FETTE TABLET PRESS 3090i WIP # ACCESSORIES

Transcription

1 FAT Tablet press FETTE TABLET PRESS # and ACCESSORIES ISSUED BY : FETTE/ZYL DATE : Customer : --- TEVA, Israel --- VERSION No. : GB/ VERSION DATE : 07. Nov GB/ of 80

2 Tablet press FAT FETTE FAT APPROVAL PAGE Listed below are individuals who are involved in the execution of verifications, tests and / or procedures in this document. Each individual will provide the following information: name (printed), company name, title, full signature, initials and the date. Name (printed) / Company / Title Signature Initials Date Fette GmbH Sales Fette GmbH FAT --- Operator Uwe Zyball (Author) Fette GmbH Documentation ZYL 07. Nov of 80 GB/

3 FAT Tablet press FETTE FAT Table of contents PART A INTRODUCTION... 5 A.1 Objective A.2 Purpose PART B PLANT DESCRIPTION... 6 PART C KEY ASPECTS OF EQUIPMENT... 7 Identify machine and components as specified in the purchase order PART D OPERATIONAL PROCEDURES PART E TESTING BASIC OPERATIONS PART F TESTING MACHINE FUNCTIONS PART G TABLETTING (Testing Parameter/Diagnoses/Washing) 21 PART H SUMMARY ERROR REPORT SHEET GB/ of 80

4 Tablet press FAT FETTE FAT 4 of 80 GB/

5 FAT Tablet press FETTE FAT PART A INTRODUCTION A.1 Objective The Objective of this Protocol is to define the Requirements for Installation of the FETTE Compressing Machine, for use in the customer plant, once the performance test has been successfully completed. The Machine is designated and is used for compressing tablets. A.2 Purpose. THE EQUIPMENT WILL BE DESIGNED, INSTALLED AND TESTED IN ACCORDANCE WITH CUSTOMER AND SUPPLIER SPECIFICATIONS.. THE EQUIPMENT WILL SATISFY THE ACCEPTANCE CRITERIA SPECIFIED IN THIS PROTOCOL.. THE OPERATION OF ALL POSSIBLE GUARDS; INTERLOCKS, etc. ARE TO BE DEMONSTRATED AND MODIFIED IF REQUIRED. ALL ALARMS AND OTHER FUNCTIONS ARE TO BE DEMONSTRATED.. THEPERFORMANCEOFTHETABLETPRESSMACHINEWILLBE CHECKED AGAINST SPECIFICATION TO DETERMINE AS FAR AS POSSIBLE AT THIS STAGE TO ENSURE THE EQUIPMENT WILL PASS THE FINAL ACCEPTANCE TESTS AT CUSTOMER S WORKS.. PROTOCOLS HAVE TO BE ESTABLISHED BY CUSTOMER IN COOPERATION WITH THE SUPPLIER.. ANY CHANGES REQUIRED DURING FAT PHASE MUST FOLLOW THE ERROR REPORT SHEET AND SIGNED BY CUSTOMER AND SUPPLIER. GB/ of 80

6 Tablet press FAT FETTE FAT PART B PLANT DESCRIPTION 0 Purchase Order Number : 1 Unit Name : Tablet Press 2 Manufacturer : FETTE 3 Item Number : 4 Asset Number : 5 Serial Number : Model Number : 7 Department : 8 Building Number : 9 Room Number : 10 Operating Voltage : V, 50/60 Hz, 3 Ph 11 Max. pressuring force : 100 kn 12 Max. pre---pressuring force : 100 kn 13 Dimensions : 1370 X 1370 mm 14 Weight : 4500 kg 15 Number of stations : 16 Pitch circle diameter : 680 mm 17 Specification Reference : User Req. Spec. Docum. No. : Signed : Date : 6 of 80 GB/

7 FAT Tablet press FETTE FAT PART C KEY ASPECTS OF EQUIPMENT. Identify machine and components as specified in the purchase order :. sign all open points (non---order) with : N/A Sign. Date 1. Machine Control unit (Monitor, computer, printer and key---board installed) 3. Rotor package ( ) stations Rotor package (Option) : 4a. Die Table Hard Chrome Plated 5. Fill cam built in : mm, mm / mm, mm 6. Additional Fill cams : 7. Upper punch shaft lubrication 8. Extra cooling of motor area 9. Ejection Force Measurement 10. Mounting device for additional rotor 11. Handling system and tools 12. add. Main transformer 13. Deduster GB/ of 80

