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1. R0407 PULULLELLL sey ay Ega Es cea ae eee EE Administrative Setup Delete Validations Original Instructions inSITE Inflation and Integrity Test System Manual 69 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe ELAS 70 A part of Thermo Fisher Scientific SCREEN PANEL EVENT HISTORY This panel below shows the options which are available for User Accounts with an Engineer privilege level or higher This panel appears when the user presses the EVENT HISTORY button on the Main Screen Panel The Event History panel is the screen that contains log records for all traceable events The primary purpose is to comply to the 21 CFR Part 11 guidelines The controls operate as follows Start Date and Time When this selection is checked it allows the user to set the start date and time to set the range for the event history log End Date and Time When this selection is checked it allows the user to set the end date and time to set the range for the event history log Duration When this selection is checked it allows the user to set the duration for the event history log from one of the available options Refresh Press this button to display the event history log based on the checked selections Export Press this button to export the entire Event History Log Note The maximum number of
2. y in SI INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL INFLATION amp INTEGRITY TEST SYSTEM Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe Thermo Fisher Scientific 163 Research Lane Millersburg PA 17061 1 717 692 2104 1 800 724 4158 wwwaasisus com ASI A Part of Thermo Fisher Scientific is an FDA Registered ISO 13485 2003 Certified Manufacturer MK 00296 10 27 15 A part of Thermo Fisher Scientific INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe Y A part of Thermo Fisher Scientific TABLE OF CONTENTS 1 Applicable Documents 2 11 13 Liquid Filling Cycle 64 2 Scope gt 11 14 Administrative Setup 65 11 15 Event History 70 3 General Description 3 11 16 Maintenance 71 4 Specifications 4 4 1 Model Specifications 4 12 inSITE Unit Maintenance 72 4 2 Operating Pressure 4 12 1 Between Each Operation 72 4 3 Measuring Ranges 4 l 12 2 Annually 72 4 4 Operating Conditions 4 4 5 Sound Level Range 4 13 Troubleshooting Faults and Alarms 72 4 6 Program Revisions 4 13 1 Faults 72 13 2 Al 73 5 inSITE Components 5 iai P 2 e Madine Conrol 14 Recommended Spare Parts 8 l 14 1 List of Spare Parts 82 6 1 Symbol Legend for Electrical Controls 6 6 2 Main Power 6 15 Warranty 82 P i 16 Contact Information 82 6 4 Operation Control
3. INFLATION amp INTEGRITY TEST SYSTEM 11 12 2014 QUALIFICATION TEST RESULT QUALIFY BEGIN 19 56 PM RESULT PRESSURE DROP 4 91 mbar OPERATOR ID aadmin AT RESULT SECONDS 30 SECS JOB NUMBER 37000 0000 NON FLAWED MIN PRESSURE DELTA 0 08 mbar PRODUCT ID B101234 I FLAWED MAX PRESSURE DELTA 4 99 mbar TANK ID TK 01010 SUGGESTED FINE LEAK FLAG 4 99 mbar FIELD 4 BLANK TARGETS CHARGE SETPOINT 25 mbar CHARGE TIME 30 SECS 3 NON FLAWED BAGS SETTLE TIME 10 SECS 3 FLAWED BAGS PRESSURE TOLERANCE 10 CHARGE SPEED 25 0 Hz FLAW SIZE 100 u RECHARGE SPEED 25 0 Hz TEST TIME 90 SECS CHARGE STEP DOWN 25 0 mbar QUALIFY LEAK FLAG 1 00 mbar Successful Qualification Test Result Label Continued Qualify Begin Time Displays the date time when the INFLATE button was pressed on the Qualification Test panel to begin the test Operator ID Displays the User ID used to login to the inSITE unit Job Number Displays the job number as entered by the user Product ID Displays the Product ID as entered by the user Tank ID Displays the Tank ID as entered by the user Field 4 This field is an additional custom field that can be used for other product specifications In case this field was used it will display the information added by the user Charge Set Point mbar Displays the pressure value set as a charge set point by the user in Administrative Setup Charge Time secs Displays the Charge Time as determin
4. Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe N A part of Thermo Fisher Scientific 11 1 2 Main Maintenance This panel below shows the options which are available for User Accounts with a Maintenance privilege level or higher Note the Maintenance button is the only addition from the previous lower level privilege This button allows the user to take manual control of the system s valve s and blower R 7 38 55 AM e SAST 10 22 2015 shutdown inSITE Inflation and Integrity Test System mA SinSITE INFLATION amp INTEGRITY TEST SYSTEM GROSS FINE LEAK TEST LEAK TEST PRESSURE LIQUID CONTROLLED FILLING INFLATION CYCLE Main Screen Panel Maintenance Login 11 1 3 Main Engineer This panel below shows the options which are available for User Accounts with a Engineer privilege level or higher Note the Qualification Test button is the only addition from the previous lower level privilege ze 7 39 36 AM SASL 10 22 2015 Shutdown inSITE Inflation and Integrity Test System wens SinSITE INFLATION amp INTEGRITY TEST SYSTEM GROSS QUALIFICATION FINE LEAK TEST TEST LEAK TEST PRESSURE LIQUID CONTROLLED FILLING INFLATION CYCLE MAINTENANCE Main Screen Panel Engineer Login Original Instructions inSITE Inflation and Integrity Test System Manual 21 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single C
5. iii Vent stays open Must be manually closed Maintenance a Idle i No effect b Inflate i Reset to Idle ii Allowed to restate the test when AC power is resumed c Vent Valve Open i Valve remains open ii Valve can be closed while in any Alarm State Original Instructions inSITE Inflation and Integrity Test System Manual 75 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe Y A part of Thermo Fisher Scientific PendoTECH Sensor Cable Disconnect Prior conducting any tests PendoTECH sensor and transmitter shall be connected through a cable joint In the event if the cable joint is disconnected the PendoTECH transmitter would send a signal to the PLC to prompt this condition In addition an HMI displays an Alarm and an audible buzzer sounds which can be silenced by pressing the ACKNOWLEDGE button on the Alarm Window or by reattaching the cables The blower if running will immediately stop Also any running test would be immediately terminated and appropriate test results would be saved for traceability purpose General Alarm Condition a Alarm State UNACK i Audible buzzer is heard ii ALARM window is displayed 1 Banner is displayed with the following a PendoTECH pressure sensor disconnected 2 ACKNOWLEDGE button is enabled 2 10 57 13 AM SASI 10 27 2015 F PRESSURE CONTROLLED inSITE Inflation and Integrity
6. AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific 11 3 SCREEN PANEL GROSS LEAK INFORMATION ENTRY This panel below shows the options which are available for User Accounts with any of the four privilege levels The Gross Leak Information Entry Screen Panel will appear after making a size selection on the Gross Leak Select Screen Panel This panel allows the user to enter information for the Gross Leak test The information can be scanned with the bar scanner or entered manually The following controls are displayed on this panel Job Number Press this button to enter the Job Number Product ID Press this button to enter the Product ID Tank ID Press this button to enter Tank ID Field 4 This field is an additional custom field that can be used for other product specifications If this field is in use press this button to enter the information needed for the custom field Bag Size Displays the bag size as determined by the Gross Leak Test Selection Charge Set Point mbar Displays the pressure value set as a charge set point by the user in Gross Leak Setup Charge Time Secs Displays the Charge Time as determined by the Gross Leak setup of the Test Selection Settle Time Secs Displays the Settle Time as determined by the Gross Leak setup of the Test Selection Pressure Tolerance Displays the Pressure Tolerance determined by the Gross Leak setup of the Test
7. FE GrossLeak_20151021080222 pdf FE FineLeak_20150909105646 pdf FE FineLeak_20150909093919 pdf F FineLeak_20150908153140 pdf FE FineLeak_20150908143521 pdf 6 FineLeak_20150908135524 pdf FE FineLeak_20150904152534 pdf FE FineLeak_20150904145349 pdf F FineLeak_20150904132926 pdf FI FineLeak_20150904114439 pdf R E 2 exe FE FineLeak_20150902113651 pdf PL FineLeak 20150902110836 pdf 10 21 2015 12 05 PM 10 21 2015 11 35 AM 10 21 2015 10 59 AM 10 21 2015 10 59 AM 10 21 2015 10 59 AM 10 21 2015 10 58 AM 10 21 2015 8 24 AM 10 21 2015 8 02 AM 9 9 2015 10 56 AM 9 9 2015 9 39 AM 9 8 2015 3 31 PM 9 8 2015 2 35 PM 9 8 2015 1 55 PM 9 4 2015 3 25 PM 9 4 2015 2 53 PM 9 4 2015 1 29 PM 9 4 2015 11 44 AM 9 3 2015 12 13 PM 9 2 2015 11 36 AM 9 2 2015 11 08 AM hl Adobe Acrobat Doc Adobe Acrobat Doc CSV File Adobe Acrobat Doc Adobe Acrobat Doc CSV File Adobe Acrobat Doc Adobe Acrobat Doc Adobe Acrobat Doc Adobe Acrobat Doc Adobe Acrobat Doc Adobe Acrobat Doc Adobe Acrobat Doc Adobe Acrobat Doc Adobe Acrobat Doc Adobe Acrobat Doc Adobe Acrobat Doc Application Adobe Acrobat Doc Adobe Acrobat Doc Administrative Setup Open PDF Report Archive Windows Folder Factory Defaults Press this button to reset parameters saved on the Gross Leak Setup window and in the User Field Title 1 and 2 Note This will not modify any parameters saved on t
8. FINE LEAK TEST 10 0 1 0 0 mbar STEP DOWN Fine Leak Information Entry After all the information is entered the PROCEED TO FINE LEAK TEST button will appear highlighted and the test can be initiated Press the PROCEED TO FINE LEAK TEST button to proceed to the test 54 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific 11 11 SCREEN PANEL FINE LEAK TEST This panel below shows the options which are available for User Accounts with any of the four privilege levels 7 24 00 AM SASL 10 22 2015 inSITE Inflation and Integrity Test System FINE LEAK TEST LOGGED IN AS aadmin 3 65359 AM 6 58 59 AM 71259 AM 7 23 59 AM 10222015 10222015 70859 AM 7 13 59 AM 1022205 1022705 10222015 1022 2015 7 02 59 AM 1 22 2015 BAG INFLATOR SCL BaseFit 00 00 00 30 84 TEMPERATURE F fo SETPOINT mbar 4 z s i ro we T 72 2 G 25 0 21 7 amA vofot POF Access VACUUM o 0 0Hz __ VENT VALVE CLOSED Fine Leak Test Confirm Pressure Sensor The Fine Leak Test Screen Panel will appear after the user presses the PROCEED TO FINE LEAK TEST button on the Fine Leak Information Entry Screen Panel The following controls are displayed on this panel Confirm Confirm Pressure Sensor Prior to condu
9. JE aaReplicationUs gE aaUsers Jel Acronis Remote gel ASBSolution JE HelpLibraryUpdz Admin de Teng gl Taint roper Se SOLServer 2005 Users or Builtin secunty principals From this location Enter the abject names to select examples Customer User Check Names Advanced Cancel i aa Changes to a user s group membership are not effective until the t the next time the user logs on Tal Remove 10 3 13 Step 13 Apply Settings and Restart The new user Account ID is now added to the current list When finished press the APPLY button to complete the process Once all of the desired user accounts are added restart the system to login using any of the new accounts This concludes the New User Account Setup Procedure FEl Administrators ZH Backup Operators LI ax JE cryptographic T Hl Distributed COM Se Event Log Reach FEl Guests Seis USRS Zl Network Configu Performance Low de Performance Mo JE Power Users Jel Remote Desktop dE Replicator del Users JE aaAdministrator Se aaPowerUsers JE aaReplicationUs gel aaUsers Jel Acronis Remote gel ASBSolution JE HelpLibraryUpde Se SOLServer 2005 Administrators have complete and u Backup Operators can override SECU General D om Description wad Operator Members Customer User 1 Bo Changes to a user s group membership paid i Ses time the aa sane re Original Instructions inSITE Inflation a
10. Resets to beginning of the test il Allowed to restart the test when ALARM window is no longer displayed b Settle Test Cycle i Test discontinues ii Label pop up is displayed over ALARM window iii PDF label is created with test result as PendoTECH Pressure Transmitter Failure iv Label pop up hides v ALARM window is visible again c Idle i No effect d Pressure Confirm i Idle 1 No effect il Inflate 1 Test discontinues 2 Allowed to restate the test when ALARm window is no longer displayed iii Confirm Complete 1 Proceed to Test button disappears 2 Allowed to restart the test when ALARM window is no longer displayed e Vacuum Function in Progress i Vacuum stops and the VACUUM button are disabled ii Does not restart when alarm is acknowledged and cleared iii Vent stays open Must be manually closed f Vent Valve Open i Valve remains open ii Valve can be closed while in any Alarm State A part of Thermo Fisher Scientific Original Instructions inSITE Inflation and Integrity Test System Manual 81 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe Y A part of Thermo Fisher Scientific 14 RECOMMENDED SPARE PARTS To assure that there is the minimum amount of machine downtime ASI recommends that the following items be kept in inventory minimum quantity in the manufacturing facility s
