| 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 |
|