8 Tablet press FAT FETTE FAT Sign. Date 14. Parts butler 15. Punch tightness ---lower Tabl. jam monitoring 17. Feed level control (Hopper) 18. Two cycle lubrication 19. Pre---press. force measurement 20. Extraction vacuum control 21. Same punch bad 22. Start relief 23. Punch saving system 24. Multipl. punches 25. Missing punches 26. Indiv. Sorting 27. Password protection indiv. pressing forces 29. Diagnoses record 30. Production record 31. Record of changes 32. Upper cams made of plastic 33. Filling wheel with rod inserts 34. Distribution wheel with rod inserts 35. Checkmaster 8 of 80 GB/

9 FAT Tablet press FETTE FAT Sign. Date 36. Metal Check 37. Ext. Vacuum cleaner 38. Pneumatic tablet sampling system 39. Munters dry unit 40. WIP center OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : GB/ of 80

10 Tablet press FAT FETTE FAT PART D OPERATIONAL PROCEDURES a. Documentation : Objective : Ensure that all documentation is available : Operating Instruction : Binder 1 (Operator ) Binder 2 (Maintenance) Binder 3 (Electr. circuit diagrams) sets... yes ( ) No ( ) Validation : --- IQ/OQ yes ( ) No ( ) --- FDS yes ( ) No ( ) b. Cabling / wiring / components control : Objective : Ensure that all components / cables / wires are present, clearly marked or numbered and correctly connected in accordance to the layout diagram. The parts to be tested will be chosen on the spot All cables are numbered. yes ( ) No ( ) All parts are clearly marked. yes ( ) No ( ) Check dimensions (layout diagram) yes ( ) No ( ) Check materials finishes yes ( ) No ( ) Verify correctness of nameplate data yes ( ) No ( ) 10 of 80 GB/

11 FAT Tablet press FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : GB/ of 80

12 Tablet press FAT FETTE FAT PART E TESTING BASIC OPERATIONS TEST NUMBER : 1 MAIN POWER TEST DESCRIPTION : Turn Main Power Switch ON Control unit computer boots up. Operator must Log---in. OBSERVATION : Date : Name of Observer OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : 12 of 80 GB/

13 FAT Tablet press FETTE FAT TEST NUMBER : 2 PARAMETER LIST B, C, D, E, F, G TEST DESCRIPTION : Press B, Parameter list B displays Press C, Parameter list C displays Press D, Parameter list D displays Press E, Parameter list E displays Press F, Parameter list F displays Press G, Parameter list G displays OBSERVATION : Date : Name of Observer OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : GB/ of 80

14 Tablet press FAT FETTE FAT TEST NUMBER : 3 MACHINE START/STOP TEST DESCRIPTION : Press START, machine starts Press STOP, machine stops OBSERVATION : Date : Name of Observer OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : 14 of 80 GB/

15 FAT Tablet press FETTE FAT TEST NUMBER : 4 EMERGENCY BUTTONS TEST DESCRIPTION : Press START, press one EMERGENCY BUTTON and verify that the press stops immediately. Release button and check all Emergency buttons in same order. OBSERVATION : Date : Name of Observer OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : GB/ of 80

16 Tablet press FAT FETTE FAT TEST NUMBER : 5 WINDOW FLAP INTERLOCK TEST DESCRIPTION : Press START, open one of the window flaps and verify that the machine stops. Check the four window flaps and verify that when one of the four doors is open the press stops immediately. OBSERVATION : Date : Name of Observer OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : 16 of 80 GB/

17 FAT Tablet press FETTE FAT TEST NUMBER : 6 LOADING OF NEW FORMULATION TEST DESCRIPTION : Machine STOP, Select COMPUTER RUN I, select Formulation list A, select a new product by entering a new line number (press LOAD). Select parameter list B,C,D,E,F,G. Verify correct parameters are displayed. OBSERVATION : Date : Name of Observer OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : GB/ of 80

18 Tablet press FAT FETTE FAT TEST NUMBER : 7 DIRECT KEY OPERATION TEST DESCRIPTION : Select machine operation in JOG MODE. (Rotor turnes with slow speed.) Select machine operation in PUNCH TO PUNCH MODE (Rotor moves from punch to punch every time the key is pressed) Select FILL --- O --- MATIC key. (Fill --- o --- matic turns) OBSERVATION : Date : Name of Observer OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : 18 of 80 GB/