11. inSITE Inflation and Integrity Test System j Log OFF LOGGED IN AS Training Administrator CONFIRM mbar 28 1 ACTUAL mbar 28 3 Pressure Confirm Test Complete 28 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific e Set Points Press this button if the user wishes to review the setup prior to beginning the test press the SET POINTS button on the test panel This would open a pop up window with all the appropriate details required to review the setup parameters The user can view the Set Points pop up at any stage of the test cycle JOB NUMBER 37000 0000 PRODUCT ID B10123 I TANK ID TK 01010 FIELD 4 BLANK SETPOINTS CHARGE TIME 180 SECS SETTLE TIME 600 SECS PRESSURE TOLERANCE 10 FLAW SIZE 100 u 26 0 Hz 26 0 Hz 25 0 mbar CHARGE SPEED RECHARGE SPEED CHARGE STEP DOWN Gross Leak Test Set Points Pop Up Window e Inflate When ready to initiate the test press the INFLATE button The system will run through the test and indicate a pass or fail at the conclusion e PDF Access Once the test is completed the test results will be automatically saved as a PDF file Press this button to open a window screen showing all archived PDF labels including the latest test results la
12. 501 to 1 000 Liters 1 001 2 000 L Press this button to perform the Gross Leak test on a bag from 1 001 to 2 000 Liters 2 001 5 000 L Press this button to perform the Gross Leak test on a bag from 2 001 to 5 000 Liters ry 8 47 33 AM SASI 10 22 2015 l Shutdown inSITE Inflation and Integrity Test System eee LOGGED IN AS o 501 1000 L 21 100L 1001 2000 L 101 250L 2001 5000 L 251 500 L Gross Leak Select Operator Maintenance 24 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe N A part of Thermo Fisher Scientific 11 2 2 Gross Leak Select Engineer Administrator This panel below shows the options which are available for User Accounts with an Engineer privilege level or higher Note the Gross Leak Setup button is the only addition from the previous lower level privilege Press this button to edit the gross leak validation parameters ref 11 5 SASL 10 21 2015 GROSS LEAK Shutdown i i i inSITE Inflation and Integrity Test System SELECT 501 1000 L 21 100 L 1001 2000 L 101 250 L 2001 5000 L 251 500 L Gross Leak Select Engineer Administrator Original Instructions inSITE Inflation and Integrity Test System Manual 25 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel
13. AM QUALIFICATION TEST BAG SIZE 5L 3 17 2015 QUALIFY BEGIN 10 53 52 AM fi FAL QUALIFICATION y n TEST INFLATION amp INTEGRITY TEST SYSTEM 3 17 2015 PENDOTECH SENSOR QUALIFY BEGIN 10 53 52 AM DISCONNECTED OPERATOR ID Training Administrat JOB NUMBER 34500 0000 PRODUCT ID B101234 I TANK ID TK 01010 TARGETS CHARGE SETPOINT 25 mbar CHARGE TIME 30 SECS 3 NON FLAWED BAGS SETTLE TIME 60 SECS 3 FLAWED BAGS PRESSURE TOLERANCE 10 CHARGE SPEED 24 5 Hz FLAW SIZE 25 p RECHARGE SPEED 24 5 Hz TEST TIME 90 SECS CHARGE STEP DOWN 25 0 mbar QUALIFY LEAK FLAG 0 00 mbar PendoTECH Sensor Disconnected Qualification Test Result Label Original Instructions inSITE Inflation and Integrity Test System Manual 49 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific PendoTECH Transmitter Failure The Qualification Test was unsuccessful to complete the testing of the test unit During settle or test cycle the power supply available to pendoTECH transmitter was discontinued Therefore it was not possible to continue to monitor the actual pressure of the test unit 11 38 54 AM 19 39 30 AM 11 4006 AM 11 40 42 AM 11 49 18 AM Mi72008 VIT2015 17 2015 V172015 Y17 2015 SAG INFLATOR _SCL BestFit 00 00 00 03 054 mp Pressure Pk Tag Timesta Z NE BAG O2 113818AM_ O 0
14. ENTRY FINE LEAK SELECT MAIN VALIDATION SAVE 1 20 FINE LEAK SETUP FINE LEAK SELECT MAIN QUALIFICATION INFO ENTRY MAIN GROSS LEAK TEST GROSS LEAK INFO ENTRY GROSS LEAK SELECT MAIN QUALIFICATION TEST ADMINISTRATIVE SETUP MAIN LIQUID FILLING CYCLE MAIN VALIDATION RECALL 1 20 FINE LEAK SETUP FINE LEAK SELECT MAIN FINE LEAK TEST FINE LEAK INFO ENTRY VALIDATION SELECT 1 20 FINE LEAK INFO ENTRY FINE LEAK SELECT MAIN VALIDATION SAVE 1 20 FINE LEAK SETUP FINE LEAK SELECT MAIN QUALIFICATION INFO ENTRY MAIN GROSS LEAK TEST GROSS LEAK INFO ENTRY GROSS LEAK SELECT MAIN Screen Panel Event History Original Instructions inSITE Inflation and Integrity Test System Manual 41 records displayed INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific 11 16 SCREEN PANEL MAINTENANCE This panel below shows the options which are available for User Accounts with a Maintenance privilege level or higher The Maintenance Screen Panel appears when the user presses the MAINTENANCE button on the Main Screen Panel This panel allows the user to take manual control of system valve s blower and alarm In addition this panel is also required while performing the calibration for primary or secondary pressure sensors and temperature sensor The controls operate as follows e
15. Integrity Test System INFLATION Maln Sereen J i 1 48 50 PM sao SASL 10 21 2015 Single Inflate CHARGE TIME SETPOINT 1 25 mbar Continuous Inflate TIME REMAINING 0 SECS ACCEPT DEFAULT DEFAULT SECEET SETPOINTS SETPOINTS 0 0 BLOWER RECHARGE SPEED 0 0 iz 0 0 CHARGE STEP DOWN mbar TEMPERATURE F Fog SETPOINT mbar ACTUAL mbar a 78 1 ae 25 0 26 0 7 VACUUM Screen Panel Pressure Controlled Inflation This Screen Panel will appear after the user presses the PRESSURE CONTROLLED INFLATION button on the Main Screen Panel The following controls are displayed on this panel Bag Size Press this button to enter the bag size to be tested Set Point Press this button to set the inflation pressure measured in mbar Single Inflate Select this radial button when user wishes to reach the Set Point pressure and then stop Pressure Controlled Inflation automatically Timed Inflate Select this radial button when the user wishes to reach to Set Point pressure and wants to maintain the set point pressure for a set period of time The user is required to press the CHARGE TIME button and enter the duration in seconds for timed inflation Continues Inflate Select this radial button when the user wishes to reach to Set Point pressure and wants to maintain the set point pressure for an indefinite period of time Default Set points Displays the default settings from Gross Leak Setup fo
16. Leak Test panel to begin the test Operator ID Displays the User ID used to login to the inSITE unit Job Number Displays the job number as entered by the user Product ID Displays the Product ID as entered by the user Tank ID Displays the Tank ID as entered by the user Field 4 This field is an additional custom field that can be used for other product specifications In case this field was used it will display the information added by the user Process Validation Displays the Process Validation number as selected by the test user Charge Set Point mbar Displays the pressure value set as a charge set point by the user in Administrative Setup Charge Time secs Displays the Charge Time as determined by the Fine Leak Process Validation setup of the Test Selection Settle Time secs Displays the Settle Time as determined by the Fine Leak Process Validation setup of the Test Selection Pressure Tolerance Displays the Pressure Tolerance determined by the Fine Leak Process Validation setup of the Test Selection Flaw Size u Displays the Flaw Size as determined by the Fine Leak Process Validation setup of the Test Selection Fine Leak Test Time secs Displays the Fine Leak Test Time as determined by the Fine Leak Process Validation Setup of the Test Selection Fine Leak Flag mbar Displays the Fine Leak Flag as determined by the Fine Leak Process Validation Setup of the Test Selection Test Start Time Di
17. PENDOTECH PRESSURE SENSOR DISCONNECTED Acknowledge Original Instructions inSITE Inflation and Integrity Test System Manual 77 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe Fine Gross Quantification Tests Pressure Controlled Inflation Maintenance a Inflate Charge Cycle i Resets to beginning of the test il Allowed to restart the test when ALARM window is no longer displayed b Settle Test Cycle i Test discontinues ii Label pop up is displayed over ALARM window iii PDF label is created with test result as PendoTECH Pressure sensor disconnected iv Label pop up hides v ALARM window is visible again c Idle i No effect d Pressure Confirm i Idle 1 No effect il Inflate 1 Test discontinues 2 Allowed to restate the test when ALARm window is no longer displayed iii Confirm Complete 1 Proceed to Test button disappears 2 Allowed to restart the test when ALARM window is no longer displayed e Vacuum Function in Progress i Vacuum stops and the VACUUM button are disabled ii Does not restart when alarm is acknowledged and cleared iii Vent stays open Must be manually closed f Vent Valve Open i Valve remains open ii Valve can be closed while in any Alarm State 78 Original Instructions inSITE Inflation and Integrity Test System Manual A part of Thermo Fisher Scientific INSI
18. Pressure Confirm test is successful the user can proceed to the fine leak test If the Pressure Confirm test fails to meet the requirement the pop up screen will not prompt the proceed button The user will be required to press the MAIN SCREEN button to terminate the Pressure Confirm test for further investigation SASI 10 27 2015 inSITE Inflation and Integrity Test System pan i nTa IROCEED TO FINE LEAK Pressure Confirm Test Complete Panel 56 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific e Set Points Press this button if the user wishes to review the setup prior to beginning the test press the SET POINTS button on the test panel This would open a pop up window with all the appropriate details required to review the setup parameters The user can view the Set Points pop up at any stage of the test cycle JOB NUMBER 37000 0000 PRODUCTID B101234 I TANK ID TK 01010 FIELD 4 BLANK PROCESS VALIDATION 01 SETPOINTS BAG SIZE 250L CHARGE TIME 90 SECS SETTLE TIME 90 SECS PRESSURE TOLERANCE 10 FLAW SIZE 100 u TEST TIME 90 SECS FINE LEAK FLAG 2 00 mbar CHARGE SPEED 60 0 Hz RECHARGE SPEED 27 0 Hz CHARGE STEP DOWN 7 5 mbar Fine Leak Test Set Points Pop Up Window Inflate When read
19. SECS 3 FLAWED BAGS PRESSURE TOLERANCE 10 CHARGE SPEED 25 0 Hz FLAW SIZE 50 p RECHARGE SPEED 25 0 Hz TEST TIME 90 SECS CHARGE STEP DOWN 25 0 mbar QUALIFY LEAK FLAG 0 00 mbar Settle Time Failure Qualification Test Result Label 46 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific Ambient Temperature Failure The Qualification Test was unsuccessful to complete the testing of all the non flawed and flawed bags as set by the user Once the INFLATE button was pressed on the Qualification Test screen for the first non flawed bag until the testing of the last flawed bag is complete the room temperature was unstable by more than the predetermined limits for at least 60 seconds causing the test to fail 6 03 14 PM 6 08 50 PM amp 10 26 PM amp 1t 02 PM 141 122014 141 122014 11122014 11122014 11 122014 11 12 2014 BAG_INFLATOR_SCL BesiFit 00 00 00 03 054 ES NE BAGO E00 PM 6 07 59 PM 00079 NF BAG 02 608 02PM QUALIFICATION TEST BAG SIZE 5L _ 11 12 2014 QUALIFY BEGIN 60 47 PM o inSITE ego eee eS 44 12 2014 AMBIENT TEMPERATURE FAILURE SRY PESEE OAT PM START TEMP 71 90 DEG OPERATOR ID aadmin FAILURE TEMP 188 70 DEG JOB NUMBER 37000 0000 PRODUCT ID B101234 I TANK ID TK 01
20. main power switch is located on the rear door of the unit FESP ee Se e a EI MAIN AIR oe eye ae vav somon The air supply disconnect air outlet is mounted on the right side of the unit OPERATION CONTROLS e Wonderware HMI Touchscreen This is the touchscreen that controls basic machine functions and is the main operator interface device e Emergency Stop An Emergency Stop push button is integrated in the inSITE units This E Stop button can be pressed at any time to de energize the blower and stop inflation of the bag e Bar Code Scanner The scanner is used to quickly enter information from the job ticket e Temperature Sensor The sensor mounted on the exterior of the cabinet is used to monitor the environment temperature of the room e USB Port This port allows the user to download testing results as needed Wonderware HMI Touchscreen Monitor Temperature Sensor USB Port Emergency Stop Barcode Scanner Onboard Label Pressure Input Wire Printer Drawer Clean Room Grade Casters Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe N G5 Pressure A part of Thermo Fisher Scientific INSITE TESTING The inSITE Inflation and Integrity Test System has the capabilities to perform the follo
21. successful the user can proceed to the Pressure Controlled Inflation If the Pressure Confirm test fails to meet the requirement the pop up screen will not prompt the proceed button The user will be required to press the MAIN SCREEN button to terminate the Pressure Confirm test for further investigation Main Screen EA F yaj _ Main Se OJ SASL 10 27 2015 shutdown inSITE Inflation and Integrity Test System je Eaa LOGGED IN AS Training Administrator CONFIRM mbar TEMPERATURE F e SETPOINT mbar ACTUAL mbar S x cc 25 0 27 9 oar ae Pressure Confirm Test Complete e Vent If necessary the user can also press the VENT button to vent the air out from the bag without making any disconnections When the VENT button is pressed it will turn the box displayed on the top right corner of the button to green and replace the symbol 0 to I opening the vent In case the vent is opened manually the VACUUM button would also be enabled for vacuuming operation e Vacuum When the VACUUM button is on it would turn the box displayed on the top right corner of the button to green and replace the symbol 0 to I When completed press the VACUUM and VENT buttons displayed on the same location e Stop The Stop button can be pressed at any time to terminates the Pressure Controlled Inflation The user can toggle the display units for temperature from available selections prior the beg
