TABLE OF CONTENT
- OBJECTIVE
- SCOPE
- RESPONSIBILITIES
- MACHINE DESCRIPTION
- FLUID BED DRYER
- FLUID BED PROCESSOR
- LOADING & UNLOADING OF MATERIAL
- EQUIPMENT SUBASSEMBLIES & PARTS
- MAIN BODY
- AIR INLET SHUT OFF VALVE
- BLOWER INLET SHUT OFF VALVE
- AIR PREPARATION UNIT
- PRODUCT CONTAINER & TROLLEY
- DEHUMIDIFIER & MIST ELIMINATOR
- EXPLOSION FRAME & FLAP
- FILTER BAG SHAKING DEVICE
- DUCTINGS
- BLOWER ASSEMBLY
- SEALING GASKETS
- CONTROL PANEL & POWER PANEL
- CONTROL SYSTEM, FIELD INSTRUMENTS ETC.
- TECHNICAL SPECIFICATION
- MATERIAL OF CONSTRUCTION
- ENCLOSURES
- Utilities Specification
- SAFETY FEATURES
- FAT PROCEDURE:
- CHANGE CONTROL PROCEDURE
- DESIGN QUALIFICATION REPORT
- OBJECTIVE:
To design, engineer, and supply the Fluid Bed Processor and to provide assurance that the machine is manufactured as per the URS and it complies with the Scope of Supply.
To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in the document, are the same at utmost transparency.
- SCOPE:
The scope of this qualification document is limited to the Design Qualification of Fluid Bed Processor for the Pharmaceutical Company. This qualification document is part of a validation activity for the Fluid Bed Processor.
- RESPONSIBILITIES:
- CLIENT:
- To Check and Approve the design qualification.
- MANUFACTURER:
- To design, engineer and provide the complete technical details of the
equipment pertaining to its design qualification viz.
- Machine overview,
- P&ID drawing,
- Equipment orientation with layout,
- Specifications of the sub-components/ bought out items, and their make, model & quantity, and backup records/ brochures,
- Details of Utilities,
- Identification of components for calibration
- Material of construction of all components
- Safety features and alarms
- To facilitate the client for the Factory acceptance test of the machine at their works/ site.
- To confirm the safe delivery of the equipment to the user site.
- To ensure that no un-authorized and or unrecorded design modifications shall take place. If at any point in time, any change is desired in the mutually agreed design, Change control procedure shall be followed and documented.
- To ensure the proper installation and commissioning of the equipment.
- MACHINE DESCRIPTION:
- FLUID BED DRYER
The Principle of Fluid Bed Dryer is to create a fluidal turbulence in and a granulated or Powdery wet product by means of hot air (or dehumidified air) flowing in an upward Direction & to dry the same to the final required degree in a careful manner.
SUITABILITY
In Fluid Bed Dryer the wet material is transposed to a fluidized state by hot air stream that surrounds the material completely & therefore the heat Transfer rate achieved is very high & the temperature distribution throughout the product is uniform. Due to this, drying time is considerably Reduced & therefore high production rates are achieved in comparison to other dryers. As the product is in the close contact with hot Air at low temperature & also for short duration, the physical & chemical properties of the product are generally not affected & therefore the dryer can effectively be used for the heat sensitive products. Due to movement of
product during drying, lump formation, case hardening etc., is minimized. The Fluid Bed Dryers are not suitable for drying of liquids or pasty material.
- FLUID BED PROCESSOR
The principle of Fluid Bed Processor is to produce the uniform sized granules from the dry powder / crystalline material by addition of binder material and spraying the liquid solution through top spray atomizing nozzle, peristaltic spray pump etc. The liquid is transported to spray nozzle by peristaltic pump and mixed with compressed air to spray trial runs to achieve the optimum results and fine quality granules.
The success of processor also depends on good binder composition. The ingredients are PVP, KBO, CMC, Starch, Gelatin, Sugar Methyl cellulose, ethyl cellulose, Lactose
- LOADING & UNLOADING OF MATERIAL
Material should be transferred to product bowl either manually or mechanically. Material unloading can be done by tilting the bowl and by manual operation. The unloading may be done means of Pn. Conveying system or mechanical tipper.
- EQUIPMENT SUBASSEMBLIES & PARTS
- MAIN BODY
M.O.C. – S.S. 316 / S.S. 304 THICKNESS – 3 mm
It is a Cylindrical Retarding Chamber & Filter Bag Housing, Vertical Explosion Chamber etc. supported on slabs. A cylindrical bottom body resting on floor Level.
