DESIGN QUALIFICATION OF FLUID BED PROCESSOR

FLUID BED PROCESSOR

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 . Conveying system or mechanical tipper. 

DESIGN QUALIFICATION PROTOCOL

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
  • APPENDIX

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 . 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. 

EQUIPMENT SUBASSEMBLIES & PARTS 

MAIN BODY

M.O.C.  –  S.S. 316 ,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: –

  1. Vertical Cylindrical Body
  2. PC Bottom & Top Sealing Gaskets.
  3. Safety Device for PC.
  4. L / S Glass Windows
  5. Farthing Device
  6. Air Inlet Nozzle
  7. Blower Inlet Nozzle
  8. Explosion Frame & Flap (Vertical)
  9. Lifting Eyebolts & Lugs
  10. Spray Window & Cover
  11. Pneumatic Shaking Cylinder
  12. Pneumatic Component for PC Sealing
  13. Pneumatic component for bag sealing & shaking
  14. Bottom Dish, Leg supports.
  15. Bottom Drain Triclover union with blind cover
  16. Charging Nozzle
  17. CIP Nozzle & Manifold
  18. Manholes
  19. Support bracket frames
  20. 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

  1. Steam Inlet & Outlet Nozzle
  2. Air Guide Cone
  3. Air Heater
  4. Δ P Connection Ports
  5. Access Door
  6. Hot & Cold Air Damper.
  7. Air Filter 20 + 5 Micron
  8. Fine Filter 3 Micron
  9. Hepa Filters 0.3 Micron
  10. Hepa test window with cover
  11. Hepa Filter fixing Frames
  12. Temperature Sensor Socket
  13. 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: –

  1. Bottom perforated plate
  2. Dutch Weave Mesh
  3. L/S Glass window
  4. Quick change Clamps
  5. Sampling Device
  6. Support bars
  7. 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 + Aluminum 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.

  1. Chilled water inlet & outlet nozzle
  2. Temp. Sensor socket
  3. RH sensor socket
  4. Chilled water control valve
  5. Auto-drain siphon tube
  6. Lifting lugs
  7. Structural support etc.
  8. Mist Eliminator 

EXPLOSION FRAME & FLAP: 

M.O.C   – S.S. 304 or Aluminum ,THICKNESS   – 32 G

The S.S. 304 or aluminum 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:

  1. Filter bag sealing gasket
  2. FBT housing ring
  3. Multiple finger filter bag
  4. Filter bag hooks
  5. Filter bag hanger
  6. Quick change coupling
  7. 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:

  1. Dynamically balanced backward curved Aluminum Impeller
  2. Blower Casing
  3. Supporting Structure
  4. Anti vibration pads
  5. Blower suction nozzle
  6. Air guide cone
  7. Manually operated flow control damper
  8. Blower Inlet Shut Off Valve on/off type.
  9. Blower outlet extension duct
  10. Electric motor directly coupled with impeller
  11. 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:

  1. Inflatable sealing gaskets.
  2. Pressure regulating valve with gauge.
  3. Pressure switches etc.
  4. 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.

  1. The S.S. 304 pneumatic control panel is integral with control panel & fitted with Pneumatic instruments viz.
  2. The SS 304 Control Panel is Top Pendent mounted type located suitably near equipment & fitted with Electrical & pneumatic Instruments Viz.
  3. Man machine Interface (MMI) or operator interface terminal of PLC (OIT)
  4. Audio Signal Hooter, Emergency off Push Button
  5. Push Buttons, Rotary Switches etc.
  6. Printer for data recording with s.s. Trolley
  7. Pressure gauges
  8. Pressure regulating valves
  9. 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:

  1. PLC Controller
  2. Analog Modules
  3. Motor Contactors
  4. MCB’S
  5. Ammeter
  6. Voltmeter
  7. Indication Lamps
  8. Δ P Transmitters
  9. Cooling Fan & Air filters
  10. Panel Door Switch
  11. Connector terminals
  12. Earth safety relay
  13. Emergency Push Button
  14. Solid Flow Monitor
  15. Electrical

Due to high voltage switchgears, 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.

