Freeze Dryer Monitoring Function

1.152 m² shelf area, in-situ silicone-oil stoppering, ±1 °C uniformity — engineered for clinical-supply lyophilization cycles.

The Freeze Dryer Monitoring Function is a pilot-scale in-situ silicone-oil freeze dryer engineered for pharmaceutical scale-up, clinical supply and process development. It combines a CIP-ready 304 stainless-steel chamber, automatic hydraulic stoppering and recipe-driven PLC control for repeatable lyophilization cycles.

The Freeze Dryer Monitoring Function delivers production-grade lyophilization hardware at pilot scale, with in-situ silicone-oil thermal transfer and vacuum hydraulic stoppering in a compact footprint.

  • In-situ silicone-oil thermal transfer with ±1 °C shelf uniformity
  • 304 stainless-steel drying chamber and condenser with hydraulic stoppering
  • PLC + 10″ HMI with recipe library and freeze-dry curve logging
  • Air-cooled compressor and vacuum pump; water-cooling option available
  • Optional 21 CFR Part 11 data-integrity package
ModelRNE90359
Shelf Area50.8 m²
Shelves17 + 1
Shelf Temperature−50 °C to +70 °C
Condenser Temperature≤ −75 °C
Ice Capacity800 kg / batch
Vacuum Level≤ 5 Pa
ControlPLC + touch HMI (per layout drawing)

One line, five steps, zero hand-offs

One vessel, one recipe, repeatable lyophilization

Shelf temperature, vacuum and condenser performance are controlled through a single HMI recipe, enabling direct scale-up from the LGJ-50FG/Y and LGJ-10NA models.

1

Loading & pre-freeze

Vials or trays are loaded and shelves ramp down to freeze the product in place.

2

Primary drying

Sublimation under ≤ 5 Pa vacuum; shelf temperature follows the programmed ramp.

3

Secondary drying

Desorption stage raises shelf temperature to strip residual moisture.

4

In-situ stoppering

Hydraulic press seats stoppers inside the chamber under vacuum or inert gas.

5

Backfill & unload

Chamber is backfilled with nitrogen and sealed vials are unloaded.

Product description

The Freeze Dryer Monitoring Function delivers production-grade lyophilization hardware at pilot scale, with in-situ silicone-oil thermal transfer and vacuum hydraulic stoppering in a compact footprint.

  • In-situ silicone-oil thermal transfer with ±1 °C shelf uniformity
  • 304 stainless-steel drying chamber and condenser with hydraulic stoppering
  • PLC + 10″ HMI with recipe library and freeze-dry curve logging
  • Air-cooled compressor and vacuum pump; water-cooling option available
  • Optional 21 CFR Part 11 data-integrity package

Product related

Frequently Asked Questions (FAQs)

Please visit our FAQ page before reaching out to our customer support. Our team regularly updates this resource to provide you with the most up-to-date and comprehensive information, saving you valuable time.

Are your machines GMP-compliant?

All DIAGNOSEX process equipment is designed and manufactured in accordance with GMP / cGMP principles. Documentation packages supporting regulatory submissions — including material certificates, calibration records, and design qualifications — are available upon request.

Yes. Vial and stopper formats, throughput, automation level, cleanroom classification, and integration with upstream or downstream equipment can all be tailored to your process. Share your requirements and our engineers will propose a configuration.

Standard configurations generally ship within 8–12 weeks after order confirmation. Customized or fully integrated lines typically require 12–16 weeks, depending on the scope of engineering involved.

Yes. Our engineers provide on-site installation, commissioning, and structured operator and maintenance training. Remote commissioning support and English-language video training are also available.