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.

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

Check Out Auto Coater Installation and Performance Qualification Protocol Also.

1.0	PROTOCOL 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:

FUNCTION	NAME	DEPARTMENT	SIGNATURE	DATE
PREPARED BY		QUALITY ASSURANCE
REVIEWED BY		PROJECTS / ENGINEERING
REVIEWED BY		PRODUCTION
APPROVED BY		QUALITY ASSURANCE

2.0

OVERVIEW:

2.1	OBJECTIVE:
	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.
2.2	PURPOSE:
	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.
2.3	SCOPE:
	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)
2.4	RESPONSIBILITY:
	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

2.5

EXECUTION 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.

DEPARTMENT	DESIGNATION	NAME	SIGNATURE	DATE
PROJECTS/ ENGINEERING
PRODUCTION
QUALITY ASSURANCE

3.0	ACCEPTANCE CRITERIA:
3.1	Ensure that the equipment functions in accordance with its defined operational Procedure
3.2	All SOPs for the related equipment are to be Checked and Varified by the concerned Departments
3.3	Training shall be given to all the concerned personnel
3.4	All materials of construction of the contact parts are to be checked as per the specifications.
3.5	All the functionality of equipment components is to be checked.

4.0	REQUALIFICATION 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

5.0	OPERATIONAL QUALIFICATION PROCEDURE:

5.1
Equipment Name		Auto coater
Manufacturer		XYZ Company Name
Model		Specify Modal Name
Location		Coating Area
Equipment Serial No		XYZ
Working Capacity		129~215 kg (Working Capacity Range)
Service it offers		Film 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. 

5.2	INSTRUCTION FOR FILLING THE CHECKLIST
5.2.1	In case of compliance of the test use the word ‘Complies’ otherwise use‘ Does not comply ‘ to indicate non-compliance.
5.2.2	For 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
5.2.3	Give detailed information in the summary and conclusion part of the Operational Qualification report.
5.2.4	Whichever column is blank or not used ‘NA’ shall be used.

5.3	TEST 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 Instrument	Inst. ID. Number	Calibration valid up to	Checked by/Date

5.4	VERIFICATION OF FUNCTIONAL CHECKS:

NAME OF SYSTEM COMPONENT	SPECIFIED FUNCTION	MATCHES WITH THE SPECIFIED FUNCTION(YES / NO)	VERIFIED BY(SIGN)	DATE
Machine Emergency Stop	To Stop the machine, PLC,
Exhaust Air Pressure Manometer.	To monitor the air pressure of exhausting top duct
Programmable logic controller	To control the process
Operator Interface Terminal	To monitor the process
Temperature sensor for inlet and outlet air	To measure the temperature
Main Air Gauge	To monitor the total compressed air pressure
Pump Air Gauge	To monitor the compressed air pressure of the diaphragm pump
Atom Air Pressure Gauges	To monitor atomizing air pressure supplying to spray gun
Air Flow Meter	Delicate adjusting of atomizing air pressure to spray gun
Lamp ON/OFF Switch	Observation of coating operation
Pan RPM	To show speed of Pan
RPM Sensor	Checking the rotating speed of the Coating Pan

NAME OF SYSTEM COMPONENT	SPECIFIED FUNCTION	MATCHES WITH THE SPECIFIED FUNCTION(YES / NO)	VERIFIED BY(SIGN)	DATE
WIP Sensor	It makes the coating pan stop one by one for washing each duct.
Peristaltic pump	To control the supplying volume of the coating solution.
Peristaltic pump RPM	0-220 RPM Maximum
Sight Glass Window	To view the coating function.
Discharge Chute	To discharge the complete coated tablets.
Tablet Temperature sensor	To measure the tablet bed temperature.
Spray Gun	Spray the coating solution to tablets on the coating pan.
Ball valve lever	To control the opening/closing of the ball valve for material discharge.
Tower Lamp	For Indication of machine status.
Power failure Recovery	The 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 COMPONENT	SPECIFIED FUNCTION	MATCHES WITH THE SPECIFIED FUNCTION(YES / NO)	VERIFIED BY(SIGN)	DATE
DOP Test	DOP penetration shown by the photometer should be less than 0.03% through the filter media and should be ‘zero’ through mounting joints

5.5	VERIFICATION OF KEY FUNCTIONALITY OF CONTROL PANEL:

OPERATING PANEL	:	Programmable logic controller
Make	:

COMPONENT OF CONTROL PANEL	SPECIFIED FUNCTION	MATCHES WITH THE SPECIFIED FUNCTION(YES / NO)	VERIFIED BY(SIGN)	DATE
2. Pan ON/OFF	To screen display
2.Pan ON/OFF	To control coating pan operation
3. Discharge pan ON/OFF	To turn the coating pan count clockwise
4. Spray on	To spray of a spray gun.
5. Spray off	To Stop Spray.
6. RPM Meter	To Indicate pan RPM.
7. Suppling Air Temperature Meter	For Measurement of inlet air temperature.
8. Exhausting Air Temperature Meter	For Measurement of outlet air temperature.
9. Buzzer Reset Push Button	To stop the buzzer sound.

5.6	VERIFICATION OF SAFETY FEATURES:

SAFETY FEATURES DESCRIPTION	FUNCTION	VERIFIED BY(SIGN)	DATE
1. Earthing	To avoid the electrical shock due to leakage current.
2. Hooter	To give an audio signal in case of any deficiency.
3. Emergency Stop Button	To stop the machine if the problem appears in running condition.

5.7	VERIFICATION 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 TITLE	SOP NUMBER	VERIFIED BY	DATE

5.8	TRAINING RECORD OF PERSONNEL (S) :

Sr. No.	Name of Personnel	Designation	Sign. & Date	Trained By	Remark
1.
2.
3.
4.

5.9	VERIFICATION 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 CALIBRATED	IDENTIFICATION 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

5.10	DEFICIENCY 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

6.0	OPERATIONAL QUALIFICATION FINAL REPORT:

6.1	SUMMARY:
6.2	CONCLUSION:

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.

NAME	DESIGNATION	DEPARTMENT	SIGNATURE	DATE
		PROJECTS / ENGINEERING
		PRODUCTION
		QUALITY ASSURANCE