19 FAT Tablet press FETTE FAT PART F TESTING MACHINE FUNCTIONS Option for 2. rotor YES ( ) NO ( ). Remove and re---install the die plate subassembly in accordance to the Operating Instruction binder 2.. Verify that removal and installation are worked out correct and safety. Observe that specified removal---tools are used only.! The removal cart or the removal arm must only be used to remove and install the die plate assembly. Any other use is not permitted! GB/ of 80

20 Tablet press FAT FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : 20 of 80 GB/

21 FAT Tablet press FETTE FAT PART G TABLETTING (Testing Parameter / Diagnoses). 1. Create a new preparation in Formulation list A 2. Set new parameters to make tablets in accordance to customers specification (weight, thickness, hardness) 3. Record all test results that do not meet the acceptance criteria on ERROR REPORT SHEET Reference 4. Print screen displays of all lists and include with test---results. The following parameters must be entered : Param. 66 : No. of punches rotor Param. 39 : Fill cam size Param. 35 : Tabl. diameter Param. 38 : Tabl. form Param. 6 : Tabl. filling depth Param. 18 : Tabl. cyl. ht. mainpress. Param. 19 : Tabl. cyl. ht. prepress. Param. 20 : Penetr. mainpress. Param. 21 : Penetr. prepress. Param. 57 : Statistic No. of tabl. Param. 59 : Filling depth reg. no. Param. 1 : Tabl. / h x1000 Param. 3 : Fillomatic speed GB/ of 80

22 Tablet press FAT FETTE FAT 5. Change value of parameters to produce Good tablets 6. Set parameters to run Performance Test in accordance to customers specification. Performance Test : Run time (Production time) : h Param. 1 : Tabl. / h x1000 Param. 3 : Fillomatic speed Param. 18 : Tabl. cyl. ht. mainpress. Param. 19 : Tabl. cyl. ht. prepress. Param. 39 : Fill cam size Param. 14 : Good---Production x 1000 OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : 22 of 80 GB/

23 FAT Tablet press FETTE FAT. 1. To demonstrate that, according to the manufacturer s specifica--- tion, the machine functions are working correct, include the following checks to the production---test. 2. Record all test results that do not meet the acceptance criteria on ERROR REPORT SHEET Reference 3. Print screen displays of all tests and include with test---results. Test 1 : Permissible punch load (A) OBJECTIVE To demonstrate that the machine will stop, if the actual compression force (in KN ) exceeded the permissible punch load and the following message will be displayed: (5110 Press. force greater than permiss. punch load) (B) DETAILED TEST PROCEDURE 1. Set parameter 38 to 9 (manual input) 2. Start the machine 3. Set parameter 4 permissible punch load lower than the actual reading of the main compression force mean value in parameter Set parameter 5 to Zero. 5. Record set and actual values in the table below ACTUAL VALUE SETTING ACTUAL VALUE PARAMETER 5 PARAMETER 4 PARAMETER 4 KN KN KN 6. Record the diagnose displayed on the monitor Diagnose displayed: (C) ACCEPTANCE CRITERIA The machine will stop immediately if the permissible punch load is exceeded and the correct diagnose be displayed. GB/ of 80

24 Tablet press FAT FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : 24 of 80 GB/

25 FAT Tablet press FETTE FAT Test 2 : Main pressing force max. (A) OBJECTIVE To demonstrate that the machine will stop, if the actual compression force mean value (in KN ) exceeded the specified limit in parameter 7 (in %) and the message 5114 Max. limit for average pressuring force exceeded will be displayed. (B) DETAILED TEST PROCEDURE 1. Set parameter 7 to 5 %. 2. Start the machine. 3. Read actual compression force mean value in parameter 5 and record the valueinthetablebelow. 4. Increase the compression force by decreasing the setting in parameter 18 (tablet cylindrical height) 5. Read actual compression force mean value in parameter 5 after the machine stopped and record the value in the table below. MAIN COMP.FORCE (KN) PARAMETER 5 MACH. RUN. MACH. STOP 6. Record the diagnose displayed on the monitor Diagnose displayed : (C) ACCEPTANCE CRITERIA The machine will stop if the limit for main compression force exceeds the spec value by more than 5% and the correct diagnose will be displayed. GB/ of 80