22. to use a hydrophobic filter in the vent line to prevent liquid from entering the internal piping If there is no filter or if the wrong type of filter is used there is a risk that liquid could enter the machine s internal piping and may permanently damage the blower circuit If the flow of the liquid flowing in the bag is faster than the air vent speed it is possible that the internal pressure of the test unit may overshoot by 5 mbar above the Open Vent Set Point In such a condition an audible buzzer sounds and a notification will appear on the HMI screen to alert the user of an unsafe condition It is NOT advised to press the E STOP button It would close the coaxial valve and speed up the pressure build up in the test unit Immediately stop the liquid filling pump or re adjust to a slower speed Vent If necessary the user can also press the VENT button to vent the air out from the bag without making any disconnections When the VENT button is pressed it will turn the box displayed on the top right corner of the button to green and replace the symbol 0 to I opening the vent In case the vent is opened manually the VACUUM button would also be enabled for vacuuming operation Vacuum When the VACUUM button is on it would turn the box displayed on the top right corner of the button to green and replace the symbol 0 to I When completed press the VACUUM and VENT buttons displayed on the s
23. was successful to detect the qualification leak flag for the given flaw size within the test duration as set by the user The user can use the test results to set their respective fine leak program 6624 PM 6 34 50 PM 6 35 16 PM 6 35 42 PN 6 36 08 PM 1122014 1122014 1122014 11 12 2014 1122014 BAG_INFLATOR_SCL BestFit 00 00 00 02 205 QUALIFICATION TEST BAG SIZE 5L 11 12 2014 QUALIFY BEGIN 6 19 56 PM Successful Qualification Test Result Label e Bag Size Displays the Bag Size as entered by the user Qualify Begin Displays the date time when the PROCEED TO QUALIFICATION TEST button was pressed on the Qualification Info Entry Screen Tag Displays the non flawed or flawed bag numbers as tested by the user Time Stamp Displays the time when the INFLATE button was pressed on the Qualification Test screen for each non flawed and flawed bag It also displays the end time when the test time cycle for each non flawed and flawed bag was completed Pressure Delta Displays the pressure difference observed between the startup and the end of each non flawed and flawed bag test cycle Original Instructions inSITE Inflation and Integrity Test System Manual 43 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific f QUALIFICATION j l n TEST
24. when ACKNOWLEDGE button is pressed ii ALARM window is displayed 1 Banner is displayed with the following a AC POWER FAILURE SYSTEM RUNNING ON BATTERY b SYSTEM WILL SHUT DOWN IN 600 SECONDS c UPS BATTERY MODE 2 ACKNOWLEDGE button is disabled Z 10 14 47 AM SAST 10 27 2015 dw inSITE Inflation and Integrity Test System wen LOGGED IN AS Training Administrator AC POWER FAILURE SYSTEM RUNNING ON BATTERY SYSTEM WILL SHUT DOWN IN 524 SECONDS Tag Comment 10 27 2015 10 14 44 AM ACK UPS BATTERY MODE Acknowledge c Alarm State UNACK_RTN i Audible buzzer is silenced ii ALARM window is displayed 1 Banner is displayed with the following a UPS BATTERY MODE If the ACKNOWLEDGE button is pressed iii ALARM window is no longer displayed A 10 16 35 AM SASI 10 27 2015 inSITE Inflation and Integrity Test System MAN LOGGED IN AS Training Administrator Time State Tag Comment 10 27 2015 10 16 29 AM UNACK_RTN UPS BATTERY MODE 10 27 2015 10 16 22 AM UNACK UPS BATTERY MODE Acknowledge 74 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe Gross Leak Test a Inflate Charge Cycle i Resets to beginning of the test ii Allowed to restart the test when AC power is resumed b Settle Cycle i Test continues as normal until UPS battery is
25. 0 Hz FLAW SIZE 100 pu RECHARGE SPEED 25 0 Hz TEST TIME 90 SECS CHARGE STEP DOWN 25 0 mbar QUALIFY LEAK FLAG 0 10 mbar Unsuccessful Qualification Test Result Label Original Instructions inSITE Inflation and Integrity Test System Manual 45 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific Settle Time Failure The Qualification Test was unsuccessful to complete the testing of all the non flawed and flawed bags as set by the user During non flawed or flawed bag testing the pressure decayed more than the predetermined limits set for the settle test failure causing the test to fail 5 65 40 Pts 5 56 10 PM 5 58 40 PM 5 57 10 PM 5 57 40 PM 141 122014 141 122014 1141 122014 1122014 11122014 11 12 2014 BAG_INFLATOR_SCL BestFit 00 00 00 02 544 Tag ee mem NF BAG O1 5 51 10 PM 5 54 57 PM NF BAG 02 5 55 10 PM Pressure Delta 0 1897 QUALIFICATION TEST BAG SIZE 10L _ 11 12 2014 QUALIFY BEGIN 20 ce PM SinSITE INFLATION amp INTEGRITY TEST SYSTEM 11 12 2014 SETTLE TIME FAIL START 26 76 mbar QUALIFY BEGIN 5 50 56 PM RESULT PRESSURE 24 08 mbar OPERATOR ID aadmin RESULT SECONDS 7 SECS JOB NUMBER 37000 0000 PRODUCT ID B101234 I TANK ID TK 01010 FIELD 4 BLANK TARGETS CHARGE SETPOINT 25 mbar CHARGE TIME 30 SECS 3 NON FLAWED BAGS SETTLE TIME 30
26. 010 FIELD 4 BLANK TARGETS CHARGE SETPOINT 25 mbar CHARGE TIME 30 SECS 3 NON FLAWED BAGS SETTLE TIME 60 SECS 3 FLAWED BAGS PRESSURE TOLERANCE 10 CHARGE SPEED 25 0 Hz FLAW SIZE 100 p RECHARGE SPEED 25 0 Hz TEST TIME 90 SECS CHARGE STEP DOWN 25 0 mbar QUALIFY LEAK FLAG 0 00 mbar Ambient Temperature Failure Qualification Test Result Label Original Instructions inSITE Inflation and Integrity Test System Manual 47 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific Insufficient Test Time The Qualification Test was unsuccessful to detect the qualification leak flag for two consecutive readings as necessary by the program logic for given flaw size within test duration as set by the user In this situation if possible the user can either extend the test duration or can lower their qualification leak flag 6 34 24 PM em 6 35 16 PM 6 35 42 PM 6 36 06 Pil 11 12 2014 141 122014 12 201 1122014 11 12 2014 11122014 BAG_INFLATOR_SCL BestFit 00 00 00 02 205 II NE BAG OI 620O2 Bm 6 22 23 PM Oou Si F o i x NF BAG 02 6 22 25 PM 6 24 40 PM 0 2161 QUALIFICATION TEST Z P BAGO 6 28 03 PM 6 30 40 PM 257768 F BAGO2 6 31 24 PM 6 33 45 PM 20 8274 BAG SIZE 5L QUALIFY BEGIN 6 19 56 PM F f inSITE ss INFLATION amp INTEGRITY TEST SYSTEM Quauiry Bean 19 13 7
27. 014 INSUFFICIENT TEST DATA 9 22 00 AM RETEST WITH HIGHER TEST TIME OPERATOR ID a JOB NUMBER 37000 0000 PRODUCT ID B101234 I TANK ID TK 01010 FIELD 4 BLANK TARGETS CHARGE SETPOINT 25 mbar CHARGE TIME 10 SECS 3 NON FLAWED BAGS SETTLE TIME 10 SECS 3 FLAWED BAGS PRESSURE TOLERANCE 10 CHARGE SPEED 25 0 Hz FLAW SIZE 100 p RECHARGE SPEED 25 0 Hz TEST TIME 90 SECS CHARGE STEP DOWN 25 0 mbar QUALIFY LEAK FLAG 0 10 mbar Insufficient Test Data Qualification Test Result Label 48 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific PendoTECH Sensor Disconnected The Qualification Test was unsuccessful to complete the testing of the test unit During settle or test cycle the cable joint between pendoTECH sensor and transmitter was disconnected Therefore it was not possible to continue to monitor the actual pressure of the test unit 30 00 28 00 25 00 24 00 22 00 20 00 18 00 16 00 14 00 12 00 10 00 8 00 600 4 00 2 00 0 00 10 57 58 AM 10 58 34 AM 10 59 10 AM 10 59 46 AM 11 00 22 AM 11 00 58 AM M7205 WiT205 V172015 MIT2015 M172015 M17 2015 BAG_INFLATOR_SCL BestFit 00 00 00 03 054 Tag Timestamp Pressure Delta mmm NF BAG O1 10 54 18 AM 10 57 28 AM 0 4611 NF BAG 02 10 57 58
28. 2 328 CHARGE SETPOINT 25 mbar CHARGE TIME 30 SECS SETTLE TIME 30 SECS TEST START TIME 5 27 06 PM PRESSURE TOLERANCE 10 TEST END TIME 5 27 36 PM FLAW SIZE 100 p RESULT SECONDS 30 SECS CHARGE SPEED 25 0 Hz TEST START PRESSURE 26 99 mbar RECHARGE SPEED 25 0 Hz TEST END PRESSURE 26 83 mbar CHARGE STEP DOWN 25 0 mbar TEST RESULTS GROSS LEAK PASS Pass Test Gross Leak Test Result Label Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific Fail Test The pressure decay observed in the test unit during the test cycle has decayed more than the predetermined limit inSITE INFLATION amp INTEGRITY TEST SYSTEM 11 12 2014 TEST BEGIN TIME 5 28 35 PM OPERATOR ID aadmin JOB NUMBER 37000 0000 PRODUCT ID B101234 I TANK ID TK 01010 FIELD 4 BLANK TARGETS CHARGE SETPOINT 25 mbar CHARGE TIME 30 SECS SETTLE TIME 30 SECS PRESSURE TOLERANCE 10 FLAW SIZE 100 pu GROSS LEAK TEST 0 00 52835000 PM 52842000 PM 1122014 11122014 52049000 PM 52556000 PM 52903000PM 52910000 PM 12204 11122014 111220 1112204 BAG_INFLATOR_SCL BestF it 0O 00 0001 276 TEST RESULTS GROSS LEAK FAIL TEST START TIME 5 29 09 PM TEST END TIME 5 29 10 PM RESULT SECONDS 1 SECS CHARGE SPEED 25 0 Hz TEST STA
29. ACUUM e Print Once the PDF file is saved the user can print the results to the onboard printer by pressing this button ref 11 4 1 Vent If necessary the user can also press the VENT button to vent the air out from the bag without making any disconnections When the VENT button is pressed it will turn the box displayed on the top right corner of the button to green and replace the symbol 0 to I opening the vent In case the vent is opened manually the VACUUM button would also be enabled for vacuuming operation Vacuum When the VACUUM button is on it would turn the box displayed on the top right corner of the button to green and replace the symbol 0 to I When completed press the VACUUM and VENT buttons displayed on the same location e Stop The Stop button can be pressed at any time to terminates the Gross Leak Test The user can toggle the display units for temperature from available selections prior the beginning of each test The user can also toggle the display units for pressure from available selections any time during each test Original Instructions inSITE Inflation and Integrity Test System Manual 29 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe 30 A part of Thermo Fisher Scientific 11 4 1 Gross Leak Test Results Five different outcomes are possible up
30. AM 0 3582 QUALIFICATION TEST BAG SIZE 5L 3 17 2015 QUALIFY BEGIN 11 34 37 AM ITE auatieeaqion y n TEST NFLATION amp INTEGRITY TEST SYSTEM 3 17 2015 PENDOTECH TRANSMITTER 11 34 37 AM FAILURE OPERATOR ID Training Administrat JOB NUMBER 34500 0000 PRODUCT ID B101234 I TANK ID TK 01010 QUALIFY BEGIN TARGETS CHARGE SETPOINT 25 mbar CHARGE TIME 30 SECS 3 NON FLAWED BAGS SETTLE TIME 60 SECS 3 FLAWED BAGS PRESSURE TOLERANCE 10 CHARGE SPEED 24 5 Hz FLAW SIZE 25 p RECHARGE SPEED 24 5 Hz TEST TIME 90 SECS CHARGE STEP DOWN 25 0 mbar QUALIFY LEAK FLAG 0 00 mbar PendoTECH Transmitter Failure Qualification Test Result Label 50 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific 11 8 2 Qualification Test in Progress The Test in Progress Screen Panel as shown below appears when a user with Operator or Maintenance privilege level logs in in while the Qualification Test is in progress Note the caution message on the screen CAUTION Pressing the MAIN SCREEN button will cancel the currently running test In this case the user with the Operator or Maintenance privilege level is advised to request a user with a higher privilege level Engineer or Administrator to log in and gr
31. Corporate Team is here for one purpose and that is to make sure you obtain maximum results from our equipment If you need assistance please call immediately ASI Customer Care Department 163 Research Lane Millersburg PA 17061 1 717 692 2104 customerservice2 asisus com 82 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe N A part of Thermo Fisher Scientific 17 SAMPLE OF EC DECLARATION OF CONFORMITY Advanced Scientifics Inc ASI A part of Thermo Fisher Scientific Inc A part of Thermo Fisher Scientific 163 Research Lane Millersburg PA 17061 1 717 692 2104 1 800 724 4158 www asisus com EC DECLARATION OF CONFORMITY Company Name and Address ASI 163 Research Lane Millersburg PA 17061 Name and address of the company authorized to compile the Technical File ACC Services Contact 105 route des pommiers Centre Ubidoca 74370 St Martin Boulevard France ASI declares under our sole responsibility that the product described as Equipment Name inSITE Equipment Description Inflation and Integrity Test System Model Type IN1006 Serial Number Complies with the requirements of the following European Directives Machinery Directive 2006 42 EC Low Voltage Electrical Equipment Directive 2006 95 EC Electromagnetic Comp
32. D TITLE 4 IMPORT PARAMETERS EXPORT PARAMETERS ENABLE VACUUM FACTORY DEFAULTS I CE 50 Hz Version OPEN PDF DELETE REPORT ARCHIVE VALIDATIONS WINDOWS FOLDER Administrative Setup Software Revision Button 68 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL SASL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe N A part of Thermo Fisher Scientific e Delete Validations The Validation Delete panel displays a list of previously saved Process Value parameter sets Pressing a PV NUMBER button deletes that set of Process Validation The controls on this panel operate as follows PV Number Displays the label of the set of Process validation numbers Press the appropriate button to delete the corresponding set of Process Validations e Product ID Displays the Product ID of the corresponding PV Number Tank ID Displays the Tank ID of the corresponding PV Number Return To Admin Returns to the Administrative Setup Screen Panel e Next Set Select Navigates to the next page of 20 saved PV parameter files This button title can be customized per the customer s selection as defined in administrative setup panel a 1 57 53 PM SASI 10 21 2015 i i i VALIDATION PETRS Pichi Inflation and Integrity Test System BEET 1256 PV NUMBER PRODUCTID TANK ID PV NUMBER PRODUCT ID TANK ID B0404
