Technical Specification
MODEL : Lyoph-Pride100R(SCM2)
Submitted by R&D Center, ilShin Bio Base Co., Ltd.
Date: 2010. 12. 15
- Procedure –
1. Summarized Specification for Freeze Dryer 100R(SCM2).
2. Cabinet (INCLUDE FRAME) Specification.
3. Control System.
1) Operation Control System.
2) Plate Control System.
4. Drying/Cold Trap Chamber Specification.
1) Drying Chamber.
2) Spiral Oil Path Plate.
3) Drying Tray.
4) Cold Trap Chamber.
5) Cold Trap.
6)
Freezing System.
7) Brine System.
8) Defrosting System of Cold Trap.
5. Vacuum Control System.
1) Vacuum Controller/Vacuum Pump/Booster Pump.
2) Door Lock Device.
6. Stoppering System
7. C I P (CLEAN IN PLACE)
8. S I P (Sterilization Place):
9. GMP Validation
1) DQ(Design Qualification)
2)
IQ (Installation Qualification)
3) OQ (Operation Qualification
4) CSV (Computer System Validation)
5) Validation Tanning
10. Accessories.
11. Documentation
1. Summarized specification for Freeze Dryer 100(SCM2)
1) Electrical Requirement
380V, 50Hz/60Hz, 3PH, 30Kw (220V, 50Hz/60Hz, 3PH, 30Kw)
2) Ice Capacity
Type
Ice Holding Capacity(ℓ(kg)/Batch)
Vial
Vial(Φ40X100L) of Qty
120 kg
3,744 EA
3) Chamber and Door Specifications
Type
Dimension(External)
Material
Thickness
Drying Chamber
Chamber
Rectangular Chamber
1,250(W)x1,200(D)x1,500(H)
SUS304
8
Auto( Hydraunic Clamp)
Cold Chamber
Circle Chamber
Φ1200 x 1200L
SUS304
5
Manual ( Hinge Clamp )
Door Lock Device
4) Shelf Specifications
Dimension(mm)
Capacity (Qt'y)
32 EA
805(W)x1005(D)x20(H)/8+1 Shelf
Material
Temperature(℃)
Cooling / Heating Method
SUS304
ㅡ45 ~ 75
Indirect
Area
(㎡)
Vial(Qt'y)
Tray (Qt'y)
Size:400x500x40H
1 Shelf
0.8
468
4
2 Shelf
1.6
936
3 Shelf
2.4
1,404
4 Shelf
3.2
1,872
16
4
2,340
20
Configuration
Area
(㎡)
Vial(Qt'y)
Tray (Qt'y)
Size:400x500x40H
6 Shelf
4.8
2,808
24
8
7 Shelf
5.6
3,276
28
12
8 Shelf
6.4
3,744
32
Configuration
9 Shelf
5 Shelf
Assistance
5) Cold Trap Specifications
Capacity (kg)
Dimension (mm)
Φ22.3 x 78m
120
Material
Temperature(℃)
SUS304
Less than -75 ℃
Cooling Method
-
6) Refrigeration System Utility
Names of Goods
Maker
Model
Capacity
Refrigeration/Cooling Method
Compressor
Bitzer
4V-10.2
10 HP x 2
Cascade System
Condenser
DongHwa Win
DHCD-100
15 HP
Water Cooling Method
Names of Goods
Maker
Model
Capacity
Vacuum Pump
BOC Edward
E2M80
7) Vacuum System Utility
Ultimate Vacuum Type
20 mTorr
Oil Rotary
1600L/min
Booster Pump
N/A
N/A
N/A
N/A
8) Control System Utility
Item
Method
Model (Maker)
Remark
Controller
P.L.C(P.I.D)
MK-120S (LS Industrial Systems)
-
Monitoring
Touch Screen
XP-70 (LS Industrial Systems)
Size : 10"
Recorder
Digital (SD Card)
Digital Recoder
Channel : 6 CH
9) Stoppering, SIP(Sterilization Place), CIP(Clean in Place)
