Auto Coater Operational Qualification Protocol/ Annexures

The purpose of the Auto Coater Operational Qualification protocol is to establish the documentary evidence to ensure that the installed Auto Coater shall operate reproducibly and consistently within its full dynamic range of operation according to the manufacturer’s specifications.

Auto Coater Operational Qualification written on the colored file background
SERIAL NO.ITEM DESCRIPTION
1.0PROTOCOL APPROVAL
2.0OVERVIEW:
2.1Objective
2.2Purpose
2.3Scope
2.4Responsibility
2.5Execution Team
3.0ACCEPTANCE CRITERIA
4.0REQUALIFICATION Criteria
5.0OPERATION QUALIFICATION PROCEDURE
5.1Equipment Description
5.2Instruction on filling out the checklist
5.3Test instrument details
5.4Verification of functional checks
5.5Verification of key Functionality of the control panel
5.6Verification of safety Feature(s)
5.7Verification of Standard Operating Procedure
5.8Training Record of Personnel(s)
5.9Verification of Component (s) to be calibrated
5.10Deficiency And Corrective Action(s) (Reports)
6.0Operational Qualification Final Report
6.1Summary
6.2Conclusion
6.3Final Report Approval

Check Out Auto Coater Installation and Performance Qualification Protocol Also.

1.0PROTOCOL APPROVAL:

The signing of this approval page of Protocol No. XYZ indicates agreement with the qualification approach described in this document. If a modification to the qualification approach becomes necessary, an addendum shall be prepared and approved. The procedure is only permissible for implementation upon receiving authorization from the designated authorities as below.

This Operational Qualification Report of Auto coater has been reviewed and approved by the following persons:

FUNCTIONNAMEDEPARTMENTSIGNATUREDATE
PREPARED BY QUALITY ASSURANCE  
REVIEWED BY PROJECTS / ENGINEERING  
REVIEWED BY PRODUCTION  
APPROVED BY QUALITY ASSURANCE  
2.0OVERVIEW:
2.1OBJECTIVE: 
 The objective of the operational qualification is to prove that each operation proceeds as per design specification and the tolerances prescribed there in the document are the same at utmost transparency.
2.2PURPOSE: 
 The purpose of this protocol is to establish the documentary evidence to ensure that the installed Auto coater shall operate reproducibly and consistently within its full dynamic range of operation according to manufacturer’s specification.
2.3SCOPE: 
 This protocol shall define the test procedures, documentation, references, and acceptance criteria to establish that the Auto coater operates and performs as intended in accordance with the design qualification. The equipment shall be preceded by the performance qualification procedure. The Scope of this protocol is limited to the operational Qualification of Auto Coater in Pharmaceutical (Company Name)
2.4RESPONSIBILITY: 
 The following shall be responsible; Quality assurance officer/Executive  – For Preparation of Protocol /ExecutionProjects / Engineering Head – For execution, Production Head – For execution support Quality Assurance Head – For adequacy and final approval
2.5EXECUTION TEAM:
 The satisfactory operation of the Auto coater shall be verified by executing the qualification studies described in this protocol. The successfully executed protocol documents that the Auto coater is operational and is satisfactorily working. The execution team is responsible for the execution of the operation of Auto Coater. All executors involved with this protocol shall sign within the prescribed format given below.
DEPARTMENTDESIGNATIONNAMESIGNATUREDATE
PROJECTS/ ENGINEERING    
PRODUCTION    
QUALITY ASSURANCE    
3.0ACCEPTANCE CRITERIA:
3.1Ensure that the equipment functions in accordance with its defined operational Procedure
3.2All SOPs for the related equipment are to be Checked and Varified by the concerned Departments
3.3Training shall be given to all the concerned personnel
3.4All materials of construction of the contact parts are to be checked as per the specifications.
3.5All the functionality of equipment components is to be checked.
4.0REQUALIFICATION CRITERIA:
 The machine shall be requalified if
 Any major changes in system components affect the performance of the system·   After a major breakdown maintenance is carried out.·   As per revalidation date and schedule
5.0OPERATIONAL QUALIFICATION PROCEDURE:
5.1
Equipment NameAuto coater
ManufacturerXYZ Company Name
ModelSpecify Modal Name
LocationCoating Area
Equipment Serial No XYZ
Working Capacity129~215 kg (Working Capacity Range)
Service it offersFilm Coating of tablets and Caplets

Mechanism

Under the supplied electric power the main driving motor produces the turning movement. While the Coating pan turns, the spray gun sprays the coating pan.

