Lyophilizer — Technical Specification

Official Equipment Specification

This document provides the technical specification for lyophilization systems used at SENO Biotechnology. For commercial inquiries, visit the SENO Biotechnology Official Website.

1. Technical Parameters

Parameter	Specification	Notes
Condenser Temperature	−80 °C	Two-stage cascade refrigeration, CFC-free
Shelf Temperature Range	−40 °C to +60 °C	Silicone oil circulation
Temperature Control Accuracy	±1.0 °C across all shelves	Uniformity verified by 3-point mapping
Ultimate Vacuum	<0.01 mbar	Dry scroll or oil-sealed rotary vane pump
Vacuum Control Range	0.01 – 1.0 mbar	Pirani gauge, adjustable setpoint
Shelf Material	316L Stainless Steel	Ra ≤0.8 µm surface finish
Shelf Flatness	±0.5 mm	For uniform heat transfer
Number of Shelves	4 – 8 (model-dependent)	Adjustable spacing
Total Shelf Area	0.5 – 5.0 m²	Model-dependent
Ice Capacity	10 – 40 kg	Before defrost required
Refrigerant	R-404A / R-508B (cascade)	CFC-free, low GWP alternatives available

2. System Components

Component	Type	Specification
Chamber	316L SS cylindrical	Pressure-rated for full vacuum to 2 bar overpressure
Condenser	Internal coil, −80 °C	Direct expansion refrigeration
Refrigeration	Two-stage cascade	Stage 1: −40°C, Stage 2: −80°C
Vacuum Pump	Dry scroll or oil-sealed rotary vane	10 – 40 m³/h displacement
Control System	PLC with color touchscreen HMI	Recipe programming, data logging, alarm management
Temperature Sensors	PT100 RTD (shelf-mounted)	±0.1 °C accuracy
Pressure Sensor	Pirani + Piezo (dual)	1 × 10⁻³ to 1000 mbar
Vent Filter	0.22 µm hydrophobic PTFE	Sterile nitrogen backfill

3. Cycle Phase Parameters

Phase	Target Temp	Ramp Rate	Hold Time	Vacuum Setpoint	Purpose
Loading	4 °C	—	Variable	Atmospheric	Product placement
Freezing	−40 °C	0.5 – 2.0 °C/min	2 – 4 h	Atmospheric	Complete solidification
Primary Drying	−10 °C	0.3 – 0.5 °C/min	12 – 36 h	0.05 – 0.1 mbar	Ice sublimation
Secondary Drying	+25 °C	0.1 – 0.3 °C/min	4 – 8 h	<0.02 mbar	Bound water desorption
Backfill	+25 °C	—	5 min	N₂ to atmospheric	Product removal

4. Acceptance Criteria

Parameter	Criteria	Method
Residual Moisture	≤1.0% (bulk), ≤0.5% (formulated)	Karl Fischer coulometric titration
Cake Appearance	Uniform, no collapse or melt-back	Visual inspection
Product Temperature	Within 2 °C of shelf temperature at end of each phase	In-process PT100 probe
Vacuum Stability	Stable <0.02 mbar for ≥1 h before termination	Pirani gauge trend
Pressure Rise Test	<0.01 mbar/min	Valve isolation test

5. Maintenance Schedule

Frequency	Activity
After each cycle	Chamber wipe-down with 70% IPA; inspect door seal
Weekly	Condenser defrost (manual or automatic); drain condensate
Monthly	Vacuum pump oil level check (if oil-sealed); inlet filter inspection
Quarterly	Temperature sensor calibration (PT100 vs certified reference, ±0.5 °C)
Semi-annually	Vacuum pump oil change (oil-sealed) or bearing inspection (dry)
Annually	Refrigerant pressure check; vacuum leak test; full PM