Compression Machine OQ (Operational Qualification)

Compression Machine OQ (Operational Qualification)

TABLE OF CONTENTS FOR COMPRESSION MACHINE OQ

	Approval
	Objective
	Responsibility
	System Description
	Pre-requisite of Operational Qualification
	Operational Qualification Procedure
		Training of concern personnel
		Critical Instrument Calibration
		Key Functionality Test
		Test Data Report Sheet
		Safety key Features Test
		SOP Verification
	Deviation Details(If Required)
	Change Control (If Required)
	Revalidation Criteria
	Acceptance Criteria
	Summary Report
	Conclusion
	Reference Documents

APPROVAL OF COMPRESSION MACHINE OQ

Prepared By	Signature	Date
Quality Assurance

Checked By	Signature	Date
Production
Engineering

Approved By	Signature	Date
Quality Assurance

• OBJECTIVE OF COMPRESSION MACHINE OQ: –
• The purpose of operational Qualification protocol is: –
• To qualify the equipment for its operational attributes of equipment.
• To ensure that the major critical instruments identified in the Installation Qualification protocol are calibrated.
• To establish that the Equipment operates within it’s desired operating ranges.
• To assure that the Equipment serves the intended purpose.
• To establish the draft SOP prepared for the operation ,cleaning and preventive maintenance of Equipment.
• RESPONSIBILITY: – 
• The validation team comprising of a representative from each of the following concern departments shall be responsible for the overall compliance with this Qualification protocol:

• Engineering Department
• Production Department
• Quality Assurance Department
•  The Production and Engineering shall be responsible for checking the operation and recording operational data as per the procedures outlined in this protocol.
• The Manager Engineering shall be responsible for verifying the data recorded in the Operational Qualification Protocol.
• The Quality Assurance Department shall be responsible for the final review of the qualification documents and its compliance to meet the acceptance criteria of the Operational Qualification protocol.
• SYSTEM DESCRIPTION: –

• The major components of the equipment are identified as:-

• Powder Feeding unit.
• Powder transfer unit
• Compression unit
• Hydraulic power pack assembly
• Discharge unit
• The Compression machine 26 station D tooling, a single rotary high speed tablet press, is a machine in incorporated with the force-feeding arrangement, auto-lubrication, electromagnetic clutch, power level sensor and rejection / sampling port.
• Powder feeding unit has S.S. 316 Hopper of capacity 20 Liter rests on top of the machine which holds the powder in it and delivers to the feeding assembly through a butterfly valve which control the flow of the powder between the hopper and the feeding assembly. The hopper consists of an agitator, which enhanced the powder flow. A barrel –type powder level sensor is mounted on a bracket and fixed against the sight glass of the hopper.
• Powder transfer unit Consists S.S. 316 inlet connector, which links the hopper and the force feeder, the force feeder has two counter rotating paddles of S.S. 316, driven by reduction gearbox and variable frequency AC drive motor. The tail over die is an essential feature of the high – speed tablet press. The function of the tail over die is to keep the filled die covered until the last moment before the upper punch enters the die.
• Drive unit has main motor of 5HP drives a very high reduction gearbox unit using an electromagnetic clutch and a timing belt. The gearbox unit consists of a Phosphorus bronze worm wheel and a worm shaft.
• Turret is a three piece structure having the center die tablet of S.S. 316 and upper and lower piece of cast iron of SG 400/15. The upper piece holds the upper punches, which rests on the upper cam tracks with the cam plate. Similarly, the lower piece holds the lower punches that travel on the lower cam tracks and Dozer.
• Compression unit comprises upper main pressure roll assembly having a roll centre, pressure roll and pressure roll pin. The roll centre holds the pressure roll and is locked by using external circlips upper punch penetration assembly is responsible for the entry height of the upper punch in the die. Tablet thickness assembly is responsible in deciding the tablet thickness.
• Weight dozer assembly is responsible for adjusting the weight of the tablet by varying the depth of fill. The depth of fill is adjusted by the upward and downward movement of the weight adjusting head through a dozer adjusting screw with the help of dial.
• Hydraulic power pack assembly system control the safety overload mechanism, which governs the maximum pressure, level, at which particular tablets are being made. The oil reservoir for this system is located in front LH corner within lower cabinet. It can be accessed by removing the lower side guard (LH). The oil level in the reservoir should be checked regularly through the oil level indicator.
• Tablet discharge unit comprises of ejection cam, tablet scrapper assembly & tablet discharge chute. The height of the ejection cam needs to be set in such a way that the tip of the lower punch is slightly above the die so as to avoid tablet-chipping problem. As soon as the tablet is ejected out it strikes the tablet scrapper assembly, which directs the tablet to the discharge chute. Tablet discharge chute is made S.S. 316 with acrylic cover. Tablets slide out through this chute to the container.
• Auto lubrication system provided for the lubrication of all critical pinpoints like roll pins, it comprises of a lubrication tank, a motorized pump, distribution manifold and pipelines. This pump operates on timer set in the PLC. It should be noted that the ON time should be less then the OFF time, to prevent the oil flooding. The dozing of oil respective critical points can be throttled through the distribution manifold.
• Lower punch lubrication system helps mainly for smooth and easy ejection of tablets. In addition the tablet gets a clean, smooth surface at the web. The lower punch has an extractor groove below the tip for the lubrication support, which may be a lubrication felt or woolen thread winding. In order to avoid lubricant, the scraper mechanism is built in. the stripper oil is collected in a collecting tray. The scraper keeps the external diameter of the die plate and lower punch guide clean. From the collecting tray the oil is transported downward through a funnel and a hose line and returned back into the tank.
• The working principle of compaction force control is whenever the powder is compressed to from a tablet an impact is generated. The oil in the hydraulic cylinder absorbs this impact. The load cell, which is mounted between the upper roll lever and the hydraulic cylinder, senses the load received. The value is transferred to the data control screen through the transducer and the PLC. The data control screen displays the individual force of all the 26 punches.
• PRE REQUISITE OF COMPRESSION MACHINE OQ (OPERATIONAL QUALIFICATION): –