The Accessories of main body are: –
- Vertical Cylindrical Body
- PC Bottom & Top Sealing Gaskets.
- Safety Device for PC.
- L / S Glass Windows
- Farthing Device
- Air Inlet Nozzle
- Blower Inlet Nozzle
- Explosion Frame & Flap (Vertical)
- Lifting Eyebolts & Lugs
- Spray Window & Cover
- Pneumatic Shaking Cylinder
- Pneumatic Component for PC Sealing
- Pneumatic component for bag sealing & shaking
- Bottom Dish, Leg supports.
- Bottom Drain Triclover union with blind cover
- Charging Nozzle
- CIP Nozzle & Manifold
- Manholes
- Support bracket frames
- Explosion duct extension and canopy.
- AIR INLET SHUT OFF VALVE
M.O.C. – S.S. 304 THICKNESS – 35 mm
It is an isolating valve between main body and air preparation unit. The type of valve is On/Off. The flap is operated through a double acting pneumatic actuator. This remains close when the equipment is not in use or during bag shaking.
- BLOWER INLET SHUT OFF VALVE
M.O.C. – S.S. 304 THICKNESS – 35 mm
This valve is provided between the blower suction nozzle & main body. The type Of valve is On/Off. The flap is operated through a double acting Pneumatic Actuator and this valve also remain close when the equipment is not in use or during bag shaking.
- AIR PREPARATION UNIT
M.O.C. – S.S. 304 THICKNESS – 3 mm
It is Rectangular Housing to accommodate Air Filters (20+5 Micron, 3 Micron & 0.3Hepa) and air heater. The one end is provided with filter Mounting frame while other with a transition duct for changing rectangular section to circular duct.
The Accessories Fitted are
- Steam Inlet & Outlet Nozzle
- Air Guide Cone
- S. Air Heater
- Δ P Connection Ports
- Access Door
- Hot & Cold Air Damper.
- Air Filter 20 + 5 Micron
- Fine Filter 3 Micron
- Hepa Filters 0.3 Micron
- Hepa test window with cover
- Hepa Filter fixing Frames
- Temperature Sensor Socket
- Lifting Lugs
- PRODUCT CONTAINER & TROLLEY
- PRODUCT CONTAINER
M.O.C. – S.S. 316 THICKNESS – 3 mm
This is a conical shaped container having the formed end at top and a welded flange at bottom. The wet product is loaded in the container, as per its working capacity i.e. 250 kg.
Accessories fitted are: –
- Bottom perforated plate
- Dutch Weave Mesh
- L/S Glass window
- Quick change Clamps
- Sampling Device
- Support bars
- Temperature Sensor
- TROLLEY
M.O.C. – S.S. 304 SIZE – 40 NB PIPE
This is a tubular structure to support the product container, provided With Provided for S.S. 304 swivel castors and PU Wheels. There are four nos. Guide wheel brackets easy locating with main body. The Product container can be transported from one place to other easily with the help of trolley.
- DEHUMIDIFIER & MIST ELIMINATOR
M.O.C. – S.S. 304 Tubes + Aluminium Fins
M.S. Water Box & Structural Support
The dehumidifier is provided at inlet side of FBD. This is being used to control the relative humidify of process air by removal of excess moisture at the particular temperature.
This is rectangular in shape with end flanges for connection with air inlet ducting. The chilled water is being circulated at a controlled flow rate through the finned tubes that condense the excess moisture present in process air. This condensate is being drained automatically from bottom of dehumidifier through a siphon tube.
The accessories fitted are.
- Chilled water inlet & outlet nozzle
- Temp. Sensor socket
- RH sensor socket
- Chilled water control valve
- Auto-drain siphon tube
- Lifting lugs
- Structural support etc.
- Mist Eliminator
- EXPLOSION FRAME & FLAP:
M.O.C – S.S. 304 or Aluminium THICKNESS – 32 G
The S.S. 304 or aluminium explosion flap comprising of 32 G. thick S.S. 304 foil sand witched between S.S. Z frame + base frame & supported by a flat rubber gasket. This entire assembly is fitted on topside of main body as safety device. It suddenly releases the excess pressure developed inside due to explosion & prevents the equipment & building from damages. It recommended that there should not be any obstruction in the vicinity of Explosion Flap up to a reasonable distance of about 3 meters or more. The suitable extensions Ducts may be provided to suit site requirements.
