LYODRY Mitex Pro Series Laboratory-Scale Freeze Dryer
| Brand | MechaTech |
|---|---|
| Origin | United Kingdom |
| Model | LSM55P / LSM85P |
| Type | Shelf-Type Freeze Dryer |
| Application | Pilot-Scale Processing |
| Freeze-Drying Area | 44.5 L |
| Ultimate Vacuum | <20 Pa |
| Condensate Capacity (24 h) | 44.5 L |
| Condenser Temperature | −55 °C (LSM55P) / −85 °C (LSM85P) |
| Main Unit Dimensions | 945 × 700 × 950 mm |
| Construction | 316L Stainless Steel Chamber & Condenser |
| Control Interface | Touchscreen HMI |
| Defrost Method | Hot-Gas Defrost |
| Data Storage | Internal + USB Export |
| Mobility | Integrated Casters |
Overview
The LYODRY Mitex Pro Series Laboratory-Scale Freeze Dryer is an engineered solution for pilot-scale lyophilization, designed to bridge the gap between benchtop development and early-stage process validation. Built upon the principles of primary and secondary drying under controlled vacuum and sub-zero condensation, this system employs a dual-stage refrigeration architecture to maintain stable condenser temperatures of −55 °C (LSM55P) or −85 °C (LSM85P), enabling efficient water vapor capture from heat-sensitive biologicals, pharmaceuticals, diagnostics, and specialty chemicals. Its 44.5 L condensate capacity supports continuous operation over 24-hour cycles without manual intervention, while the stainless steel (316L) chamber and front-mounted condenser with bottom drain ensure structural integrity, corrosion resistance, and ease of maintenance—critical for GLP-compliant environments.
Key Features
- Modular shelf-type design compatible with multiple drying configurations: bulk trays, flask manifolds (with optional stopcock valves), vial racks, ampoule holders, and pilot-scale drying cabinets
- Touchscreen human-machine interface (HMI) with intuitive recipe programming, real-time parameter monitoring (chamber pressure, shelf temperature, condenser temp, elapsed time), and alarm logging
- Hot-gas defrost system significantly reduces cycle downtime by accelerating ice removal without requiring external heating elements or manual disassembly
- Integrated casters and compact footprint (945 × 700 × 950 mm) allow flexible placement on laboratory benches or within ISO Class 5–7 cleanroom support zones
- Full data traceability via internal memory and USB 2.0 port; exportable logs include timestamped pressure curves, temperature profiles, and event histories
- Front-access condenser with bottom drainage simplifies routine cleaning and minimizes cross-contamination risk during multi-batch operations
Sample Compatibility & Compliance
The Mitex Pro Series accommodates diverse sample formats—including aqueous solutions, suspensions, emulsions, and viscous formulations—across vials (2–50 mL), serum bottles, scintillation vials, and open trays up to 44.5 L volume equivalence. Its vacuum stability (<20 Pa) and precise shelf temperature control (±0.5 °C) meet critical requirements for USP , ISO 22058, and ASTM F2476 protocols governing lyophilized product quality attributes. The 316L stainless steel construction complies with FDA 21 CFR Part 11-ready data integrity standards when paired with validated software configurations, supporting audit trails, electronic signatures, and role-based access control in GMP-aligned workflows.
Software & Data Management
The embedded control firmware records all operational parameters at user-defined intervals (default: 10 s), storing up to 100 complete cycle logs internally. Data export via USB enables seamless integration with LIMS platforms or statistical process control (SPC) tools such as JMP or Minitab. Optional PC-based software (sold separately) provides advanced features including remote monitoring, automated report generation (PDF/CSV), deviation alerting, and comparative cycle analysis—facilitating technology transfer and regulatory submissions under ICH Q5C and Q5D guidelines.
Applications
- Pharmaceutical R&D: Stabilization of monoclonal antibodies, vaccines, and peptide APIs prior to formulation optimization
- Biotechnology: Preservation of cell lysates, enzyme preparations, and CRISPR reagent kits requiring low-residual moisture content (<1%)
- Academic & Contract Research: Reproducible freeze-drying studies for material science (e.g., aerogel precursors) and food matrix characterization
- In Vitro Diagnostics: Lyophilization of ELISA reagents, lateral flow assay components, and calibration standards
- Contract Manufacturing Support: Process qualification runs for clients transitioning from lab-scale to commercial lyophilizers
FAQ
What is the maximum batch size supported by the LSM55P and LSM85P models?
Both models support up to 44.5 L of total liquid volume across compatible drying configurations—equivalent to approximately 1,200 standard 20-mL vials or 40 L of bulk tray loading.
Does the system comply with 21 CFR Part 11 for electronic records?
Yes—the firmware supports audit trail generation, user authentication, and data immutability when deployed with validated software modules and documented SOPs.
Can the unit be integrated into a nitrogen-purged glovebox environment?
Yes; optional inert gas inlet ports (N₂ or argon) are available for backfilling during loading/unloading to prevent oxidation of oxygen-sensitive compounds.
Is IQ/OQ documentation available for installation and operational qualification?
Comprehensive IQ/OQ templates aligned with ISO 13485 and EU Annex 15 are provided upon request and may be customized for site-specific validation protocols.
What maintenance intervals are recommended for optimal long-term performance?
Oil change for the vacuum pump every 500 operating hours; condenser cleaning after every 10–15 cycles; annual calibration verification of pressure and temperature sensors using NIST-traceable references.
