Protocol For Factory Acceptance Test of the Fluid Bed Processor

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Factory Acceptance Testing (FAT) makes sure that recently produced and packaged equipment serves the purpose for which it was designed. The FAT verifies the equipment’s functionality and confirms that all other requirements and the customer’s purchase order parameters have been met. Below is the detailed protocol for the Factory Acceptance Test of Fluid Bed Processor.

Factory Acceptance Test of the Fluid Bed Processor

Process flow for Factory Acceptance Test of the Fluid Bed Processor

1.0 APPROVAL

Initiated by:

DESIGNATIONNAMESIGNATUREDATE
Production Executive

Checked by:

 DESIGNATIONNAMESIGNATUREDATE
 Validation Executive   

Reviewed by:

 DESIGNATIONNAMESIGNATUREDATE
 Quality Assurance Manager   
 Quality Control Manager   
 Manager Engineering   
 Manager  Production   

Approved by:

 DESIGNATIONNAMESIGNATUREDATE
 GM QA /QC   
 GM Production   

1.0 Purpose:

1.1 To ensure that the dry heat sterilization tunnel is manufactured by (Company Name) is manufactured as per design specification.

1.2 The machine performs as per the agreed performance specification at the manufacturer’s site.

2.0 References:

2.1 Design Qualification of the machine obtained from the manufacturer.

2.2 Purchase Order No: EN/year / 1183, dated – XX.XX.XXXX.

2.3 User Requirement Specification Document No: AL/URF/XX(Year)/XX(serial no.).

3.0 Attachments

3.1 Drawing of the proposed installation Room, Room No.

4.0 Procedure for Factory Acceptance Test of the Fluid Bed Processor:

4.1 Take out the photocopy of the approved protocol for the Factory Acceptance Test of the Fluid Bed Processor to be carried out at the manufacturer’s site.

4.2 Carry out the tests mentioned in Table Number 1 at the manufacturer’s site & mention the observation in an “ACTUAL” column of the protocol photocopy.

4.3 In case of any additional information or mode of checking mentioned in the “REMARKS” column.

4.4 Check the basic installation & operation of the Fluid Bed Processor.

4.5 In case any deviation observes during FAT, document it in the Observed deviation section.

4.6 Ensure that corrective action taken is meeting the user requirement specification.

4.7 If the deviation is acceptable, document it in the Observed Deviation section and provide proper justification.

4.8 If deviation does not acceptable, inform the manufacturer for necessary action.

4.9 If the deviation is acceptable, provide final conclusion.

4.10 Ensure that the following listed documents are provided/ will be provided with the machine.

  • User’s Manual
  • Schematic electrical diagram
  • Spare parts list
  • MOC and test certificate of all parts of the machine from an accredited Lab.
  • Supporting documents from the sub-suppliers.

4.11 Attach all relevant drawings, Manual, and Critical spare part list with FAT report.

Read Also: Multimill Design Qualifications in Pharma

5.0 Documentation for Factory Acceptance Test of the Fluid Bed Processor

5.1 All documentation work shall be completed concurrently during the execution of the FAT. However, the protocol does not define the sequence of the test/ documentation to be carried out.
5.2 Use indelible black/blue ink for the recording.
5.3 Fill out complete information in the format provided.
5.4 Do not leave any blank space.
5.5 Correct the wrong entry by drawing a single line through incorrect data, recording the correct data, and then signing and dating the change.
5.6 Enter “N/A” in a space that is not applicable.
5.7 During the protocol any deviation must be addressed and attended to as per the defined procedure.
5.8 During protocol execution, the report shall be prepared with the following details:

  • Discussion of all studies in the observation column.
  • FAT is successfully completed or not
  • Conclusion.
  • Recommendation, if any.