FILTER BAG SHAKING DEVICE:
`M.O.C. – S.S. 304
This is an automatic type bag shaking arrangement. When the bag Hanger & bag is connected through telescopic cylinder (3 stage),the shaking frequency and interval is variable parameters, which can be set through PLC controller. The bag Shaking is required to remove the adhered product particles on the bag contact surface to improve its permeability and avoid choking of the bags.
The accessories provided are:
- Filter bag sealing gasket
- FBT housing ring
- Multiple finger filter bag
- Filter bag hooks
- Filter bag hanger
- Quick change coupling
- Cylinder for shaking & lowering
- DUCTINGS
M.O.C. – S.S. 304 & M.S. THICKNESS – 2 mm / 3 mm
The ducting are provided between air preparation unit, main body, product Container, blower inlet etc. made out of S.S. 304, this ducting conveys the air through filters bags to the blower suction.Then the air is exhausted through the blower outlet ducting made out of M.S. The size & length of ducting are designed to suit the site requirements.
The duct flanges are provided with FGN rubber gasket and C.S. /S.S. bolt & nuts.
- a) BLOWER ASSEMBLY
M.O.C. – M.S. THICHNESS – 4 / 5 mm
The blower is provided in the system to create an induced draft to pass the heated and conditioned air through wet product and create the fluidization state of material, which produces a uniformly dry product in a reasonably less time period.
The accessories of this assembly are:
- Dynamically balanced backward curved Aluminium Impeller
- Blower Casing
- Supporting Structure
- Anti vibration pads
- Blower suction nozzle
- Air guide cone
- Manually operated flow control damper
- Blower Inlet Shut Off Valve on/off type.
- Blower outlet extension duct
- Electric motor directly coupled with impeller
- Silencer
Direction of rotation of impeller is very critical & must be checked at the time of installation & trial run. Airflow is controlled through pn. Operated blower inlet shut off valve. This valve is located in the blower inlet duct and as near to main body as possible. The valve remains close during auto pneumatic shaking and at the end of process.
- b) SILENCER
M.O.C. – M.S. THICHNESS – 1.6 & 3 MM
The silencer is provided after the blower outlet damper & duct the sound level up to 90 – 95 dB.
The accessories / parts of silencer are: –
1) Perforated shell 2) Jacket Shell
3) Sound absorbing material 4) End flanges
c) EXHAUST FILTER HOUSING
M.O.C. – M.S. THICHNESS – 3 mm
The exhaust filter housing will be normally installed between main body and the blower. This is provided with 5-micron air filters to arrest the fine particles escaping to atmosphere and caters the requirement of pollution control to some extent.
SEALING GASKETS
M.O.C. Food Grade Quality rubber Silicon / FGN Rubber
For sealing the product container top and bottom face, as well the filter bag bottom end,pneumatically operated inflatable sealing tubes are used. The tubes are inflated by compressed air at an operating pressure ranging of 1.8-to 2.2-kg/ cm². Low-pressure safety switches are provided for safety of products.
The accessories of the assembly are:
- Inflatable sealing gaskets.
- Pressure regulating valve with gauge.
- Pressure switches etc.
- Flow Control Valve.
- CONTROL PANEL & POWER PANEL
M.O.C. – Control Panel – S.S. 304 THICKNESS – 2 mm Thk.
M.O.C. – Pneumatic Panel – S.S. 304 THICKNESS – 2 mm Thk.
M.O.C. – Power Panel – M.S. THICKNESS – 1.6 mm Thk.
- The S.S. 304 pneumatic control panel is integral with control panel & fitted with Pneumatic instruments viz.
- The SS 304 Control Panel is Top Pendent mounted type located suitably near equipment & fitted with Electrical & pneumatic Instruments Viz.
- Man machine Interface (MMI) or operator interface terminal of PLC (OIT)
- Audio Signal Hooter, Emergency off Push Button
- Push Buttons, Rotary Switches etc.
- Printer for data recording with s.s. Trolley
- Pressure gauges
- Pressure regulating valves
- Pressure gauges.
An operator can control the equipment operation & process through these control panels.
