Item |
Description |
Specifications |
1 |
General Detail |
|
1.1 |
Model |
|
1.2 |
Output (approx.) |
|
1.3 |
Maximum ice capacity |
|
1.4 |
Stoppering |
|
1.5 |
Control |
|
1.6 |
Dimension of unit (approx.) (L × W × H) (mm) (with hydraulic cylinder) |
|
1.7 |
Weight (approx.) |
|
2 |
Chamber (ASME Compliance?) |
|
2.1 |
Chamber type |
|
2.2 |
Design pressure |
|
3.3 |
Design temperature |
|
2.4 |
Sloping |
|
2.5 |
Finish |
|
|
Internal |
|
|
External |
|
2.6 |
Corner |
|
2.7 |
Validation port |
|
2.8 |
Viewing port |
|
2.9 |
Number |
|
2.10 |
Location |
|
2.11 |
Dimension |
|
2.12 |
Material |
|
2.13 |
Internal |
|
2.14 |
Sterile wall plate in clean room providing tightness between chamber and clean room partition |
|
2.15 |
External cover in machine room |
|
2.16 |
Insulation |
|
2.17 |
Vacuum manometer for chamber vacuum measurement |
|
2.18 |
Brand |
|
2.19 |
Type |
|
2.20 |
Number |
|
2.21 |
Water cooling jacket for quick cooling chamber wall after SIP |
|
2.22 |
Easy accessible strainer filter to recover stoppers or any glass debris |
|
3 |
Door |
|
3.1 |
Slot door |
|
3.2 |
Actuator |
|
3.3 |
Moving direction |
|
3.4 |
Gasket |
|
3.5 |
Safety light curtain to prevent accidental closing during loading and unloading operations. |
|
3.6 |
Finish |
|
3.7 |
Internal |
|
3.8 |
External |
|
3.9 |
Material |
|
3.10 |
Constant height loading and unloading mechanism |
|
3.11 |
Constant height |
|
3.12 |
Position Transducer |
|
4 |
Main door |
|
4.1 |
Type |
|
4.2 |
Finish |
|
4.3 |
Internal |
|
4.4 |
External |
|
4.5 |
Viewing port |
|
4.6 |
Number |
|
4.7 |
Location |
|
4.8 |
Open direction |
|
4.9 |
Open angle |
|
4.10 |
Gasket |
|
4.11 |
Locking arrangement |
|
4.12 |
Material |
|
4.13 |
Internal |
|
4.14 |
External |
|
4.15 |
Insulation |
|
4.16 |
Water cooling jacket for quick cooling door wall after SIP |
|
5 |
Shelves |
|
5.1 |
Temperature range |
|
5.2 |
RTD temperature sensors (PT100) for measuring inlet and outlet shelf fluid temperature |
|
5.3 |
Brand |
|
5.4 |
Quantity |
|
5.6 |
Location |
|
|
|
|
5.7 |
Thermocouples for measuring product temperature and shelf surface temperature |
|
5.8 |
Brand |
|
5.9 |
Quantity |
|
5.10 |
Number of shelves |
|
5.11 |
Dimension (L × W × T) (mm) |
|
5.12 |
Total usable area (sq. m) |
|
5.13 |
Partial loading |
|
5.14 |
Spacing (mm) |
|
5.16 |
Type connection of hoses |
|
5.17 |
Finish |
|
5.18 |
Level |
|
5.19 |
Shelves tolerance for automatic loading and unloading mechanism |
|
5.20 |
Shelves thickness tolerance |
|
5.21 |
Shelves spacing tolerance |
|
5.22 |
Shelves length tolerance |
|
5.23 |
Shelves width tolerance |
|
5.24 |
Material |
|
6 |
Stoppering Device |
|
6.1 |
Stoppering condition |
|
6.2 |
Stoppering direction |
|
6.3 |
Operation location |
|
6.4 |
Hydraulic motor |
|
6.5 |
Brand |
|
6.6 |
Power motor |
|
6.7 |
Hydraulic units |
|
6,8 |
Brand |
|
6.9 |
Oil Volume |
|
6.10 |
Bellows |
|
6.11 |
Bellows leakage on-line test |
|
6.12 |
Stoppering force |