33. ESSURE TOLERANCE FLAW SIZE TEST TIME CHARGE SPEED RECHARGE SPEED CHARGE STEP DOWN 25 0 mbar Qualification Test Set Points Pop Up Window Make sure that Qualification Test begins with a non flawed bag When ready press the INFLATE button to initiate the test When all non flawed bags are tested a pop up window will appear on the left corner of the HMI screen The pop up will display the maximum Delta P of non flawed bags and request the user to enter the Qualification Leak Flag to progress with the remaining testing of flawed bags 7 05 17 AM SASI 10 22 2015 inSITE Inflation and Integrity Test System QUALIFICATION LOGGED IN AS aadmin 703 37 AM 70407 AM 1022016 err ur ash OrO_rRLATOR_SCL Mirt ONON tah QUALIFICATION TEST BAG SIZE SL 10 22 2015 6 53 44 Qualification Test Set Points Panel Continued e Qualification Leak Flag This is defined as a fail i i NF 1 AP1 i NF 2 AP2 NF 3 AP3 point pressure variance between the highest Delta P SS ofa e bags and the est Delta P of a flawed C U UUU 7 bags The variance between the highest Delta P of a ff non flawed bag and the lowest Delta P of a flawed bag Pressure Qualification eak Flag F 2 AP2 determines the buffer zone The buffer zone is the F 3 AP3 established point of time for the Qualification Leak Flag o This also establishes the validated pass fail point criteria F 1 AP1 GT Buffer Zone Non Fl
34. ETE VALIDATIONS IMPORT PARAMETERS WINDOWS FOLDER Administrative Setup Export Parameters Button Import Parameters Press this button to import setup parameters from the hard drive to Gross Leak Setup and Fine leak Setup 5 1 55 53 PM SASI 10 21 2015 shutdown inSITE Inflation and Integrity Test System PMINISTRATIVE LOGGED IN AS aadmin USER FIELD TITLE 1 amp 2 CANNOT BE BLANK SOFTWARE REVISION Maximum of 15 Characters ssivrooun Timeout Setpoint JOB NUMBER 9999 9999 Will Disable Timeout 0 PRODUCT ID G F a TANK ID V ENABLE REMOTE TARE USER FIELD TITL V ENABLE VACUUM M CE 50 Hz Version WINDOWS FOLDER VALIDATIONS Administrative Setup Import Parameters Button Original Instructions inSITE Inflation and Integrity Test System Manual 67 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific Software Revision Press this button to review the latest PLC and HMI revision s of the system 3 1 55 24 PM SASI 10 21 2015 inSITE Inflation and Integrity Test System PMINISTRATIVE LOGGED IN AS aadmin USER FIELD TITLE 1 amp 2 CANNOT BE BLANK Maximum of 15 Characters HMI SHUTDOWN Timeout Setpoint JOB NUMBER 9999 9999 Will Disable Timeout 0 PRODUCT ID TEMP DEVIATION STATIC TITLE TANK ID V ENABLE REMOTE TARE USER FIEL
35. I SHUTDOWN Timeout Setpoint JOB NUMBER 9999 9999 Will Disable Timeout 0 PRODUCT ID TEMP DEVIATION STATIC TITLE IMPORT PARAMETERS TANK ID I ENABLE REMOTE TARE USER FIELD TITLE 4 V ENABLE VACUUM EXT FACTORY DEFAULTS EXPORT PARAMETERS M CE 50 Hz ersion OPEN PDF REPORT ARCHIVE WINDOWS FOLDER DELETE VALIDATIONS Screen Panel Administrative Setup Original Instructions inSITE Inflation and Integrity Test System Manual 65 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific Open PDF Archive Windows Folder When this button is pressed on the Administrative Setup panel the data reports folder is displayed Archived files from the folder would allow the user to either view or print any test result file from the available list through the printer onboard the inSITE unit LAR AFF l A C data Shutdown SASI inSITE Inflation and Integrity Test System 1 57 13 PM 10 21 2015 ADMINISTRATIVE SETUP lol x gO J Computer Local Disk C data gm Computer a Local Disk A i 195 items f 195 items Unspecified 195 by GrossLeak_20151021120532 pdf E FineLeak_20151021113500 pdf QL_TREND_DATA_20151021092034 csv F qualTest_20151021105909 pdf FE qualTest_20151021105900 pdf QL_DATA_20151021092034 csv GrossLeak_20151021082435 pdf
36. IFICATION TESTS button on the Qualification Information Entry Screen Panel The following controls are displayed on this panel Confirm Confirm Pressure Sensor Prior to conducting the Qualification Test the user should make sure the pressure sensor attached to the test unit is placed away from any heat source and subjected to the 10 minute warm up that is suggested with all PendoTECH Sensors before any data is captured Press the CONFIRM button on the test panel to conduct an acceptance test of disposable PendoTECH Sensor that is attached with the test unit The user is asked to follow the procedure below Tare the main i e Disposable pressure sensor Press the TARE button on the HMI touchscreen and make sure the inlet tube filter attached to the pressure sensor is open to the atmosphere and not under any pressure influence Once the TARE operation is complete assemble the tube filter attachment to the tri clover air supply outlet on the right side of the cabinet Clamp the supply line after the disposable pressure sensor and press the START button If the pressure at the permanent and disposable sensor are within 1 0 mbar remove the pinch clamp and proceed to the integrity test Original Instructions inSITE Inflation and Integrity Test System Manual 39 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europ
37. ION amp INTEGRITY TEST SYSTEM 3 17 2015 TEST BEGIN TIME 10 49 08 AM OPERATOR ID Training Administrat JOB NUMBER 34500 0000 PRODUCT ID B101234 I TANK ID TK 01010 eee F F Drip a po e a a hoe cee ZSRR ae Be St Gs ee SS DRDO AM 10 49 18 600 AM 104529 200 AM 10 40 35 900 4M 105 50 200 AM 10 80 07 000 4M YT ets anami epa YANS ean e 201s Laer PROCESS VALIDATION 1 TARG ETS BSG INFLATOR SEL BestFit 00 Git Baz CHARGE SETPOINT 25 mbar CHARGE TIME 30 SECS SETTLE TIME 60 SECS TEST START TIME 10 49 45 AM PRESSURE TOLERANCE 10 TEST END TIME 10 50 01 AM FLAW SIZE 25 p RESULT SECONDS 16 SECS CHARGE SPEED 24 5 Hz TEST TIME 60 SECS TEST START PRESSURE 26 17 mbar RECHARGE SPEED 24 5 Hz FINE LEAK FLAG 1 00 mbar TEST END PRESSURE 0 00 mbar CHARGE STEP DOWN 25 0 mbar TEST RESULTS PENDOTECH TRANSMITTER FAILURE PendoTECH Transmitter Failure Fine Leak Test Result Label 60 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific 11 12 SCREEN PANEL FINE LEAK SETUP This panel below shows the options which are available for User Accounts with a Engineer privilege level or higher The Fine Leak Setup Screen Panel will appear after the user presses the Fine Leak Setup button on the Fine Leak Select S
38. Insert the USB drive Memory stick provided with the inSITE machine in the USB port on the front right corner of the cabinet F 10 3 5 Step 5 Select Open Folder to View Files When the USB drive is connected a pop up window will automatically open in the middle of the HMI screen Click on the OPEN FOLDER TO VIEW FILES USING WINDOWS EXPLORER option Original Instructions inSITE Inflation and Integrity Test System Manual 13 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe N A part of Thermo Fisher Scientific 10 3 6 Step 6 Select Admin Tools Click on the ADMIN TOOLS folder to view more files Then click on COMPUTER MANAGEMENT shortcut A D Admin Tools EH Computer Management E g System Tools System Tools Task Scheduler a storage Computer ipi l ja Event Viewer n services and Applications a Local Disk A Shared Folders a ASI D Local Users and Groups A Performance d Additonal Manuals EE Device Manager m Admin Tools 3 Storage Extra Disk Management Es Services and Applications 10 3 7 Step 7 Select Local Users and Groups Click on LOCAL USERS AND GROUPS on the left This will open two folders USERS and GROUPS on the right Click on the USERS folder to open the user account a Computer Management Alms a Computer
39. Main Screen Panel The Qualification Information Entry panel allows the user to enter information for the Qualification Test The information can be scanned with the bar scanner or entered manually The following controls are displayed on this panel Bag Size Press this button to enter the Bag Size Job Number Press this button to enter the Job Number Product ID Press this button to enter the Product ID Tank ID Press this button to enter the Tank ID Field 4 This field is an additional custom field that can be used for other product specifications If this field is in use press this button to enter the information needed for the custom field Charge Set point mbar Sets the default inflation pressure Charge Time secs Press this button to enter the Charge Time Settle Time secs Press this button to enter the Settle Time Test Time secs Press this button to enter the Qualify Test Time Non Flawed Bags Press this button to enter the number of non flawed bags to be tested must be between 3 and 10 bags The accuracy of the test will improve with more bags tested Flawed Bags Press this button to enter the number of flawed bags to be tested must be between 3 and 10 bags The accuracy of the test will improve with more bags tested Flaw Size u Press this button to enter the Flaw Size Pressure Tolerance Press this button to enter the Pressure Tolerance percentage Accept Press this button to accep
40. Management Local if System Tools Users Task Scheduler Groups Event Viewer Shared Folders h Local Users and Groups Fal Performance Device Manager Storage Law Disk Management as Services and Applications je a 14 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific 10 3 8 Step 8 Create New User Once the USER folder is open right click on the blank area below the list of current user accounts This will open a pop up window Click on NEW USER 3 Computer Management Fit Go Be Computer Management Local Name FullName Description E System Tools Aa a Task Scheduler Baa aa Event Viewer aadmin aadmin More Actions Shared Folders a Administrator Built in account for administering the cE ag Users and Groups 83 sdonofrio Alex Donofrio ASI mered archestra Performance gt AsBService ASBService User Account for starting WatchDog ckarmilowicz Chris Karmilowicz ASI g Device Manager a E Gs Storage dhoffman David Hoffman ASI Users E Disk Management e Test Engineer Ss Services and Applications Guest Built in account for quest access to t Test Maintenance m o a vshukla wwadmin Test Operator Vib Shukla wwadmin a
41. Manual Blower Speed Hz Press this button to set the frequency of the blower through Variable Frequency Drive e Start Stop Press the START button to set the blower in ON condition Press the STOP button to set the blower in the OFF condition e Press to Test Alarm Press this button to set the buzzer on e Primary Pressure Sensor These parameters are used for scaling the disposable pressure transducer analog signals to engineering units e Secondary Pressure Sensor These parameters are used for scaling the permanent pressure transducer analog signals to engineering units e Actual Displays the current actual reading from the pressure measurement sensor in raw un scaled units e Input Min Max Press the INPUT MIN button to set the value for zero pressure in raw un scaled units Press the INPUT MAX button to set the value for max pressure in raw un scaled units e Scaled Min Max SCALED MIN Displays the scaled minimum value in mbar SCALED MAX displays the scaled maximum value in mbar e Actual mbar Reading Displays the current actual reading from the pressure measurement sensor in scaled units mbar e Calibrate Press this button to measure the actual reading from the pressure measurement sensor in raw un scaled units for 5 seconds and then display the average as output below the calibrate button e Zero Press this button to measure the actual reading from the pres
42. N AS sadmin JOB NUMBER 34000 0000 PROCESS VALIDATION NUMBER PROCESS VALIDATION NUMBER Fine Leak Information Entry Process Validation Number Entry Original Instructions inSITE Inflation and Integrity Test System Manual 53 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific Once the Process Validation Number is entered the following buttons will appear e Product ID Press this button to enter the Product ID The Product ID entry must match to Product ID displayed on the right side o Tank ID Press this button to enter the Tank ID The Tank ID entry must match to the Tank ID displayed on the right side e Field 4 This field is an additional custom field that can be used for other product specifications If this field is in use press this button to enter the information needed for the custom field e Blower Charge Speed Hz Displays the Blower frequency as determined by the selected Fine Leak Test Process Validation e Blower Recharge Speed Hz Displays the Blower frequency as determined by the selected Fine Leak Test Process Validation e Bag Size Displays the bag size as determined by the selected Fine Leak Test Process Validation e Charge Set Point mbar Displays the pressure value determined by the selected Fine Leak Test Process Validation e Charge Time secs Dis
43. NFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific 11 4 SCREEN PANEL GROSS LEAK TEST This panel below shows the options which are available for User Accounts with any of the four privilege levels Main Sereen a 7 15 52 AM SASL 10 22 2015 Shutdown inSITE Inflation and Integrity Test System GROSS LEAK TEST LOGGED IN AS aadmin 0 00 6 45 52 AM 50 6 55 52 AM 7 00 52 AM 7 05 52 AM 7 10 52 AM 7 15 52 AM 10 22 2015 10 22 2015 10 22 2015 10 22 2015 10 22 2015 10 22 2015 BAG_INFLATOR_SCL BestFit 00 00 00 30 094 _est_ in we BLOWER OFF INFLATE _0 0H Hz STOP VALVE CLOSED Gross Leak Test Screen Panel The Gross Leak Test Screen Panel will appear after the user presses the PROCEED TO GROSS LEAK TEST button on the Gross Leak Information Entry Screen Panel The following controls are displayed on this panel e Confirm Confirm Pressure Sensor Prior to conducting the Gross Leak Test the user should make sure the pressure sensor attached to the test unit is placed away from any heat source and subjected to the 10 minute warm up that is suggested with all PendoTECH Sensors before any data is captured Press the CONFIRM button on the test panel to conduct an acceptance test of disposable PendoTECH Sensor that is attached with the test unit The user is asked to fol