PARTICULARSMAKE FUNCTION
Differential Pressure Gauge or Transmitter For Hepa FilterDwyerMonitor Δ P Across Hepa filter
Differential Pr. Gauge for exhaust filtersDwyerMonitor Δ P Across exhaust filters
Programmable Logic ControllerMitsubishiProgramming of process Logic
Variable Frequency DriveMitsubishiTo vary motor speed & air flow control
Operator Interface TerminalBeijerProcess Monitoring
PrinterEpsonProcess Records
Temperature Sensor For Inlet Air, Outlet Air ,Product BedRadixTemp. Measurement & control
RH Sensor & TransmitterE+E or EquivalentMonitor & control air dehumidifier
Air Velocity SensorE+E or Equiv.Monitor & control air flow
Heating Control Valve (On/Off Type)SamsonSteam Flow Control
Chilled water control valve (On/Off Type)SamsonChilled water diverting
Pr. Gauges and Regulators For PC Bottom,PCT Top & F.B.Tube GasketsRadix / FestoAir Pr. Regulation
Pressure Gauge For Air Filter, Regulation UnitFestoAir Pr. Regulation
Pneumatic CylinderAirconOperating bag shaking
Pneumatic ActuatorEl-O-MaticOperating Inlet Shut Off Valves
Pneumatic Actuator With PositionerEl-O-MaticFor By Pass Damper
Earth Relay & SensorAECEnsure Earth Contact Off Product Container
Ammeter & VoltmeterMeco-GMeasuring Current & Voltage
Indication LampsTeknicEnsure The Elec. Supply
Pneumatic Hand Valve & Solenoid ValvesFestoOperating Sealing Gasket
Safety Pressure SwitchFesto/SwitzerFor Sealing Gaskets
Air FiltersPharmatekAir Filtration & Pollution Control
Explosion FlapAECSafety of equipment & personnel
SilencerAllianceTo reduce noise level of blower
Solid Flow MonitorSTECSTo Detect Bag Damage
Condensate Drain ValveAiraRemoval of condensate from air Heater
CIP/ WIP NozzleSiddarth /EquivalentWashing main body
Peristaltic Spray pumpElectro LabSpraying solution
Spray NozzleSchlick or EquivalentAtomizing the spray solution
Flameproof LampTrimitiFor better visualization in R.C.

