Lyophilization is the critical preservation technology for biologics, vaccines, injectable APIs, and any product where heat or moisture degrades potency during conventional drying. A lyophilizer failure — cycle deviation, shelf temperature non-uniformity, or inadequate vacuum performance — cannot simply be repeated: the batch is lost. Selecting the right freeze dryer, and a manufacturer with proven scale-up continuity from lab to production, is a formulation development decision as much as an equipment decision.
Canaan has over 15 years of lyophilization technology experience, supplying pharmaceutical freeze dryers from benchtop R&D scale (0.5 m² shelf area) to large-scale commercial production (41.2 m², 182,000+ vials per load) — with the same system design and control logic across all scales to ensure smooth, validated scale-up. Complete lyophilization line solutions including automated loading/unloading systems are available.
Full range from LYOMINI 10 (0.5 m², 2,347 vials) to LYOROCK 800 (41.2 m², 182,865 vials) — with consistent system design enabling validated scale-up without reformulation.
LYOMINI 10 condenser reaches ≤−75°C — critical for trapping sublimated water vapour efficiently and maintaining vacuum integrity throughout primary and secondary drying cycles.
SIEMENS PLC + SCADA system complying with 21 CFR Part 11 for electronic batch records, audit trail, and data integrity — standard on all production-scale LYOROCK units.
All Canaan lyophilizers comply with cGMP, FDA, and EU GMP requirements. Isolator/oRABS integration and automated loading/unloading system available for aseptic processing lines.
Select your freeze dryer based on your current development stage and target production scale. Canaan's consistent system design across all models means process parameters developed on the LYOMINI 10 transfer predictably to the LYOROCK production units — reducing the number of validation cycles required during scale-up.
| Stage | Typical application | Shelf area | Vials (Φ16mm) | Model |
|---|---|---|---|---|
| Lab / Formulation R&D | Formulation screening, cycle development, small-batch feasibility studies | 0.5 m² | 2,347 | LYOMINI 10 |
| Pilot / Scale-up | Process development bridge, clinical trial material, small commercial batches | 1.1 – 2.8 m² | 4,032 – 9,720 | LYOMINI 20 / LYOMINI 60 (Pilot) |
| Small-scale Production | Phase III / commercial launch quantities, orphan drug, high-value biologics | 5.0 – 10.0 m² | 22,038 – 44,244 | LYOROCK 100 / 150 / 200 |
| Commercial Production | High-volume injectable manufacturing, vaccines, large-scale biologics | 14.9 – 41.2 m² | 63,690 – 182,865 | LYOROCK 300 – 800 |
All Canaan lyophilizers use the same SIEMENS PLC control architecture, Atlas vacuum systems, and SIHI HALBERG/SPECK water ring pumps across scales — ensuring process parameter transferability and consistent regulatory documentation from lab through commercial production.
A lyophilizer and a freeze dryer are the same equipment — "lyophilizer" is the pharmaceutical industry term (from "lyophilization"), while "freeze dryer" is the more general term used across food, chemical, and research applications. Both refer to equipment that removes water from a product by first freezing it, then reducing the surrounding pressure and applying controlled heat to allow the frozen water to sublimate directly from solid to vapour, bypassing the liquid phase. In pharmaceutical manufacturing, "lyophilizer" specifically implies compliance with cGMP requirements and pharmaceutical-grade design standards for injectable product manufacturing.
Lyophilization is used for any product where moisture removal is required but the product cannot tolerate the temperatures of conventional drying. Common pharmaceutical applications include: injectable biologics (monoclonal antibodies, proteins, enzymes), vaccines (live attenuated, recombinant), peptides and amino acid formulations, small molecule APIs that are unstable in aqueous solution, liposomal drug products, diagnostic reagents and reference standards, and oral pharmaceutical products such as orally disintegrating tablets and oral lyophilizates. Food and nutrition products (instant coffee, nutraceuticals), cosmetics, and chemical intermediates can also be processed on Canaan lyophilizers.
Canaan designs all lyophilizer models — from LYOMINI 10 to LYOROCK 800 — with the same system architecture, control logic, and PLC programming. This means a freeze drying cycle (shelf temperature ramp rates, primary drying pressure and temperature setpoints, secondary drying parameters) developed on a small LYOMINI unit can be transferred to the LYOROCK production unit with minimal adjustment. The consistent shelf thickness (22 mm across all production units) and heat transfer design also contribute to predictable scale-up. This reduces the number of engineering batches required for process validation at production scale — a significant time and cost advantage over transferring between equipment with fundamentally different designs.
Yes. Canaan supplies complete lyophilization line package solutions beyond the lyophilizer itself — including automated loading and unloading systems for transferring vials into and out of the lyophilizer chamber under aseptic conditions, and isolator/oRABS integration for high-containment applications. For commercial-scale facilities, the automated loading/unloading system eliminates manual operator intervention in the aseptic zone during the most contamination-critical transfer steps. Contact Canaan's project engineering team with your facility layout, production target, and aseptic processing classification to discuss a complete lyophilization line design.
All Canaan lyophilizers for pharmaceutical use comply with cGMP (current Good Manufacturing Practice), FDA equipment design requirements, and EU GMP Annex 1 requirements for sterile medicinal products. The SCADA control system on production-scale LYOROCK units complies with 21 CFR Part 11 for electronic records and electronic signatures — providing audit trail, access control, and tamper-proof batch record generation. CIP (clean-in-place) and SIP (sterilise-in-place) systems are integrated, with pure steam supply for SIP. IQ/OQ/PQ validation documentation packages are available to support customer site qualification.
Select the LYOROCK model based on your target vials per batch or shelf area requirement. Start with your annual production target: divide by your planned number of batches per year and your cycle time to calculate vials per load. Then select the model where your vials per load falls within the capacity — allowing for 10–15% headroom to accommodate future demand growth without requiring a larger unit. For bulk product lyophilization, use the bulk solution volume column. Contact our application engineers with your product type, vial size, fill volume, batch size, and annual production target — we will calculate the appropriate model size and confirm utility requirements for your facility.
Tell us your product type, vial size and fill volume, target batch size, annual production requirement, and facility layout — our lyophilization engineers will recommend the right model and provide a detailed technical and commercial proposal within 24 hours.
✓ Response within 24 hours ✓ 15+ years lyophilization experience ✓ NDA available on request
Lyophilization is typically one part of an injectable or biologic manufacturing line. Canaan supplies related upstream and packaging equipment.
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