26 Tablet press FAT FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : 26 of 80 GB/

27 FAT Tablet press FETTE FAT Test 3 : Main pressing force Srel max. (A) (B) OBJECTIVE To demonstrate that the machine will stop if the actual main compressing force Srel value (parameter 8) exceeds the specified limit in parameter 9 and the message will be displayed : (5112 S---rel max.pressuring force limit exceeded), DETAILED TEST PROCEDURE 1. Set parameter 8 and 9 to 0. Start the machine 2. Read actual Srel value in parameter 8 and record the value in the table below. 3. In parameter 9 set the specified value 0.5 % higher than the actual value showninparameter8 4. Change the feeder speed in parameter 3, to increase the Srel value. 5. Read actual Srel value in parameter 8 after the machine stopped and record the value in the table below. Parameter 8 6. Record the diagnose displayed on the monitor Diagnose displayed : (C) ACCEPTANCE CRITERIA The machine will stop if the limit for main compression force Srel max is exceeded and the correct diagnose and machine status light will be displayed. GB/ of 80

28 Tablet press FAT FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : 28 of 80 GB/

29 FAT Tablet press FETTE FAT Test 4 : Test of reject gate ( individual limit, upper ) (A) (B) OBJECTIVE To demonstrate that the machine will identify individual compression forces which have exceeded the specified limit in parameter 10 and will reject these tablets. The message 5010 Lim. on indiv. val. of press. force exceeded for punch... will be displayed. DETAILED TEST PROCEDURE In order to perform this test one upper punch must be modified. Use the upper punch no. 10 and attach a piece of tape to the punch face. 1. Set the individual limit upper in parameter 10 to 15 %. 2. Start the machine. 3. Collect the rejected tablets and visually verify that these tablets are produced from station no. 10 by looking for the tape marks. Parameter Record the diagnose displayed on the monitor Diagnose displayed : (C) ACCEPTANCE CRITERIA The machine will display the deviation of compression force in % for the upper limit and will display the correct diagnose and punch no. The machine will reject the correct tablet. GB/ of 80

30 Tablet press FAT FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : 30 of 80 GB/

31 FAT Tablet press FETTE FAT Test 5 : Test of reject gate ( individual limit, lower ) (A) OBJECTIVE To demonstrate that the machine will identify individual lower compression forces which have exceeded the specified limit in parameter 11 and will reject these tablets. The 5012 Press. force fallen below lim.on indiv. value for punch... will be displayed. (B) DETAILED TEST PROCEDURE In order to perform this test, one upper punch must be modified. Use a shorter upper punch in station no. 10. (or remove this punch) Set parameter 10 to 0 1. Set the individual lower limit in parameter 11 to 15 %. 2. Start the machine. 3. Reduce value in parameter 11 in small steps until tablets come off the machine as a result of low press. force. 4. Record the diagnose displayed on the monitor Diagnose displayed : (C) ACCEPTANCE CRITERIA The machine will display the deviation of compression force in % for the lower limit and will display the correct diagnose and punch no. The machine will reject the correct tablet. GB/ of 80

32 Tablet press FAT FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : 32 of 80 GB/

33 FAT Tablet press FETTE FAT Test 6 : Individual limit max. (A) OBJECTIVE To demonstrate that the machine will identify individual compression forces which exceeded the specified limit in parameter 12 and will stop the machine. The stop message 5106 Press. force has exceeded limit for max. of ind. value will be displayed. (B) DETAILED TEST PROCEDURE In order to perform this test, one upper punch must be modified. Use a longer upper punch in station no Set the individual limit max in parameter 12 to 10 %. 2. Start the machine 3. Read actual value in parameter 12 and record this in the table below. READING PARAMETER Record the diagnose displayed on the monitor Diagnose displayed : (C) ACCEPTANCE CRITERIA The machine will identify individual compression forces which exceeded the specified limit and will stop the machine. The correct diagnose and punch no. will be displayed. GB/ of 80

34 Tablet press FAT FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : 34 of 80 GB/

35 FAT Tablet press FETTE FAT Test 7 : Verification of First control loop (A) OBJECTIVE To demonstrate that the first control loop will adjust the filling depth in order to maintain the compression force. (B) DETAILED TEST PROCEDURE 1. Set parameter 32 to Start the machine. 3. Increase the specified value in parameter 5 to 2 KN above previous setting. 4. Observe that the machine will increase the filling depth in parameter 6 in order to maintain the compression force. 5. Decrease the specified value in parameter 5 to 2 KN below the previous setting. 6. Observe that the machine will decrease the filling depth in parameter 6 in order to maintain the compression force. (C) ACCEPTANCE CRITERIA The machine will adjust the filling depth in order to maintain the specified compression force. GB/ of 80