 TECHNICAL SPECIFICATION           

DescriptionSpecification
Pre-Filter
Filter MakePharmatek
Micron rating / Material5 + 20 Micron /(HDP /Dry Fabric)
Filter Size24” X 24” X 12”
Capacity2000 CFM
Efficiency60 – 65 % on ASHRE STD.
Grade20 + 5 m
Total No.04
HEPA-Filter
DOP Penetration0.03 %
Filter MakePharmatek
Micron rating / Material0.3 micron/Micro glass Fiber
Filter Size24” X 24” X 12”
Capacity1100 CFM
Efficiency99.97%
Total No.04
Filter bag
Filter MakeAlliance
Micron rating / Material5-10 micron / Anti static polyester cloth
No of Finger37 finger
Air permeability5 m3/m2/min at 10mm wc
Product container
CapacityWet material-250 kg
Temp. Sensing PortTo be Provided
Sample PortTo be Provided
Silicon GasketTo be Provided
Dutch weaveTo be Provided
xpansion Chamber
TypeCylindrical
MOCSS 316
Qty. of Bull eye03 nos.
MOC for Bull eyeToughened Glass
Explosion ValveTo be provided
Spray Nozzle Window
Spray Nozzle windowTo be provided
Qty.04 nos.
Material Charging Nozzle
Qty01 No.
MOCSS 316
Blower Motor
TypeFlame proof, 3 phase induction motor
Power rating30 HP / 415±10%V /  50±5% Hz
RPM2955
MakeCrompton Greaves
Air Inlet ON /  off  Valve
Air Inlet ON /  off  ValveTo be provided
Pressure Cylinder for shaking
TypeTelescopic, double acting
Size100 mm Ø, 700 mm Stroke x 3 Stage
End shaftSS 304 ,To be provided
SealsNitrile rubber
PLC Controller
ModelFX2N, 32 MR
Digital I/P16 Input
Digital O/P16 Output
MakeMitsubishi
Analog Input module
MakeMitsubishi
ModelFXON, 3 A
ConversionAnalog signal to digital signal
Quantity4 Nos.
MMI
TypeCEPL / M52A
Serial portRS 422
Serial portRS 232
DisplayTouch screen
Supply voltage24 VDC
Printer
TypeLX300+ Dot matrix printer
ModelP170A
MakeEpson
Variable frequency drive
TypeFRA540-18.5K
ModelFRA 500
MakeMitsuibishi
Pressure Gauge for Steam inlet
MakeRadix
Least Count0.2 kg / cm2
Range0 – 10 kg/cm2
MountingBottom entry male type
Pressure Gauge Steam Solenoid Valve PRV
MakeRadix
Range0 – 4.2 kg/ cm2
Least Count0.1 kg / cm2
Pressure Gauge for I/ P Converter
MakeRadix
Range0 – 4.2 kg/ cm2
Least  Count0.1 kg / cm2
Pressure Gauge for PC PRV
MakeRadix
Range0 – 4.2 kg/ cm2
Least  Count0.1 kg / cm2
Pressure Gauge for filter bag PRV
MakeRadix
Range0 – 4.2 kg/ cm2
Least  Count0.1 kg / cm2
Pressure Gauge for filter bag sealing tube
MakeRadix
Range0 – 4.2 kg / cm2
Least count0.1 kg / cm2
LocationControl Panel
Pressure gauge for PC sealing
MakeRadix
Range0 – 4.2 kg / cm2
Least count0.1 kg / cm2
LocationControl Panel
Air Velocity Sensor
ManufacturerE+E Electronics
SpecificationEE 70 – VT XX
Power Rating24 VDC ± 20 %
Flow Rate – Range0 – 20 [m/s]
Temperature Sensor for Inlet air
ManufacturerRadix
ModelPT 100 3 wire
Insert Length12”
Temperature Range0 –250 oC
Pressure Gauge (Chilled water inlet)
MakeWaaree
Range0 – 16 kg / cm2
Least Count0.2 kg / cm2
Pressure Gauge (Chilled water outlet)
MakeWaaree
Range0 – 16 kg / cm2
Least Count0.2 kg / cm2
Temperature Sensor for Outlet air
ManufacturerRADIX
ModelPT 100 3 wire
Insert Length8”
Temperature Range0 –250 oC
Temperature Sensor for Product bed
ManufacturerRADIX
ModelPT 100 3 wire
Insert Length6”
Temperature Range0 –250 oC
Differential Pressure transmitter across HEPA filters
ManufacturerDwyer Instruments
Model616C-2
Input Range0 –6” WC
Differential Pressure transmitter across Product Filter bag
ManufacturerDwyer Instruments
Model616C-5
Input Range0 -40” WC
Max. Pressure15 PSIG
Police Filter
Capacity60 – 65 %
Size(24 X 24 X 12 ) mm
Micron Rating5 m
MakePharma Tek
I to P Converter
MakeWatson smith
Type100 X
Input4-20mA
Output pressure0.2 – 1 bar
Inlet pressure5.5 bar
Solid Flow Monitor
MakeSTECS
Size300 mm long sensor
Earth Safety  relay
MakeAlliance
Input supply220 VAC / 50 Hz / 5 A
OutputPotential free contacts
InputEarth contact
Sealing gaskets for Product container (top& bottom) and Filter bag
TypeInflatable tubes
MOCNon toxic Food grade silicone rubber/ Neoprene + PLC (White)
Pneumatic Actuator for Drain Pump
MakeAIRA
Size40 mm
ValveBall type
Rating150
Operating Pressure80 PSI
Pressure Actuator with Positioner for Air inlet
MakeEL-O- Matic
TypePD-150
Input range4 to 20 mA
Output range3-15 PSI
Pressure Actuator with Positioner for Bypass damper
MakeEL-O- Matic
TypePD-60
Pressure Actuator with positioner for outlet air
MakeEL – O – Matic
TypePD – 150
Rotary valve positioner
MakeEL – O – Matic
ModelLC
Range0 – 900
Emergency Switch Off
Qty.02 Nos.
PositionPLC/control Panel
Product container sensor
MakeRadix
Pressure Gauge for rotary valve positioner closing
MakeWika
Range0 – 10 kg / cm2
Least count0.5 kg / cm2
Pressure Gauge for rotary valve positioner opening
MakeWika
Range0 – 10 kg / cm2
Least count0.5 kg / cm2
RH sensor cum transmitter
MakeRotronic
Power10 – 35 VDC
Range0 – 100 % RH
Lamp
MakeTrimiti
TypeFlange proof / Water proof
Rating100 W
Dehumidifier
Chilling Coil
MakeAlliance
Heat transfer area238 Sq meter
MOC

