Tablet Compression Machine IQ (Installation Qualification)

Tablet Compression Machine IQ (Installation Qualification)

TABLE OF CONTENTS

	Approval
	Objective
	Responsibility
	Equipment Identification
	Equipment location
	Documentation
	Pre-requisite of Installation Qualification
	Installation Qualification Procedure
	System Description
	Procedure
		Installation Check List
		Inspection Check list
		Leveling and Alignment
		Material of Construction Check Points
		Certificates for motor
		Drawing
		Identification of Standard Operating Procedures
		Checklist for Supporting Utilities
		Identification of Critical Instruments for Calibration
	Deviation Details(If Any)
	Change Control (If Any)
	Revalidation Criteria
	Acceptance Criteria
	Summary
	Conclusion

APPROVAL

Prepared By	Signature	Date
Quality Assurance

 

Checked By	Signature	Date
Production
Engineering

Approved By	Signature	Date
Quality Assurance

• The validation team comprising of a representative from each of the following departments shall be responsible for the overall compliance with this protocol:
• RESPONSIBILITY: –  
• Standard Operating Procedure have been identified and listed.
• The equipment operation has been verified for its intended use.
• No unauthorized or unrecorded modifications have taken place.
• All critical components have been identified and calibrated.
• All supporting utilities are properly connected.
• The system meets the current Good Manufacturer’s Practice (cGMP) requirements.
• The system is installed according to the manufacturer’s recommendations.
• The system meets the Design Specification / URS.
• The purpose of this protocol is to provide an outline for the inspection of equipment for static attributes to verify that:
• OBJECTIVE: –
• Engineering Department
• Production Department
• Quality Assurance Department
• The Production and Engineering shall be responsible for checking the installation and recording installation data as per the procedures outlined in this protocol.
• Engineering Personnel shall be responsible for verifying the data recorded in the Installation Qualification Protocol.
• Quality Assurance Department shall be responsible for the final review of the qualification documents and its compliance to meet the acceptance criteria of the Installation Qualification protocol.
• EQUIPMENT DETAILS:

The Equipment Name	:	Tablet Compression Machine.
Model No.	:	26 Station
Serial No.	:
Tag No.	:
Name of the Supplier	:
Purchase Order Number / Date	:

 

• EQUIPMENT LOCATION 
• Facility :Tablets Manufacturing Facility
• Area :Tablets manufacturing Area
• Room Name:Tablet Compression Room
• Room ID No. :
• DOCUMENTATION:- 

S. No.	Document Name	Attachment No.
	URS
	Purchase Order Copy
	Design Qualification

PERFORMANCE QUALIFICATION FOR TABLET COMPRESSION

• PREREQUISITE OF Tablet Compression Machine IQ: –
• Machine should be open in front of validation Team.
• Ensure the cleanliness of the area.
• Check the correctness of location of the equipment to be installed with respect to layout.
• Check for correctness of mounting of equipment with respect to manufactures recommendation.
• Ensure the Electric connections required for installation.
• Ensure the other supporting utilities required for Installation.

Tablet Compression Machine IQ Procedure:

• Instructions:

• Check the installation of equipment :
• To verify the location of installation as per the equipment layout.
• To verify the proper assembly of the components as per the equipment drawings and  record the installation location and verification of assembly.
• To check the leveling and alignment as per the procedure and record the observation.

• Identify the critical components of equipment and verify that the components are complying as per desired specifications and record the observations.
• Check the MOC of the component and record the observation of the MOC.
• Identify the utility supplies required for equipment operation and verify that utilities are as per the specification and record the observatio.
• Identify the critical instruments supplied with the equipment or installed on the utility supply line. Verify that instruments are as per the desired specifications. Review the calibration status of the instruments & record the status.
• List the available drawing and record the Ref. No. for their location / availability.
• Identify the SOPs and assign SOP Numbers, record the SOP Title and Number.
• Record the deviation (if any)
• SYSTEM DESCRIPTION:
• The major components of the equipment are identified us:-

• 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 Ltrs. 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 26 punches.
• PROCEDURE :

• Tablet Compression Machine IQ (Installation) Check List: 

S. No.	Statement	Y/ N / NA	Checked By Sign & Date	Verified By Sign & Date
	Equipment Position with respect to layout and room ID
	All Electrical connections as per configuration
	Main Control panel positioned on service floor.
	Control Cable connectivity to CFC panel
	Dust Extracting system from PVC. hose to main machine
	De-dusting machine connectivity for main machine
	Compressed air supply
	Oil level of lubrication tank
	Feeder drive gear box
	Main drive gear box
	Machine guards

• Checklist for Inspection of Tablet Compression Machine IQ:

S. No.	Description	Specification	Observation	Checked By Sign & Date
	Overall Dimension in mm. (L x W x H)
	Level of main body	Perfectly level
	Machine guards	Transparent acrylic sheet – 15 mm. thickness
	Hopper	20 Ltrs.
	Agitator	06 No’s
	Main Drive Motor	5HP, 415V, 50Hz, 3 Phase, 1440rpm Make:
	Feeder Drive Motor	0.25HP, 415V, 50Hz, 3 Phase, 1380rpm Make: Bharat Bijlee
	Hydraulic Motor	1HP, 415V, 50Hz, 3 Phase, 1405rpm Make: Crompton Greaves
	Lubrication Pump Unit	Make: Cenlub] Model:
	Electro Magnetic Clutch.	Make: Golden Model:
	MCB for main motor	Make: Indokopp 16Amp, 3 Pole
	MCB for feeder motor	Make: Indokopp 4Amp, 3 Pole
	MCB for lubrication motor	Make: Indokopp 4Amp, 3 Pole
	MCB for power plug	Make: Indokopp 1Amp, 3 Pole
	MCB for fan	Make: Indokopp 2Amp, Single Pole
	MCB for control transformer &  SMPS	Make: Indokopp 4Amp, Di Pole
	MCB for power plugs	Make: Indokopp 4Amp, 3 Pole
	MCB for PLC	Make: Indokopp 2Amp, Single Pole

	MCB for MMI	Make: Indokopp 2Amp, Single Pole
	Contactor for main motor	Make: Sprecher & Schuh CA3-23-10, 23 Amps / 24V, AC
	Contactor for feeder motor	Make: Sprecher & Schuh CA3-12-10, 12 Amps / 24V, AC
	Contactor for hydraulic motor	Make: Sprecher & Schuh CA3-12-10, 12 Amps / 24V, AC
	Overload relay for hydraulic motor	Make: Sprecher & Schuh CA3-12-1.6 to 2.5 Amps.
	Contactor for lubrication motor	Make: Sprecher & Schuh CA3-12-10, 12 Amps / 24V, AC
	Overload relay for lubrication motor	Make: Sprecher & Schuh CA3-12-10, 0.38 to 0.62 Amps.
	Contactor for power plug	Make: Sprecher & Schuh CA3-12-10, 12 Amps / 24V, AC
	Overload relay for power plug	Make: Sprecher & Schuh CA3-12, 1.6 to 2.5 Amps.
	Overload relay for die fill motor	Make: Sprecher & Schuh CA3-12, 0.38 to 0.62Amps.
	Solid state relay for die fill motor	Make: Phoenix Input – 24 VDC, Output – 220V, AC–2No.
	MCB for agitator motor	Make: Indokopp 2 Amps. / Di – Pole

	Contactor for agitator motor	Make: Sprecher & Schuh CA3-12, 10, 12Amps / 24V, AC.
	Overload relay for agitator motor	Make: Sprecher & Schuh CA3-12-10, 0.38 to 0.62Amps.
	Relay	Make: Phoenix 3 c/o, 24 V, AC, 11 Pin, (06 Nos.)
	Relay	Make: Phoenix 1 c/o, 24 V, AC, 5 Pin, (06 Nos.)
	Timer for turret delay in mechanical over ride	Make: Bharti Cutt;er Hammer 24V, AC
	Control transformer	Make: Narmada 250V, AC
	Mono block rectifier bridge	Make: Semikron MD5 BU 1016
	SMPS	Make: Phoenix 10 Amps. / 24V, DC
	Cooling fan	Make: Rexnord 4”
	Main Isolator switch	Make: Salzer 25 Amps., 3 Watts.
	Powder level sensor	Make: IFM Cat. No. K15023 KIE3015-FPKG/NI
	Tablet counting proxy	Make: Katlax M18 PNP-NO 10-30 VDC, 200/400mA
10.2.43	Tower lamp	Make: Allen Bradley. 24V, DC
	Data control panel	Make: RITTAL Model: PC4609703
	Printer	Make: EPSON Model: P170A 25 Pin Connector, 220-240V, 50-60Hz, 0.3A
	VFD for Main motor	Make: Allen Bradley, 7.5 HP.

	MMI	Make: Pro-face Model: GP-2301
	Compaction force Control Panel	Make: Rittal Model:
	VFD for Force Feeder Motor	Make: Allen Bradley, 01 HP.
	VFD for Agitator Motor	Make: Allen Bradley, 0.5 HP.

• Leveling and alignment of Machine during Tablet Compression Machine IQ
  :

S. No.	Item Description	Leveling / Alignment OK / Not OK	Mode of Verification	Checked By Sign / Date
	Turret		Spirit Level
	Machine Level		Water Level
	Hopper		Spirit Level
	Control Panel		Water Level / Spirit Level

• Method for checking the Leveling of the Equipment:
• – Using Spirit Level Indicator

• Place the spirit level indicator at different points on the machine frame.
• Acceptance Criteria:
• The air bubble of the spirit level indicator shall be observed in the center.
• – Using Water Level Indicator:
• Place transparent tube filled with water of suitable length at various corners. Compare the levels of water and align the equipment.
• Acceptance Criteria:
• The water level at both the locations should match with the edges of those locations, if required should be repeated for other edges of the equipment on same plane.
• Method for checking the Alignment:
• Dial Indicator Method:

• Place the dial indicator on the coupling.
• Rotate the shaft slowly by hand.
• Observe the indicator reading on both sides’ rotation of the shaft.
• Acceptance Criteria:
• The total indicator reading should not be more than 0.305 mm.
• Straight Edge Method:
• Place the straight edge along the circumferences of both driver and driven pulleys simultaneously.