36 Tablet press FAT FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : 36 of 80 GB/

37 FAT Tablet press FETTE FAT Test 8a : Extraction vacuum Option : yes( ) / no( ) (A) OBJECTIVE To demonstrate that the machine will control the extraction vacuum for the compression area. (B) DETAILED TEST PROCEDURE 1. Set parameter 49 extraction vacuum to Observe, that the machine will adjust the displayed vacuum in the actual field to the specified value. 3. Set parameter 49 extraction vacuum to Observe, that the machine will adjust the displayed vacuum in the actual field to the specified value. 5. Set parameter 49 extraction vacuum to Observe, that the machine will adjust the displayed vacuum in the actual field to the specified value. Tolerance : < +0.5 hpa // > hpa. (C) ACCEPTANCE CRITERIA The machine will control and adjust the extraction vacuum. GB/ of 80

38 Tablet press FAT FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : 38 of 80 GB/

39 FAT Tablet press FETTE FAT Test 8b : Check negativeextraction vacuum Option : yes( ) / no( ) (A) OBJECTIVE To determine that the machine will stop and the diagnosis 5158 Check negative extraction vacuum will be displayed. (B) DETAILED TEST PROCEDURE 1. Switch off your negative extraction unit 2. Set parameter 49 to 5 3. Start machine and record diagnosis when machine stops. Diagnose display : (C) ACCEPTANCE CRITERIA If the control unit is not able to adjust the negative extraction the machine will stop and diagnosis 5158 Check negative extraction vacuum will be displayed. GB/ of 80

40 Tablet press FAT FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : 40 of 80 GB/

41 FAT Tablet press FETTE FAT Test 9 : Same punch bad Option : yes( ) / no( ) (A) OBJECTIVE To demonstrate that the machine will stop if the limit in parameter 53 same punch bad is exceeded and the message 5120 Same punch defective will be displayed. (B) DETAILED TEST PROCEDURE In order to perform this test one upper punch must be modified. Use the upper punch no. 10 and attach a piece of tape to the punch face. 1. Set the individual limit upper in parameter 10 to 15 %. 2. Set parameter 33 reject to Set parameter 52 permitted bad tablets to Set parameter 53 same punch bad to Calculate three times the number of station from the die table and set this number as the specified value in parameter Start the machine. 7. Observe that the machine will stop when more than 2 tablets are rejected. 8. Record the diagnose displayed on the monitor Diagnose displayed : (C) ACCEPTANCE CRITERIA The machine will stop if the limit in parameter 53 same punch bad is exceeded and will show the correct diagnose. GB/ of 80

42 Tablet press FAT FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : 42 of 80 GB/

43 FAT Tablet press FETTE FAT Test 10 : Starting relief Option : yes( ) / no( ) (A) OBJECTIVE To demonstrate that the machine will increase the tablet cylindrical height for the pre and main compression station at machine stop and will go back to the setting value for pre and main compression station at machine start. (B) DETAILED TEST PROCEDURE 1. Set parameter 64 starting relief to 0.5mm. 2. Record the actual value from parameter 18 tablet cylindrical height main compression and from parameter 19 tablet cylindrical height pre compression in the table below. 3. Start the machine. 4. Stop the machine and record the actual value from parameter 18 and 19 in the table below. 5. Verify that every time the machine is stopped the cylindrical height will increase for the amount of 0.5 mm and every time the machine is started the cylindrical height is decreasing to the set value. VALUE PARAMETER 18 VALUE PARAMETER 19 MACHINE START MACHINE STOP MACHINE START MACHINE STOP (C) ACCEPTANCE CRITERIA That the cylindrical height will increase by 0.5 mm on machine stop and return to the original value on machine restart. GB/ of 80