Stpoppering
Hydraunic Cylinder
Top & Down
Connection : Bellows Type
S.I.P
Pure Steam
125 ℃, 30 min
Operating Method : P.L.C
C.I.P
Pure Water
2S, 3kgf/㎠
Operating Method : P.L.C
R & D SC HAN , Manager / JY KIM, Chief
2. Cabinet Specification included the Frame.
①
Dry Chamber Dimensions : 1460W)×1670(L)x1970H) (Feature 2-1-1/2-1-2 )
②
Material : SUS304
③
Machine Room Dimensions : 1300(W)x1850(L)x1955(h)
(Feature 2-1-1 Front)
(Feature 2-1-2 Side)
3. Control System
1) Operation Control System
① Control Panel :
AA) All system can be controlled as real-time. (Feature 3-1-1).
BB) Easy to in-put date to individual control program
Through cooling/heating temp, drying time, Vacuum
Control of the plate you want (Feature 3-1-2).
CC) Easy to dry sample, which is programmed with
Automatic Function quickly and perfectly (Feature 3-1-3).
DD) With RS485/RS-232C port, It can be controlled to
Changing of program and modification by PC.
EE) Displaying all functions of each system by color in
real-time perfectly.
(Feature 3-1-1)Control Panel
FF) Chart Recorder
a) Record sample temp. to program #1, #2, #3. in real-time.
b) Record the temp. of plate in real-time.
c) Record the temp. in Cold Trap in real-time.
d) Record the vacuum in Chamber in real-time.
(Feature 3-1-2) Plate Manual Control System
①
(Feature 3-1-3) Plate Automatic Control System
Touch Screen :
AA) Configuration: PMU730TT (Feature 3-1-4)
a) Prepared for electricity fault
BB) Controller: Data input/output is possible through
CC) Dialing system can be alerted by system error.
DD) Displaying of each step as below. (Feature 3-1-5)
a) Pre. Freeze, - Primary dry, - Secondary dry, -Cycle complete
b) Vacuum release, -Unloading, -Defrost, -Loading
c) Lyophilizing procedure time, Vacuum pumping time, Alarm for accomplishment.
(Feature 3-1-4) Touch Screen
(Feature 3-1-5) Process Program
2) Plate Control System:
① Controller: Automatic control by PLC (PROGRAMABLE LOGIC CONTROLLOR) System Plate
② PLC Specification (Feature 3-2-1)
AA) Control thermal plate temperature by brine heat exchange for drying of sample
Automatic temperature control by program, 10 levels.
BB) Easier Automatic Control or Manual Control by Program.
CC) RS-232C / RS-485 communication output is possible.
DD) Figure: PLC MK120S
EE) Condition: difference should be less than ±0.15℃. And it should re reach to the
Set temperature easily. Maintenance of temperature should be easy.
(Feature 3-2-1) PLC Controller (MK120S)
(Feature 3-2-2) Electrical Panel
4. Drying/Cold Trap Chamber Specification
1) Drying Chamber (Feature 4-1-1)
① Type
: Rectangle Chamber
② Dimensions : 1,250(W)x1,200(D)x1,500(H)x8(T)
③ Material : SUS316L
④ Door : SUS316L
⑤ Chamber Drain : Auto Pneumatic valve (1.5S)
⑥ Surface Roughness: Less than Ra 0.65 ㎛
(Feature 4-1-1)Drying Chamber
2) SPIRAL OIL PATH PLATE (Feature 4-2-1)
①
Dimensions : 805(W)×1005(D)×20(H)
②
Material : SUS316L
③
Quantity: 9 shelves(8+1shelf)
(8shelves Drying Plate + 1shelf Extra Heating Plate)
④
Clearance : 80mm
⑤
Area: 6.4㎡/9 shelves
⑥
Surface Roughness: Below Ra 0.65 ㎛
⑦
Plate Flow System:
(Feature4-2-1) Spiral Oil Path Plate
⑧
Plate Temp. Control range: -45℃ ~ 75℃
⑨
Plate Temp. Accuracy: ±1.5℃
⑩
Flat form heat exchanger: Indirect cooling down and heating up by heating material of heat exchanger.
⑪
Heating materials: Silicon oil (viscosity: 10 CS) (Feature 4-2-4).
⑫
Spiral oil path plate with Top Plate and Bottom Plate should keep level gauge within
±1mm/m.