• Shift the motor base so as to adjust the gap between the straight edge and the circumferences of both the pulleys
• Check the gap with filler gauge.
• Acceptance Criteria:

The gap between the straight edge and pulleys should not be more than 1.0 mm

• Material of Construction of contact Part:

S. No.	Name of Components	MOC	Mode of verification	Checked By Sign & Date
	Turret	SG 400/15	Test  Report
	Die Table	SS316	Test  Report / Confirmed by Molybdenum Test.
	Press roll – Main	OHNS	Test  Report
	Press roll – Tamping	OHNS	Test  Report
	Powder Scrapper	Brass	Test  Report
	Tablet Take Off Plate	Brass	Test  Report
	Tail over Die	UHMHDPE	Test  Report
	Feeder sole plate	Gun metal	Test  Report
	Worm wheel (main drive)	PB	Test  Report
	Worm wheel (feeder drive)	PB	Test  Report
	Paddle for force feeder	SS 316	Test  Report / Confirmed by Molybdenum Test.
	Agitator Blades	SS 316	Test  Report / Confirmed by Molybdenum Test.
	Hopper	SS 316	Test  Report / Confirmed by Molybdenum Test.
	Hopper lid	SS 316	Test  Report / Confirmed by Molybdenum Test.
	Butterfly valve	SS 316	Test  Report / Confirmed by Molybdenum Test.

	Initial rejection / sampling flaps	UHMHDPE	Test  Report
	Discharge chute	SS 316	Test  Report / Confirmed by Molybdenum Test.
	Lower guard	SS 316	Test  Report / Confirmed by Molybdenum Test.

• Method for checking Material of Construction (MOC) of Stainless Steel (SS) material (Molybdenum Test):
• Put 1 drop of electrolyte solution of the Molybdenum test kit on clean metal surface, which is to be tested.
• Switch ON the detector and touch the metal tip of the detector on metal surface and carbon point in electrolyte.
• Do not pass the current for more than 3 to 4 seconds.
• If the red color appears and is stable for more than 2 seconds then it can be concluded that material of construction of the part being tested is S.S. 316
• If the solution remains colorless or green color appears then it can be concluded that the material of construction of the part being tested is S.S. 304.
• If the Black color appears and is stable for more than 2 seconds then it can be concluded that material of construction of the part being tested is S.S. 302.
• Certificate for Motors:

S. No.	Component / Sub Component	Report No.
	Main Drive motor
	FFS Motor
	Hydraulic power pack motor
	Die fill motor
	Agitator motor
	ACVFD – Main motor
	ACVFD – FFS motor
	PLC
	MMI
	Lubrication pump
	Electromagnetic clutch
	Hydraulic pressure gauge
	Accumulator spring

• Drawings:

Name of Drawings	Drawing No.	Checked By Sign & Date	Approved By Sign & Date
GA / Schematic Diagram
Electrical Panel
Pneumatic Circuit
Control Panel

• List of Identified of Standard Operating Procedures:

S. No.	SOP’s	SOP’s No.	Title	Identified By / Date
	Operating		SOP for Operation of Compression Machine
	Cleaning		SOP for Cleaning of Compression Machine
	Preventive Maintenance		SOP for Preventive Maintenance of Compression Machine

• Checklist for Supporting Utilities:

S. No.	Utility	Specification	Observation	Checked By Sign & Date	Approved By Sign & Date
	Compressed air	5 Kg/cm²
	Electrical	6kw,3HP,50/60 Hz, 220/380/415V

• Identification of Critical Instruments for Calibration:

S. No.	Component	Parameter/ Function	Instrument Details	Checked By Sign / Date
	Pressure Gauges.	For incoming air	Make: FESTO Range: 0-16kg/cm² Instrument No. 356759S2
	Pressure Gauges.	For discharge chute.	Make: FESTO Range: 0-16kg/cm² Instrument No. 345395S3
	Pressure Gauges.	For Tonnage	Make: GLUCK Range: 0-105kg/cm²

• DEVIATION DETAILS(If Any):
• Description of deviation and date observed
• CHANGE CONTROL (If Any)

Sr.	Change Control	Reason	initiated By (Production)	Approved By (Q.A.)

• REVALIDATION CRITERIA for Tablet Compression Machine IQ:Installation Qualification to be re-qualified on
• Replacement of major component of the equipment with a new component
• Any major modification in the existing equipment
• Transfer/Shifting of the equipment from one location to another.
• ACCEPTANCE CRITERIA for Tablet Compression Machine IQ :
• Installation Qualification shall be considered acceptable when all the conditions specified in various checklist have been met.
• SUMMARY:
• The acceptance criteria of the protocol and Specific check points  are checked and verified as per above mentioned instillation checklist and found that all the parameter met the specification.

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