The spray gun sprays the coating solution into tablets in the coating pan. The Baffles attached on perforated plates help coated tablets move up for efficient spraying and drying. After spraying the coating solution to the tablets, high-temperature air is being supplied into the coating pan. The damper plates are worked by the compressed air which is supplied into the cylinder. The heat exchanger produces the high-temperature heated air and supplies the air to the coating pan.

Auto Coater comprises of following components: –

  1. Air Flowing System.
  2. Coater.
  3. Solution tank.
  4. Manual damper.
  5. Dust collector.
  6. Heat exchanger.
  7. Touch screen.

Air Flowing System

The compressed air pressure can be adjusted by the regulator, which is located at the rear side of the coating machine. Compressed air is supplied to the following area.

a. Solution tank.
b. Coater.
c. Manual damper.
d. Dust collector.
e. Integrated electric electric control panel.

COATER

The coater is the main part, where coating is performed through the mechanical functioning with other parts Viz. Solution tank, Heat exchanger, Dust collector, and Damper. Coater is constituted of the following areas.

a. Driving area
b. Working area
c. Operating control part.

a. Driving area:

The driving area consists of:

  1. Main power driving motor
  2. Worm reducer
  3. Chain
  4. RPM, WIP sensor
  5. Pneumatic Chamber
  6. Pumps for solution

b. Working area :

The working area of the coater is constituted:

a.     Coating pan.
b.     Baffle and discharging guide.
c.     Heated air supply dust pipe.
d.     Spray gun.
e.     Heated air discharging duck and other auxiliary parts

Coating pan:

The coating pan consists of a round pan and 8 air ducts. The air-exhausting punching plates are located at the side between the duct and the pan. It has a heated air flowing system to supply heated air from the air duct pipe which is located at the rear side of the pan and exhausts the air after drying at the coating pan through the 8 air duct flange of the pan. 8 baffles are installed at the in the side of the pan for helping the mixing and drying the products as making easy air passing through among the products when they are falling to the bottom of the pan.

Discharging chute:

For discharging the products to the outside of the pan. It will be turned in the reverse direction and the discharging guide helps easy outcoming.

Heated air supply duct :

Heated air is supplied through 8 positions of jackets and the perforated holes on the surface of the coating pan.

Spray gun :

The spray gun sprays the coating solution into tablets during coating. On the spray gun coating solution supplying line, the Compressed air supplying line and nozzle withdraw line are attached to the atomizing air, the spray gun can supply coating solution equally to tablets.

There are 3 spray guns on the setting bar for cleaning or maintenance, operator can take out the spray gun by pressing ‘OUT’ of the GUN SLIDING SYSTEM on the operation screen.

Heated air discharging duct :

This duct is installed at the left side of the coating pan and has the function of exhausting heated air that was used for drying the tablets.

SOLUTION TANK:

The solution tank has the function of containing and supplying the coating solution

MANUAL DAMPER:

The opening and shutting of the damper is done by compressed air to the damper cylinder

Dust collector

dust collector has the function of filling the exhausting air that is supplied for the coater. As passing through the dust collector air will be cleaned by the filter.

HEAT EXCHANGER

The heating coil which is installed at the inside of the heat exchanger will be heated by the supplied high-temperature system. Heat exchanger constituted by following parts:

1.     Driving area.
2.     Air heating area.
3.     Filter.

TOUCH SCREEN

The operating control panel consists of the operation switches part and the operation screen part.