- The M.S. power panel is foot mounted Twin Cabinet self-supporting type, located away from the production area consisting of:
- PLC Controller
- Analog Modules
- Motor Contactors
- MCB’S
- Ammeter
- Voltmeter
- Indication Lamps
- Δ P Transmitters
- Cooling Fan & Air filters
- Panel Door Switch
- Connector terminals
- Earth safety relay
- Emergency Push Button
- Solid Flow Monitor
- Misc. Electrical
Due to high voltage switch gears, which are hazardous for flameproof areas, this panel is located away from equipment. At the non-production area same time maintenance becomes easier due to its remote location.
- CONTROL SYSTEM, FIELD INSTRUMENTS.
The equipment is provided with control system & field instruments as list below.
Sr. No. | PARTICULARS | MAKE | FUNCTION |
01. | Differential Pressure Gauge or Transmitter
For Hepa Filter |
Dwyer | Monitor Δ P Across Hepa filter |
02. | Differential Pr. Gauge for exhaust filters | Dwyer | Monitor Δ P Across exhaust filters |
03. | Programmable Logic Controller | Mitsubishi | Programming of process Logic |
04. | Variable Frequency Drive | Mitsubishi | To vary motor speed & air flow control |
05. | Operator Interface Terminal | Beijer | Process Monitoring |
06. | Printer | Epson | Process Records |
07. | Temperature Sensor For
Inlet Air Outlet Air Product Bed |
Radix | Temp. Measurement &
control |
08. | RH Sensor & Transmitter | E+E or
Equivalent |
Monitor & control air dehumidifier |
09. | Air Velocity Sensor | E+E or Equiv | Monitor & control air flow |
10. | Heating Control Valve (On/Off Type) | Samson | Steam Flow Control |
11. | Chilled water control valve (On/Off Type) | Samson | Chilled water diverting |
12. | Pr. Gauges and Regulators For PC Bottom,PCT Top & F.B.Tube Gaskets | Radix / Festo | Air Pr. Regulation |
13. | Pressure Gauge For Air Filter, Regulation Unit | Festo | Air Pr. Regulation |
14. | Pneumatic Cylinder | Aircon | Operating bag shaking |
15. | Pneumatic Actuator | El-O-Matic | Operating Inlet Shut Off Valves |
16. | Pneumatic Actuator With Positioner | El-O-Matic | For By Pass Damper |
17. | Earth Relay & Sensor | AEC | Ensure Earth Contact Off
Product Container |
18. | Ammeter & Voltmeter | Meco-G | Measuring Current & Voltage |
19. | Indication Lamps | Teknic | Ensure The Elec. Supply |
20. | Pneumatic Hand Valve & Solenoid Valves | Festo | Operating Sealing Gasket |
21. | Safety Pressure Switch | Festo/
Switzer |
For Sealing Gaskets |
22. | Air Filters | Pharmatek | Air Filtration & Pollution Control |
23. | Explosion Flap | AEC | Safety of equipment & personnel |
24. | Silencer | Alliance | To reduce noise level of blower |
25. | Solid Flow Monitor | STECS | To Detect Bag Damage |
26. | Condensate Drain Valve | Aira | Removal of condensate from air Heater |
27. | CIP/ WIP Nozzle | Siddarth /
Equivalent |
Washing main body |
28. | Peristaltic Spray pump | Electro Lab | Spraying solution |
29. | Spray Nozzle | Schlick or
Equivalent |
Atomizing the spray solution |
30. | Flameproof Lamp | Trimiti | For better visualization in R.C. |
TECHNICAL SPECIFICATION
Description | Specification |
1. Pre-Filter | |
Filter Make | Pharmatek |
Micron rating / Material | 5 + 20 Micron /(HDP /Dry Fabric) |
Filter Size | 24” X 24” X 12” |
Capacity | 2000 CFM |
Efficiency | 60 – 65 % on ASHRE STD. |
Grade | 20 + 5 m |
Total No. | 04 |
2. HEPA-Filter | |
