Command SJ-100F(T)
GMP Production Systems
GMP Compliance 1.0m2 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_x0002_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
Specification
Chamber
Name | Model/Specifications/Material | Number |
|---|---|---|
Chamber | AISI 304L /316L | 1 |
Shelves | AISI 304L /316L | 1 |
Shelf Size | 450*600 | 4+1 |
vials load capaticy:dia 16mm:4144 pcs; | vials load capaticy:dia 22mm:2160- pcs; | |
Chamber Door | Acrylic or stainless door | 1 |
Door lock system with safe bolt | 1set | |
Product sensors | Pt-100 | 4 |
Temperature sensors(thermal fluid) | Pt-100 | 1 |
Performace
Finish | Ra≤0.4µm |
|---|---|
Level | 0.5mm/m |
Shelves temperature Min | ＜-60℃ (canbe special made to -70C) |
Shelves temperature Max | +65℃ |
Shelves temperature uniformity | ±0.5 °C(after balance） |
Spacing | 100mm (Top stopper type is 80mm) |
Chamber type | Rectangular |
Insulation | B1 Cotton insulation |
Open direction | Left or right |
Sealing strips for doors | Silicon rubber |
Condenser
Name | Model/Specifications/Material | Number |
|---|---|---|
Condenser | AISI 304 ,316 optional | 1 |
Condenser coiled pipe | Coil inside or round type(coil outside) | 1 |
Temperature sensors(condenser) | Pt-100 | 1 |
performance
Coiled temperature Min | ≤-85℃ |
|---|---|
ice capacity in 24hour | 10kg |
Condenser frosting capacity | Max 15kg/batch |
Condenser type | round |
Refrige system
Name | Model/Specifications/Material | Number |
|---|---|---|
Compressor model and number | 3HP Tecumseh | 2 |
Refrigerant | R507+R508B | Right quantity |
Oil separator | Emerson | 1 |
Automatic protective device for pressure | DANFOSS | 2 |
Pressure meter | REFCO | 3 |
Expansion valve | DANFOSS | 4 |
performance
Shelf cooling time (without load) | +20 ～ -40°C ≤ 60 minutes |
|---|---|
Condenser cooling time(without load) | +20 ～ -40°C ≤ 30 minutes |
Vacuum system
Name | Model/Specifications/Material | Number |
|---|---|---|
Vacuum pump | DRV30 | 1 |
Isolation valve of pump well | Electric valve | 1 |
Vacuum gauge | Posifa | 2 |
Performance
Final vacuum | ⇐1Pa |
|---|---|
Evacuation time | From atm to 20pa≤30min |
Leakage rate | 5×10-3pa.m3/sec |
Recycling system
Name | Model/Specifications/Material |
|---|---|
Circulation pump | Grundfos |
Thermal fluid | 5cs,USA Dowcorning Silicon oil (low viscosity) |
Heater | 1000w |
Plate heat exchanger | |
Temperature sensors(thermal fluid) | Pt-100 |
Heating rate | 1°C/min |
Electricity
Name | Model/Specifications/Material | Number |
|---|---|---|
Electric standard | IEEE | |
PLC | Simens S7-200 | 1 |
Breaker | schneider | |
AC contactor | schneider |
Soft
Freeze drying (switch the type between manual and automatic randomly) |
|---|
Technique setting (recipe management) |
Utility
Electricity-total electrical load | 6.5Kw (380V, 50Hz, 3Phase) or 220V-240V 3 phase |
|---|
Machine construction | Wall mounted ,GMP type |
|---|---|
Weight (appox) | 650KG |
Capacity of raw material for freeze drying(suggestive value) | 10kg/batch,max 15kg |
cerification documents system The details of verification documents system
Document:
Operation manual |
|---|
Maintenance manual |
Wiring drawing |
Instruction for the main parts |
PQ,OQ,IQ Document |
