CONTENT

TABLE OF CONTENT

1. Objective

2. Scope

3. Responsibility (Client and manufacturer)

4. URS (User Requirement Specification)

5. Machine description

6. Technical specification of sub components/brought out items.

7. Specification of Automation.

8. Machine operation control through PLC

9. Details of power consumption

10. Material of construction of component

11. Test certificates/Inspection reports

12. Surface Area of the product contact parts

13. Brief Process Description

14. Safety-Interlocks/Alarms messages

15. Load calibration chart

16. Lubrication requirements

17. FAT procedure

18. Change control procedure

19. Appendix

1.0 OBJECTIVE:

To design, engineer, and supply the Cadmach CPD-II-37 station with Bi Layer attachment as per cGMP and cGEP guidelines and to provide assurance that the machine is manufactured as per the URS and it complies with the Scope of Supply.

To prove that each operation proceeds as per the design specification and the tolerances prescribed there in the document, are the same at utmost transparency. Validation procedure is set for complete satisfaction of the customer & building confidence of the user about the machine.

2.0 SCOPE:

The scope of this qualification document is limited to the Design Qualification of Cadmach CPD-II-37 station with Bi Layer Attachment for M/s USV Limited, in Daman. This qualification document is part of a validation activity for the Cadmach CPD-II-37 station.

Qualification of support utilities is not within the scope of this qualification document.

The equipment shall be used for compressing the powder into tablets. The equipment shall operate under dust free environment and conditions as per the GMP requirements.

3.0 RESPONSIBILITIES:

3.1 CLIENT:

3.1.1 To provide the URS for the equipment.

3.1.2 To perform the Factory Acceptance Test (FAT).

3.2 MANUFACTURER:

3.2.1 To design, engineer and provide the complete technical details of the equipment pertaining to its design qualification viz.

3.2.1.a Machine overview,

3.2.1.b Specifications of the sub-components/ bought out items, and their

make, model & quantity, and backup records/ brochures,

3.2.1.cDetails of Utilities,

3.2.1.d Material of construction of all components

3.2.1.e Brief process description

3.2.1.f Safety features.

3.2.2 To facilitate the client for the Factory acceptance test of the machine at their works/ site.

3.2.3 To confirm the safe delivery of the equipment to the user site.

3.2.4 To ensure that no un-authorized and / or unrecorded design modifications shall take place. If at any point in time, any change is desired in the mutually agreed design, Change control procedure shall be followed and documented.

3.2.5 To ensure the proper installation and commissioning of the equipment.

4.0 URS ( User Requirement Specification) :

Please refer attached Annexure No. DQ/ANX/03 for the User Requirement Specification.

5.0 MACHINE DESCRIPTION

5.1 Process Equipment Description

The Cadmach CPD-II-37 station with Bi Layer Attachment, a double rotary tablet press, is a versatile machine in the range of tabletting. It is also incorporated with the force-feeding arrangement, Lubrication (Intermittent + Continuous), electromagnetic clutch and Programmable Logic Controller. The Bi Layer attachment facilitates in producing twin colour tablets.

Complete machine can be divided in following sub sections:

5.1.1 Powder feeding unit (LHS & RHS)

5.1.2 Powder Transfer unit (LHS & RHS)

5.1.3 Drive unit, Turret and Compression unit

5.1.4 Weight Dozer (LHS & RHS)

5.1.5 Hydraulic Power Pack Assembly.

5.1.6 Tablet discharge unit (LHS & RHS)

5.1.1 Powder Feeding Unit (LHS & RHS) :

This comprises of the following

5.1.1.a Hopper with Butterfly valve (LHS & RHS)

5.1.1.b Powder level sensor (LHS & RHS)

5.1.1.a Hopper with Butterfly valve (LHS & RHS)

An SS 316 L Hopper of capacity 18 Liters rests on top of the machine which holds the powder in it and delivers to the feeding assembly through a butterfly valve which controls the flow of the powder between the Hopper and the Feeding assembly. It comprises of a flap, which can be operated using a knob. In case of Bi Layer tablets, both the hoppers shall contain different colour powder/granules.

5.1.1.b Powder Level Sensor (LHS & RHS): - This is set on a sight glass fit to the hopper. The setting is done using two adjustable nuts. As soon as the powder in the hopper drops down the level, the sensor senses the same and gives the respective signal to the PLC and stops the machine.

5.1.2 Powder Transfer Unit: -

This comprises of the following

5.1.2.a Inlet Connector (LHS & RHS)

5.1.2 b Force Feeder Assembly (LHS & RHS)

5.1.2.a Inlet Connector (LHS & RHS)

It is a SS 316 L connector, which links the Hopper and the Force feeder.