44 Tablet press FAT FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : 44 of 80 GB/

45 FAT Tablet press FETTE FAT Test 11 : Punch tight movement, bottom / Eject force, max. Option : yes( ) / no( ) (A) OBJECTIVE To determine that if the actual value of a tight bottom punch exceeds the value set in parameter 46 Punch Tight Movement Bottom N and the actual value of Ejection Force exceeds the value set in parameter 92 Ejection Force max. the machine will cease to operate and display Diagnosis 5105 Bottom Punch Stiffness exceeded and 5182 Ejection Force exceeded (B) DETAILED TEST PROCEDURE 1. Set Parameter 45 and 92 to 0 2. Set parameter 46 to Start the machine in Standard Run Mode Display Diagnosis when machine stopped : 4. Set parameter 46 to 0 5. Set parameter 92 to Start the machine in Standard Run Mode Display Diagnosis when machine stopped : (C) ACCEPTANCE CRITERIA If the actual value of a tight bottom punch exceeds the value set in parameter 46 Punch Tight Movement Bottom N the machine will cease to operate. If the actual value of Ejection Force exceeds the value set in parameter 92 Ejection Force max. N the machine will cease to operate. GB/ of 80

46 Tablet press FAT FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : 46 of 80 GB/

47 FAT Tablet press FETTE FAT Test 12 : Tablet congestion in good channel Option : yes( ) / no( ) (A) OBJECTIVE To determine that if tablets build up in the good tablet chute the machine will cease to operate and diagnosis 5159 Tablet congestion in good Channel will be displayed. (B) DETAILED TEST PROCEDURE During machine operation cover the end of the good tablet chute to stop the flow of tablets. Observe the build up of tablets to the level detection sensor. (C) ACCEPTANCE CRITERIA On blocking the tablet chute the machine must cease to operate before the build up of tablets reach the machine turret. The diagnosis 5159 Tablet congestion in good Channel will be displayed. OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : GB/ of 80

48 Tablet press FAT FETTE FAT Test 13 : Level control reached in the feeding hopper. Option : yes( ) / no( ) (A) OBJECTIVE To determine that if the Material level within the machine hopper falls below the level sensor diagnosis 5006 Level control reached in the feeding hopper will be displayed. (B) DETAILED TEST PROCEDURE Set parameter 86 to 0. Run the tablet press until the material level falls below the level sensor in the hopper. Observe diagnosis. Diagnose display : (C) ACCEPTANCE CRITERIA When the material level falls below the level sensor in the machine hopper diagnosis 5006 Level control reached in the feeding hopper must be displayed. The tablet press must continue to operate. OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : 48 of 80 GB/

49 FAT Tablet press FETTE FAT Test 14 : Lubrication cycle 1 (bottom) Option : yes( ) / no( ) (A) Note : OBJECTIVE To demonstrate that the lubrication pump 1 (lower punches) will operate in the correct cycle as specified in parameter no. 47 lubrication cycle 1. If no value is entered this parameter is automatically set at 50 seconds without display. (B) DETAILED TEST PROCEDURE 1. Set parameter 47 to 90 seconds and record the value in table below. 2. Start the machine. 3. Use a stopwatch to take the time between two lubrication cycles and record the value in the table below. SPECIFIED VALUE sec ACTUAL VALUE sec (C) ACCEPTANCE CRITERIA The displayed time in the actual field of parameter 47 and the visually recorded time arewithin10%ofeachother. GB/ of 80

50 Tablet press FAT FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : 50 of 80 GB/

51 FAT Tablet press FETTE FAT Test 15 : Lubrication cycle 2 (top) Option : yes( ) / no( ) (A) Note : OBJECTIVE To demonstrate that the lubrication pump 2 (upper punches) will operate in the correct cycle as specified in parameter no. 48 lubrication cycle 2. If no value is entered this parameter is automatically set at 50 seconds without display. (B) DETAILED TEST PROCEDURE 1. Set parameter 48 to 60 seconds and record the value in table below. 2. Start the machine. 3. Use a stopwatch to take the time between two lubrication cycles and record the value in the table below. SPECIFIED VALUE sec ACTUAL VALUE sec (C) ACCEPTANCE CRITERIA The displayed time in the actual field of parameter 48 and the visually recorded time arewithin10%ofeachother. GB/ of 80

