Pharmaceutical freeze dryers
Advanced automatic loading and unloading systems that fulfill the highest level of cleanliness and following strictly the first air principle.
Built for the pressures facing modern lyophilization
Built for the most strict requirements from Top tier Pharmaceutical companies.
Annex 1 compliance, high speed loading/unloading systems, cold shelf loading, solvents and high potent configurations, all integrated under RABS or Isolators.
Fewer interventions. Every line, Every batch.
How to connect freeze dryers to barrier systems under Annex 1?
Legacy freeze dryer lines without barrier compatibility force costly retrofits or re-qualification before they pass Annex 1 inspections. To meet this, Syntegon integrates freeze dryers into complete RABS and isolator lines, helping fill-finish processes stay ready for current and future regulatory requirements. Our solutions include:
- Barrier system integration with oRABS, cRABS or isolator
- Freeze dryers engineered for new and retrofit line configurations
- IQ/OQ documentation to support qualification
How to protect batch consistency at scale?
Temperature gradients across shelves cause inconsistent cake structure and unpredictable reconstitution behavior in lyophilized biologics and peptides. To reduce this risk, Syntegon keeps every shelf within 1°C of the shelf average and within 2°C across the full stack. Our process includes:
- Shelf temperature uniformity within 1°C per shelf, 2°C across the stack
- Lyonuc controlled nucleation for consistent crystal structure and pore size
- CIP validated with riboflavin test for repeatable process conditions
How to reduce manual interventions in changeovers and vial sampling?
Manual loading and unloading in Grade A zones exposes both product and operators to contamination risk with every batch. In response, Syntegon offers fully automated loading and unloading with no operator intervention after set-up. Our systems include:
- Fully automatic, semi-automatic or manual loading and unloading options
- Smart R3 automated vial reject, sampling and reintroduction
- Smart Format automatic changeover from 2R to 100R vials
Pharmaceutical freeze dryer line
Bioprocess equipment
Prepares bulk drug substance upstream, preserving product integrity before formulation and fill.
Filling and Closing
Fills and closes vials aseptically, setting up consistent conditions for freeze-drying downstream.
Freeze dryer
Removes moisture under precise shelf temperature control, protecting batch consistency at scale.
Inspection
Detects defects in lyophilized containers with automated visual inspection, verifying product quality before release.
Sterilizer
Sterilizes vials and components before fill, reducing bioburden risk ahead of Grade A processing.
Service Agreements - Ramp-Up Packages
Our Service Agreement packages with defined ramp-up add-ons get you straight from performance qualification to commercial production, designed to help meet applicable regulations.
Bioprocess equipment
Prepares bulk drug substance upstream, preserving product integrity before formulation and fill.
Filling and Closing
Fills and closes vials aseptically, setting up consistent conditions for freeze-drying downstream.
Freeze dryer
Removes moisture under precise shelf temperature control, protecting batch consistency at scale.
Inspection
Detects defects in lyophilized containers with automated visual inspection, verifying product quality before release.
Sterilizer
Sterilizes vials and components before fill, reducing bioburden risk ahead of Grade A processing.
Service Agreements - Ramp-Up Packages
Our Service Agreement packages with defined ramp-up add-ons get you straight from performance qualification to commercial production, designed to help meet applicable regulations.
Explore the complete line
Find the right freeze dryer for your production stage
LyoBeta
Best if you want:
A compact R&D unit with production-matched heating and cooling rates
LyoZeta
Best if you want:
Fast delivery and competitive pricing across formats
LyoTris
Best if you want:
A pilot unit that mirrors production behavior for scale-up
LyoMega
Best if you want:
Engineered-to-requirements freeze dryer with full automation
Download the pharmaceutical freeze dryer brochure
Download to learn how to match freeze dryer scale to your production stage.
- Compare R&D, pilot and production-scale freeze dryer configurations
- See barrier and isolator integration options across the freeze dryer range
- Review automation levels from manual to fully automatic loading
Freeze dryer technology built to solve production problems
Automatic format changeover solution
Syntegon's Smart Format changes vial formats from 2R to 100R automatically inside the freeze dryer. This removes the need to stock, store and manually swap multiple sets of format-specific parts every time your production shifts to a different vial size. That automation shows up directly in what the feature delivers:
- Automatic format changeover from 2R to 100R vials
- Removes the need for multiple sets of format parts
- Available across the LyoZeta and LyoMega platforms
Freeze dryer design modeled to your exact chamber
With a large range of Freeze dryer models, there will be a right fit for every application. With our FEM simluation models, Syntegon can calculate special solutions without risking the quality.
Lab results that mirror production performance
Syntegon's LyoBeta uses brazed plate heat exchangers to deliver heating and cooling rates of 1°C per minute, the same rate used in production freeze dryers. That means process parameters developed at lab scale align closely with commercial-scale thermal behavior, narrowing the gap between R&D trials and full production. This scale-up fidelity is built into the core equipment design:
- Heating and cooling rates of 1°C per minute, matching production units
- Chamber-condenser valve enables pressure rise testing and thermodynamic control
- Refrigeration system reaches -83°C ±3°C at the condenser and -60°C at the shelves
Frequently asked questions
Syntegon integrates pharmaceutical freeze dryers directly into complete RABS and isolator lines, including oRABS, cRABS and isolator configurations. This design approach helps fill-finish processes stay ready for current and future regulatory requirements, including EU GMP Annex 1.
Temperature gradients across shelves are the most common cause of inconsistent cake structure and unpredictable reconstitution behavior in lyophilized vials.
With a proper temperature mapping of all shelves during qualification, we ensure that the temperature homogeneity is achieved to ensure the highest quality for every batch. The use of wireless probes can also help ensure the repeatability batch after batch. See our solution with single use Sublime wireless probes.
Lab-scale results transfer more reliably when the equipment shares core thermal characteristics with production units. LyoBeta's brazed plate heat exchangers deliver a 1°C per minute heating and cooling rate, aligning lab-scale thermal behavior with Syntegon's commercial freeze dryers. This alignment narrows the gap between R&D trials and full-scale manufacturing, reducing the risk of unexpected process behavior during scale-up. Syntegon cannot guarantee identical scale-up outcomes for every formulation, since product-specific factors also affect performance.
LyoBeta is a compact R&D freeze dryer for research centers and clinical trials, with heating and cooling rates matched to production units. LyoTris bridges R&D and production as a pilot-scale cGMP unit. LyoZeta offers modular solutions across a wide range of sizes, with competitive pricing and fast delivery for pharmaceutical applications. LyoMega is engineered to requirements with several available options to fulfill the most strict specifications. Each model shares barrier system integration options, letting you scale from lab to commercial production within one connected freeze-drying approach.
Selection depends on your production stage and batch volume. Small freeze dryers like LyoBeta suit R&D, clinical trials and small batch production, with compact footprints and manual bench-scale operation. Medium options like LyoTris fit pilot-scale cGMP production, bridging R&D and commercial output. LyoZeta and LyoMega range are prepared to fulfil large size batches. Reviewing your batch size and vial type, there will be a perfect model for every application. Reviewing your batch size, format range and automation needs against the comparison table on this page helps narrow the right fit.
Interested in a pharmaceutical lyophilizer?
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