|
7 |
Condenser (Certification Compliance) |
|
7.1 |
Condenser type |
|
7.2 |
Refrigeration [Direct, recirculated] |
|
7.3 |
Viewing port |
|
7.4 |
Number |
|
7.5 |
Dimension |
|
7.6 |
Final temperature |
|
7.7 |
Maximum design pressure |
|
7.8 |
Maximum design temperature |
|
7.9 |
Finish |
|
7.10 |
Corner |
|
7.11 |
Coiled pipe welding |
|
7.12 |
Isolation valve |
|
7.13 |
Type |
|
7.14 |
Size |
|
7.15 |
Actuator |
|
7.16 |
Bellows protection with leakage on line test |
|
7.17 |
Coiled pipe material |
|
7.18 |
Material |
|
7.19 |
Internal |
|
7.20 |
External cover |
|
7.21 |
Insulation |
|
7.22 |
Vacuum manometer for condenser vacuum measurement |
|
7.23 |
Brand |
|
7.24 |
Type |
|
7.25 |
Number |
|
7.26 |
Water cooling jacket for quick cooling condenser wall after SIP |
|
7.27 |
Easy accessible external drain catchpot , with strainer filter to recover stoppers or any glass debris |
|
7.28 |
Condenser to shelf area (>/= 1 to 1) |
|
8 |
Shelf Heating and Cooling System |
|
8.1 |
Circulation pump |
|
8.2 |
Brand |
|
8.3 |
Type |
|
8.4 |
Model |
|
8.5 |
Number |
|
8.6 |
Motor power |
|
8.7 |
Plate heat exchanger |
|
8.8 |
Brand |
|
8.9 |
Model |
|
8.10 |
Type |
|
8.11 |
Number |
|
8.12 |
Heater |
|
8.13 |
Maximum heating power |
|
8.14 |
Thermal fluid |
|
8.15 |
Brand |
|
8.16 |
Class [flammability] |
|
8.17 |
Silicon oil loop dryer |
|
8.18 |
Shelf cooling time (+20°C to -40°C) |
|
8.19 |
Heating rate |
|
8.20 |
Shelves temperature uniformity |
|
8.21 |
Compressor |
|
8.22 |
Brand |
|
8.23 |
Model |
|
8.24 |
Type |
|
8.25 |
Number |
|
8.26 |
Motor power |
|
8.27 |
Refrigerant |
|
8.28 |
Main refrigerating unit |
|
8.27 |
Thermostatic expansion valve |
|
8.28 |
Solenoid valve |
|
8.29 |
Sight glass |
|
8.30 |
Sub-cooling heat-exchanger |
|
8.31 |
Pressure meter |
|
8.32 |
Pressure controller |
|
9 |
Vacuum System |
|
9.1 |
Final vacuum |
|
9.2 |
Evacuation time |
|
9.3 |
Leakage rate |
|
9.4 |
Vacuum pump |
|
9.5 |
Brand |
|
9.6 |
Model |
|
9.7 |
Type |
|
9.8 |
Number |
|
9.9 |
Flow rate |
|
9.10 |
Motor power |
|
9.11 |
Mechanical booster pump |
|
9.12 |
Brand |
|
9.13 |
Model |
|
9.14 |
Type |
|
9.15 |
Number |
|
9.16 |
Flow rate |
|
9.17 |
Motor power |
|
9.18 |
Pump isolation valve |
|
9.19 |
Brand |
|
9.20 |
Type |
|
9.21 |
Number |
|
9.22 |
Size |
|
9.23 |
Actuator |
|
9.24 |
Anti-suck valve |
|
10 |
Pneumatic Units |
|
10.1 |
Brand |
|
10.2 |
Compressed filter oiler |
|
11 |
Venting Filter System |
|
11.1 |
Primary filter |
|
11.2 |
Brand |
|
11.3 |
Number |
|
11.4 |
Aperture |
|
11.5 |
Secondary filter |
|
11.6 |
Brand |
|
11.7 |
Number |
|
11.8 |
Aperture |
|
11.9 |
Both filters sterilized and dried |
|
11.10 |
Besides clean air inlet, nitrogen connection port also available? |
|
12 |
CIP/SIP/De-icing |
|
12.1 |
Water-ring pump |
|
12.2 |
Brand |
|
12.3 |
Model |
|
12.4 |
Type |
|
12.5 |
Number |
|
12.6 |
Motor power |
|
12.7 |
Spray Ball
|
|
12.8 |
Fixed Nozzles |
|
12.9 |