6.0 Verification criteria for Factory Acceptance Test of the Fluid Bed Processor :

Table 1
ItemExpectationActualRemarks
Machine(Company Name) Fluid Bed Processor FBE 500    
Make(Company Name) and Address  
Machine DimensionsLength: 4255 mm   Width:  1790  mm   Height: 2300  mm    
TypeSubstances in powdery or granular form ( bulk materials ) into a suspended state. The fluidizing air in this equipment will enable a very efficient heat and mass transfer  ( Heating, Cooling, Drying, Granulating ).    
Capacity  600 Litres.  
Power supplyThree-phase 415 Hz, 50 Hz    
Machine mountingOn sturdy SS 304 molded angles welded & grinded surface & fully cladded with SS sheets.    
Machine InstallationInstallation of the machine should be suitable as per the attached drawing. Compare the installation parameters with respect to room, pendant, drain, exhaust, etc.    
ItemExpectationActualRemarks
Product Container Trolley Material Trolley WheelsSS 304   Nylon Wheel ( 2 Fix – 2 Swivel )                 
 Support Column   Position Manufacturer Specification Material Surface Finish Winch Provided Foundation Bolts Column mounting Bolts Length and pitchLateral Support – Machine tower Pam (Company Name). Pvt. Ltd.   Support column FBE 500 SS 304 Matt Finish ( Grit 120 ) Yes  ( LHS ) SS 304 M12  X 140 long standard pitch                     0
Lower Plenum Position Manufacturer Specification Material Surface Inside    Weld Inside Polished Material – Sealing   Drain Point Provided InsulationInlet section – machine tower   (Company Name). Pvt. Ltd.   Lower Plenum FBE 500 SS 304 Matt Polished ( Grit 120 )   Yes Inflatable Silicone Gasket       Yes   No                          
Product Container Position Manufacturer Specification Material Surface Inside Weld Inside Polished Bottom Disconnect Material – SealingTamperature Probe Port Sample Port Window Material Sealing Material – Window Bottom Perforated Plate – Free Surface Quick Disconnect Bottom Sieve Mesh Size  
Expansion Chamber Position Manufacturer Specification Material Surface finish -Inside Surface finish –outside Weld Inside Polished Material – Sealing Bull eye Window Window Material Sealing material – Window Spray Nozzle Port – Diameter Sealing Material – Nozzle Port Connection Charging Port Port Cleaning Nozzle – Material / Diameter Filter Wetting NozzlesTemperature Probe Port Connection Outlet Air Automatic Filter shaking Provided Explosion Relief plate sealing Material – Explosing Relief Plates  
Clamping Assembly Position Manufacturer Specification Material Surface Inside Weld Inside Polished Material – Sealing  
Inside Air Handler Manufacturer Specification Material Surface Inside Connection Inlet AirConnection outlet AirPre filter / Material Face & Bypass / Material Window Material Sealing material – Window    
ItemExpectationActualRemarks
Stabilizing / Cooling zone Length Cover MOC AC Drive make No of HEPA HEPA Size1595 mm SS 304   ABB 02 No EU – 13 915 x 762 mm                        
Conveyor Motor Make TypeBonifiglioli Three-phase, aligned with a belt to the conveyor drive            
Blowers Make Type Airtech Engineers   3 Phase, 1 HP, 1400 RPM          
Heating Element Make Type Size Capacity Resistance (Company Name).‘U’ Type Heating Elements   1070 mm + 25 mm long   1500watts at 230 volts   35 ohms + 10 % at 230 volts                          
ItemExpectationActualRemarks
PLC   Make Model Mitsubishi   FX2N-32 MT            
MMI   Make ModelBeijers/ Mitsubishi   E 615            
Printer Make ModelEpson   LX – 300 Plus   
Fresh Air IntakeShould be available with prefilters discharging before HEPA filters.Should be situated at least four feet above the floor surface.            
ItemExpectationActualRemarks
Pre Filters   Type MakeShould be washable and reusable and Should be of reputed make                
HEPA Filters Hot HEPA Make   HEPA of DZ/SZ/CZ makeKlenzaids, Umbergaon Klenzaids, Umbergaon.            
Magnehelic Gauges Make  RangeDwyer, USA   0 to 50 mm of water            
RTDs   Make Model   Range  Radix   PT 100   0 to 400 °C              
ItemExpectationActualRemarks
Proximity Sensors   Type Make  Tubular   Tecknic/Accent / Contrinex/IFM            
Safety FeaturesEmergency Stop   Independent Emergency Heater Cut-Off facility upon high temperature.   Blowers not ON/ Tripped – Heater gets OFF.   Different password levels (At least Three) in PLC for recipe setting and operation                      
ItemExpectationActualRemarks
Additional Facilities Validation Ports   View Ports in Drying, cooling and stabilizing zones  Should be available for giving in DOP smoke before HEPA for all zones Should be available with a lock and key                              
ItemExpectationActualRemarks
Operational InterlocksIntake and exhaust blowers cannot be switched OFF until the chamber temp is below the set point.   Temp falls below-set point – Conveyor stops and restarts after the set delay after temperature achieving   Filling machine LAF not operational – tunnel will not start   Filling machine LAF trip – Conveyor stop   In feed max accumulation – Washing machine stop   Inadequate infeed – conveyor stops after a delay period   Outfeed max accumulation – Conveyor stop immediately and the heater banks get off after a delay time.   Any of the blowers OFF – Heater and conveyor gets OFF Out feed vial temperature high – Conveyor stops                                                                      