Operation switches are:

  1. Control power ON/OFF select switch.
  2. Pan ON/OFF select switch.
  3. Discharge ON/OFF select switch.
  4. Spray ON/OFF push button switch.
  5. Emergency switch.
  6. RPM meter.
  7. Supplying /Exhaust air temperature.
  8. Solution Temperature.
  9. Buzzer reset push button switch.
  10. Tower lamp switch.

Operation Screen:

All the functions of the system can be controlled by the operation screen. The functional description of the operation screen is as follows.

  1. Main control start/stop switch.
  2. Exhaust fan start/stop switch.
  3. Supply fan start/stop switch.
  4. Agitator start/stop switch.
  5. Agitator start/stop switch.
  6. Gun sliding system OUT/IN.
  7. Alarm screen.
  8. Running time.
  9. Spray screen.
  10. Intermittent drive.
  11. Supply velocity.
  12. Tab bed temperature. 
  5.2INSTRUCTION FOR FILLING THE CHECKLIST
5.2.1In case of compliance of the test use the word ‘Complies’ otherwise use‘ Does not comply ‘ to indicate non-compliance.
5.2.2For identification of the components of the equipment and utilities use the word ‘’yes’’ to show its presence and use ‘No’ to indicate the absence of the identity
5.2.3Give detailed information in the summary and conclusion part of the Operational Qualification report.
5.2.4Whichever column is blank or not used ‘NA’ shall be used.
5.3TEST INSTRUMENT DETAILS
 This test is intended to describe the equipment/instruments and their complete details to have a traceability to the national standard which is to be used for the verification of the operation of the Auto coaterInstrument/Equipment required. 1. Tachometer, 2. Ammeter, 3. Photometer, 4. Anemometer
Sr. No.Name of InstrumentInst. ID. NumberCalibration valid up toChecked by/Date
     
     
     
     
5.4VERIFICATION OF FUNCTIONAL CHECKS:
NAME OF SYSTEM COMPONENTSPECIFIED FUNCTIONMATCHES WITH THE SPECIFIED FUNCTION(YES / NO)VERIFIED BY(SIGN)DATE
Machine Emergency StopTo Stop the machine, PLC,   
Exhaust Air Pressure Manometer.To monitor the air pressure of exhausting top duct   
Programmable logic controllerTo control the process   
Operator Interface TerminalTo monitor the process   
Temperature sensor for inlet and outlet airTo measure the temperature   
Main Air GaugeTo monitor the total compressed air pressure   
Pump Air GaugeTo monitor the compressed air pressure of the diaphragm pump   
Atom Air Pressure GaugesTo monitor atomizing air pressure supplying to spray gun   
Air Flow MeterDelicate adjusting of atomizing air pressure to spray gun   
Lamp ON/OFF SwitchObservation of coating operation   
Pan RPM To show speed of Pan   
RPM SensorChecking the rotating speed of the Coating Pan   
NAME OF SYSTEM COMPONENTSPECIFIED FUNCTIONMATCHES WITH THE SPECIFIED FUNCTION(YES / NO)VERIFIED BY(SIGN)DATE
WIP SensorIt makes the coating pan stop one by one for washing each duct.   
Peristaltic pumpTo control the supplying volume of the coating solution.   
Peristaltic pump RPM0-220 RPM Maximum   
Sight Glass WindowTo view the coating function.   
Discharge ChuteTo discharge the complete coated tablets.   
Tablet Temperature sensorTo measure the tablet bed temperature.   
Spray GunSpray the coating solution to tablets on the coating pan.   
Ball valve leverTo control the opening/closing of the ball valve for material discharge.   
Tower LampFor Indication of machine status.   
Power failure RecoveryThe processing time elapsed should be in the PLC memory and the process shall continue from where the power interruption has occurred Switch off the mains for 5 minutes and observe the operation after resumption of power.   
NAME OF SYSTEM COMPONENTSPECIFIED FUNCTIONMATCHES WITH THE SPECIFIED FUNCTION(YES / NO)VERIFIED BY(SIGN)DATE
DOP TestDOP penetration shown by the photometer should be less than 0.03% through the filter media and should be ‘zero’ through mounting joints   
5.5VERIFICATION OF KEY FUNCTIONALITY OF CONTROL PANEL:
OPERATING PANEL:Programmable logic controller
Make: 
COMPONENT OF CONTROL PANELSPECIFIED FUNCTIONMATCHES WITH THE SPECIFIED FUNCTION(YES / NO)VERIFIED BY(SIGN)DATE
2. Pan ON/OFFTo screen display   
2.Pan ON/OFFTo control coating pan operation   
3. Discharge pan ON/OFFTo turn the coating pan count clockwise   
4. Spray onTo spray of a spray gun.   
5. Spray offTo Stop Spray.   
6. RPM MeterTo Indicate pan RPM.    
7. Suppling Air Temperature MeterFor Measurement of inlet air temperature.   
8. Exhausting Air Temperature MeterFor Measurement of outlet air temperature.   
9. Buzzer Reset Push ButtonTo stop the buzzer sound.   
5.6VERIFICATION OF SAFETY FEATURES:
SAFETY FEATURES DESCRIPTIONFUNCTIONVERIFIED BY(SIGN)DATE
1. EarthingTo avoid the electrical shock due to leakage current.  
2. HooterTo give an audio signal in case of any deficiency.  
3. Emergency Stop ButtonTo stop the machine if the problem appears in running condition.  
5.7VERIFICATION OF STANDARD OPERATING PROCEDURE (SOP)