(Feature4-2-2) Surface Test
(Feature4-2-3)Checking Surface Test
(Feature4-2-4) Silicon Oil
(Feature 4-3-1)
3) Drying Tray
①
Dimension : 400(W) × 500(D) × 40(H) mm
②
Material
③
Quantity : 32EA/8 shelves
④
Weight
⑤
Feature : Quality and configuration of the Sample
: SUS 316L
: 2 kg/1EA, Unload
Drying Tray should not be changed in chemical/
physical properties during lyophilizing
(Feature 4-3-1) Drying Tray
procedure time of sample.
4) Cold Trap Chamber (Feature 4-4-1)
①
Type
②
Dimensions : Φ1210 × 1200(L) x 5(T)
③
Material
④
Door : SUS 316L
⑤
Chamber Drain : Automatic Drain (1.5S)
⑥
Surface Roughness: less than Ra 0.65 ㎛
: Circle Chamber
: SUS 316L
(Feature 4-4-1) Cold Trap Chamber
5) Cold Trap
(Feature 4-5-1)
①
Dimensions
②
Ice Holding Thickness : 15 mm
③
Ice Holding Capacity : over 120ℓ(Kg)
④
Material
⑤
Temperature : -75℃ Lower (at unload)
⑥
Defrost Method : Hot Gas Solenoid & Water Rinse
: Φ 21.7 mm x 78 m(L)
: SUS304
(Feature 4-5-1) Cold Trap
6) Freezing System: (Feature 4-6-1)
①
Compressor
a.
Capacity : 10 HP × 2EA
b.
Function: Reciprocating Compressor
c.
Maker: Copeland or Bitzer
d.
Refrigeration System: Cascade System
e.
Condenser : With more than 15Hp
(Feature 4-6-1) Freezing System
f.
Refrigerant : High Stage(R-408A) / Low Stage(R-23)
g.
Insulation: HI-FLEX
h.
Oil Separator: Kyungan Engineering (7/8”) (Feature 4-6-3)
i.
Receiver Tank: Kyungan Engineering(10HPx1EA, 20HPx1EA) (Feature 4-6-4)
j.
Accumulator: Kyungan Engineering(10HP×2EA) (Feature 4-6-5)
k.
Heat Exchanger: WP(10HP, 20HP) (Feature 4-6-6)
l.
Solenoid Valve: Danfoss (Feature 4-6-7)
m. Exchange Valve: Danfoss (Feature 4-6-8)
n.
Brine Pump : Trocoid Pump(36L/min-1EA) (Feature 4-6-9)
o.
Brine: Silicon Oil, 10 cs (Feature 4-6-10)
(Feature 4-6-2)Condenser
(Feature 4-6-5)Accumulator
(Feature 4-6-8)Expansion Valve
(Feature 4-6-3) Oil Separator
(Feature 4-6-4) Receiver Tank
(Feature 4-6-6) Heat Exchanger
(Feature 4-6-7)Solenoid Valve
(Feature 4-6-9) Brine Pump
(Feature 4-6-10) Brine
7) Brain System:
①
Part name: Circulation pump, Heat exchanger(plate type), Heater, Brine etc
②
Brine circulation pump: capacity: 2.5HP×1EA, Non-Seal Canned Type (Feature 4-6-9)
③
Heat exchanger(plate type): between refrigeration system and brine circulation system (Feature 4-6-6)
④
Heater: Heater capacity 9Kw
⑤
Brine: Silicon oil, colorless and clear liquid, smoke-proof, water-proof, cold-proof, chemical proof,
Odor-free transparent -60℃ ~ 200℃, Brine: Silicon Oil, 5cs
(Feature 4-6-10)
8) Defrosting System of Cold Trap:
① System method: Water Rinse & Steam injection (Feature 4-8-1)
② Defrosting capacity: more than ice 120Kg
③ Defrosting time: within 60 min.
