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 Qualification of support utilities is not within the scope of this qualification document. 2. The equipment shall operate under dust free environment and conditions as per the GMP requirements. Validation procedure is set for complete satisfaction of the customer & building confidence of the user about the machine. . The equipment shall be used for compressing the powder into tablets. This qualification document is part of a validation activity for the Cadmach CPD-II-37 station.transparency.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. Change control procedure shall be followed and documented.b their Machine overview.1. . 3.4 To ensure that no un-authorized and / or unrecorded design modifications shall take place.2.2. model & quantity. 3. engineer and provide the complete technical details of the equipment pertaining to its design qualification viz.e Brief process description 3.2. Specifications of the sub-components/ bought out items.1.2.f Safety features.2.1. 3. 3.a 3.1.1.2. 3.2. If at any point in time.0 RESPONSIBILITIES: 3.1 CLIENT: 3. and backup records/ brochures. 3. 3.1 To provide the URS for the equipment. and make.2 MANUFACTURER: 3.2.2 To facilitate the client for the Factory acceptance test of the machine at their works/ site.2.3 To confirm the safe delivery of the equipment to the user site.d Material of construction of all components 3.3.c Details of Utilities.2.1.2 To perform the Factory Acceptance Test (FAT).1 To design. any change is desired in the mutually agreed design. 3.1.1. 4.0 URS ( User Requirement Specification) : Please refer attached Annexure Requirement Specification.2.5 To ensure the proper installation and commissioning of the equipment. a double rotary tablet press. No. is a versatile machine in the range of tabletting.0 MACHINE DESCRIPTION 5.3.1 Process Equipment Description The Cadmach CPD-II-37 station with Bi Layer Attachment. It is also . DQ/ANX/03 for the User 5. 5.b Powder level sensor (LHS & RHS) 5.1.1.1.3 Drive unit.1.This is set on a sight glass fit to the hopper.b Powder Level Sensor (LHS & RHS): .1 Powder Feeding Unit (LHS & RHS) : This comprises of the following – 5.1. Complete machine can be divided in following sub sections: 5.1.1. Turret and Compression unit 5. As soon as .1. 5.1. which can be operated using a knob. The setting is done using two adjustable nuts. In case of Bi Layer tablets.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.4 Weight Dozer (LHS & RHS) 5.1.1.2 Powder Transfer unit (LHS & RHS) 5.1.1. electromagnetic clutch and Programmable Logic Controller.1. both the hoppers shall contain different colour powder/granules.1 Powder feeding unit (LHS & RHS) 5. The Bi Layer attachment facilitates in producing twin colour tablets.incorporated with the force-feeding arrangement.5 Hydraulic Power Pack Assembly. It comprises of a flap.6 Tablet discharge unit (LHS & RHS) 5. Lubrication (Intermittent + Continuous).a Hopper with Butterfly valve (LHS & RHS) 5.1. the powder in the hopper drops down the level. which links the Hopper and the Force feeder.iii Nozzle outlet for suction.ii Tail over die.1.2.ii Tail over die.b. 5.2.1. Ensure that the bottom surface of the tail over die rests flat and matches with the die table. .2.1. 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.b Force Feeder Assembly (LHS & RHS) It comprises of 5. the force feeder is operated for initial filling prior to rotating the machine and in “AUTO MODE”.b.b. 5.1.1. always put the feeder in “AUTO MODE”.1. Failure to keep the die covered will result in granules spilling out of the die with subsequent variation of the tablet weight.1.2 Powder Transfer Unit: This comprises of the following – 5. scrappers and feeder The tail over die is an essential feature of the high-speed tablet press.i.2. While machine is in production.2. driven by reduction gearbox and variable frequency AC drive motor. the force feeder will run along with the machine. The pressing material enters the feeder in the middle between the two paddles. the sensor senses the same and gives the respective signal to the PLC and stops the machine.1.a Inlet Connector (LHS & RHS) It is a SS 316 L connector.i Force Feeder 5. With the feeder in the “MANUAL MODE”. 