5.1.2.b Force Feeder Assembly (LHS & RHS)

It comprises of

5.1.2.b.i Force Feeder

5.1.2.b.ii Tail over die, scrappers and feeder

5.1.2.b.iii Nozzle outlet for suction.

5.1.2.b.i. Force Feeder

The force feeder has two counter rotating paddles of SS 316 L, driven by reduction gearbox and variable frequency AC drive motor. The pressing material enters the feeder in the middle between the two paddles. With the feeder in the MANUAL MODE, the force feeder is operated for initial filling prior to rotating the machine and in AUTO MODE; the force feeder will run along with the machine. While machine is in production, always put the feeder in AUTO MODE.

5.1.2.b.ii Tail over die, scrappers and feeder

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. Failure to keep the die covered will result in granules spilling out of the die with subsequent variation of the tablet weight. The tail over die is fitted freely over the turret die table and is pressed against the die table by spring action. Ensure that the bottom surface of the tail over die rests flat and matches with the die table.

The spring-loaded scrappers are inserted in the scrapper support bracket and tail over die respectively. The springs press the scrappers against the turret die table to scrap off. the tabletting powder

5.1.2.b.iii Nozzle outlet for suction

This comprises of a PVC pipe that is connected to the dust extraction unit. The powder dust coming from the preceding feeder is completely sucked thereby avoiding mixing of granules & reduce the dust generation.

5.1.3 Drive unit, Turret and Compression Unit

5.1.3.a Drive unit

A main motor of 7.5 HP drives a very high reduction gearbox unit using an electromagnetic clutch and a timing belt. The gearbox unit consists of a Phosphorus bronze (SAE65) worm wheel and a Worm shaft of SAE 8620 (with case hardening having 58 62 HRC). The worm wheel shaft holds the Pinion. The turret has an internal helical ring, which meshes externally to the pinion. The rotation of the pinion is responsible for turret motion. Thus, CPD II 37 stations is purely eccentric drive.

N.B.: - The rotation of CPD-II-37 station is clockwise.

5.1.3. b Turret This tool holding body is a 3 piece structure having the center die table of SS 316 L and the Upper and Lower piece of Cast iron of grade FG-260. 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. The Dies lie in the die cavities provided in the die table with the help of die locking screw assembly. The lower punches are secured using punch holding device comprising of brake plug, anti-turning spring strip and button head screw.

5.1.3.c Compression Unit

This comprises of

5.1.3.c.i Upper Main Pressure Roll Assembly (Front and Rear)

5.1.3.c.ii Lower Main Pressure Roll Assembly (Front and Rear)

5.1.3.c.iiiUpper Punch Penetration Assembly (Main Front & Rear)

5.1.3.c.iv Tablet Thickness Assembly (Main - Front and Rear)

5.1.3.c.i Upper Main Pressure Roll Assembly (Front & Rear)

It comprises of a Roll Center, Pressure Roll and Pressure Roll Pin. The Roll Center holds the Pressure Roll and is locked using External Circlips. The rotation of the Roll is taken care by 02 No. cylindrical roller bearing (NJ-310).

5.1.3.c.ii. Lower Main Pressure Roll Assembly (Front & Rear)

It comprises of a Roll Center, Pressure Roll and Pressure Roll Pin. The Roll Center holds the Pressure Roll and is locked using External Circlips.The rotation of the Roll is taken care by 02 Nos. cylindrical roller bearing (NJ-2310).

5.1.3.c.iii Upper Punch Penetration Assembly (Main Front & Rear)

This is the assembly, which is responsible for the entry height of the upper punch in the die. Whenever the wheel of upper punch penetration is rotated, the entire upper pressure assembly with the carrier along with the lower pressure assembly is moved up and down. Always care needs to be taken to set the upper punch penetration initially and only then the thickness.

5.1.3.c.iv Tablet Thickness Assembly (Main Front & Rear)

This is the assembly, which is responsible in deciding the tablet thickness. The upward and downward movement of the lower pressure carrier assembly varies the thickness.

5.1.4 Weight Dozer (LHS and RHS)

This 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.

5.1.5 Hydraulic Power Pack Assembly

This system controls 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 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.

5.1.6 Tablet discharge unit

This comprises of-

5.1.6.a Ejection Cam (LHS & RHS)

5.1.6.b Tablet take off plate assembly (LHS & RHS)

5.1.6.c

Tablet discharge chute (LHS & RHS).

5.1.6.a. Ejection Cam (LHS & RHS)

The lower punch glides on the ejection cam and ejects the tablet. 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. In case of Bi Layer operation, the ejection cam and fill cam of the LHS are removed. This is done to facilitate the filling of the second layer on the initial layer.