a) Tube

b) Fin

 

SS 304

Aluminium

inlet/ Outlet temp. °C7-8°C / 12-13°C
Air flow rate8000 m3/ hr
Steam Air Heater
TypeFinned tube
MakeVirtex
MOCSS + SS 304
Heat Transfer Area80 m2

MATERIAL OF CONSTRUCTION 

DescriptionSpecification
Product ContainerSS 316
Dutch weave MeshSS 316
Retarding chamberSS 316
Explosion chamberSS 316
Filter bag tube ringSS 316
Filter bag hangerSS 316
Charging nozzleSS 316
TrolleySS 304
Air inlet ductSS 304

ENCLOSURES: 

DescriptionDrawing No.
General arrangement drawing of Fluid bed Processor
  •  Utilities Specification 
DescriptionSpecified
Electrical ConnectionTo be provided
Compressed Air ConnectionTo be provided
Steam connection to the heating coilTo be provided
Chilled water for dehumidifierTo be provided

 SAFETY FEATURES

The equipment shall be provided with safety features as listed below.

FEATURESPECIFIED
Slab Mounted EquipmentFor cGMP Site Layout
Motor Overload Relay, If Overload The Switch Gear TripFor Motor Safety
Earth Safety Relay, If Improper Earthing Halts The ProcessFor Equipment & Operator Safety
Emergency Off, If Activated Stops The ProcessFor Equipment & Operator Safety
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
Temp. Sensors Air Inlet, If Inlet Temp. Increases Than Set Value, The Steam Control Valve Closes.For Product Safety
Password Protection To Operate PLC, Recipe Features Via Operator Interface TerminalFor Product Safety & Batch Integrity
Explosion Flap, If Released Relieves The Excess Pressure Developed During ExplosionFor Plant Building, Equipment& Human Safety
Safety Clamps (Manual) For Holding Product Container & Acting As A Jumper For Earth Continuity Of PC & RCFor Equipment & Product Safety
Solid Flow Monitor, If activated stops blowerFor Preventing Product Loss
RH Sensor, if the RH value exceeds the set point then cold water flow gets divertedFor 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: 

  1. Test criteria
  2. Design Verification Check list
  3. Deficiency & Corrective Action report
  4. Pre-installation requirements
  5. Final report

CHANGE CONTROL PROCEDURE: 

Change in the agreed design shall be addressed through the well-defined Change control procedure.

DESIGN QUALIFICATION REPORT

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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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