• Ensure the cleanliness of the area where equipment to be installed.
• Equipment should be installed properly as defined in Installation Qualification protocol of the equipment.
• All the utilities are connected properly and verify for Operational.
• All the Electrical connections are connected properly and verify for Operational.
• The training has been imparted to the all concern personnel including validation team team for conducting Operational Qualification.
• COMPRESSION MACHINE OQ (OPERATIONAL QUALIFICATION) PROCEDURE: –

• A draft SOP’s shall be prepared on the basis of supplier guide for operation,cleaning and preventive maintenance before the qualification testing.
• Prior to the operational qualification test, the concern personnel shall be trained by the engineer from the supplier on the operational features of the equipment / system this training shall be recorded.
• Calibrate the critical instruments located on the equipment (as identified during installation qualification) as per in house SOP of the instrument calibration or the manufacturer’s instruction. Record the date of calibration & due date.
• The trained personnel shall carry out the Operational Qualification and record the observations of qualification test.
• Operate the equipment as per the draft SOP’s, record the change if any and confirm the SOP’s.
• Report the deviations if any observed.
• TRAINING DETAILS: – The Concern personnel and validation team should be qualified for Operation of the equipment by supplier’s representative / qualified person.
• Title: Operation,function and trouble shooting procedure of equipment.
• Name of the Trainer: 

S. No.	Name of the Trainee	Employee Number	Signature

PERFORMANCE QUALIFICATION FOR TABLET COMPRESSION

• INSTRUMENT CALIBRATION: –Calibrate the critical instrument as identified below prior to operation of the equipment. 

S. No.	Name of the Instrument	Location	Calibration Done on	Calibration Due on	Calibrated by
	Pressure Gauges.	Near incoming air
	Pressure Gauges.	Near discharge chute.
	Pressure Gauges.	For Tonnage

•  KEY FUNCTIONALITY DURING COMPRESSION MACHINE OQ: –
• Purpose:
• The purpose of this procedure is to demonstrate that the control panel and other manual operations of Tablet Compression Machine function as specified by the manufacturer.
• Testing:
• Check all the displays on the panel are identified.
• Turn on the power from the electrical panel.
• Set the control on the panel.
• Verify functionality of each component on the control panel against its Specified functions.
• Red switch for main electric supply ON / OFF
• Mushroom head red emergency stop button
• Observe and record the responses in the Testing Data Sheet
• TESTING DATA SHEET FOR COMPRESSION MACHINE OQ: – 

S. No.	Test Particulars	Specified Function	Observations	Checked By
	Turn the isolator knob to “ON” position.	PLC should display “welcome” screen.
	Press the “Main Menu” touch button.	PLC should display “Main Menu” Screen.
	Press “Operator Screen” touch button.	PLC should display “Operator Screen”.
	Press “Product Name” touch button.	PLC should display numeric and alphabet touch button.
	Enter product name “CEFF 500” (up to eight characters) using alphabets and numeric touch buttons.	PLC should accept Product name up to eight characters. PLC should display “CEFF 500” against Product Name.
	Again press the “Product Name” touch button.	PLC should display operator screen again.
	Press “Batch Size” touch button.	PLC should display numeric touch buttons.
	Enter Batch size 200,000 (upto 6 characters) using numeric touch buttons.	PLC should accept Batch size upto 6 characters. PLC should display 200,000 against Batch Size.
	Press “Batch Size” touch button again to go back to operator screen.	PLC should display “Operator Screen”.
	Press “Batch Number” touch button.	PLC should display numeric and alphabetic touch buttons.
	Enter “Batch Number” A 2001 (upto 8 characteristics) using alphabetic and numeric keys.	PLC should accept Batch Number upto 8 characters. PLC should display     A 2001 against Batch Number.
	Again press “Batch Number” touch button.	PLC should display “Operator Screen”.
	Press “Batch Reset” touch button.	PLC should display 000000 against Tablet produced.