52 Tablet press FAT FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : 52 of 80 GB/

53 FAT Tablet press FETTE FAT Test 16 : Check Deduster unit Option : yes( ) / no( ) (A) OBJECTIVE To determine that if the drum of the Deduster is not turning or the Unit is not connected to the machine diagnosis 8000 Check Deduster Unit will be displayed and the machine will stop (cont. red lights). (B) DETAILED TEST PROCEDURE --- Turn off Deduster Unit --- Start the machine and record diagnosis after machine stop Diagnose display : Machine status lights : (C) ACCEPTANCE CRITERIA If the drum of the Deduster Unit is not turning or the Unit is not connected to the machine, the machine must stop after approx. 15 seconds and diagnosis 8000 and the correct machine status lights will be displayed. OBSERVATIONS: Test pass ( ) Test fail ( ) GB/ of 80

54 Tablet press FAT FETTE FAT Test 17 : Check function of ---Metal Detector--- Option : ( ) yes / ( ) no (A) OBJECTIVE To determine that the machine will stop if the Metal Detector is not working and diagnosis 8502 Check Metal Detector will be displayed. (cont. red lights) (B) DETAILED TEST PROCEDURE 1. Start the machine 2. Unplug connector X933 at the main plug drawer 3. Record diagnosis when machine stop Diagnose display : Machine status lights : (C) ACCEPTANCE CRITERIA If the Metal Detector is not working the machine must stop and diagnosis 8502 and correct machine status lights will be displayed. 54 of 80 GB/

55 FAT Tablet press FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) GB/ of 80

56 Tablet press FAT FETTE FAT Test 18 : Verification of password management (A) OBJECTIVE To demonstrate that selected functions in the Password management are working correct. (B) DETAILED TEST PROCEDURE 1. LOGIN with level 9 (Operator, Password, --- ENTER ---, --- OK Select Configuration / Level setup 3. In the level setup list set Parameterlist to level 1. Press OK. 4. Log IN/OFF, enter password, --- ENTER Select Operator list and create new operator for level Press OK and LOGOFF 7. LOGIN with level You are allowed to change your password. 9. You are not allowed to enter the Operator list. 10. Select F3---Parameter / Parameter list. 11. Select any parameter and try new input. 12 No input possible and warning Permission denied for operator will be displayed. 13. LOGOFF and LOGIN with level 9. Select Operator list. 14. Level 9 is allowed to delete any operator (except the active one) from the Operator list and to change passwords. 15. Repeat all steps for any other combination in accordance to customer password management. (C) ACCEPTANCE CRITERIA Selected functions in the password input list are working correct. 56 of 80 GB/

57 FAT Tablet press FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : GB/ of 80

58 Tablet press FAT FETTE FAT Test 19 : System startup after unplanned shutdown (A) OBJECTIVE To demonstrate that all relevent product data, after having been created, are immediately stored on the hard disc and is not lost as a result of a unplanned shutdown. (B) DETAILED TEST PROCEDURE 1.PrintparameterlistsB,C,D,E,F,Gandtheproductionrecord. 2. Start the machine to produce tablets for 5 minutes 3. Stop the machine by turning off the main switch, wait 5 minutes (until terminal is complete down) and turn on again 4.Watchstartup.Afterboot---upprintparameterlistsB,C,D,E,F,Gandthe production record. (C) ACCEPTANCE CRITERIA The printouts in 1 and 4 are identically with exception to changes made during the 5 minutes production and the machine setup has not changed. 58 of 80 GB/

59 FAT Tablet press FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : GB/ of 80

60 Tablet press FAT FETTE FAT Test 20: Rotor and FOM turn (A) OBJECTIVE To show that the rotor and FOM turn at the start of the washing program. (B) DETAILED TEST PROCEDURE 1. Select washing program A. 2. Start washing program. (C) ACCEPTANCE CRITERIA Visual check that the rotor and FOM are turning. 60 of 80 GB/

61 FAT Tablet press FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : GB/ of 80

62 Tablet press FAT FETTE FAT Test 21: Washing program (A) OBJECTIVE To prove correct function of washing mode, with opening customer s supply valve (output signal on PILZ A1.4, O24). (B) DETAILED TEST PROCEDURE 1. Select washing program A. 2. Start the program. 3. Connect hose of spray lance to fast coupling on machine. 4. Put lance inside compression chamber and activate gun. (C) ACCEPTANCE CRITERIA Waterisspraying,nozzleisrotating. 62 of 80 GB/

63 FAT Tablet press FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : GB/ of 80

64 Tablet press FAT FETTE FAT Test 22: Glove port interlock (A) OBJECTIVE To prove that interlock is working. By opening glove port during washing. (B) DETAILED TEST PROCEDURE 1. Select washing program A. 2. Start the washing program. 3. Activate spraylance. 4. Open glove port while spray lance is activated. (C) ACCEPTANCE CRITERIA Water stops as soon as glove port is open. 64 of 80 GB/