DOP Penetration | 0.03 % |
Filter Make | Pharmatek |
Micron rating / Material | 0.3 micron/Micro glass Fiber |
Filter Size | 24” X 24” X 12” |
Capacity | 1100 CFM |
Efficiency | 99.97% |
Total No. | 04 |
3. Filter bag | |
Filter Make | Alliance |
Micron rating / Material | 5-10 micron / Anti static polyester cloth |
No of Finger | 37 finger |
Air permeability | 5 m3/m2/min at 10mm wc |
4. Product container | |
Capacity | Wet material-250 kg |
Temp. Sensing Port | To be Provided |
Sample Port | To be Provided |
Silicon Gasket | To be Provided |
Dutch weave | To be Provided |
5. Expansion Chamber | |
Type | Cylindrical |
MOC | SS 316 |
Qty. of Bull eye | 03 nos. |
MOC for Bull eye | Toughened Glass |
Explosion Valve | To be provided |
6. Spray Nozzle Window | |
Spray Nozzle window | To be provided |
Qty. | 04 nos. |
7. Material Charging Nozzle | |
Qty | 01 No. |
MOC | SS 316 |
8. Blower Motor | |
Type | Flame proof, 3 phase induction motor |
Power rating | 30 HP / 415±10%V
/ 50±5% Hz |
RPM | 2955 |
Make | Crompton Greaves |
9. Air Inlet ON / off Valve | |
Air Inlet ON / off Valve | To be provided |
10. Pressure Cylinder for shaking | |
Type | Telescopic, double acting |
Size | 100 mm Ø, 700 mm Stroke x 3 Stage |
End shaft | SS 304
To be provided |
Seals | Nitrile rubber |
11. PLC Controller | |
Model | FX2N, 32 MR |
Digital I/P | 16 Input |
Digital O/P | 16 Output |
Make | Mitsubishi |
12. Analog Input module | |
Make | Mitsubishi |
Model | FXON, 3 A |
Conversion | Analog signal to digital signal |
Quantity | 4 Nos. |
13. MMI | |
Type | CEPL / M52A |
Serial port | RS 422 |
Serial port | RS 232 |
Display | Touch screen |
Supply voltage | 24 VDC |
14. Printer | |
Type | LX300+ Dot matrix printer |
Model | P170A |
Make | Epson |
15. Variable frequency drive | |
Type | FRA540-18.5K |
Model | FRA 500 |
Make | Mitsuibishi |
16. Pressure Gauge for Steam inlet | |
Make | Radix |
Least Count | 0.2 kg / cm2 |
Range | 0 – 10 kg/cm2 |
Mounting | Bottom entry male type |
17. Pressure Gauge Steam Solenoid Valve PRV | |
Make | Radix |
Range | 0 – 4.2 kg/ cm2 |
Least Count | 0.1 kg / cm2 |
18. Pressure Gauge for I/ P Converter | |
Make | Radix |
Range | 0 – 4.2 kg/ cm2 |
Least Count | 0.1 kg / cm2 |
19. Pressure Gauge for PC PRV | |
Make | Radix |
Range | 0 – 4.2 kg/ cm2 |
Least Count | 0.1 kg / cm2 |
20. Pressure Gauge for filter bag PRV | |
Make | Radix |
Range | 0 – 4.2 kg/ cm2 |
Least Count | 0.1 kg / cm2 |
21. Pressure Gauge for filter bag sealing tube | |
Make | Radix |
Range | 0 – 4.2 kg / cm2 |
Least count | 0.1 kg / cm2 |
Location | Control Panel |
22. Pressure gauge for PC sealing | |
Make | Radix |
Range | 0 – 4.2 kg / cm2 |
Least count | 0.1 kg / cm2 |
Location | Control Panel |
23. Air Velocity Sensor | |
Manufacturer | E+E Electronics |
Specification | EE 70 – VT XX |
Power Rating | 24 VDC ± 20 % |
Flow Rate – Range | 0 – 20 [m/s] |
24. Temperature Sensor for Inlet air | |
Manufacturer | Radix |
Model | PT 100 3 wire |
Insert Length | 12” |
Temperature Range | 0 –250 oC |
25. Pressure Gauge (Chilled water inlet) | |
Make | Waaree |
Range | 0 – 16 kg / cm2 |
Least Count | 0.2 kg / cm2 |
26. Pressure Gauge (Chilled water outlet) | |
Make | Waaree |
Range | 0 – 16 kg / cm2 |
Least Count | 0.2 kg / cm2 |
27. Temperature Sensor for Outlet air | |
Manufacturer | RADIX |
Model | PT 100 3 wire |