5.1.6.b Tablet take off plate assembly (LHS & RHS)

As soon as the tablet is ejected out it strikes the tablet take off plate assembly, which directs the tablet to the discharge chute. Care should be taken so that the tip of the lower punch does not strike the tablet scrapper assembly. In case of Bi Layer operation, this assembly is present on the RHS feeder only as there is no ejection on LHS.

5.1.6.c Tablet discharge chute (LHS & RHS)

It is made of SS 316 L with acrylic cover. Tablets slide out through this chute to the container. In case of Bi Layer operation, only one discharge chute is present i.e., on the RHS.

6.0 Technical specification of sub components / bought-out items.

7.0 Specification of Automation

Specification of programmable logic control systems :

8.0 Machine operation control through PLC

Switch on the mains, `Welcome screen will be displayed

Enter valid password, `Main menu screen will be displayed

Three levels of password will be provided as follows:

a) Operator Level

b) Supervisor Level

c) Manager Level Press machine control touch button, detailed `Machine control menu screen will be displayed

Press turret control touch button, detailed `Turret control menu screen will be displayed

Press feeder control touch button, detailed `Feeder control menu screen will be displayed

Press compaction force touch button, detailed `Compaction force menu screen will be displayed

Press lubrication control touch button, detailed `Lubrication control menu screen will be displayed

Press machine status touch button, detailed `Machine status-1 menu screen will be displayed

Press recipe management touch button, `Recipe password screen will be displayed Press batch data touch button, detailed `Batch data menu screen will be displayed Press technical data touch button, detailed `Technical data menu screen will be displayed

More detail about machine operation control through PLC is as per the attached Working Instruction Manual of PLC Touch Screen.

Note: Separate Instruction Manual is attached as annexure

9.0 Details of power consumption

MotorRated specification

Main

Voltage

Hp

Amperage

415

7.5

14.5

Feeder (R.H.)

Voltage

Hp

Amperage

415

0.25

0.58

Feeder (L.H.)

Voltage

Hp

Amperage

415

0.25

0.58

Power packVoltage

Hp

Amperage

415

1

1.8

Total power consumption for main machine: 9 Kw

10. 0 Material of Construction of component

DescriptionLocationMOC

Turret

a) Upper / Lower piece

b) Die tableUpper cabinetFG-260

SS 316 L

Pressure RollRoll CarrierOHNS

Worm ShaftMain drive Gear BoxSAE 8620 with case hardening having 58-62 HRC

Worm Wheel

(Main Drive)Main drive Gear BoxPhosphorus Bronze

(SAE65)

Worm ShaftFeeder drive Gear BoxMild Steel

Worm Wheel

(Feeder Drive)Feeder Gear BoxPhosphorus Bronze

Feeder housingUpper CabinetGun Metal

Paddle for force feederFeeder housingSS 316L

HopperRoofSS 316L

Discharge chuteNear die tableSS 316L

Lower guardsLower cabinetSS 304

11.0 Test certificates / Inspection reports.

12.0 Surface Area of the product contact parts.

Sr.

No.Name of the partProduct contact surface area in sq. cm / pieceTotal quantity used in the machineTotal product contact surface area in sq. cm

1Hopper307826156

2Extension for hopper802160

3Flap for flow control632126

4Bellows portion662132

5Inlet flange at bowl2562512

6Bowl962192

7Feeder frame56121122

8Paddle (First)842168

9Paddle (Second)1192238

10Turret (Die table only)196411964

11Tablet chute (Inner)4482896

12Tablet chute (Outer)71921438

TOTAL FOR MACHINE13104

N.B. The total product contact surface area of the parts of CPD-II-37 station machine with Bi Layer attachment is 13104 sq. cm.

13.0 Brief Process Description.

13.1 Mono layer Operation

13.1.1 Force Feeding

The formulated powder in the hopper is pulled down using a Force Feeding arrangement consisting of rotary force feeders. The advantage of force feeder is, ensured die filling.

13.1.2 Compression

The lower punches, which always remain in the die, hold the powder that is fed into the die, onto it. Further, due to the rotation of the turret, these punches move on the dozer assembly where only required quantity of the powder is held back and the rest is scrapped out. Punches then glide on to pressure roll. At this stage the upper punch moves down the Upper cam track Lowering, and then the pressure roll. Both the punches get pressurized under the pressure rolls. At this instant, due to the heavy compression force the tablet is formed. The excessive backpressure generated in this process is absorbed by the hydraulic cylinder, which is suspended onto the lower pressure roll carrier. After the tablet is formed inside the die, it needs to be ejected out. The lower punch moves further on to the ejection cam track and the tablet gets ejected out. At this stage, the upper punch moves onto the Upper cam track Lifting and glides idly on the upper cam piece. After the tablet is ejected out, the lower punch moves in the lower cam track and comes beneath the feeder and the cycle continues. In one revolution, there is double ejection of tablets.

