Command SJ-50F(T)
GMP Production Systems
GMP Compliance 0.5m2 shelves load; Shelf Temp :-65C to 65C Vacuum Control ESignatures(21 CFR Part 11)
Overview：
Command OS2.1 control system was developed to meet the lyophilization requirements of today’s pharmaceutical and biotechnology applications.
The system packs the highest level process control and flexibility into a software package that is as easy to use as it is multi-functional.
The SCADA system solution to deliver superior functionality, as well as faster, more intelligent control of
the freeze-drying process and related functions.
Key Features：
Graphical synoptic display with real-time system status. Full system alarming. Historical data trending, with quick export capability.
Power outage protection including product recovery routines. Comprehensive programming of unlimited custom recipes.
Semiautomatic and fully automatic modes of operation. Available optional features include automatic Batch
Reports.
21 CFR Part 11 Compliance CapabilitiesESignatures attached to all recipe changes.Secure Database
alarms and events database. Proficy Historian for secured historical data archiving.
Full security integration with the Microsoft Windows operating system environment
Technical Specifications
A | |||
|---|---|---|---|
SN | Name | Model/Specifications/Material | Number |
1 | Chamber | AISI 304L /316L | 1 |
2 | Shelves | AISI 304L /316L | 1 |
Shelf Size | 350 x 400 | 4+1 | |
3 | Chamber Door | Acrylic or stainless door | 1 |
4 | Door lock system with safe bolt | 1set | |
5 | Product sensors | Pt-100 | 4 |
6 | Temperature sensors(thermal fluid) | Pt-100 | 1 |
Performance | parameters | ||
1 | Finish | Ra≤0.4µm | |
2 | Level | 0.5mm/m | |
3 | Shelves temperature Min | ＜-60℃ | |
4 | Shelves temperature Max | +65℃ | |
5 | Shelves temperature uniformity | ±1°C(after balance） | |
6 | Spacing | 100mm (Top stopper type is 80mm) | |
7 | Chamber type | Rectangular | |
8 | Insulation | B1 Cotton insulation | |
9 | Open direction | Left or right | |
10 | Sealing strips for doors | Silicon rubber | |
B | Condenser (with coiled pipe) | ||
SN | Name | Model/Specifications/Material | Number |
1 | Condenser | AISI 304 ,316 optional | 1 |
2 | Condenser coiled pipe | Coil inside or round type(coil outside) | 1 |
3 | Temperature sensors(condenser) | Pt-100 | 1 |
Performance | parameters | ||
5 | Coiled temperature Min | ≤-85℃ | |
ice capacity in 24hour | 8kg | ||
6 | Condenser frosting capacity | Max 10kg/batch | |
7 | Condenser type | round | |
D | Refrigeration system | ||
SN | Name | Model/Specifications/Material | Number |
1 | Compressor model and number | 2HP | 2 |
2 | Refrigerant | R507+R508B | Right quantity |
3 | Oil separator | Emerson / similiar type | 1 |
5 | Automatic protective device for pressure | DANFOSS | 2 |
7 | Pressure meter | REFCO or similiar type | 3 |
8 | Expansion valve | DANFOSS | 4 |
Performance | parameters | ||
1 | Shelf cooling time (without load) | +20 ～ -40°C ≤ 60 minutes | |
2 | Condenser cooling time(without load) | +20 ～ -40°C ≤ 30 minutes | |
E | Vacuum system | ||
SN | Name | Model/Specifications/Material | Number |
1 | Vacuum pump | DRV24 (24m³ /h) | 1 |
2 | Isolation valve of pump well | Electric valve | 1 |
3 | Vacuum gauge | Posifa | 2 |
Performance | parameters | ||
1 | Final vacuum | ⇐1Pa | |
2 | Evacuation time | From atm to 20pa≤30min | |
3 | Leakage rate | 5×10-3pa.m3/sec | |
G | Circulation system | ||
SN | Name | Model/Specifications/Material | |
1 | Circulation pump | Grundfos | |
2 | Thermal fluid | 5cs,USA Dowcorning Silicon oil (low viscosity) | |
3 | Heater | 500w | |
4 | Plate heat exchanger | ||
5 | Temperature sensors(thermal fluid) | Pt-100 | |
Performance | parameters | ||
1 | Heating rate | 1°C/min | |
K | Electric control system | ||
SN | Name | Model/Specifications/Material | Number |
1 | Electric standard | IEEE | |
2 | PLC | Simens S7-200 | 1 |
3 | Breaker | schneider | |
4 | AC contactor | schneider | |
Control type | Manual and automatic | ||
Software function | |||
1 | Freeze drying (switch the type between manual and automatic randomly) | ||
3 | Technique setting (recipe management) | ||
L | Utility list | ||
1 | Electricity-total electrical load | 5.5Kw (380V, 50Hz, 3Phase) or 220V-240V 3 phaseor | |
The | equipment’s main technique parameter | ||
1 | Machine construction | Wall mounted ,GMP type | |
2 | Weight (appox) | 480 kg | |
3 | Gross weight (appox) | 580kg | |
4 | Package size | 850 x 1450 x 1980 mm | |
5 | Capacity of raw material for freeze drying(suggestive value) | 5 kg/batch | |
Document | |||
SN | Name | Number | |
1 | Operation manual | 1 | |
2 | Maintenance manual | 1 | |
3 | Wiring drawing | 1 | |
4 | Instruction for the main parts | 1 | |
5 | PQ,OQ,IQ Document | 1 |