Insert Length | 8” |
Temperature Range | 0 –250 oC |
28. Temperature Sensor for Product bed | |
Manufacturer | RADIX |
Model | PT 100 3 wire |
Insert Length | 6” |
Temperature Range | 0 –250 oC |
29. Differential Pressure transmitter across HEPA filters | |
Manufacturer | Dwyer Instruments |
Model | 616C-2 |
Input Range | 0 –6” WC |
30. Differential Pressure transmitter across Product Filter bag | |
Manufacturer | Dwyer Instruments |
Model | 616C-5 |
Input Range | 0 -40” WC |
Max. Pressure | 15 PSIG |
31. Police Filter | |
Capacity | 60 – 65 % |
Size | (24 X 24 X 12 ) mm |
Micron Rating | 5 m |
Make | Pharmatek |
32. I to P Converter | |
Make | Watson smith |
Type | 100 X |
Input | 4-20mA |
Output pressure | 0.2 – 1 bar |
Inlet pressure | 5.5 bar |
33. Solid Flow Monitor | |
Make | STECS |
Size | 300 mm long sensor |
34. Earth Safety relay | |
Make | Alliance |
Input supply | 220 VAC / 50 Hz / 5 A |
Output | Potential free contacts |
Input | Earth contact |
35. Sealing gaskets for Product container (top& bottom) and Filter bag | |
Type | Inflatable tubes |
MOC | Non toxic Food grade silicone rubber/ Neoprene + PLC (White) |
36. Pneumatic Actuator for Drain Pump | |
Make | AIRA |
Size | 40 mm |
Valve | Ball type |
Rating | 150 |
Operating Pressure | 80 PSI |
37. Pressure Actuator with Positioner for Air inlet | |
Make | EL-O- Matic |
Type | PD-150 |
Input range | 4 to 20 mA |
Output range | 3-15 PSI |
38. Pressure Actuator with Positioner for Bypass damper | |
Make | EL-O- Matic |
Type | PD-60 |
39. Pressure Actualator with positioner for outlet air | |
Make | EL – O – Matic |
Type | PD – 150 |
40. Rotary valve positioner | |
Make | EL – O – Matic |
Model | LC |
Range | 0 – 900 |
41. Emergency Switch Off | |
Qty. | 02 Nos. |
Position | PLC/control Panel |
42. Product container sensor | |
Make | Radix |
43. Pressure Gauge for rotary valve positoner closing | |
Make | Wika |
Range | 0 – 10 kg / cm2 |
Least count | 0.5 kg / cm2 |
44. Pressure Gauge for rotary valve positoner opening | |
Make | Wika |
Range | 0 – 10 kg / cm2 |
Least count | 0.5 kg / cm2 |
45. RH sensor cum transmitter | |
Make | Rotronic |
Power | 10 – 35 VDC |
Range | 0 – 100 % RH |
46. Lamp | |
Make | Trimiti |
Type | Flange proof / Water proof |
Rating | 100 W |
47. Dehumidifier | |
47.1 Chilling Coil | |
Make | Alliance |
Heat transfer area | 238 Sq meter |
MOC
a) Tube b) Fin |
SS 304 Aluminium |
inlet/ Outlet temp. °C | 7-8°C / 12-13°C |
Air flow rate | 8000 m3/ hr |
47.2 Steam Air Heater | |
Type | Finned tube |
Make | Virtex |
MOC | SS + SS 304 |
Heat Transfer Area | 80 m2 |
- MATERIAL OF CONSTRUCTION
Description | Specification |
Product Container | SS 316 |
Dutch weave Mesh | SS 316 |
Retarding chamber | SS 316 |
Explosion chamber | SS 316 |
Filter bag tube ring | SS 316 |
Filter bag hanger | SS 316 |
Charging nozzle | SS 316 |
Trolley | SS 304 |
Air inlet duct | SS 304 |
- ENCLOSURES:
Sr. No. | Description | Drawing No. |
1 | General arrangement drawing of Fluid bed Processor PGM 250 S |
- Utilities Specification
Description | Specified |
Electrical Connection | To be provided |
Compressed Air Connection | To be provided |
Steam connection to the heating coil | To be provided |
Chilled water for dehumidifier | To be provided |
- SAFETY FEATURES
The equipment shall be provided with safety features as listed below.
