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.

PARTICULARS MAKE FUNCTION
Differential Pressure Gauge or Transmitter For Hepa Filter Dwyer Monitor Δ P Across Hepa filter
Differential Pr. Gauge for exhaust filters Dwyer Monitor Δ P Across exhaust filters
Programmable Logic Controller Mitsubishi Programming of process Logic
Variable Frequency Drive Mitsubishi To vary motor speed & air flow control
Operator Interface Terminal Beijer Process Monitoring
Printer Epson Process Records
Temperature Sensor For Inlet Air, Outlet Air ,Product Bed Radix Temp. Measurement & control
RH Sensor & Transmitter E+E or Equivalent Monitor & control air dehumidifier
Air Velocity Sensor E+E or Equiv. Monitor & control air flow
Heating Control Valve (On/Off Type) Samson Steam Flow Control
Chilled water control valve (On/Off Type) Samson Chilled water diverting
Pr. Gauges and Regulators For PC Bottom,PCT Top & F.B.Tube Gaskets Radix / Festo Air Pr. Regulation
Pressure Gauge For Air Filter, Regulation Unit Festo Air Pr. Regulation
Pneumatic Cylinder Aircon Operating bag shaking
Pneumatic Actuator El-O-Matic Operating Inlet Shut Off Valves
Pneumatic Actuator With Positioner El-O-Matic For By Pass Damper
Earth Relay & Sensor AEC Ensure Earth Contact Off Product Container
Ammeter & Voltmeter Meco-G Measuring Current & Voltage
Indication Lamps Teknic Ensure The Elec. Supply
Pneumatic Hand Valve & Solenoid Valves Festo Operating Sealing Gasket
Safety Pressure Switch Festo/Switzer For Sealing Gaskets
Air Filters Pharmatek Air Filtration & Pollution Control
Explosion Flap AEC Safety of equipment & personnel
Silencer Alliance To reduce noise level of blower
Solid Flow Monitor STECS To Detect Bag Damage
Condensate Drain Valve Aira Removal of condensate from air Heater
CIP/ WIP Nozzle Siddarth /Equivalent Washing main body
Peristaltic Spray pump Electro Lab Spraying solution
Spray Nozzle Schlick or Equivalent Atomizing the spray solution
Flameproof Lamp Trimiti For better visualization in R.C.