The following Standard Operating Procedures were verified as important for the effective performance of Auto Coater operation.

Sr.No.SOP TITLESOP NUMBERVERIFIED BYDATE
     
     
     
5.8TRAINING RECORD OF PERSONNEL (S) :
Sr. No.Name of PersonnelDesignationSign. & DateTrained ByRemark
1.     
2.     
3.     
4.     
5.9VERIFICATION OF COMPONENT (S) TO BE CALIBRATED

Verify that the drafted calibration procedures for different identified components in Auto Coater are adequate and appropriate covering the operating range(s). e.g. Pressure gauge, temperature gauge, temperature indicator cum controller, etc (As applicable). 

COMPONENT / PART TO BE CALIBRATEDIDENTIFICATION NO.EXTERNAL CALIBRATION(Attach Certificate)VERIFIED BY(SIGN)DATE
1. Pump air pressure gauge    
2. Main air gauge    
3. Pump air pressure gauge    
4. Cil air pressure gauge    
5. Atom air pressure gauge    
7. RPM meter    
8. In/Outlet temperature sensor    
9. Solution tank air pressure gauge.    
10. Inlet/Outlet temperature controller    
5.10DEFICIENCY AND CORRECTIVE ACTION(S) REPORT(S)
The following deficiency was verified and corrective actions were taken in consultation with the Engineering Department.
Description of deficiency:
 
 
 
 
 
 
 
Corrective action(s) taken:
 
 
 
 
 
 
 

Reviewed by

Date

6.0OPERATIONAL QUALIFICATION FINAL REPORT:
6.1SUMMARY:
 
 
 
 
 
 
 
6.2CONCLUSION:
 
 
 
 
 
 
 

6.3 FINAL REPORT APPROVAL

It has been verified that all tests required by the Auto Coater Operational Qualification protocol are completed, reconciled, and attached to this protocol or included in the Operation qualification summary report. Verified that all amendments and discrepancies are documented, approved, and attached to this protocol.

The signature in the block below indicates that all items in this Auto Coater Operational Qualification report have been reviewed and found to be acceptable and that all variations or discrepancies have been satisfactorily resolved. After the successful operational qualification of the Auto coater, the equipment can be taken for performance qualification.

NAMEDESIGNATIONDEPARTMENTSIGNATUREDATE
  PROJECTS / ENGINEERING  
  PRODUCTION  
  QUALITY ASSURANCE  

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