5.2. Force Feeder The force feeder has two counter rotating paddles of SS 316 L. The tail over die is fitted freely over the turret die table and is pressed against the die table by spring action.1.1. 5.2.b.2 b Force Feeder Assembly (LHS & RHS) 5. scrappers and feeder 5.b.2.a Inlet Connector (LHS & RHS) 5. 3.B.3. The powder dust coming from the preceding feeder is completely sucked thereby avoiding mixing of granules & reduce the dust generation.5 HP drives a very high reduction gearbox unit using an electromagnetic clutch and a timing belt. Turret and Compression Unit 5. 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). 5. the lower piece holds the lower punches that travel on the lower cam tracks and dozer.b. The lower punches are secured using punch holding device comprising of brake plug.1.c. which rests on the upper cam tracks with the cam plate.3 Drive unit. The turret has an internal helical ring.ii Lower Main Pressure Roll Assembly (Front and Rear) 5. N.c.1.1.3. 5.1. The worm wheel shaft holds the Pinion. anti-turning spring strip and button head screw.The spring-loaded scrappers are inserted in the scrapper support bracket and tail over die respectively.a Drive unit A main motor of 7.i Upper Main Pressure Roll Assembly (Front and Rear) 5.: .1. which meshes externally to the pinion. Similarly.3. the tabletting powder 5.3.The rotation of CPD-II-37 station is clockwise. 5.1.2.1. Thus. The Dies lie in the die cavities provided in the die table with the help of die locking screw assembly.3.iii Nozzle outlet for suction This comprises of a PVC pipe that is connected to the dust extraction unit.c.c Compression Unit – This comprises of 5.iii Upper Punch Penetration Assembly (Main – Front & Rear) . The rotation of the pinion is responsible for turret motion. CPD – II – 37 stations is purely eccentric drive.1. 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. The springs press the scrappers against the turret die table to scrap off. c.iv Tablet Thickness Assembly (Main – Front & Rear) This is the assembly. The oil reservoir for this system is located in front corner within lower cabinet. which is responsible for the entry height of the upper punch in the die.iii Upper Punch Penetration Assembly (Main – Front & Rear) This is the assembly.3. The upward and downward movement of the lower pressure carrier assembly varies the thickness.iv Tablet Thickness Assembly (Main . Whenever the wheel of upper punch penetration is rotated. cylindrical roller bearing (NJ2310).c. level.4 Weight Dozer (LHS and RHS) This assembly is responsible for adjusting the weight of the tablet by varying the depth of fill.Front and Rear) 5. 5. 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. at which particular tablets are being made.3. 5.1. Lower Main Pressure Roll Assembly (Front & Rear) It comprises of a Roll Center. The Roll Center holds the Pressure Roll and is locked using External Circlips.1.5 Hydraulic Power Pack Assembly This system controls the safety overload mechanism.1. 5. which is responsible in deciding the tablet thickness.1. 5. Pressure Roll and Pressure Roll Pin.The rotation of the Roll is taken care by 02 Nos. which governs the maximum pressure.ii.3. cylindrical roller bearing (NJ310).c.5.3. The Roll Center holds the Pressure Roll and is locked using External Circlips.3.c.1.c. . The rotation of the Roll is taken care by 02 No.1. Pressure Roll and Pressure Roll Pin. 5.1.i Upper Main Pressure Roll Assembly (Front & Rear) It comprises of a Roll Center. 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. 1.6.a Ejection Cam (LHS & RHS) 5. 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. Ejection Cam (LHS & RHS) The lower punch glides on the ejection cam and ejects the tablet. which directs the tablet to the discharge chute. .e. only one discharge chute is present i.b Tablet take off plate assembly (LHS & RHS) As soon as the tablet is ejected out it strikes the tablet take off plate assembly.It can be accessed by removing the lower side guard (LH).1. 5.6.6. Care should be taken so that the tip of the lower punch does not strike the tablet scrapper assembly.1.1.1. The oil level in the reservoir should be checked regularly through the oil level indicator.6. 5. 5.1. Tablets slide out through this chute to the container.6 Tablet discharge unit This comprises of5.c Tablet discharge chute (LHS & RHS) It is made of SS 316 L with acrylic cover. on the RHS.1. 