 

	Decrease the pressure load using pressure release knob manually up to 30 KN.	Digital force indicator provided on the right hand side of the machine should display 30 KN.
	Further, decrease the pressure load using pressure release knob manually up to 20 KN.	Digital force indicator provided on the right hand side of the machine should display  20 KN.
	Press “Manual Operation” touch button, on the ‘Main Menu’ Screen.	PLC should display “Manual Operation” screen.
	Press engage touch button of clutch control and then press “jog” touch button of Main motor. Check the direction of rotation of the Turret.	Main motor should start rotating. Turret should rotate smoothly in anti-clockwise direction
	Leave the “jog” touch button of Main motor.	The main motor and Turret should stop rotating.
	Press “Start” touch button of main motor.	The main motor and Turret should start rotating.
	Press “Stop” touch button of main motor.	Main motor and Turret should stop rotating.
	Press Jog touch button of feeder motor. Check the direction of rotation of the feeder.	Feeder motor should start rotating. Feeder should rotate smoothly in clockwise direction.
	Leave the “jog” touch button of feeder motor.	The feeder motor and feeder should stop rotating.
	Press “Start” touch button of feeder motor.	The feeder motor and feeder should start rotating.
	Press “Stop” touch button of Feeder motor.	Feeder motor and feeder should stop rotating.
	Press “Manual” touch button to go to “Auto” mode.	PLC should display “Auto” in place of “Manual”.

	Press “Start” touch button of main motor and feeder motor.	Main motor and feeder motor should not run in “Auto” mode.
	Press “Main” touch button.	PLC should display “Main” menu screen.
	Press “Operator Screen” touch button.	PLC should display “Operator Screen”.
	Check ‘Operator Screen’ for ‘Product Name’, ‘Batch Size’, ‘Batch Number’, ‘Set Turret RPM’.	The PLC should display Product Name Batch Size 200,000 Batch Number  and Set Turret RPM 20.
	Press “Batch Start” touch button and Check for the sequence of operations.	The main motor should start rotating, followed by Turret, feeder motor and feeder.
	Check for any abnormal sound during operation.	No abnormal sound should be heard.
	Check the “Turret” RPM	The Turret should rotate at a RPM of 14 ± 10%.
	Increase the Turret RPM by pressing the ‘+’ touch of the “Set Turret RPM”, to 30.	The Turret should rotate at a RPM of 30 ± 10%
	Further increase the Turret RPM by pressing the ‘+’ touch of the “Set Turret RPM”, to 50.	The Turret should rotate at a RPM of 50 ± 10%.
	Press “Batch halt” touch button.	The machine should stop running.
	Press “Main” touch button.	PLC should display “Main Menu Screen”.
	Switch off the main supply by turning isolator knob to ‘Off’ position.	PLC should be switched Off.

• SAFETY FEATURES TEST FOR COMPRESSION MACHINE OQ (If applicable)

S. No.	Safety Feature Description	Specified Function	Observations	Checked By
	Password locking.	Machine will not run in auto/manual mode without correct password login in required stage.
	Low compressed air.	Machine status will indicate low air pressure in red.
	Safety Guard	Machine will not running auto mode while gate is open.
	Reason entry	Machine will not re-start without entering proper stopping reason.
	Batch counting	Machine will automatically stop after compression off one batch in Nos.
	Stop during continuous rejection.	Machine will stop while rejection will continuous.

• SOP VERIFICATION DURING COMPRESSION MACHINE OQ:

S. No.	SOP Title	Draft SOP No.	Verification Date	Operated By
	Operating
	Cleaning
	Preventive Maintenance

• DEVIATION DETAILS (If Applicable)
• CHANGE CONTROL (If Applicable)
• RE-VALIDATION CRITERIA :
• Operation Qualification to be re-qualified on
• Replacement of major component of the equipment with a new component.
• Any major modification in the existing equipment
• Shifting of the equipment from one location to another
• During monitoring if equipment is found to be malfunctioning

• ACCEPTANCE CRITERIA FOR COMPRESSION MACHINE OQ:
• Operational Qualification shall be considered acceptable when all the conditions specified in various have been met.

• SUMMARY FOR COMPRESSION MACHINE OQ:
• The acceptance criteria of the protocol and Specific check points  are checked and verified as per above mentioned operational checklist and found that all the parameter met the specification.

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