BIOCOOL LYO-3 Production-Scale Freeze Dryer
| Brand | BIOCOOL |
|---|---|
| Origin | Beijing, China |
| Model | LYO-3 |
| Instrument Type | Standard Shelf-Type Freeze Dryer |
| Application | Production-Scale Lyophilization |
| Freeze-Drying Area | 3 m² |
| Ultimate Vacuum | <3 Pa |
| Condensate Capacity (24 h) | 60 L/24 h |
| Cold Trap Temperature | <−70 °C |
| Shelf Temperature Range | −55 °C to +80 °C |
| Shelf Uniformity | ±1.0 °C |
| Power Consumption | 21 kW |
| Shelf Configuration | 6+1 shelves (600 × 900 mm) |
| Compliance | Meets GB150-2011, PED, ASME, FDA 21 CFR Part 11, GMP, and CIP/SIP requirements |
Overview
The BIOCOOL LYO-3 is a production-scale, shelf-type freeze dryer engineered for reproducible, scalable lyophilization under strict regulatory conditions. It operates on the fundamental principle of sublimation—removing water from frozen materials under deep vacuum while maintaining product integrity through precise thermal control. Designed for pharmaceutical, biotechnology, and high-value industrial applications, the LYO-3 integrates robust pressure vessel construction, fully validated CIP (Clean-in-Place) and SIP (Sterilize-in-Place) systems, and deterministic process control architecture compliant with current Good Manufacturing Practice (cGMP) and FDA 21 CFR Part 11 requirements. Its 3 m² shelf area supports batch processing of up to 6,300 vials (Ø22 mm), making it suitable for clinical trial material production, pilot-scale process development, and commercial manufacturing support.
Key Features
- Shelf pre-freezing capability enables uniform nucleation and eliminates secondary freezing artifacts.
- Programmable process control system with 2,000 user-definable or factory-loaded lyo cycles; all parameters—including shelf temperature ramp rates, hold times, vacuum setpoints, and pulse backfill profiles—are fully editable and auditable.
- Triple-mode pulse backfill system (slow/medium/fast) minimizes particle displacement during inert gas repressurization, preserving morphology of fragile amorphous or fibrous products.
- Real-time endpoint determination via integrated residual moisture assessment logic during desorption drying, reducing cycle time without compromising final moisture content specifications.
- Dynamic vacuum regulation during primary and secondary drying stages prevents melt-back, collapse, and vial deformation in sensitive formulations.
- Industrial-grade 15-inch touchscreen HMI with intuitive workflow navigation; no operator manual required for routine operation.
- High-frequency data acquisition at 50 ms intervals for shelf temperature, condenser temperature, chamber pressure, and vacuum rate—enabling granular process characterization and PAT (Process Analytical Technology) readiness.
- Temperature and vacuum calibration functions ensure metrological traceability over extended operational lifetimes.
- Comprehensive freeze-drying curve visualization (shelf temp, product temp, chamber pressure, condenser load) for post-run analysis and cycle optimization.
Sample Compatibility & Compliance
The LYO-3 accommodates a wide range of biologicals, proteins, vaccines, diagnostics, and sterile small-molecule APIs. Its stainless-steel chamber (AISI 316L), mirror-polished interior surfaces, and zero-radius internal corners comply with ISO 13485 and EU Annex 1 hygienic design principles. Pressure containment is certified to 0.15 MPa positive / 0.5 Pa negative per GB150-2011 and PED 2014/68/EU. All welds—including those in vacuum lines, CIP/SIP piping, and chamber internals—are executed using orbital TIG welding and verified by helium mass spectrometry leak testing. The SIP system employs pulsed vacuum steam sterilization with Fo-value calculation, real-time recording, triple overpressure protection, and integrated cooling—validated to deliver ≥12-log microbial reduction at 150 °C. CIP validation includes residue recovery studies using conductivity and TOC endpoints. Full audit trails, electronic signatures, and immutable data storage satisfy FDA 21 CFR Part 11 requirements.
Software & Data Management
The embedded control software provides full lifecycle data governance: event-driven logging, role-based access control, digital signature enforcement, and automatic backup to redundant local SSD and optional network-attached storage. Raw process data (CSV/SQL export) includes timestamped values for all controlled and monitored variables. PC-based remote monitoring supports secure Ethernet/WAN connectivity up to 1.5 km with TLS 1.2 encryption. Optional add-ons include co-located coagulation point measurement (for formulation-specific eutectic determination), dry vacuum pump integration (oil-free operation), organic solvent trapping, and cascade refrigeration for ultra-low condenser temperatures (<−85 °C). All firmware updates undergo version-controlled release validation prior to deployment.
Applications
The LYO-3 is routinely deployed in: (1) Phase I–III clinical drug substance manufacturing where batch consistency and regulatory submission readiness are critical; (2) cell therapy and mRNA vaccine lyophilization requiring strict oxygen exclusion and nitrogen backfilling; (3) diagnostic reagent stabilization under cGMP-aligned environments; (4) high-value nutraceutical and enzyme preservation where activity retention >95% is mandated; and (5) contract development and manufacturing organization (CDMO) facilities performing tech transfer from lab-scale to commercial processes. Its modular architecture allows seamless integration into automated fill-finish lines via SECS/GEM or OPC UA protocols.
FAQ
What regulatory standards does the LYO-3 meet?
It complies with GB150-2011, PED 2014/68/EU, ASME BPVC Section VIII Div. 1, FDA 21 CFR Part 11, EU GMP Annex 1, and ISO 13485.
Is the system qualified for sterile manufacturing?
Yes—fully validated CIP and SIP systems, including Fo-based sterilization cycles, pressure vessel certification, and helium-leak-tested integrity make it suitable for aseptic processing environments.
Can process data be exported for regulatory submissions?
All raw sensor data, alarm logs, operator actions, and electronic signatures are exportable in ALCOA+ compliant formats (CSV, PDF, SQL) with full metadata and hash-verified integrity.
What maintenance support is included?
One-year comprehensive warranty, onsite installation and commissioning, two days of operator training, one lyophilization process optimization session (sample submission required), and lifetime technical support with optional service contracts.
Are IQ/OQ/PQ protocols available?
Yes—BIOCOOL supplies vendor-qualified IQ/OQ documentation packages aligned with ASTM E2500 and ISPE Baseline Guide principles; PQ execution support is provided on-site.