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.c Tablet discharge chute (LHS & RHS).6. In case of Bi Layer operation. this assembly is present on the RHS feeder only as there is no ejection on LHS..6.b Tablet take off plate assembly (LHS & RHS) 5. 5.a. In case of Bi Layer operation. In case of Bi Layer operation. .6.0 Technical specification of sub components / bought-out items. C. 48 digital I / O 2 Analog I / O Type F 940 GOT LWD 5. 415 V Type FX2N 48 MR + 2 AD + 2DA.5 HP.0.Drive for Main Motor A.7.Drive for Feeder Motor PLC System MMI Touch screen Make Mitsubishi Mitsubishi Mitsubishi Mitsubishi Specification Type FR E 500 . 3 Phase.7 " Colour . 3 Phase.0 Specification of Automation Automation A. 415 V Type FR S 500 .C.75 K Rating 1 HP.5.5 K Rating 7. `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. 11 MS. Catalogue No. CE. UL 508. 147 m/sec -->acceleration.2 A 24 DC sink / source MR . detailed `Turret control menu’ screen will be displayed Press feeder control touch button.3 to 0.ES / UA Number of Input/Output Number of Input/Output Line Power Inrush current Input circuit type Output circuit type Operating temperature Storage temperature Operating humidity Vibration Shock Resistance Agency certification Terminal screw torque 24 Inputs 24 outputs 100 .48 MR .9 n / sec --> acceleration 2 EN 68 . detailed `Compaction force menu’ screen will be displayed Press lubrication control touch button. detailed `Feeder control menu’ screen will be displayed Press compaction force touch button.240 V AC 50/60 HZ 0. FX2N .ES / UL (Relay output) o o O o + 0 to 55O c ( + 32 F to 131 F ) Ambient o o O o . detailed `Machine control menu’ screen will be displayed Press turret control touch button.2. 0. 0. 3 to 6 Kgf .e. UL / cUL.6 Nm I.035 mm.Specification of programmable logic control systems : Make : MITSUBHISHI.condensing) Operating : 10 to 57 Hz. detailed `Lubrication control menu’ screen will be displayed . 4.0 Machine operation control through PLC Switch on the mains.20 C to +70 C( -4 F to +158 F) Ambient 5 % to 95 % relative humidity ( Non. CE complaint for all applicable directives. Hlaf 2 Amplitude .57 to 150 Hz.cm 8.27. 58 415 1 1.8 Total power consumption for main machine: 9 Kw .58 415 0.H. detailed `Batch data menu’ screen will be displayed Press technical data touch button. Press machine status touch button.5 415 0.25 0.5 14. 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. `Recipe password’ screen will be displayed Press batch data touch button.) Voltage Hp Amperage Power pack Voltage Hp Amperage Rated specification 415 7.) Voltage Hp Amperage Feeder (L.0 Details of power consumption Motor Main Voltage Hp Amperage Feeder (R.H. Note: Separate Instruction Manual is attached as annexure 9. detailed `Machine status-1 menu’ screen will be displayed Press recipe management touch button.25 0. OHNS SAE 8620 with case hardening having 58-62 HRC Phosphorus Bronze (SAE65) Mild Steel Phosphorus Bronze Gun Metal SS 316L SS 316L SS 316L SS 304 . 0 Material of Construction of component Description Turret a) Upper / piece b) Die table Pressure Roll Worm Shaft Location Upper cabinet Lower Roll Carrier Main drive Gear Box Main drive Gear Box Worm Shaft Feeder drive Gear Box Feeder Gear Box Upper Cabinet Feeder housing Roof Near die table Lower cabinet Paddle for force feeder Hopper Discharge chute Lower guards 11.0 FG-260 SS 316 L Worm Wheel (Main Drive) Worm Wheel (Feeder Drive) Feeder housing MOC Test certificates / Inspection reports.10. O.B.18 11. Fitcast Founders M/s.23 11...29 11. Metalab Enterprise M/s.0 T.28 11.1 11. of Worm Shaft (M.O. Metalab Enterprise M/s.C.P.O.NO. Sr.C. Golden Engg.32 11. M/s.33 Main Drive Motor Force Feeder Motor Force Feeder Motor Hyd. Ltd. Metalab Enterprise M/s. of Worm Wheel (Main) M. Meter M.4 11.C. M/s.Ltd. Cadmach Machinery M/s. M/s.7 11. of Lower Guard M. of Worm Shaft (F. M/s. Bharat Bijlee Ltd M/s. Messung System Pvt.O.O.O.30 11.1 11.s Enercon Systems Pvt.26 11.C.O.2 11. Surface Area of the product contact parts. Ltd.Ltd. Metalab Enterprise M/s. Gear Box Insp. IFM Electronics M/. M/s. Crompton Greaves M/s. of Discharge Chute SS 316L M.1 11.C. CIEPT .6 11.34 11.CIM 06AB1-20 11.21 11.C.19 11.Ahmedabad M/s Dynamatic Techn.35 11.C.22 11.Report of F. of Hopper