44. NPUT MIN ae F7 y a 12447 16081 ewe SCALED MAX EURIE ACTUAL 25 96 mbar MANUAL BLOWER SPEED INPUT MAX TEMPERATURE F ip SETPOINT mbar ACTUAL mbar moar _ps 78 2 25 0 26 0 a ee ed IDLE ST ART ae a VALVE CLOSED CLOSED Screen Panel Maintenance INPUT MIN 7059 7059 14133 SCALED vin eae SCALED MAX URGEL ACTUAL ey eee INPUT MAX STOP Original Instructions inSITE Inflation and Integrity Test System Manual 71 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe N A part of Thermo Fisher Scientific 12 INSITE UNIT MAINTENANCE The following is a list of maintenance items to be performed at varying intervals Please Refer to Supporting Component Manuals for Individual Maintenance Schedules 12 1 BETWEEN EACH OPERATION e Cleaning Wipe down the inSITE unit with a dry lint free cloth e HMI Touchscreen Wipe screen with dry lint free cloth or mild LCD screen cleaner 12 2 ANNUALLY On an annual basis the following maintenance Is required e Replace the air filter of the air circulation fan mounted on the bottom of the cabinet e Replace the air filter mounted on the inlet line of the blower connection e Attach ASI Part Number 30 MS 1059 to the inSITE unit outlet and conduct a piping system and control valve test to confirm the integrity of the joints
45. Powered Europe A part of Thermo Fisher Scientific PendoTECH Sensor Disconnected The Gross Leak Test was unsuccessful to complete the testing of the test unit During settle cycle the cable joint between pendoTECH sensor and transmitter was disconnected Therefore it was not possible to continue to monitor the actual pressure of the test unit a A A GROSS LEAK INSITE a INFLATION amp INTEGRITY TEST SYSTEM 3 17 2015 TEST BEGIN TIME 10 34 11 AM OPERATOR ID Training Administrat JOB NUMBER 34500 0000 p PRODUCT ID B101234 I e TANK ID TK 01010 2 00 0 00 10 34 17 000 AM 10 34 22 600 AM 10 34 34 200 AM 10 34 45 800 AM 10 34 57 400 AM 10 35 09 000 A 317 2015 3niMms5 2172015 317 2015 317 2015 317205 TARG ETS BAG_INFLATOR_SCL Best it 00 00 0002 075 CHARGE SETPOINT 25 mbar TEST RESULTS PENDOTECH SENSOR DISCONNECTED CHARGE TIME 30 SECS SETTLE TIME 60 SECS TEST START TIME 10 34 48 AM PRESSURE TOLERANCE 10 TEST END TIME 10 35 09 AM FLAW SIZE 100 yp RESULT SECONDS 21 SECS CHARGE SPEED 24 5 Hz TEST START PRESSURE 25 47 mbar RECHARGE SPEED 24 5 Hz TEST END PRESSURE 0 00 mbar CHARGE STEP DOWN 25 0 mbar PendoTECH Sensor Disconnected Gross Leak Test Result Label PendoTECH Transmitter Failure The Gross Leak Test was unsuccessful to complete the testing of the test unit During settle cycle the power supply available to pendoTECH transmitter was discontinued Therefore it was not possible to contin
46. RT PRESSURE 26 88 mbar TEST END PRESSURE 24 16 mbar RECHARGE SPEED 25 0 Hz CHARGE STEP DOWN 25 0 mbar Fail Test Gross Leak Test Result Label Ambient Temperature Failure The Gross Leak Test was unsuccessful to complete the testing of the test unit During the settle cycle the room temperature was unstable by more than the predetermined limits for at least 60 seconds causing the test to fail inSITE INFLATION amp INTEGRITY TEST SYSTEM 11 12 2014 TEST BEGIN TIME 5 30 42 PM OPERATOR ID aadmin JOB NUMBER 37000 0000 PRODUCT ID B101234 I TANK ID TK 01010 FIELD 4 BLANK GROSS LEAK TEST 0 00 5 42 PM 11122014 5 31 01 PM 117122014 5 31 21 PM Wizz 3140 PM Wig 5 32 00 PM Iua 53220 PM 11122014 TARGETS BAG_INFLATOR_SCL BestFit 00 00 00 03 405 CHARGE SETPOINT 25 mbar CHARGE TIME 30 SECS TEST RESULTS AMB TEMPERATURE FAILURE SETTLE TIME 75 SECS PRESSURE TOLERANCE 10 FLAW SIZE 100 p TEST START TIME 5 31 18 PM TEST END TIME 5 32 20 PM RESULT SECONDS 62 SECS CHARGE SPEED 25 0 Hz TEST START PRESSURE 26 90 mbar TEST END PRESSURE 26 85 mbar RECHARGE SPEED 25 0 Hz CHARGE STEP DOWN 25 0 mbar Ambient Temperature Failure Gross Leak Test Result Label Original Instructions inSITE Inflation and Integrity Test System Manual 31 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC
47. Selection Flaw Size u Displays the Gross Leak Size as determined by the Gross Leak setup of the Test Selection Blower Charge Speed Hz Displays the Blower frequency as determined by the Gross Leak Setup of the Test Selection Blower Recharge Speed Hz Displays the Blower frequency as determined by the Gross Leak Setup of the Test Selection Charge Step Down mbar Displays the pressure offset from the Charge Set Point to restart blower as determined by the Gross Leak Setup of the Test Selection These button titles can be customized per the customer s selection as defined in administrative setup panel After all the information is entered the PROCEED TO GROSS LEAK TEST button will appear highlighted and the test can be initiated Press the PROCEED TO GROSS LEAK TEST button to proceed with the test P 7 14 21 AM SASI 10 22 2015 dw inSITE Inflation and Integrity Test System recone INFO ENTRY LOGGED IN AS aadmin JOB NUMBER PROCEED TO pear GROSS LEAK 34000 0000 hh PRODUCT ID B101234 1 CHARGE SETPOINT mbar vi CHARGE TIME 180 SECONDS TANK ID TK 01010 SETTLE TIME 600 SECONDS 0 PRESSURE TOLERANCE FIELD 4 100 aans BLOWER CHARGE SPEED 26 0 Hz 25 a Ea BLOWER RECHARGE SPEED BAG SIZE 26 0 Hz 5 4 20 L 25 0 Emi See STEP DOWN Gross Leak Information Entry Panel 26 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE I
48. T RESULTS FINE LEAK FAIL TEST START TIME 5 40 35 PM TEST END TIME 5 40 53 PM RESULT SECONDS 17 SECS TEST START PRESSURE 28 33 mbar TEST END PRESSURE 19 68 mbar CHARGE SPEED 25 0 Hz RECHARGE SPEED 25 0 Hz 2 50 mbar CHARGE STEP DOWN 25 0 mbar Fail Test Fine Leak Test Result Label Settle Time Failure The pressure decay observed in the test unit during the settle cycle has decayed more than the predetermined limit inSITE INFLATION amp INTEGRITY TEST SYSTEN TEST BEGIN TIME OPERATOR ID JOB NUMBER PRODUCT ID TANK ID FIELD 4 PROCESS VALIDATION TARGETS CHARGE SETPOINT CHARGE TIME SETTLE TIME PRESSURE TOLERANCE FLAW SIZE TEST TIME FINE LEAK FLAG 60 SECS 50 u 60 SECS 2 50 mbar FINE LEAK TEST 11 12 2014 5 42 41 PM aadmin 37000 0000 B101234 I TK 01010 BLANK 01 0 00 42 41 000 PM 542 50 800PM 5 43 00 600FM 54310400PM 54320 200PM 53 30 000FM 11122014 LAAPA 1112204 11122014 WIZ maou BAG INFLATOR_SCL Best 00 000001 NA 25 mbar TEST RESULTS SETTLE FAIL 30 SECS TEST START TIME 5 43 18 PM TEST END TIME 5 43 30 PM RESULT SECONDS 11 SECS TEST START PRESSURE 27 11 mbar TEST END PRESSURE 24 39 mbar 10 CHARGE SPEED 25 0 Hz RECHARGE SPEED 25 0 Hz CHARGE STEP DOWN 25 0 mbar Settle Time Failure Fine Leak Test Result Label Ambient Temperature Failure The Fine Leak Test was unsuccessful to complete the testing of the test unit In eith
49. T SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe N 14 4 A part of Thermo Fisher Scientific SCREEN PANEL MAIN The Main Panel is the screen displayed after a user logs into the inSITE machine The following are main panels for each privilege level 11 1 1 Main Operator This panel below shows the options which are available for User Accounts with any of the four privilege levels Select from the following procedures Gross Leak Test Pressure Controlled Inflation Fine Leak Test and Liquid Filling Cycle F 7 37 33 AM SAS 10 22 2015 dowel inSITE Inflation and Integrity Test System wens aSr LOGGED IN AS o inSITE INFLATION amp INTEGRITY TEST SYSTEM GROSS FINE LEAK TEST LEAK TEST PRESSURE LIQUID CONTROLLED FILLING INFLATION CYCLE Main Screen Panel Operator Login e Gross Leak Test The Gross Leak Test enables the end user to find a gross leak in the disposable system during the Settle cycle The Gross Leak Test does not require the program to progress up to Test cycle similar to Fine Leak and Qualification Tests The unit inflates a bag to a predetermined Pressure pressure and monitors the pressure over time If the pressure is stable the bag passes if the pressure decays more than the predetermined limits the bag fails the test Hon Fired Bag Inflation Charge Sottla Test _ _ Time Original Instruct
50. TE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe Yk A part of Thermo Fisher Scientific PendoTECH Transmitter power off For the proper function of the PendoTECH transmitter the terminal needs powered on In the event if power source is discontinued to the PendoTECH transmitter a signal would be send to the PLC to prompt this condition In addition the HMI displays an Alarm and an audible buzzer sounds which can be silenced by pressing the ACKNOWLEDGE button on the Alarm Window or restoring the power back to PendoTECH transmitter The blower if running will immediately stop Also any running test would be immediately terminated and appropriate test results would be saved for traceability purpose General Alarm Condition a Alarm State UNACK i Audible buzzer is heard ii ALARM window is displayed 1 Banner is displayed with the following a PendoTECH pressure transmitter failure 2 ACKNOWLEDGE button is enabled GROSS LEAK shutdowns inSITE Inflation and Integrity Test System TEST LOGGED IN AS Training Administrator z 11 12 16 AM SASI 10 27 2015 Time State Tag Comment 10 27 2015 11 06 44 AM UNACK PENDOTECH PRESSURE TRANSMITTER FAILURE Acknowledge Original Instructions inSITE Inflation and Integrity Test System Manual 79 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Po
51. TIONS Room Temperature 65 75 F 18 24 C Relative Humidity 5 95 Non Condensing 4 5 SOUND LEVEL RANGE Blower On 65 70 dB Blower Off 50 55 dB 29 4 6 PROGRAM REVISIONS HMI E2 PLC Ey 4 Original Instructions inSITE Inflation and Integrity Test System Manual 73 7 cm 26 66 0 cm INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe 5 INSITE COMPONENTS PRODUCT NUMBER 30 IN 1002 30 IN 1003 30 IN 1004 30 IN 1005 30 IN 1006 30 IN 1008 30 IN 1009 30 IN 1011 30 IN 1012 30 IN 1013 30 IN 1014 30 IN 1015 30 IN 1018 30 IN 1019 30 IN 1020 30 IN 1021 30 IN 1022 30 IN 1025 30 IN 1026 30 IN 1032 30 IN 1033 30 IN 1034 30 IN 1035 30 IN 1036 30 IN 1037 30 IN 1038 30 IN 1039 30 IN 1041 30 IN 1042 30 IN 1043 30 IN 1044 30 IN 1045 DESCRIPTION 1400 Micrologix PLC Analog Input Card PendoTECH PMAT SHR System 2 Way Coaxial Valve 1 NPT 24 VDC Notifier Alarm for the Liquid Fill Cycle Regenerative Blower 1HP 115 230 VAC 50 60Hz 3ph Bar Code Scanner Omega Temperature Transmitter For J Thermocouple Thermocouple Type J Solid Thermocouple Wire with FEP Insulation and Jacket Printer 1 HP Variable Frequency Drive 110 V Human Machine Interface Computer Panel Mount Air Circulation Fan Blower Fan Flat Pack 180X40 mm 24VDC Power Line Filter Spider 5T
52. Test System INFLATION LOGGED IN AS Training Administrator Tag Comment 10 27 2015 10 57 10 AM UNACK PENDOTECH PRESSURE SENSOR DISCONNECTED Acknowledge 76 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe N A part of Thermo Fisher Scientific b Alarm State ACK i Audible buzzer is silenced when ACKNOWLEDGE button is pressed ii ALARM window is displayed 1 Banner is displayed with the following a PendoTECH pressure sensor disconnected 2 ACKNOWLEDGE button is disabled Fa 10 57 39 AM SASI 10 27 2015 PRESSURE CONTROLLED inSITE Inflation and Integrity Test System INELATION LOGGED IN AS Training Administrator Time State Tag Comment 10 27 2015 10 57 35 AM ACK PENDOTECH PRESSURE SENSOR DISCONNECTED Acknowledge c Alarm State UNACK_RTN i Audible buzzer is silenced ii ALARM window is displayed 1 Banner is displayed with the following a PendoTECH pressure sensor disconnected If the ACKNOWLEDGE button is pressed iii ALARM window is no longer displayed z 10 58 48 AM SASI 10 27 2015 Shutdown inSITE Inflation and Integrity Test System PRESSURE CONTROLLED LOGGED IN AS Training Administrator Time State Tag Comment 10 27 2015 10 58 46 AM UNACK_RIN PENDOTECH PRESSURE SENSOR DISCONNECTED 10 27 2015 10 58 41 AM UNACK
53. The main operator interface on the machine is the Wonderware HMI Touchscreen This section describes each of panels and their controls Touching in the active area of the button on the screen causes the function described to occur 10 2 1 Mode Selection Navigation Buttons Each panel has navigation buttons setup button s and alphanumeric entry buttons When the machine is in one mode certain other functions may be disabled 10 2 2 Text Number Entry On screen panels where a word or number can be modified the authorized personnel will touch the field to be modified An alohanumeric keypad will be displayed on the screen to allow entry of a new value Key in the new value and press the ENTER button to change the value Press the CANCEL button to abort the change 10 2 3 User Group Privileges iNSITE s Graphical User Interface GUI is used to apply privilege levels to each user group during system operations When users are added to the user groups by the End User IT Department i e Administrator level access they are then able to log in and execute operations commensurate with their privilege level Each user can view and or access different panels pop ups and buttons depending on their user group privilege level Below is a list of user privilege groups that are standard with inSITE User Group User Group Privileges Administrator Change ALL system set points shutdown the GUI to access the Windows Operating S