Tablet output / revolution = No. of stations x 2

13.2 Bi Layer Operation

13.2.1 Force Feeding

In case of Bilayer operation, two hoppers on the either sides would contain two different granules. The granules for the first layer are fed in using right hand feeder while for the second layer, using the left hand feeder.

13.2.2 Compression

The granules for the first layer are fed into the dies by the right hand force feeder; the weight-adjusting cam regulates the correct amount. Excess granules are ejected from the die cavity and rejected through the excess power rejection slot. The material then passes between the front pressure rolls where the granules are tamped by the upper and lower punches. The degree of pressure applied should be just sufficient to produce a sharp demarcation between layers without affecting the bonding of the first and second layers. Adjusting the lower roll by the tablet thickness control can regulate the degree of tamping. The lightly compressed tablet, maintained at a height fixed by the amount of top punch penetration at the first compression station, passes under the second feeder and receives its second charge of granules. Again the appropriate weight-adjusting cam controls the fill of granules and the surplus granules are ejected from the die cavity and rejected through the excess power rejection slot. But, it should be noted that the maximum depth of fill is controlled by the amount of the upper punch entry at the first compression. The dies, containing the two layers of material pass between the final compression rolls, which are adjusted to give the required final tablet hardness. The compressed tablet is ejected and deflected down the take-off chute (R.H.)

13.2.2 Sampling

The weight of the layers can be checked whilst the machine is in operation. To affect this the lower pressure roll of the first compression station is mounted on an eccentric pin, which has a gear cut on one end. This gear meshes with a rack mounted on the end of an air cylinder piston rod. When a weight check of the first layer is required the selector switch is put in ON condition. This actuates the air cylinder, which in turn pushes the rack upwards, and thus rotates the eccentric pin. The movement of the eccentric pin lifts the lower pressure roll and increases the hardness of the first layer. Due to this increased hardness no bonding between layers will take place during the final compression and the two layers will separate on ejection.

Weight of the first layer can be obtained by direct weighing the first layer sample and the weight of the second by subtraction the first layer sample tablet weight from the total weight of the completed two-layered tablet.

14.0 Safety - Interlocks / Alarms messages.

Due to any of the following interlocking reasons the m/c will not start or will stop immediately, if in operation. The m/c healthy messages will be displayed in green colour while the interruption messages are displayed in red colour.

The following are the alarm functions. The alarm messages will be displayed in red colour, and machine should not be run longer.

15.0 Load calibration chart

Punch force depends upon tablet size, shape, product characteristics and requirement of tablet hardness. The load on punches between two main compression rolls is developed by a hydraulic system. It should be set with the hydraulic system as required. The load on punches will be displayed on the digital force indicator in KN.

16.0 Lubrication requirements

17. 0 FAT PROCEDURE

Factory Acceptance Test Procedure shall be as follows:

After the completion of erection work of the machine, client shall be informed to perform the factory acceptance test (FAT)

Client shall perform the FAT at the manufacturer site and record all the data in the prescribed FAT document as per the details given below:

1. Test Criteria

2. Design verification check list

3. Deficiency and corrective action report

4. Pre installation requirements

5. Final reports.

18.0 Change Control Procedure

Change in the agreed design shall be addressed through the well-defined change control procedure.

19.0 QUALIFICATION DOCUMENT REPORT APPROVAL

19.1 Summary:

19.2 Certifications:

20.0 APPENDIX

20.1 List of Abbreviations.

20.2 Reference documents

20.2.1 Manufacturers Brochure(s) / Manual(s)

To be supplied with the installation qualification documents.

a) Instruction and Maintenance Manual.

b) MOC Certificates

c) Test Reports

d) Inspection Reports

20.3 Annexure list

Sr. No.DescriptionAnnexure Number

01Equipment Brochure DQ/ANX/01

02Purchase Order DQ/ANX/02

03URSDQ/ANX/03

04Scope of supplyDQ/ANX/04

05FAT ReportDQ/ANX/05

06Inspection ReportDQ/ANX/06

20.4 Drawing list

S.N.DescriptionDrawing Number

01G.A. Drawing for CPD-II-37 station with PLC systemDQ/ANX/07

02Continuous and Intermittent lubricationDQ/ANX/08