Steam/cleaning water inlet valves |
|
12.10 |
Brand |
|
12.11 |
Type |
|
12.12 |
Steam/cleaning water outlet valves |
|
12.13 |
Brand |
|
12.14 |
Type |
|
12.15 |
Safety valve |
|
12.16 |
Steam trap |
|
13 |
Control System |
|
13.1 |
Electronic contactor |
|
13.2 |
Software |
|
13.3 |
21CFR part 11 compliance |
|
13.4 |
Automatic |
|
13.5 |
Semi-automatic |
|
13.6 |
Manual |
|
13.7 |
PLC |
|
13.8 |
Recorder |
|
13.9 |
Computer |
|
13.10 |
Touch screen (HMI) |
|
13.11 |
Breaker |
|
13.12 |
Contactor |
|
13.13 |
Relay |
|
13.14 |
UPS for PLC and PC |
|
14 |
Safety System |
|
14.1 |
Vacuum failure protection |
|
14.2 |
Temperature failure protection |
|
14.3 |
Compressor protection |
|
14.4 |
Other motors protection |
|
14.5 |
SIP protection |
|
14.6 |
Interlock protection |
|
15 |
Utility Requirement (approx.) |
|
15.1 |
Electricity – total electrical load |
|
15.2 |
Cooling water for refrigerant cooling |
|
15.3 |
Water for injection for CIP |
|
15.4 |
Compressed air for pneumatic valves |
|
15.5 |
Average pure steam consumption |
|
15.6 |
Pure steam for de-icing |
|
16 |
Other services |
|
16.1 |
Documentation |
|
16.2 |
General Arrangement Drawing |
|
16.3 |
P&ID |
|
16.4 |
Wiring Drawing |
|
16.5 |
Installation qualification protocol |
|
16.6 |
Operational qualification protocol |
|
16.7 |
Installation Instructions |
|
16.8 |
Operation Manual |
|
16.9 |
Maintenance Manual |
|
16.10 |
Materials certificates |
|
16.11 |
Calibration certificates |
|
16.12 |
Pressure vessel certificates |
|
16.13 |
Welded certificates and log |
|
16.14 |
Spare Parts |
|
16.15 |
Full-size rear main door similar to front main door except slot door |
|
16.16 |
Filter Integrity Test by Water Intrusion Test: |
|
16.17 |
Primary filter |
|
16.18 |
Brand |
|
16.19 |
Size |
|
16.20 |
Number |
|
16.21 |
Porosity |
|
16.22 |
Secondary filter |
|
16.23 |
Brand |
|
16.24 |
Size |
|
16.25 |
Number |
|
16.26 |
Porosity |
|
16.27 |
Dry air control unit |
|
16.28 |
Nitrogen control unit |
|
16.29 |
Electric heater |
|
16.30 |
Steam / air inlet valve |
|
16.31 |
Brand |
|
16.32 |
Type |
|
16.33 |
Other drain valve |
|
16.34 |
Brand |
|
16.35 |
Type |
|
16.36 |
Manual valve |
|
16.37 |
brand |
|
16.38 |
Type |
|
16.39 |
Check valve |
|
16.40 |
Brand |
|
16.42 |
Piping |
|
16.43 |
Material |
|
16.44 |
Welding |
|
16.45 |
RTD or Thermocouple temperature sensor (PT100) for measuring SIP temperature |
|
16.46 |
PID controlled valve for vacuum control |
|
16.47 |
Type |
|
16.48 |
Installation assistance, FAT, SAT, IQ/OQ performed at customer’s location |
|
17 |
WIT Test device |
|
17.1 |
Brand |
|
17.2 |
Control method |
|
17.3 |
Number |
|
18 |
Payment terms |
|
19. |
Delivery |
|
20. |
Guarantee |
|
21. |
Specification Validity |
|
22. |
SAT |
|
23 |
FAT |
|
24 |
IQ/OQ documentation |
|
25 |
IQ/OQ execution at factory |
|
26 |
IQ/OQ execution assistance at your factory |
|
27 |
Installation assistance |
|
28 |
Startup assistance |
|
39 |
Training |
|