54. V NUMBER PRODUCT ID B0404 et rar a eae a H405 BU406 RD407 lt a a eae rr al a pe pg Fine Leak Setup Validation Save Parameters Original Instructions inSITE Inflation and Integrity Test System Manual 63 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific 11 13 SCREEN PANEL LIQUID FILLING CYCLE This panel below shows the options which are available for User Accounts with any of the four privilege levels The Liquid Filling Cycle Screen Panel appears when the user presses the LIQUID FILLING CYCLE button on the Main Screen Panel This panel is used to fill the bag with liquid while simultaneously venting the air out of the bag as it is filled The controls on this panel operate as follows Open Vent Set Point Press this button to enter the value for the Open Vent Set Point This is the point at which the liquid entering the bag builds sufficient pressure for the valve to open releasing air from the bag Close Vent Set Point Displays the Close Vent Set Point 10 mbar below Open Vent Set Point This is the point at which the pressure has lowered for the valve to close allowing the pressure to build up again Start When setup is ready press this button to begin the Liquid Filling Cycle Note During the Liquid Filling Cycle it is crucial
55. WWUser WWUser 10 3 9 Step 9 New User Details Create a new user by filling out the fields in the pop up window Uncheck the USER MUST CHANGE PASSWORD AT NEXT LOGON option and check PASSWORD NEVER EXPIRES When finished press the CREATE button User name Customer User 1 eseese Usermust change password at next logon User cannot change password M Password never expires Account is disabled Original Instructions inSITE Inflation and Integrity Test System Manual 15 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe 16 10 3 10 Step 10 Add Privileges to the New User Account A part of Thermo Fisher Scientific After the new user account is created press the GROUPS folder on the left to add the recently created user to one of the current privileged groups i e TTAdmin ITEng ITMaint and ITOper for appropriate access to the system 3 Computer Management 5 2 m o mim Computer Management Local E if System Tools E 2 Task Scheduler f Event Viewer Shared Folders E Local Users and Groups C Users Groups Performance ay Device Manager amp Storage f Disk Management E F Services and Applications Administrators have complete and u Backup Operators can override secu Members are authorized to perform Members are allowed to launch acti Mem
56. X Rail Switch INSITE Cabinet General Polyester Air Filter Rhino Power Supply 24 VDC 10A 85 264 VAC Input Legend Plate Emergency Stop Dust Cap Ethernet Port Pass Through Ethernet Port Kit USB Port with cable USB Port Cover 1 HP Variable Frequency Drive 220 V 40 mm Trigger Action Twist to release Mushroom Contact Block with Latch Composite Disconnect Open Switch Kit 16A Lockable Eaton 15 Amp Circuit Breaker 2 Pole Master Control contactor 24 VDC Coil Omega Pressure Transducer UPS Controller UPS Battery A part of Thermo Fisher Scientific Original Instructions inSITE Inflation and Integrity Test System Manual 5 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe Y A part of Thermo Fisher Scientific 6 MACHINE CONTROLS The following sections describe the control and interface devices used to control the inSITE functions 6 1 6 2 6 3 6 4 6 SYMBOL LEGEND FOR ELECTRICAL CONTROLS The table of symbols shown on the right are used in the inSITE System Electrical and i Controls drawing packages as well as the Hazardous Voltage warning label below AA m4 2P DISCONNECT Ce A eee ape oe Warning Hazardous Voltage inside Risk of electric shock or burn To reduce possibility of injury turn main disconnect switch OFF before servicing machine ier a eee COR PO F e ee LO A a The
57. ame location Stop The Stop button can be pressed at any time to terminates the Liquid Filling Cycle The user can toggle the display units for temperature from available selections prior the beginning of each test The user can also toggle the display units for pressure from available selections any time during each test tsin seen O SASL i yA inSITE Inflation a nd Integrity Test System TQUID FILLING ee OPEN VENT SET POINT 25 0 mbar CLOSE VENT SET POINT 15 0 mbar TEMPERATURE F fA F SETPOINT mbar ACTUAL mbar Pa 78 2 25 0 26 0 f vacu fren AES e ae Screen Panel Liquid Filling Cycle 64 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific 11 14 SCREEN PANEL ADMINISTRATIVE SETUP This panel below shows the options which are available for User Accounts with an Engineer privilege level or higher The Administrative Setup Screen Panel appears when the user presses the ADMINISTRATIVE SETUP button on the Main Screen Panel This panel is used to modify administrator level parameters for the inSITE system The following controls are displayed Time Out Set Point Press this button to set the timer for automatic logoff after the set time The user can set the timer to 9999 to disabl
58. ant access to the test with full features In the event of the user with the lower privilege level presses MAIN SCREEN button without having the higher privilege grant access the test will discontinue and the Main Screen will be viewed Pi 2 49 48 PM SASI 10 27 2015 Shutdown 7 inSITE Inflation and Integrity Test System 2UALEICATION LOGGED IN AS Training Operator 30 00 28 00 26 00 24 00 22 00 20 00 18 00 16 00 14 00 12 00 10 00 8 00 6 00 4 00 2 00 2 49 26 PM 3 03 32 PM 3 17 38 PM 3 31 44 PM 3 45 50 PM 3 59 56 PM 10 27 2015 10 27 2015 10 27 2015 10 27 2015 10 27 2015 10 27 2015 lt BAG_INFLATOR_SCL BestFit 00 00 01 11 761 Tag Timestamp Pressure Delta NFBAGO1 2 49 26 PM QUALIFICATION TEST BAG SIZE 5L 10 27 2015 QUALIFY BEGIN 2 48 29 PM Test In Progress Caution Pressing the Main Screen button will cancel currently running test Qualification Test in Progress Original Instructions inSITE Inflation and Integrity Test System Manual 51 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe Y A part of Thermo Fisher Scientific 11 9 SCREEN PANEL FINE LEAK SELECT The Fine Leak Select Screen Panel will appear after pressing the Fine Leak Test button on the Main Screen Panel The user will then attach the test bag to the unit input the required information on the following pane
59. atibility Directive 2004 108 EC Main standards considered EN ISO 12100 2010 EN 60204 1 2006 1 2009 EN ISO 13849 1 2008 EN 61000 6 2 2005 EN 61000 6 4 2007 A1 2011 Date At US Name of authorized company representative John Briggs Director Quality of Regulatory and Compliance Signature ASI is an FDA Reg istered ISO 13485 2003 Certified Manufacturer MK 00037 05 04 15 Original Instructions inSITE Inflation and Integrity Test System Manual 83
60. ation Setup of the Test Selection Test Start Time Displays the start time of the Settle cycle Test End Time Displays the end time of the Settle cycle e Result Seconds Displays the duration between test start and test end time in seconds Test Start Pressure mbar Displays the pressure observed at the start of the settle cycle Test End Pressure mbar Displays the pressure observed at the end of the settle cycle e Charge Speed Hz Displays the Blower frequency as determined by the Gross Leak Process Validation Setup of the Test Selection e Recharge Speed Hz Displays the Blower frequency as determined by the Gross Leak Process Validation Setup of the Test Selection e Charge Step Down mbar Displays the pressure offset from the Charge Set Point to restart blower as determined by the Gross Leak Setup of the Test Selection Test Results Displays the final Test Result of the Gross Leak Test This button title can be customized per the customer s selection as defined in administrative setup panel SinSITE e INFLATION amp INTEGRITY TEST SYSTEM 11 12 2014 TEST BEGIN TIME 5 26 29 PM OPERATOR ID aadmin JOB NUMBER 37000 0000 PRODUCT ID B101234 I TANK ID TK 01010 Jano OhASSRR RRS SSSS8SSSSSSSSSS 0 00 52629 000PM 52642400PM 52655800 PM S2709200FM 52722600PM 52736000 PM FIELD 4 BLANK 11122014 11122014 tMi 1122014 Ivai IMa TARGETS BAG_INFLATOF_SCL Best it 00 00 00 0
61. awed Bag Flawed Bag T1x30 12x30 Test Cycle _ Time gt Original Instructions inSITE Inflation and Integrity Test System Manual 41 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe 42 A part of Thermo Fisher Scientific The calculation for an exact variance as a Qualification Leak Flag is on the user to define As a guideline ASI suggests applying anywhere from 30 to 70 of the maximum Delta P of non flawed bags Normally for smaller bags the greater percentage difference is applied whereas for larger bag the percentage difference is small The user can always develop their own calculations as long they consider the following guidelines e The smaller the Qualification Leak Flag the higher the risk of rejecting a good bag as a defective e The higher the Qualification Leak Flag the higher the risk of accepting a bad bag as a good bag At the conclusion of the test a graphical representation of the pressure decay for all the bags will be displayed on the panel and if the differential between the non flawed and flawed bags is more than the qualify leak flag the test is successful and the parameters can be used in subsequent fine leak tests e PDF Access Once the test is completed the test results will be automatically saved as a PDF and CSV file Press this button to open a windo
62. bel as shown below Main Sereon Lian cee ry inSITE Inflation and Integrity Test System Uieqeecifed 199 QL RATA 20151099065 4 cee LO g Data 20S soe QL Dara DnA 8D irp eak 2015107 1120532 pdf SD FineLewh_201520211135900 pul TREND DATA 2095202 109en34 c8 SO eenlest_20 15100 SS pl SD Quatrest_20 151021205900 anll DATA Orn Th GroseLesk_20151021092435 ndf S Gpe 2015107 2080277 F Freleak MISRI TU Fneleak D19090 pdf 3G Fined eak 215050515314 pdf SD FineLewk_20 150008 143521 pal Dh pnetesk_s ose asses pdt BG Pine ek 0504182594 pel Ly irl eak J A pl FD Prnetewk_m150904L2920 pif TO fnelesk 200411445 pdt MTR OG AM POOLS 6 52 AM wizLeors 202 PM POP R015 13 05 PM BD 21 2015 11 35 AM WZY2015 1 59 AM POP RO1S 10259 AM PO D12015 10 55 AM LOFZ1 2075 M 50 AM POFEL S015 6 34 AM POP IRO 05 Be AM T2015 10 56 AM a015 9 AM A05 231 PM OFRO015 235 PA YWL eiM Ma2 5 25 PM O 43015 2 59PM gja j2015 Lazy PM J205 ILH AM tay Fie cov Fie Adobe Acrobat Dor Adobe Acrobat Darn Coy File Adahe Acrobat Dar Adobe cr obat Da Ew re Adobe Acrobat Dec Aone Aroha Dar Adobe Acrobat Dar Adobe Acrobat Doc Adshe Arohat Dar Aobe Acrobat Dar Adobe Acrobat Doc Agiohe acrobat Car Adaha tier heal Dar riire nir girat Dar Adobe Acrobat Dor Gross Leak Test PDF Access Pop Up Window 8 51 30 AM 10 22 2015 GROSS LEAK B5125 bl TOTS m V
63. bers of this group can read eve Guests have the same access as me Built in group used by Internet Infor Members in this group can have som Members of this group may schedule Members of this group can access p Power Users are included for backw Members in this group are granted t 2 administrators ey Backup Operators J Cryptographic Operators g Distributed COM Users Event Log Readers Z Guests Zl IIS_IUSRS Z Network Configuration Zl Performance Log Users Performance Monitor U a Power Users E Remote Desktop Users Replicator J Users Z aaAdministrators gl aaPowerUsers aaReplicationUsers J aaUsers acronis Remote Users ZE aspsolution Ps HelpLibraryUpdaters radmin TrEng Supports file replication in a domain Users are prevented from making ac ArchestrA administrators Historian power users group Historian replication users group Historian users group Members are allowed to remotely co Members of this group can start Wat InTouch Administrator InTouch Engineer 2 Taint InTouch Maintenance oper InTouch Operator g SQLServer20055QLBro Members in the group have the requ 10 3 11 Step 11 Privilege Group Details Actions Groups More Actions Once the user privilege group is selected in this case ITOper a pop up window will open as shown Click the ADD button to add the new user account to this privilege group El Administrat
64. ce of a final integrity test prior to use at the point of use is what inSITE provides to customers ASI s single use products undergo rigorous quality checks and integrity testing before leaving our facilities This high standard for Quality is what makes ASI a trusted single use manufacturer The technology of the inSITE Inflation and Integrity Test System protects single use consumers from potential flaws by testing bags for damage that can occur from the box to the tank More specifically inSITE detects gross or fine leaks that can occur between the end users warehouse to the clean room floor or from improper handling and loading procedures LOADING AND FILLING WITH EASE Bag loading and placement is another valuable step prior to filling The inSITE system will inflate to a specified pressure so placement in the tank is accurate and errors which can result from pinching and creasing are limited Once the bag is ready to be filled with product the Liquid filling cycle moderates the internal pressure within the bag while fluid is being introduced The cycle is configured to regulate the open close position of the coaxial value mounted on the inSITE unit This product can be used on any container up to 5 000 Liters in size With clean room grade wheels and a light weight design INSITE is completely mobile A part of Thermo Fisher Scientific ADVANTAGES Point of Use Integrity Testing Gross and Fine Leak Detection Guid
65. creen Panel 5 7 20 10 AM SASL 10 22 2015 l 5 Stio jnSITE Inflation and Integrity Test System FINE LEAK LOG OFF SETUP LOGGED IN AS admin PROCESS VALIDATION NUMBER PRODUCT ID TAD RECALL TK 01010 VALIDATION CHARGE TIME CHARGE SETPOINT PARAMETERS pete a SAVE SETTLE TIME PRESSURE TOLERANCE BAG SIZE VALIDATION 30SEC 21L PARAMETERS TEST TIME FINE LEAK FLAG FLAW SIZE VALIDATION l PARAMETERS ARE NOT SAVED UNTIL SAVE FILE BLOWER CHARGE SPEED BLOWER RECHARGE SPEED CHARGE STEP DOWN IS SELECTED 28 0Hz 26 0 Hz 22 0 mbar Screen Panel Fine Leak Setup The Fine Leak Setup Screen Panel allows the user to enter information for the Fine Leak test process validation files The following controls are displayed on this panel e Process Validation Number Press this button to enter the Process Validation Number e Product ID Press this button to enter the Product ID Tank ID Press this button to enter the Tank ID e Charge Time Press this button to enter the Charge Time e Settle Time Press this button to enter the Settle Time Test Time Press this button to enter the Test Time Blower Charge Speed Hz Press these buttons to set the initial blower frequency as an inflation cycle begins for the first time on each test unit o Charge Set Point mbar Sets the default inflation pressure o Pressure Tolerance Press this button to enter the Pressure Tolerance e Fine Leak Flag Press thi