SS 316L M. Metalab Enterprise M/s. DESCRIPTION 11. IFM Electronics M/s.12 11.37 11.G.27 11. Cadmach Machinery M/s. of Feeder Housing M.31 11.38 12. Cadmach Machinery M/s. No. Metalab Enterprise M/s.C. Enercon Systems Pvt. M/s Messung Systems Pvt.C. of Paddle SS 316L M. Metalab Enterprise M/s.C.17 11.O. Metalab Enterprise M/s.Ltd. Crompton Greaves M/s. cm 6156 .O.I Pressure Sensor 100Bar Power Level Sensor Digital Volt meter Digital Amp..C.Power Pack Motor AC Frequency Drive (Main Motor) AC Frequency Drive (Feeder Motor) PLC & MMI Electromagnetic Clutch Hyd.Report of Adj. Ltd. M/s. Cenlub Industries Ltd. of Rubber Below M. Metalab Enterprise M/s. of Turret M. Metalab Enterprise M/s.Ltd..NO.B.8 11.16 11.) M.13 11. cm / piece 1 Hopper 3078 Total quantity used in the machine 2 Total product contact surface area in sq.C. Metalab Enterprise M/s. For Tail Over Die & Strip at Feeder Test Certificate Of Hyd.5 11. Co.S.PressureGuage Lubrication Pump P. Mahendra Ugine M/s. Ltd. Sharon Engg.C.) Insp.15 11. Dated 22/06/2004 M/s Polyhydron Pvt. Messung System Pvt. EPE Process Filter M/s.3 11. Gear Pump OP3003-CPSTB Test Certificate Of Pressure SwitchIPS350-30 Test Certificate Of Check Valve C06 S1-03 Test Certificate Of Directional Operational Pressure Relief Valve-DPRH 06S4 Test Certificate Of Pilot Operated Check Valve. Name of the part Product contact surface area in sq.20 11. Dials Test Certificate Of Surface Finish Test Certificate Of PTFE Mat.. Dated 15/06/2004 M/s Polyhydron Pvt.14 11. Ltd.O.9 11.36 11.O.Report of Main Gear Box Insp.F.O. Dated 30/06/2004 M/s Polyhydron Pvt..Ltd.25 11.C.O. of Die Table SS 316L M. of Worm Wheel (Feeder) M. Cadmach Machinery M/s.Accumulator Hyd. of Pressure Roll M. M/s. Dated 03/06/2004 M/s Polyhydron Pvt. Bharat Bijlee Ltd M/s.G.& DATE CERTIFICATE DETAILS Dated 08/03/2004 Dated 13/12/2003 Dated 13/12/2003 Dated 15/03/2004 Dated 14/04/2004 Dated 14/04/2004 Dated 23/06/2004 Dated 20/09/2003 Dated 09/03/2004 817dated 09/03/2004 Dated 01/06/2004 --Dated 16/06/2004 Dated 16/06/2004 1209 dated 08/02/2004 W5010 dated 04/03/2004 2003016552 dated 11/8/03 2785 dated 30/01/2004 2698 dated 19/05/2004 2675 dated 17/05/2004 2697 dated 19/05/2004 2178 dated 22/04/2004 280 dated 19/01/2004 3098 dated 08/06/2004 3133 dated 10/06/2004 5525 dated o3/12/2003 W3405 dated 15/11/2003 Dated 14/06/2004 Dated 14/06/2004 Dated 10/06/2004 Dated 14/07/2004 922 dated 16/07/2004 -- M/s.24 11. due to the rotation of the turret. onto it. cm. 13. The total product contact surface area of the parts of CPD-II-37 station machine with Bi – Layer attachment is 13104 sq.0 Brief Process Description. 13. 13.1. Further. these punches move on the dozer assembly where only required quantity of the powder is held back and the rest is scrapped out. hold the powder that is fed into the die.2 Compression The lower punches. The advantage of force feeder is. At this stage the upper punch moves down the Upper cam track – Lowering.1 Mono layer Operation 13. and then the pressure roll.2 Extension for 80 2 160 hopper 3 Flap for flow control 63 2 126 4 Bellows portion 66 2 132 5 Inlet flange at bowl 256 2 512 6 Bowl 96 2 192 7 Feeder frame 561 2 1122 8 Paddle (First) 84 2 168 9 Paddle (Second) 119 2 238 10 Turret (Die table 1964 1 1964 only) 11 Tablet chute (Inner) 448 2 896 12 Tablet chute 719 2 1438 (Outer) TOTAL FOR 13104 MACHINE N. which always remain in the die. Punches then glide on to pressure roll.1 Force Feeding The formulated powder in the hopper is pulled down using a Force Feeding arrangement consisting of rotary force feeders. ensured die filling. Both the punches get .1.B. After the tablet is formed inside the die.1 Force Feeding In case of Bilayer operation.2. it needs to be ejected out. Adjusting the lower roll by the tablet thickness control can regulate the degree of tamping. 