Dara
Dara LyoMicron — Laboratory Freeze Dryer
Models: LyoMicron
Compact laboratory freeze dryer for R&D of APIs, peptides, biologics, and diagnostics. Enables seamless process scale-up with identical software recipes…
Lyophilisation · 7 min read
Buying a Freeze Dryer in India: Lab vs Pilot vs Production Scale
How to choose a laboratory or pilot freeze dryer (lyophilizer) in India — shelf area, condenser capacity and temperature, stoppering, 21 CFR Part 11, and scale-up without re-validation.
1. Start from batch size and container
Work out vials per batch × vial footprint, which gives the shelf area you need. Then work out fill volume × vials, which gives the water load that sets condenser capacity (kg of ice). Allow 20–30% headroom for growth.
2. Condenser temperature
Aqueous products are fine with a −55 °C condenser. Products containing organic solvents (tBuOH, ethanol) or with very low collapse temperatures need −85 °C or lower.
3. Shelf temperature range and uniformity
Look for −50 °C to +70 °C with ±1 °C uniformity. Poor uniformity shows up as vial-to-vial variability during scale-up.
4. Stoppering and process analytics
Internal stoppering under vacuum or nitrogen is essential for injectables. For development work, pressure-rise tests and comparative pressure (Pirani vs capacitance) measurement let you detect the end of primary drying instead of guessing it.
5. Data integrity
GMP use requires 21 CFR Part 11 / Annex 11 compliant software: user levels, audit trails and electronic records.
6. Plan the scale-up path
The biggest hidden cost is cycle re-development when moving from a lab unit to a pilot or production unit from a different vendor. Dara's LyoMicron and LyoLab share the same software as Dara production dryers, so recipes transfer between scales.
Frequently asked questions
What is the difference between a lab and a pilot freeze dryer?
Lab units (for example LyoMicron) are for formulation screening with small shelf areas. Pilot units (LyoLab 10–30 kg) are for process development and clinical batches, and have production-like features such as stoppering and CIP options.
Equipment mentioned in this guide
Dara
Dara LyoLab — Pilot-Scale Freeze Dryer (10 / 20 / 30)
Models: LyoLab 10, LyoLab 20, LyoLab 30
Pilot-scale lyophilisers for process development and small commercial batches. Available in LyoLab 10, 20, and 30 configurations with 10–30 kg ice condenser…
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