Sr. NO. | FEATURE | SPECIFIED |
01. | Slab Mounted Equipment | For cGMP Site Layout |
02. | Motor Overload Relay, If Overload The Switch Gear Trip | For Motor Safety |
03. | Earth Safety Relay, If Improper Earthing Halts The Process | For Equipment & Operator Safety |
04. | Emergency Off, If Activated Stops The Process | For Equipment & Operator Safety |
05. | Pressure Switches For – 1) P.C. Sealing Gasket
2) F.B. Tube Gasket If Air Pressure Lower Than Required Then Stops The Process |
For Product Safety & Gasket Safety |
06. | Temp. Sensors Air Inlet, If Inlet Temp. Increases Than Set Value, The Steam Control Valve Closes. | For Product Safety |
07. | Password Protection To Operate PLC, Recipe Features Via Operator Interface Terminal | For Product Safety & Batch Integrity |
08. | Explosion Flap, If Released Relieves The Excess Pressure Developed During Explosion | For Plant Building, Equipment& Human Safety |
09. | Safety Clamps (Manual) For Holding Product Container & Acting As A Jumper For Earth Continuity Of PC & RC | For Equipment & Product Safety |
10. | Solid Flow Monitor, If activated stops blower | For Preventing Product Loss |
11. | RH Sensor, if the RH value exceeds the set point then cold water flow gets diverted | For product quality consistency |
- FAT PROCEDURE:
Factory Acceptance Test Procedure shall be as follows:
After the completion of erection work of the machine, client shall be informed to perform the factory acceptance test (FAT).
Client shall perform the FAT at the manufacturer site and record all the data in the prescribed FAT document as per the details given below:
- Test criteria
- Design Verification Check list
- Deficiency & Corrective Action report
- Pre-installation requirements
- Final report
- CHANGE CONTROL PROCEDURE:
Change in the agreed design shall be addressed through the well-defined Change control procedure.
- DESIGN QUALIFICATION REPORT
- Abbreviations and Definitions reference Document
SR.NO. SR. NO. | ABBREVIATIONS | PARTICULARS |
01. | ∆ PG | Differential Pressure Gauge |
02. | A | Ammeter |
03. | AI | Analog Input |
04. | AO | Analog Output |
05. | AFS | Air Flow Sensor |
06. | ASS | Ammeter Selector Switch |
07. | AISOV | Air Inlet Shut Off Valve |
08. | BISOV | Blower Inlet Shut Off Valve |
09. | C | Contactor |
10. | CF | Cooling Fan |
11. | CGMP | Current Good Manufacturing Practice |
12. | CT | Current Transformer |
13. | CDV | Condensate Drain Valve |
14. | DI | Digital Input |
15. | DO | Digital Output |
16. | DS | Panel Door Switch |
17. | DH | Dehumidifier |
18. | EPB | Emergency Push Button |
19. | ER | Earth Relay |
20. | ES / ED | Earth Senor / Earthing Device |
21. | F | Fuse |
22. | FB | Filter Bag |
23. | FBD / FBP | Fluid Bed Dryer / Fluid Bed Processor |
24. | For Pn. Fitting and Accessories | Pn. Accessories, Ref. Pn. Data list & Circuit |
25. | FBT | Filter Bag Tube |
26. | FCD | Flow Control Damper |
27. | H | Hooter |
28. | HCV | Heating Control Valve |
29. | HMI or MMI | Man Machine Interface |
30. | HTW | Hepa Test Window |
31. | HP | Horse Power |
32. | HV | Hand valve |
33. | I/P | I to P Convertor |
34. | LR | Pressure Regulating Valve |
35. | M | Motor |
36. | M 1 | Proportional Pn. Actuator |
37. | MCB | Miniature Circuit Breaker |
38. | ME | MIST. Eliminator |
39. | MOC | Material of Construction |
40. | OIT | Operator Interface Terminal |
41. | O/L | Overload Relay |
42. | PB | Push Button |
43. | PC | Product Container |
44. | PID | Proportional (P), integral (I), Derivative (D) |
45. | PCB | Product Container Bottom |
46. | PCT | Product Container Top |
47. | PG | Pressure Gauge |
48. | PLC | Programmable Logic Controller |
49. | PO | Purchase Order |
50. | PS | Pressure Switch |
51. | RH | Relative Humidity |
52. | RPM | Rotations Per Minute |
53. | RS | Rotary Selector Actuator |
54. | S | Solenoid Valve |
55. | SS | Stainless Steel |
56. | SFM | Solid Flow Monitor |
57. | TR | Temp. Transmitter |
58. | TC & B | Triclover & Blind |
59. | V | Voltmeter |
60. | VSS | Voltmeter Selector Switch |
61. | VFD | Variable Frequency Drive |