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. maintained at a height fixed by the amount of top punch penetration at the first compression station.2 Bi Layer Operation 13. there is double ejection of tablets. At this instant.pressurized under the pressure rolls. The granules for the first layer are fed in using right hand feeder while for the second layer. The lower punch moves further on to the ejection cam track and the tablet gets ejected out. passes under the second feeder and receives its second charge of granules.2. The excessive backpressure generated in this process is absorbed by the hydraulic cylinder. Excess granules are ejected from the die cavity and rejected through the excess power rejection slot. In one revolution. The material then passes between the front pressure rolls where the granules are tamped by the upper and lower punches. the upper punch moves onto the Upper cam track – Lifting and glides idly on the upper cam piece. Tablet output / revolution = No. the lower punch moves in the lower cam track and comes beneath the feeder and the cycle continues. At this stage. the weight-adjusting cam regulates the correct amount. 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. After the tablet is ejected out. But. of stations x 2 13. 13. The lightly compressed tablet. using the left hand feeder.2 Compression The granules for the first layer are fed into the dies by the right hand force feeder. two hoppers on the either sides would contain two different granules. it should be noted that the maximum . due to the heavy compression force the tablet is formed. which is suspended onto the lower pressure roll carrier. This actuates the air cylinder. To affect this the lower pressure roll of the first compression station is mounted on an eccentric pin. The dies.) 13. This gear meshes with a rack mounted on the end of an air cylinder piston rod. which has a gear cut on one end. and thus rotates the eccentric pin. 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.depth of fill is controlled by the amount of the upper punch entry at the first compression.2 Sampling The weight of the layers can be checked whilst the machine is in operation. which in turn pushes the rack upwards. . The compressed tablet is ejected and deflected down the take-off chute (R.0 Safety .H. Due to this increased hardness no bonding between layers will take place during the final compression and the two layers will separate on ejection. The movement of the eccentric pin lifts the lower pressure roll and increases the hardness of the first layer.Interlocks / Alarms messages. 14. containing the two layers of material pass between the final compression rolls. which are adjusted to give the required final tablet hardness.2. When a weight check of the first layer is required the selector switch is put in “ON” condition. b) Indication on MMI R. position red-indication in theMMI 2) No tablet counting. S. If in a) Hopper running out of motion. Hydraulic motor overload Indication on theMMI PhaseFailure. if in operation. feeders by jogging. L. If in a) Hopper running out of motion. feeder motor overload a) Motor stops Material clogging between thepaddles.H. The following are the alarm functions. output in thePLC b) To check the tightness of thetiming belt c) To check for any one phasefailure. S. revolutions. M/ c guards open M/ c will not start and will M/ c set in interlock mode.N. feeder motor overload a) Motor stops Material clogging between thepaddles. it will stop after few powder.H.Not applicable mode indication in theMMI 2 Tablet countingproxy not in 1) Machines runs. but with Setting being disturbed. it will stop after few powder. Powder level is low M/ c will not start. Cause a) To check for resp.Due to any of the following interlocking reasons the m/c will not start or will stop immediately. AlarmMessage Action Cause 1 Guards selected in By-Pass Machines runs but with red. Powder level is low M/ c will not start. The alarm messages will be displayed in red colour. b) Sensor disturbed – Needs re-setting. 3 Main set pressure (Front & Machine runs with excessive 1) Suspected for hydraulic Rear) overload vibration at lower roll carrier oil leakage. L. .H. R.N. The m/c healthy messages will be displayed in green colour while the interruption messages are displayed in red colour.H. InterruptiveMessage 1 Turret motor overload 2 3 4 5 6 7 8 9 10 11 Action a) Machine stops immediately. b) Sensor disturbed – Needs re-setting. Machine selected in manual M/ c will not run in It is used to fill up the mode continuousoperation. Batch sizecompleted M/ c will not start Batch size being completed and needs resetting. stop if in motion. 