -75°C to -85°C with ice condenser capacities ranging from 5 to 40 kg/24h.

02

Chamber Build

Ra <= 0.6 μm electro-polished 316L stainless steel interior paired with a 304 stainless steel exterior frame.

03

Control & Data

Siemens PLC with an industrial touch-panel HMI supporting FDA 21 CFR Part 11 compliant real-time data logging and remote diagnostic integration.

04

Vacuum Performance

Two-stage rotary vane pump paired with a Roots blower delivering ultimate vacuum pressure < 5 Pa in a dry and clean chamber.

05

 

Product Range & Technical Comparison Table

 

Model Series

Shelf Area (m²)

Condenser Temperature (°C)

Condenser Capacity (kg/24h)

Main Applications

FD-05P (Benchtop)

0.12 - 0.25

<= -55 or -80

5 - 8

Lab formulation, small peptides

FD-10P (Floor-standing)

0.50 - 1.00

<= -75 or -85

10 - 15

Pilot plant scale, clinical trial batching

FD-30P (Production Pilot)

1.50 - 3.00

<= -75 or -85

30 - 40

Small-batch biological manufacturing

 

Technical Specifications & Architecture

 
 
01
 

Shelf Configuration

Radiant heating shelves filled with medical-grade silicone oil heat transfer fluid, maintaining a temperature uniformity of <= ± 1°C. Standard maximum shelf temperature reaches +60°C (optional high-temperature configuration up to +80°C).

 
02
 

Refrigeration System

Independent refrigeration using dual-stage hermetic compressors (Bitzer/Danfoss) with R404A/R507 refrigerants.

 
03
 

Utility Requirements

Operates on 380V/50Hz/3Ph or 208-230V/60Hz/3Ph power supplies, with a chilled water supply requirement of 15°C to 20°C for condenser cooling, compressed air (>= 0.6 MPa), and a dedicated room ventilation system.

Small IQF Tunnel Freezer

 

Applications

Pharmaceuticals

Suitable for freeze-drying heat-sensitive injectables, vaccines, antibiotics, enzymes, and diagnostic reagents.

Biotechnology

Applied in preserving live attenuated bacteria, blood plasma derivatives, and nanoparticle delivery systems.

Food Science & Material Science

Used for high-value nutrient retention research, probiotics, porous ceramic matrices, aerogels, and nano-powders requiring strict particle structure retention.

 

Selection & Operational Constraints
 

Batch Mass Sizing: Total water content per batch must be calculated (e.g., an 8 kg ice vapor load from a 10 kg batch with 80% moisture) to ensure condenser capacity exceeds the volume with a 20% safety margin.

 

Loading Method: Vial processing requires built-in hydraulic or pneumatic stoppering mechanisms, whereas bulk tray drying utilizes open-face shelving with high thermal transfer rates.

 

Solvent Compatibility: Standard units handle aqueous solutions; organic solvent applications (such as tert-butanol or ethanol) require explosion-proof electrical ratings (ATEX-rated motors, solvent traps), inert gas purging, and chemical-resistant diaphragm vacuum pumps.

 

Customization & Quality Control
 

Optional Enhancements

Includes pneumatic top-down stoppering mechanisms for serum vials, automated Clean-in-Place (CIP) and Sterilize-in-Place (SIP) systems with pure steam sterilization ports, eutectic point test probes, and direct flange mounting for isolation gloveboxes.

Compliance & Testing

Pressure vessels are manufactured strictly according to ASME Section VIII / PED 2014/68/EU standards and tested at 1.5x operating pressure. Every unit undergoes helium mass spectrometer leak testing (leak rate < 1 x 10^-7 Pa·m³/s) and a 72-hour Factory Acceptance Testing (FAT) dry-run, vacuum hold test, and thermal mapping report prior to shipment. Standard catalog configurations ship within 8 to 10 weeks, while custom units with CIP/SIP or specialized stoppering require 14 to 18 weeks.

 

Frequently Asked Questions

 

 

Q: What is the maximum shelf temperature achievable during secondary drying?

A: Standard pilot models support shelf temperatures up to +60°C, with an optional high-temperature configuration reaching up to +80°C.

Q: Can this machine handle organic solvents like ethanol or methanol?

A: Standard units are configured for aqueous solutions. For organic solvents, explosion-proof requirements must be specified so units can be equipped with ATEX-rated motors, solvent traps, and chemical-resistant seals.

Q: What is the standard lead time for a pilot freeze dryer?

A: Standard catalog configurations ship within 8 to 10 weeks, while fully customized units with CIP/SIP or specialized stoppering require 14 to 18 weeks.

Q: What utilities must be prepared on-site prior to delivery?

A: Facilities require a stable 3-phase power supply, compressed air (>= 0.6 MPa) for pneumatic valves and stoppering, an external cooling water source or chilled water loop, and a dedicated room ventilation system.

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