 TECHNICAL SPECIFICATION           

Description Specification
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
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
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
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
xpansion Chamber
Type Cylindrical
MOC SS 316
Qty. of Bull eye 03 nos.
MOC for Bull eye Toughened Glass
Explosion Valve To be provided
Spray Nozzle Window
Spray Nozzle window To be provided
Qty. 04 nos.
Material Charging Nozzle
Qty 01 No.
MOC SS 316
Blower Motor
Type Flame proof, 3 phase induction motor
Power rating 30 HP / 415±10%V /  50±5% Hz
RPM 2955
Make Crompton Greaves
Air Inlet ON /  off  Valve
Air Inlet ON /  off  Valve To be provided
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
PLC Controller
Model FX2N, 32 MR
Digital I/P 16 Input
Digital O/P 16 Output
Make Mitsubishi
Analog Input module
Make Mitsubishi
Model FXON, 3 A
Conversion Analog signal to digital signal
Quantity 4 Nos.
MMI
Type CEPL / M52A
Serial port RS 422
Serial port RS 232
Display Touch screen
Supply voltage 24 VDC
Printer
Type LX300+ Dot matrix printer
Model P170A
Make Epson
Variable frequency drive
Type FRA540-18.5K
Model FRA 500
Make Mitsuibishi
Pressure Gauge for Steam inlet
Make Radix
Least Count 0.2 kg / cm2
Range 0 – 10 kg/cm2
Mounting Bottom entry male type
Pressure Gauge Steam Solenoid Valve PRV
Make Radix
Range 0 – 4.2 kg/ cm2
Least Count 0.1 kg / cm2
Pressure Gauge for I/ P Converter
Make Radix
Range 0 – 4.2 kg/ cm2
Least  Count 0.1 kg / cm2
Pressure Gauge for PC PRV
Make Radix
Range 0 – 4.2 kg/ cm2
Least  Count 0.1 kg / cm2
Pressure Gauge for filter bag PRV
Make Radix
Range 0 – 4.2 kg/ cm2
Least  Count 0.1 kg / cm2
Pressure Gauge for filter bag sealing tube
Make Radix
Range 0 – 4.2 kg / cm2
Least count 0.1 kg / cm2
Location Control Panel
Pressure gauge for PC sealing
Make Radix
Range 0 – 4.2 kg / cm2
Least count 0.1 kg / cm2
Location Control Panel
Air Velocity Sensor
Manufacturer E+E Electronics
Specification EE 70 – VT XX
Power Rating 24 VDC ± 20 %
Flow Rate – Range 0 – 20 [m/s]
Temperature Sensor for Inlet air
Manufacturer Radix
Model PT 100 3 wire
Insert Length 12”
Temperature Range 0 –250 oC
Pressure Gauge (Chilled water inlet)
Make Waaree
Range 0 – 16 kg / cm2
Least Count 0.2 kg / cm2
Pressure Gauge (Chilled water outlet)
Make Waaree
Range 0 – 16 kg / cm2
Least Count 0.2 kg / cm2
Temperature Sensor for Outlet air
Manufacturer RADIX
Model PT 100 3 wire
Insert Length 8”
Temperature Range 0 –250 oC
Temperature Sensor for Product bed
Manufacturer RADIX
Model PT 100 3 wire
Insert Length 6”
Temperature Range 0 –250 oC
Differential Pressure transmitter across HEPA filters
Manufacturer Dwyer Instruments
Model 616C-2
Input Range 0 –6” WC
Differential Pressure transmitter across Product Filter bag
Manufacturer Dwyer Instruments
Model 616C-5
Input Range 0 -40” WC
Max. Pressure 15 PSIG
Police Filter
Capacity 60 – 65 %
Size (24 X 24 X 12 ) mm
Micron Rating 5 m
Make Pharma Tek
I to P Converter
Make Watson smith
Type 100 X
Input 4-20mA
Output pressure 0.2 – 1 bar
Inlet pressure 5.5 bar
Solid Flow Monitor
Make STECS
Size 300 mm long sensor
Earth Safety  relay
Make Alliance
Input supply 220 VAC / 50 Hz / 5 A
Output Potential free contacts
Input Earth contact
Sealing gaskets for Product container (top& bottom) and Filter bag
Type Inflatable tubes
MOC Non toxic Food grade silicone rubber/ Neoprene + PLC (White)
Pneumatic Actuator for Drain Pump
Make AIRA
Size 40 mm
Valve Ball type
Rating 150
Operating Pressure 80 PSI
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
Pressure Actuator with Positioner for Bypass damper
Make EL-O- Matic
Type PD-60
Pressure Actuator with positioner for outlet air
Make EL – O – Matic
Type PD – 150
Rotary valve positioner
Make EL – O – Matic
Model LC
Range 0 – 900
Emergency Switch Off
Qty. 02 Nos.
Position PLC/control Panel
Product container sensor
Make Radix
Pressure Gauge for rotary valve positioner closing
Make Wika
Range 0 – 10 kg / cm2
Least count 0.5 kg / cm2
Pressure Gauge for rotary valve positioner opening
Make Wika
Range 0 – 10 kg / cm2
Least count 0.5 kg / cm2
RH sensor cum transmitter
Make Rotronic
Power 10 – 35 VDC
Range 0 – 100 % RH
Lamp
Make Trimiti
Type Flange proof / Water proof
Rating 100 W
Dehumidifier
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
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: 

Description Drawing No.
General arrangement drawing of Fluid bed Processor
  •  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.

FEATURE SPECIFIED
Slab Mounted Equipment For cGMP Site Layout
Motor Overload Relay, If Overload The Switch Gear Trip For Motor Safety
Earth Safety Relay, If Improper Earthing Halts The Process For Equipment & Operator Safety
Emergency Off, If Activated Stops The Process For 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 Terminal For Product Safety & Batch Integrity
Explosion Flap, If Released Relieves The Excess Pressure Developed During Explosion For Plant Building, Equipment& Human Safety
Safety Clamps (Manual) For Holding Product Container & Acting As A Jumper For Earth Continuity Of PC & RC For Equipment & Product Safety
Solid Flow Monitor, If activated stops blower For Preventing Product Loss
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: 

  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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