65 FAT Tablet press FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : GB/ of 80

66 Tablet press FAT FETTE FAT Test 23: Float switch (A) OBJECTIVE To show that the float switch stops on reaching a certain water level within the housing middle section and does not let any more water into the compression chamber. (B) DETAILED TEST PROCEDURE 1. Select washing program A. 2 Seal off the drain opening DN 50 (e.g. adhere sticky tape to the opening). 3. Start the washing program. 4. Note the diagnosis shown on the monitor. ( diagnose 8404 may not be deactivated ) Diagnosis 8404 Index 3 (C) ACCEPTANCE CRITERIA The washing program stops before the water has reached a level of 5 mm underneath the groove between lower pressure station and lower pressure station gearbox. The right diagnosis appears. 66 of 80 GB/

67 FAT Tablet press FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : GB/ of 80

68 Tablet press FAT FETTE FAT Test 24: FOM shut---off slide (A) OBJECTIVE To show that the washing program aborts when the FOM shut---off slide does not open. (B) DETAILED TEST PROCEDURE 1. Disconnect the proximity switch of the pneumatic cylinder underneath the FOM support plate. 2 Select washing program A. 3. Start washing program. 4. Note the diagnosis shown on the monitor. ( diagnose 8404 may not be deactivated ) Diagnosis 8404 Index 1 (C) ACCEPTANCE CRITERIA The washing program aborts when the FOM shut---off slide does not open. The right diagnosis appears. 68 of 80 GB/

69 FAT Tablet press FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : GB/ of 80

70 Tablet press FAT FETTE FAT Test 25: Discharge valve (A) OBJECTIVE To show that the washing program aborts when the discharge valve does not open. (B) DETAILED TEST PROCEDURE 1. Turn the switching flag of the swivel drive for the disk valve. 2 Select washing program A. 3. Start washing program. 4. Note the diagnosis shown on the monitor. ( diagnose 8404 may not be deactivated ) Diagnosis 8404 Index 2 (C) ACCEPTANCE CRITERIA The washing program aborts when the discharge valve does not open. The right diagnosis appears. 70 of 80 GB/

71 FAT Tablet press FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : GB/ of 80

72 Tablet press FAT FETTE FAT Test 26: Washing --- external release (wash hood on product feed) (A) OBJECTIVE Wash hood in product feed has to be in place, to enable washing. (B) DETAILED TEST PROCEDURE 1. Remove jumper from X328:3---5 (simulating positive signal from wash hood). 2 Select washing program A. 3. Start program. 4. Observe functionality of water supply valves. (C) ACCEPTANCE CRITERIA Washing program will not start (water supply will not open) as long as jumper is not back in place. After replacing jumper, washing program will continue. 72 of 80 GB/

73 FAT Tablet press FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : GB/ of 80

74 Tablet press FAT FETTE FAT Test 27: Drain / free drain (A) OBJECTIVE To prove that free drain opens 30 seconds after stopping washing program. (B) DETAILED TEST PROCEDURE 1. Remove lower flap to see drain valve. 2 Select washing program A. 3. Start washing program. 4. Stop washing program. 5. Check drain valve. (C) ACCEPTANCE CRITERIA Drain valve closes 30 seconds after stopping of the washing program. Free drain valve opens when drain closes. 74 of 80 GB/

75 FAT Tablet press FETTE FAT OBSERVATIONS: Test pass ( ) Test fail ( ) PERFORMED BY : DATE : GB/ of 80

76 Tablet press FAT FETTE FAT 76 of 80 GB/

77 FAT Tablet press FETTE FAT PART H SUMMARY Test pass ( ) Test fail ( ) PERFORMED BY : DATE : GB/ of 80

78 Tablet press FAT FETTE FAT 78 of 80 GB/

79 FAT Tablet press FETTE FAT ERROR REPORT SHEET System name : Raised by : Error Report Reference : Date : Qualification Document Reference : Qualification Test Description : Nature of Fault : Reason of Fault : Rectification Undertaken or Justification for none taken : Solution Implemented by : Date : Re --- test PASS / FAIL Tested by : Date : Witnessed by : Date : Witnessed by : Date : GB/ of 80

80 Tablet press FAT FETTE FAT 80 of 80 GB/