2) Hydraulic pressure not being set before starting the machine. Lubrication oil level low Indication on theMMI Lubrication oil reservoir running short of oil. and machine should not be run longer. revolutions. b) Indication on MMI Emergency push button M/ c does not start Emergency push button operated being pressed. 15. The load on punches between two main compression rolls is developed by a hydraulic system.2 27.2 39 44. Load on punches between two main press rolls in Tons 1 2 3 4 5 6 6.6 11.5 7 8 9 10 Digital force Pressure gauge indicator reading in reading in kg/sq.7 22. shape.9 36. product characteristics and requirement of tablet hardness. The load on punches will be displayed on the digital force indicator in KN.5 50 55. cm kN 10 20 30 40 50 60 65 70 80 90 100 5.1 16.6 .8 33. It should be set with the hydraulic system as required.0 Load calibration chart Punch force depends upon tablet size. No. working hrs.H. Bearing Main drive gearbox Apply one shot Servo gem. drive motor c. Main drive gear Apply manually Servo gem– 3 motor after about 3000 b. Force feeder working hours. Hindustan Shell make 3 Gear boxfor force Within turret About 2000Pe Enklo . Tablet Adjacent upper Apply with one Enklo – 68 thickness control roll carrier shot with oil 4 Oil drip cups On uppeg run Fillda aily srequired Enklo .16. Description Location Duration Lubricant Hindustan Shell make Petroleummake 1 Reservoir for Resides main Fill asrequired Enklo . 2 Main drive Within lower About 2000 Enklo .68 Omala– 220 continuous/ inter drive gearbox mittent within lower lubrication cabinet.37 . carrier trunion with oil gun daily 7 8 9 Grease nipples for a. system. No. b.68 bine t s rollrcarrier roll Apply one shot Enklo – 68 c.68 Omala– 220 Sr. a. Pivot pin at Uppe upper roll carrier.) within lower cabinet Omala– 220 Omala– 220 Omala– 220 Omala– 220 Omala– 220 Alvania RA grease Alvania RA grease Alvania RA grease Tellus . cabinet. Hydraulic pump motor Power pack systemBesides bottomleg Fill as required Enklo – 32 oil reservoir (rear L. for bottomlink.0 Lubrication requirements Sr.68 lowe ring cam .3 with grease gun once in a month Motor bearing a. within upper shot with oil 5 Oil drip trays caB eside loweg run Fillda aily srequired Enklo . Guideblocks On cab inet top Apply with one Enklo – 68 on turre t g ua rd. Description Location Duration Lubricant gearbox. Bearing Upper and Lower Apply one shot Servo gem– 3 roll centres with grease gun once in a month b.6m 8ake Omala– 220 tro le u m 6 Oil nipplesfor feeder drive zone working hrs. Design verification check list . 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: 1.17. 0 FAT PROCEDURE Factory Acceptance Test Procedure shall be as follows: After the completion of erection work of the machine. Test Criteria 2. 3. . 18. Deficiency and corrective action report 4.0 Change Control Procedure Change in the agreed design shall be addressed through the well-defined change control procedure. Pre – installation requirements 5. Final reports. 0 QUALIFICATION DOCUMENT REPORT APPROVAL 19.0 APPENDIX .19.2 Certifications: 20.1 Summary: 19. a) b) c) d) Instruction and Maintenance Manual.20. Current Good Engineering Practices Factory Acceptance Test User Requirement Specification Programmable Logic Controller Stainless Steel Alternating Current Horse Power Rockwell Hardness Phosphorus Bronze Revolution Per Minute Millimeter Kilo Newton Volt Hertz 16 17 18 19 20 21 22 23 24 25 26 27 28 29 Amps MS DC mA W C F Nm KW OHNS Sq.2.2 Reference documents 20. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 cGMP cGEP FAT URS PLC SS AC HP HRC PB RPM mm KN V Hz Current Good Manufacturing Practices. 20.1 Manufacturers Brochure(s) / Manual(s) To be supplied with the installation qualification documents.cm M/c Amperes Micro Switch Direct Current Milli Ampere Watts Degree Centigrade Degree Fahrenheit Newton-Meter Kilo watts Oil Hardened Non Shrinkage Square centimeter Nota Benni Kilogramper square centimeter Machine.3 Annexure list Sr. Description Annexure Number . MOC Certificates Test Reports Inspection Reports 20.1 List of Abbreviations.cm N. Kg/Sq.B. Drawing for CPD-II-37 station with PLC system Continuous and Intermittent lubrication 02 Drawing Number DQ/ANX/07 DQ/ANX/08 .A. 01 02 03 04 05 06 Equipment Brochure Purchase Order URS Scope of supply FAT Report Inspection Report DQ/ANX/01 DQ/ANX/02 DQ/ANX/03 DQ/ANX/04 DQ/ANX/05 DQ/ANX/06 20.No. Description 01 G.4 Drawing list S.N.