66. cted to the 10 minute warm up that is suggested with all PendoTECH Sensors before any data is captured Press the CONFIRM button on the test panel to conduct an acceptance test of disposable PendoTECH Sensor that is attached with the test unit The user is asked to follow the procedure below Tare the main i e Disposable pressure sensor Press the TARE button on the HMI touchscreen and make sure the inlet tube filter attached to the pressure sensor is open to the atmosphere and not under any pressure influence Once the TARE operation is complete assemble the tube filter attachment to the tri clover air supply outlet on the right side of the cabinet Clamp the supply line after the disposable pressure sensor and press the START button If the pressure at the permanent and disposable sensor are within 1 0 mbar remove the pinch clamp and proceed to the integrity test 3 7 09 08 AM SASI 10 22 2015 inSITE Inflation and Integrity Test System PRESSURE Se CONFIRM LOGGED IN AS aadmin CONFIRM mbar 0 1 TEMPERATURE F fog SETPOINT mbar ACTUAL mbar 0 0 PRESS TO TARE Pressure Confirm Test Start Original Instructions inSITE Inflation and Integrity Test System Manual 35 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific Once the Pressure Confirm test is
67. cting the Qualification Test the user should make sure the pressure sensor attached to the test unit is placed away from any heat source and subjected to the 10 minute warm up that is suggested with all PendoTECH Sensors before any data is captured Press the CONFIRM button on the test panel to conduct an acceptance test of disposable PendoTECH Sensor that is attached with the test unit The user is asked to follow the procedure below e Tare the main i e Disposable pressure sensor Press the TARE button on the HMI touchscreen and make sure the inlet tube filter attached to the pressure sensor is open to the atmosphere and not under any pressure influence Once the TARE operation is complete assemble the tube filter attachment to the tri clover air supply outlet on the right side of the cabinet Clamp the supply line after the disposable pressure sensor and press the START button e If the pressure at the permanent and disposable sensor are within 1 0 mbar remove the pinch clamp and proceed to the integrity test Original Instructions inSITE Inflation and Integrity Test System Manual 55 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe N A part of Thermo Fisher Scientific 7 09 08 AM SASI 10 22 2015 PRESSURE CONFIRM CONFIRM mbar Pressure Confirm Test Start Panel Once the
68. ction displayed on the top right of the label displays the final Test Result of the Qualification Test This button title can be customized per the customer s selection as defined in administrative setup panel 44 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific Unsuccessful Test The Qualification Test was unsuccessful to detect the qualification leak flag for the given flaw size within the test duration as set by the user In this situation if possible the user can either extend the test duration or can lower their qualification leak flag 9 39 49 AM S40 11 AM 5 40 33 aM 9 40 55 4M S4t17 AM 106132014 10M132014 1013 2014 10132014 10132014 BAG _INFLATOR_SCL BestFit 00 00 0001 868 Timestam Pressure Delta 0 0711 QUALIFICATION TEST BAG SIZE 5L 10 13 2014 QUALIFY BEGIN 9 22 00 AM F f Ss inSITE osso INFLATION amp INTEGRITY TEST SYSTEM 10 13 2014 QUALIFICATION TEST RESULT QUALIFY BEGIN 52 00 AM FAILURE TO DETECT SIGNIFICANT OPERATOR ID a PRESSURE DIFFERENTIAL JOB NUMBER 37000 0000 PRODUCT ID B101234 I TANK ID TK 01010 FIELD 4 BLANK TARGETS CHARGE SETPOINT 25 mbar CHARGE TIME 10 SECS 3 NON FLAWED BAGS SETTLE TIME 10 SECS 3 FLAWED BAGS PRESSURE TOLERANCE 10 CHARGE SPEED 25
69. d determine if there is a gross leak Pressure Tolerance Press these buttons to setup edit pressure tolerance in During the Settle Time period if the pressure falls below the of the pressure tolerance set from the test pressure observed at the beginning of the settle cycle the system will indicate a failure Flaw Size u Press these buttons to setup edit the flaw size in micron Blower Charge Speed Hz Press these buttons to set the initial blower frequency as an inflation cycle begins for the first time on each test unit Blower Recharge Speed Hz Press these buttons to set the recharge blower frequency once the pressure of the test unit reaches to the step down set point The purpose of the low recharge frequency Is to prevent any overshoot from the actual set point during charge time inflation Charge Step Down mbar Press these buttons to re adjust the pressure inflation set point to toggle between charge and recharge blower set points Original Instructions inSITE Inflation and Integrity Test System Manual 33 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific 11 6 SCREEN PANEL PRESSURE CONTROLLED INFLATION This panel below shows the options which are available for User Accounts with any of the four privilege levels H PRESSURE CONTROLLED m AEFT enti Inflation and
70. e N A part of Thermo Fisher Scientific j 7 09 08 AM SASI 10 22 2015 inSITE Inflation and Integrity Test System japao aadmin CONFIRM mbar Pressure Confirm Test Start Once the Pressure Confirm test is successful the user can proceed to the Qualification test If the Pressure Confirm test fails to meet the requirement the pop up screen will not prompt the proceed button The user will be required to press the MAIN SCREEN button to terminate the Pressure Confirm test for further investigation 7 12 33 AM SASI 10 22 2015 inSITE Inflation and Integrity Test System japa J LOGGED IN AS aadmin CONFIRM mbar EMPERATURE F foa SETPOINT mbar ACTUAL mbar Pressure Confirm Test Complete 40 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific e Set Points Press this button if the user wishes to review the setup prior to beginning the test press the SET POINTS button on the test panel This would open a pop up window with all the appropriate details required to review the setup parameters The user can view the Set Points pop up at any stage of the test cycle JOB NUMBER 37000 0000 PRODUCTID B101234 I TANKID TK 01010 FIELD 4 BLANK SETPOINTS BAG SIZE CHARGE TIME SETTLE TIME PR
71. e Login as a Maintenance user and verify the proper operation of Variable Frequency Drive VFD Blower and E Stop switch e Look for any visual damage to any part of the inSITE system e Visually inspect all electrical connections to ensure they are secured Only trained users should perform this operation following all safety requirements 13 TROUBLESHOOTING FAULTS AND ALARMS The following section lists possible situations that may occur during operation of the inSITE and courses of action that will to correct them 13 1 FAULTS FAULT MESSAGE REASON RECOMMENDED SOLUTION E Stop Button Pushed Pull out all Emergency Stop push buttons Ambient Temperature Failure Check Temperature sensor adjust room temperature Test Fail Retest or replace bag Settle Time Fail Retest or replace bag Qualification Test Result Failure to Detect Significant Check all tubing and clamps Check pressure transducer Pressure Differential Remove bag re tare pressure transducer retest Qualification Test Result Insufficient Test Data Retest with higher Test Time Cycle 72 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe Yk A part of Thermo Fisher Scientific 13 2 ALARMS UPS Battery Mode The 24 VDC power supply and storage battery is wired to the UPS controll
72. e inSITE system should be trained on the operations of the machine and the integration of the single use bags filters and pressure control systems This system is not GFI protected all doors except for the printer access doors and interior access panels must remain closed during operation Only a trained electrical repair technician should access the interior It is the user s responsibility to clean and maintain the machine for optimal performance Ref 12 0 Exceeding pressure settings inflation settings or operating outside of the scope of recommended practice will void the warranty Ref 15 0 An Emergency Stop button is integrated in the inSITE unit This E Stop can be pressed at any time to de energize the blower and stop inflation of the bag During the Liquid Filling Cycle it is crucial to use a hydrophobic filter in the vent line to prevent liquid from entering the internal piping If there is no filter or if the wrong type of filter is used there is a risk that liquid could enter the machine s internal piping permanently damaging the blower circuit If the flow of the liquid flowing in the bag is faster than the air vent speed it is possible that the internal pressure of the test unit may overshoot by 5 mbar above the Open Vent Set Point In such a condition an audible buzzer sounds and a notification will appear on the HMI screen to alert the user of an unsafe condition It is NOT advised to press the E STOP but
73. e time out Temperature Deviation Sets the limit on the max temperature deviation allowed while test in progress e F C Press this radial button to change the temperature units between Fahrenheit or Celsius for all panels e Enable Vacuum Remote Tare Check these boxes to perform vacuum and remote tare functions on all tests Uncheck to disable these functions e CE 50Hz version Check this box to restrict blower high speed limit to 50Hz for EU machines Uncheck to reset the speed to 60Hz User Field Title 1 Press this button to modify the default title used on various test screens The user can not leave this title blank The maximum of 15 characters are allowed for this title User Field Title 2 Press this button to modify the default title used on various test screens The user can not leave this title blank The maximum of 15 characters are allowed for this title e Static Title Displays the default title as set during factory setup The user can not modify this title User Field Title 4 Press this button to modify the default title used on various test screens In case the user leave this title blank it would not be displayed on respective test screens The maximum of 15 characters are allowed for this title a 1 53 40 PM SASI 10 21 2015 ma ADMINISTRATIVE tera eee Inflation and Integrity Test System SETOR USER FIELD TITLE 1 amp 2 CANNOT BE BLANK SETARE RENO Maximum of 15 Characters HM
74. ed Validation Setup Tests Single Use Bags up to 5 000 Liters in Size Inflation Procedure Improves Loading and Placement in Tanks Liquid Filling Cycle Regulates Internal Pressure while Fluid is being Introduced An on board blower makes the system completely mobile Use the on board scanner to enter product labels into the system The on board printer is used to print all test result labels Uninterrupted Power Supply UPS provides 10 15 minutes of power to operate the computer system should there be a main power outage Original Instructions inSITE Inflation and Integrity Test System Manual 3 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe Y 4 SPECIFICATIONS 4 1 INSITE MODEL SPECIFICATIONS A part of Thermo Fisher Scientific MODEL NUMBER IN1005 IN1006 DESCRIPTION Single Channel AC Powered US Single Channel AC Powered Europe DIMENSIONS H x W x D 58 x 26 x 29 147 3 x 66 0 x 73 7 cm 58 x 26 x 29 147 3 x 66 0 x 73 7 cm APPROXIMATE SHIPPING WEIGHT 275 lbs 124 7 kg 275 lbs 124 7 kg POWER REQUIREMENTS ELECTRICAL UTILITIES 120 VAC 15A 60hz 220 VAC 15A 50hz 4 2 OPERATING PRESSURE Maximum Operating Pressure 25 40 mbar 4 3 MEASURING RANGES Test Pressure 0 40 mbar Maximum Measurable Volume 5 000 Liters Gross Leak Flaw Sizes 100 1 000 Microns as cm 4 4 OPERATING CONDI
75. ed by the Fine Leak Process Validation setup of the Test Selection Settle Time secs Displays the Settle Time as determined by the Fine Leak Process Validation setup of the Test Selection Pressure Tolerance Displays the Pressure Tolerance determined by the Fine Leak Process Validation setup of the Test Selection Flaw Size u Displays the Flaw Size as determined by the Fine Leak Process Validation setup of the Test Selection Test Time secs Displays the Test Time as entered by the operator on Qualification Info Entry screen of the Test Selection Qualify Leak Flag mbar Displays the Qualify Leak Flag as entered by the operator before beginning the test of first Flawed bag Charge Speed Hz Displays the blower frequency as entered by the user on the Qualification Info Entry screen of the Test Selection Recharge Speed Hz Displays the blower frequency entered by the Qualification Info Entry screen of the Test Selection Charge Step Down mbar Displays the pressure offset from the Charge Set Point to restart blower as entered by the Qualification Info Entry screen of the Test Selection Non Flawed Bags Displays the quantity as entered by the user on Qualification Info Entry screen of the Test Selection to perform the testing of Non Flawed bags Flawed Bags Displays the quantity as entered by the user on Qualification Info Entry screen of the Test Selection to perform the testing of Flawed bags Test Result The se