④ Water temp. : higher than 50℃(option)
⑤ Defrosting capacity: 0.6m3/hour
⑥ Drain system: By drain valve, normal drain system
⑦ Defrosting nozzle: SUS316L, pressure higher than 1Kgf/cm2
(Feature 4-8-1) Water Rinse Defrosting System
5. Vacuum Control System:
1) Vacuum Controller/Vacuum Pump/Booster Pump:
①
Pumping speed (unload) : Vacuum maintenance within air~ 100 mTorr/60 minutes
②
the lowest vacuum pressure in No load: 1.5 x 10‾³Torr (Feature 5-1-1)
③
Vacuum control utilities: automatic or manual separate is possible by vacuum control
④
Form: OIL ROTARY VACUUM PUMP
⑤
Capacity: Displacement: 1600 ℓ/min
⑥
Motor power : 3kw
a. Vacuum Pump (Feature 5-1-2)
- Manufacturer: BOC Edwards
- Capacity: 1600ℓ/min
- Motor power: 4HP
b.
Auxiliary part
(Feature5-1-1)Vacuum Diagram
- Vacuum Inlet Filter: filtering dirt or dust to vacuum pump during
Vacuuming (Feature 5-1-3)
- Vacuum Outlet Filter: filtering the oil mist from vacuum pump.
(Feature 5-1-4)
(Feature 5-1-2)Vacuum Pump
(Feature 5-1-3) Vacuum Exhaust Filter
(Feature 5-1-4)Gas Ballast V/V
2) Door Lock Device:
①
Drying Chamber: Auto (Swing Clamp (Feature 5-2-1)
②
Cold Chamber: Auto (Swing Clamp (Feature 5-2-1)
③
Door Gasket: Silicone Rubber (Feature 5-2-3)
※ Working Pressure: Vacuum(Atmospheric pressure ~ 20mTorr)
(Feature 5-2-1) Swing Clamp
(Feature 5-2-3)Silicone Rubber
6. Stoppering System:
1) Specification
①
Type : Hydraulic Stoppering system (Feature 6-1-1,6-1-2)
②
Feature
- Control the plate position according to step.
- Stainless Steel bellows to protect the Samples and prevent the contamination while CIP is progressing.
(OPTION)
(Feature 6-1-1) Stoppering down
(Feature 6-1-2) Stoppering up
7. C I P (CLEAN IN PLACE)
1) CIP Specification:
It sprays the R/O water though the Nozzle into the chamber to take out the substance.
The nozzles have two kinds of types which are fixed or rotate type. It made by STS 316 stainless steel. Its
Process would be done by automatically.
①
Range Drying Chamber, Cold Trap Chamber/Coil, Plate and Main Valve
②
Method: CIP water spray by fixed Nozzle. (Feature 7-1-1)
③
Spray Method: CIP water supply by several lines by bellows. Exclusively using nozzle will be located
for
Nozzle and Bellows. exclusive use
(Feature 7-1-2)
④
Test proof its performance at the design period and actual test.
⑤
Water supply: Purified water 1s, more than 1Kgf/cm2
⑥
CIP water: purified water which is not affecting the CIP 1.5s, supplying more than 1Kgf/cm2, water
consumption: 120 Litter/min
⑦
Water tank: can storage purified water more the 2400Litter
⑧
High pressure pump: supplying the water with more 3Kgf/cm2 pressure.
⑨
Exhausting the water in Chamber: By Watering Pump
⑩
Nozzles: sector form and flat shape or ball-shaped type which can be washed.
⑪
Location
of
Nozzles: Plate and
rear each two point (total 8 set) , 20EA Nozzles/point.
(Feature7-1-3)
⑫
Nozzle and CIP Pipe: SUS316L
⑬
Nozzle specification: Pressure 3Kgf/cm2.
Rinsing from right to rear then left
(ex: 10seconds by program controlled (Feature 7-1-4)
⑭
Monitoring whole process by PLC with PC.
(Feature 7-1-1) Spray Nozzle
(Feature 7-1-2) Plate Cleaning
(Feature 7-1-3) Multiple Spray Nozzle
(Feature 7-1-4) Chamber Cleaning
8. S I P (Sterilization Place):
1) SIP Specification :(Feature 8-1-1)
①
②
Sterilizing by steam controlled by automatic operation
The temperature would sustain more than 121℃ in the
chamber with more than 30 minute.
③
Drying process will be done after exhausting of
sterilizing water.
④
The design of the chamber is determined by maximum
pressure of its processing. Whole process will be done
by PLC control by PC.