ItemExpectationActualRemarks
DocumentsThe following document should be available/ will be available with the machine.   MOC certificates of conveyor   MOC of drying, sterilizing, cooling, and stabilizing zone chambers   Test certificates of HEPA Filters (Efficiency and integrity)   Test certificate of blowers   Test certificate of Magnehelic gauges   Test certificates of RTDs   Test certificate of motors   Operating and maintenance manual.   As-built architectural, electrical, and P & ID drawing                                     
7.0   Performance at the site:
OperationObservationRemarks
Take a trial of the machine on the site by operating the machine with 7.5 ml tubular clear vials (24 mm dia). Vials are loaded on the infeed turntable of the washing machine, which will be carried forward to the infeed of the tunnel. From here the vial enters the tunnel and is carried forward by the conveyor.  
The vials should be carried smoothly through the tunnel to the outfeed. The conveyor speed should be adjustable from the operator interface. The heating should be controlled according to the set value on the operator interface.

The heater bank is being controlled by the temperature of two temperature sensors in the sterilization zone.   The set points and cycle data should be printed by the printer. The printing interval can be settable on PLC.   The alarms are being displayed and acknowledged on the MMI.    
                                                               
OperationObservationRemarks
The recipe setting and operation should be with different password levels. The following parameters should be settable as a part of the recipe.  
Control Temperature (°C)  
Conveyor start temperature (°C)  
Conveyor stop temperature (°C)  
Conveyor start/restart delay (seconds)   Start-up delay (seconds)  
Overshoot temperature (°C)  
Conveyor speed (mm/min)  
The following inputs should be required to start the process of the Tunnel   Product – Alphanumeric 8-digit Batch Number – Alphanumeric 8-digit, Run Number – 04 digits Operator code – Alphanumeric 8 digit.    
                                                                 
OperationObservationRemarks
Check for the following operational interlocks and their indication on MMI:   Heater will not start if the blowers are not operational. Intake and exhaust blowers cannot be switched OFF until the temp in the sterilization chamber falls below the set value.
Infeed max accumulation – Washing machine stop     Outfeed max accumulation – conveyor stop and heater will stop after a set delay   In adequate infeed – conveyor stop after a set delay time   LAF over filling machine not operational – Tunnel will not start   Blower of any zone tripped/ stopped – conveyor stop  
                                                        
OperationObservationRemarks
The machine should not make any abnormal sound or vibration during operation   MMI & PLC support should be available during Auto operation.   There should be a manual /maintenance mode/ validation mode in which the machine can be operated to perform maintenance activity / DOP tests/particle count etc.   Before starting the tunnel the PLC should require to enter the Product, Batch Number by the operator.   The data printed by the printer should print the Product, Batch number, and recipe before the start of the cycle.   The printer should also print every stage and alarm with the date irrespective of print interval time and temperature of the various zones as well as the conveyor speed at the set print interval.                                             

8.0 Deviation/ Disscussion

Protocol For Factory Acceptance Test of the Fluid Bed Processor

9.0 Recommendation and Conclusion

Protocol For Factory Acceptance Test of the Fluid Bed Processor
Protocol For Factory Acceptance Test of the Fluid Bed Processor

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