Installation Qualification for Tablet Compression

Machine
Pharmaceutical Guidanace July 23, 2016 Installation Qualification(IQ), Qualification, Validation & Qualification
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TABLE OF CONTENTS

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OPEN

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

• PRE REQUISITE OF INSTALLATION QUALIFICATION: –

• 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.

• Installation Qualification 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 the 26 punches.

• PROCEDURE :

• Installation Check List:

S. No. Statement Y/ N / NA Checked By Verified By

 Sign & Date 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 :

Checked By

S. No. Description Specification Observation

Sign & Date

Overall Dimension in mm.

(L x W x H)

Level of main body Perfectly level

Transparent acrylic

Machine guards sheet – 15 mm.

thickness

Hopper 20 Ltrs.
Agitator 06 No’s

5HP, 415V, 50Hz, 3

Phase, 1440rpm
Main Drive Motor
Make:

0.25HP, 415V, 50Hz,

3 Phase, 1380rpm
Feeder Drive Motor
Make: Bharat Bijlee

1HP, 415V, 50Hz, 3

Phase, 1405rpm

Hydraulic Motor
Make: Crompton
Greaves

Make: Cenlub]
Lubrication Pump Unit
Model:

Make: Golden

Electro Magnetic Clutch.

Model:

Make: Indokopp
MCB for main motor
16Amp, 3 Pole

Make: Indokopp

MCB for feeder motor

4Amp, 3 Pole

Make: Indokopp

MCB for lubrication motor

4Amp, 3 Pole

Make: Indokopp

MCB for power plug

1Amp, 3 Pole
MCB for fan Make: Indokopp

2Amp, Single Pole

Make: Indokopp
MCB for control

transformer & SMPS 4Amp, Di Pole

Make: Indokopp

MCB for power plugs

4Amp, 3 Pole

Make: Indokopp

MCB for PLC

2Amp, Single Pole

Make: Indokopp
MCB for MMI
2Amp, Single Pole

Make: Sprecher &

Schuh

Contactor for main motor

CA3-23-10, 23 Amps /

24V, AC

Make: Sprecher &

Schuh
Contactor for feeder

motor CA3-12-10, 12 Amps /

24V, AC

Make: Sprecher &

Schuh
Contactor for hydraulic

motor CA3-12-10, 12 Amps /

24V, AC

Overload relay for Make: Sprecher &

hydraulic motor Schuh

 CA3-12-1.6 to 2.5

Amps.

Make: Sprecher &

Schuh
Contactor for lubrication
motor CA3-12-10, 12 Amps /
24V, AC

Make: Sprecher &

Schuh
Overload relay for

lubrication motor CA3-12-10, 0.38 to

0.62 Amps.

Make: Sprecher &

Schuh

Contactor for power plug

CA3-12-10, 12 Amps /

24V, AC

Make: Sprecher &

Schuh
Overload relay for power
plug CA3-12, 1.6 to 2.5

Amps.

Make: Sprecher &

Schuh
Overload relay for die fill

motor CA3-12, 0.38 to

0.62Amps.

Make: Phoenix

Solid state relay for die fill Input – 24 VDC,

motor Output – 220V, AC–

2No.
MCB for agitator motor Make: Indokopp

2 Amps. / Di – Pole

Make: Sprecher &

Schuh
Contactor for agitator
motor CA3-12, 10, 12Amps /
24V, AC.

Make: Sprecher &

Schuh
Overload relay for

agitator motor CA3-12-10, 0.38 to

0.62Amps.

Make: Phoenix

Relay 3 c/o, 24 V, AC, 11

Pin, (06 Nos.)

Make: Phoenix

Relay 1 c/o, 24 V, AC, 5 Pin,

(06 Nos.)

Timer for turret delay in Make: Bharti Cutt;er

mechanical over ride Hammer 24V, AC

Make: Narmada
Control transformer
250V, AC

Make: Semikron
Mono block rectifier

bridge MD5 BU 1016

Make: Phoenix

SMPS
10 Amps. / 24V, DC
 Cooling fan Make: Rexnord

4”

Make: Salzer
Main Isolator switch
25 Amps., 3 Watts.

Make: IFM

Powder level sensor Cat. No. K15023

KIE3015-FPKG/NI

Make: Katlax

Tablet counting proxy M18 PNP-NO 10-30

VDC, 200/400mA

Make: Allen Bradley.

10.2.43 Tower lamp

24V, DC

Make: RITTAL
Data control panel
Model: PC4609703

Make: EPSON

Model: P170A

Printer 25 Pin Connector,

220-240V, 50-60Hz,

0.3A

Make: Allen Bradley,

VFD for Main motor
7.5 HP.

Make: Pro-face
MMI
Model: GP-2301
 Compaction force Control Make: Rittal

Panel
Model:

VFD for Force Feeder Make: Allen Bradley,

Motor 01 HP.

Make: Allen Bradley,

VFD for Agitator Motor
0.5 HP.

• Leveling and alignment of Machine:

Leveling / Alignment Checked By

S. No. Item Description Mode of Verification

OK / Not OK Sign / Date

Turret Spirit Level

Machine Level Water Level

Hopper Spirit Level

Water Level / Spirit

Control Panel
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:

Checked By

S. No. Name of Components MOC Mode of verification

Sign & Date

Turret SG 400/15 Test Report

Test Report /

Die Table SS316 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.

Test Report /
Agitator Blades SS 316 Confirmed by
Molybdenum Test.

Test Report /

Hopper SS 316 Confirmed by

Molybdenum Test.

Test Report /

Hopper lid SS 316 Confirmed by

Molybdenum Test.

Test Report /
Butterfly valve SS 316 Confirmed by

Molybdenum Test.

Initial rejection / sampling

UHMHDPE Test Report
flaps

Test Report /

Discharge chute SS 316 Confirmed by

Molybdenum Test.

Test Report /

Lower guard SS 316 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:

Checked By Approved By
Name of Drawings Drawing No.
Sign & Date 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

SOP for Operation of

Operating
Compression Machine

SOP for Cleaning of

Cleaning
Compression Machine

SOP for Preventive

Preventive Maintenance Maintenance of

Compression Machine

• Checklist for Supporting Utilities:

Checked By Approved By
S. No. Utility Specification Observation
Sign & Date Sign & Date

Compressed air 5 Kg/cm²

6kw,3HP,50/60 Hz,
Electrical
220/380/415V

• Identification of Critical Instruments for Calibration:

Checked By

S. No. Component Parameter/ Function Instrument Details

Sign / Date

Make: FESTO

Range: 0-16kg/cm²
Pressure Gauges. For incoming air
Instrument No.

356759S2

Pressure Gauges. For discharge chute. Make: FESTO

 Range: 0-16kg/cm²

Instrument No.
345395S3

Make: GLUCK
Pressure Gauges. For Tonnage
Range: 0-105kg/cm²

• DEVIATION DETAILS(If Any):

• Description of deviation and date observed

• CHANGE CONTROL (If Any)

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

• REVALIDATION CRITERIA: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 :

• 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.