(Feature 8-1-1)SIP Piping Diagram
⑤
compounded Doubled Filter installation & In-Line steam sterilization
⑥
Matter to be Designed of SIP
Within Dead Leg3D, Instrumentation of the temperature Steam Drain.
Drain, cooling Coil units for machine, Heat resisting gasket (Silicon, Viton)
Chamber (Drying & Condenser)with STS316L
⑦
Kcal/Hr for Baring up the temperature form20℃ to 121℃: 81,000Kcal/Hr
⑧
Door closure via manual latch (vacuum) and automatic rotary pins (SIP)
⑨
Drying after Sterilization: Post-sterilization drying by Watering Pump
⑩
Controlled whole process by PLC whit computer
150kg/hr
2) Main Parts
①
0.2 micron sterile air filter and hosing
②
Pressure Analog gauge and digital gauge
③
Clean steam piping
④
Pressure reducing valve
⑤
Relief valve
⑥
Automatic Sanitary diaphragm valves
⑦
Safety valve
⑧
Steam trap
⑨
Etc
9. GMP Validation (Optional)
1) DQ (Design Qualification)
① Flow Diagram(Feature 9-1-1)
② Electrical Diagram(Feature 9-1-2)
③ Analysis of the main factors of Freeze Dryer ( Feature 9-1-3)
④ Part List / BOM(Feature 9-1-4)
(Feature 9-1-1)Flow diagram
(Feature 9-1-2) Electrical Diagram
(Feature 9-1-3) Risk Analysis
(Feature 9-1-4) BOM
2) IQ (Installation Qualification)
① Protocol Approval (Feature 9-2-1)
② Revision History(Feature 9-2-2)
③ Installation Qualification Test Contents(Feature 9-2-3)
④ Installation Qualification Protocol(Feature 9-2-4)
⑤ Mill Test Certificate(Feature 9-2-5)
(Feature 9-2-1) protocol approval
(Feature 9-2-2) Revision History
(Feature 9-2-3) Test Contents
(Feature 9-2-4) Protocol Sheet
(Feature 9-2-5) Mill Test Certificate
3) OQ (Operation Qualification)
① Protocol Approval(Feature 9-3-1)
② Revision History(Feature 9-3-2)
③ Operational Qualification Test Contents(Feature 9-3-3)
④ Operational Qualification Protocol(Feature 9-3-4)
⑤ Calibration Certificate(Feature 9-3-5)
(Feature 9-3-1) Protocol Approval
(Feature 9-3-3) Test Contents
(Feature 9-3-2) Revision History
(Feature 9-3-4) Protocol
(Feature 9-3-5) Calibration Certificate
4) CSV (Computer System Validation)
①
Diagram for CSV (Feature 9-4-1)
②
CS-IQ Protocol
③
CS-OQ Protocol (Feature 9-4-3)
(Feature 9-4-2)
(Feature 9-4-1) Diagram for CSV
(Feature 9-4-2) CS-IQ Protocol
(Feature 9-4-3) CS-OQ Protocol
5) Validation Education (Feature 9-5-1, Feature 9-5-2)
(그림 6-5-1) CS-OQ Protocol
(Feature 9-5-1)
(Feature 9-5-2)
10. Accessories
①
Exhaust Filter (EF2561)
②
Element Filter(EF2560)
③
Vacuum Oil : 4 Litters/Pkg(V04000)
④
Vacuum Grease : 5.40z(VG5400)
⑤
Chart Paper
⑥
Inlet Filter(IF2561)
⑦
Tray(SUS304)
11. Documentation
①
Equipment Arrangement drawings.
②
Material lists
③
Completely filled in Equipment data sheets. acceptance test procedure for factory and on-site(FAT)
④
Detailed description of equipment, equipment materials of construction and operation.
⑤
Reference list and contacts for a similar project.
⑥
Complete detailed equipment arrangement drawings with elevation and plan views
(to scale), with all splice points and tie-in points indicated and dimensioned.
⑦
Electrical and panel drawings
⑧
Factory calibration certifications.
⑨
Operation manual Maintenance manual
⑩
IQ/OQ documents (OPTION)
-END-