76. een Panel P P 6 51 14 AM Main Ser A SASI 10 22 2015 Shutdown UALIFICATION inSITE Inflation and Integrity Test System QYAICATIO LOGGED IN AS aadmin ACCEPT DEFAULT DEFAULT SETPOINTS SETPOINTS PROCEED TO QUALIFICATION 26 0 s CHARGE SPEED TESTS 26 0 BLOWER RECHARGE SPEED CHARGE STEP DOWN BAG SIZE 5 0 5 LITER JOB NUMBER CHARGE SETPOINT PRODUCT ID CHARGE TIME FLAWED BAGS B101234 I asosec 3 BAGS TANK ID SETTLE TIME FLAW SIZE TK 01010 600 SEC FIELD 4 TEST TIME PRESSURE TOLERANCE BLANK 3600 SEC 10 Qualification Information Entry Continued 38 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific 11 8 SCREEN PANEL QUALIFICATION TEST This panel below shows the options which are available for User Accounts with an Engineer privilege level or higher 3 2 02 05 PM SASI 10 21 2015 i UALIFICATION inSITE Inflation and Integrity Test System QUAHHTA LOGGED IN AS aadmin LOG OFF QUALIFICATION TEST BAG SIZE 5L 10 21 2015 QUALIFY BEGIN 5 04 8 PM 82 M 26 0 cot 2 7 2 Setpoints PDF A PRINT VACUUM 78 2 Ga 25 0 26 0 BLOWER OFF M INFLATE STOP Qualification Test Screen Panel This Screen Panel will appear after the user presses the PROCEED TO QUAL
77. er the settle cycle or in the test cycle the room temperature was unstable by more than the predetermined limits for at least 60 seconds causing the test to fail inSIT INFLATION amp INTEGRITY TEST SYSTEM TEST BEGIN TIME OPERATOR ID aadmin JOB NUMBER 37000 0000 PRODUCT ID B101234 I TANK ID TK 01010 FIELD 4 BLANK PROCESS VALIDATION 01 FINE LEAK TEST 11 12 2014 5 46 39 PM ei yn ae an me aay aa Ee Sch eS Sh eee ere a tah g z i Pe Sue SE PM a Taa 5 47 17 PM iiaa Roa a Ph Titi 547 56 Ph EAEE PM minaaa Tha TARGETS CHARGE SETPOINT 25 mbar CHARGE TIME 30 SECS SETTLE TIME 60 SECS PRESSURE TOLERANCE 10 FLAW SIZE 50 pu TEST TIME 60 SECS FINE LEAK FLAG 2 50 mbar BAG INFLATOR SOL Fest 00 00 00A ITR TEST RESULTS AMB TEMPERATURE FAILURE TEST START TIME 5 48 13 PM TEST END TIME 5 48 16 PM RESULT SECONDS 0 SECS TEST START PRESSURE 27 49 mbar TEST END PRESSURE 27 55 mbar CHARGE SPEED 25 0 Hz RECHARGE SPEED 25 0 Hz CHARGE STEP DOWN 25 0 mbar Ambient Temperature Failure Fine Leak Test Result Label Original Instructions inSITE Inflation and Integrity Test System Manual 59 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific PendoTECH Sensor Disconnected The Fine Leak Test was unsuccessful to complete t
78. er In the event that AC power is lost the UPS controller uses the power in the storage battery to power the system and sends a signal to the PLC that the system is running on battery power When AC power is lost the HMI displays an Alarm and an audible buzzer sounds which can be silenced by pressing the ACKNOWLEDGE button on the Alarm Window or by restoring AC power The blower if running will immediately stop After 10 minutes the HMI will start to shut down in a controlled fashion After 15 minutes the PLC and all other 24 VDC devices in the inSITE will shut down General Alarm Condition a Alarm State UNACK i Audible buzzer is heard ii ALARM window is displayed 1 Banner is displayed with the following a AC POWER FAILURE SYSTEM RUNNING ON BATTERY b SYSTEM WILL SHUT DOWN IN 600 SECONDS c UPS BATTERY MODE 2 ACKNOWLEDGE button is enabled 4 10 13 40 AM SASL 10 27 2015 Shutdews inSITE Inflation and Integrity Test System Ta LOGGED IN AS Training Administrator AC POWER FAILURE SYSTEM RUNNING ON BATTERY SYSTEM WILL SHUT DOWN IN 590 SECONDS Tag Comment 10 27 2015 10 13 30 AM UNACK UPS BATTERY MODE Original Instructions inSITE Inflation and Integrity Test System Manual 73 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe N A part of Thermo Fisher Scientific b Alarm State ACK i Audible buzzer is silenced
79. et Aee 14 53730 PM WiDdw T30 Pe Two aa yn SP iba Pee oe da GS BAG INFLATOR SOL EoeatFit 00 OO 0008 FIE TEST RESULTS FINE LEAK PASS TEST START TIME 5 37 01 PM TEST END TIME 5 38 01 PM RESULT SECONDS 60 SECS TEST START PRESSURE 26 36 mbar TEST END PRESSURE 26 29 mbar CHARGE SPEED 25 0 Hz RECHARGE SPEED 25 0 Hz CHARGE STEP DOWN 25 0 mbar Pass Test Fine Leak Test Result Label 58 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific Fail Test The pressure decay observed in the test unit during the test cycle has decayed more than the predetermined limit inSITE INFLATION amp INTEGRITY TEST SYSTEM TEST BEGIN TIME OPERATOR ID aadmin JOB NUMBER 37000 0000 PRODUCT ID TANK ID TK 01010 FIELD 4 PROCESS VALIDATION TARGETS CHARGE SETPOINT CHARGE TIME SETTLE TIME PRESSURE TOLERANCE FLAW SIZE TEST TIME 60 SECS FINE LEAK FLAG FINE LEAK TEST 11 12 2014 5 39 02 PM J Pai Zh 24 paj 20 a8 1h a LF 1 E E 4 Fi th g 1 B101234 I PEE EE EEEE EE E AAA a r dia rath mEn T3JAPM SA00 PM FM Wie T2204 Twa BLANK 34eM 01 re 54083 PM TWAaao TAR ESG INFLATOR SCL BestFit 00 000000 657 25 mbar 30 SECS 60 SECS 10 50 u TES
80. four privilege levels The Fine Leak Information Entry panel will appear after pressing the VALIDATION SETUP button on the Fine Leak Test Select Screen Panel The Fine Leak Information Entry Screen Panel allows the user to enter information for the Fine Leak test The information can be scanned with the bar scanner or entered manually The following controls are displayed per each panel Once the data is entered into the corresponding field the next fields will appear as shown on the following screens e Job Number Press this button to enter the Job Number After the Job Number is entered more panel controls will be displayed This button title can be customized per the customer s selection as defined in administrative setup panel 7 21 52 AM seen SASI 10 22 2015 ws inSITE Inflation and Integrity Test System Kit LOGGED IN AS aadmin JOB NUMBER Fine Leak Information Entry Job Number Entry Once the Job Number is entered the following buttons will appear e Process Validation Number If the user knows the Process Validation Number it can be entered by pressing the blank PROCESS VALIDATION NUMBER button If the Process Validation Number is unknown press the SELECT PROCESS VALIDATION FROM LIST button for a list of saved Tests files After the Process Validation Number is entered more panel controls will be displayed 3 ASI ias inSITE Inflation and Integrity Test System FINELEAK STE LOGGED I
81. g the vent In case the vent is opened manually the VACUUM button would also be enabled for vacuuming operation Vacuum When the VACUUM button is on it would turn the box displayed on the top right corner of the button to green and replace the symbol 0 to I When completed press the VACUUM and VENT buttons displayed on the same location e Stop The Stop button can be pressed at any time to terminates the Qualification Test and go back to the Main Screen The user can toggle the display units for temperature from available selections prior the beginning of each test The user can also toggle the display units for pressure from available selections any time during each test Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific 11 8 1 Qualification Test Results Seven different outcomes are possible upon the completion of the Qualification Test 1 Successful test to detect the flaw within test duration as set by the user Unsuccessful test to detect the flaw within test duration as set by the user Settle Time Failure Ambient Temperature Failure Insufficient Test time PendoTECH Sensor Disconnect PendoTECH Transmitter Failure N DO Mm BR W DN Successful Test The Qualification Test
82. hannel AC Powered Europe A part of Thermo Fisher Scientific e Qualification Test The Fine Leak Test is sensitive to the environment in which the unit and test bag are located To detect a small leak a series of non flawed and flawed bags must be tested to develop the conditions in which the unit can detect a flaw of a given size in a specific bag size The Qualification Test determines the time required to find a flaw The parameters are then used in the Fine Leak Test Pressure Pressure Non Flawed Bag Non Flawed Bag Flawed Bag Inflation Charge Settle Test Inflation Charge Settle Test lt Time gt lt __ Time Four Phases of the testing cycle of a non flawed bag A comparison of a flawed bag and a non flawed bag NF 1 Al NF 1 AP1 NF 2 Al NF 2 AP2 NF 3 Al Witt j a NF 3 AP3 MMMM F 1 API a RAR Prescur EN Pressure Qualification Leak Flag F 2 AP2 F 3 AP3 F 3 AP i i E 4 Yi Buffer Zone Non Flawed Bag Flawed Bag Non Flawed Bag Flawed Bag T1x30 12x30 Test Cycle Test Cycle mM Time _ Time gt A comparison of the three successful bag tests and the three The variance between the highest Delta P of a non flawed bag and intentionally flawed bags The measurements between the the lowest Delta P of a flawed bag determines the buffer zone The De
83. he Fine Leak Setup window SOFTWARE REVISION Timeout Setpoint 9999 9999 Will Disable Timeout 0 TEMP DEVIATION V ENABLE REMOTE TARE Shutdown LOGGED IN AS aadmin G C lM ENABLE VACUUM M CE 50 Hz Version DELETE VALIDATIONS inSITE Inflation and Integrity Test System USER FIELD TITLE 1 amp 2 CANNOT BE BLANK Maximum of 15 Characters JOB NUMBER PRODUCT ID STATIC TITLE TANK ID USER FIELD TITL 1 56 42 PM 10 21 2015 ADMINISTRATIVE SETUP IMPORT PARAMETERS FACTORY DEFAULTS CANCEL Administrative Setup Factory Defaults Button 66 Original Instructions inSITE Inflation and Integrity Test System Manual 7 WINDOWS FOLDER INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL SASL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific Export Parameters Press this button to export all setup parameters saved on the Gross Leak Setup and Fine Leak Setup to the hard drive Pi 1 56 21 PM SASI 10 21 2015 inSITE Inflation and Integrity Test System APMINISTRATIVE LOGGED IN AS aadmin SETUP USER FIELD TITLE 1 amp 2 SOFTWARE REVISION Maximum of 15 Characters Timeout Setpoint JOB NUMBER 9999 9999 Will Disable Timeout 0 PRODUCT ID TEMP DEVIATION STATIC TITLE TANK ID V ENABLE REMOTE TARE USER FIELD TITL I CE 50 Hz ersion EXPORT PARAMETERS DEL
84. he OFF position e Connect the power cord to a suitable 120 VAC 15A receptacle US 220 VAC 15A EU 9 HANDLING AND LIFTING RECOMMENDATIONS e Safe practices for lifting and hanging equipment should be followed e For routine usage the inSITE unit can be pushed or pulled as a trolley but it is important note the following Pushing and pulling of the unit should be done using your body s own weight when pushing you should lean forward when pulling you should lean backward You should have enough grip on the floor in order to lean forward backward You should avoid twisting turning and or bending your back inSITE is designed with a handle Always use the handle to exert force The location of the handle height is between the shoulder and waist so you are able to push pull in the correct posture The necessary care must be taken so that the wheels run smoothly Plan your route and make sure the floor is hard even and free from rubbish good housekeeping e While parked the wheels on the cabinet should always be in the locked position e WARNING Do not place the inSITE unit in freewheel mode while on an incline or decline This could cause the machine to roll uncontrollably on its own Maximum Recommended Safe Slope Ascending and Descending e Prior to any lifting operation ASI strongly recommends packaging the machine back in a crate in a same manner as it was delivered during the original shipment e Fork lif
85. he testing of the test unit During settle or test cycle the cable joint between pendoTECH sensor and transmitter was disconnected Therefore it was not possible to continue to monitor the actual pressure of the test unit inSITE e INFLATION amp INTEGRITY TEST SYSTEM _ 3 17 2015 TEST BEGIN TIME 14 44 14 AM OPERATOR ID Training Administrat JOB NUMBER 34500 0000 PRODUCT ID B101234 I TANK ID TK 01010 0 00 10 44 14 000 AM 10 44 27 600 AM 10 44 41 200 AM 1044 54 000 AM 10 45 08 300 AM 70 35 22 000 AM 31772015 P1720115 272M5 V172015 31772015 17 2015 PROCESS VALIDATION 1 TARGETS BAG INFLATOR_SCL BenFit 00 00 00 02 363 CHARGE SETPOINT 25 mbar CHARGE TIME 30 SECS SETTLE TIME 60 SECS TEST START TIME 10 44 52 AM PRESSURE TOLERANCE 10 TEST END TIME 10 45 22 AM FLAW SIZE 25 pu RESULT SECONDS 30 SECS CHARGE SPEED 24 5 Hz TEST TIME 60 SECS TEST START PRESSURE 26 25 mbar RECHARGE SPEED 24 5 Hz FINE LEAK FLAG 1 00 mbar TEST END PRESSURE 0 00 mbar CHARGE STEP DOWN 25 0 mbar TEST RESULTS PENDOTECH SENSOR DISCONNECTED PendoTECH Sensor Disconnected Fine Leak Test Result Label PendoTECH Transmitter Failure The Fine Leak Test was unsuccessful to complete the testing of the test unit During settle or test cycle the power supply available to pendoTECH transmitter was discontinued Therefore it was not possible to continue to monitor the actual pressure of the test unit i f A FINE LEAK j n TEST INFLAT
86. ilizing grade filter Charge Time During the charge time phase the bag system stretches allowing any creases that may be present to unfold If necessary the blower will add air to maintain the initial predetermined test pressure Settle Time The settle phase is the time allowed for the volume of the bag system to change and stabilize due to stresses introduced by pressurization The adiabatic Non Flawed Bag temperature also stabilizes during the settle phase Inflation Charge Settle Test i Test Time The test time is the period during which the decay i Tite E i of pressure is measured and recorded This decay in pressure will distinguish between a flawed and non flawed bag system Original Instructions inSITE Inflation and Integrity Test System Manual 7 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe Y A part of Thermo Fisher Scientific 7 SAFETY REQUIREMENTS It is the user s responsibility to comply with all safety requirements All of the doors on the inSITE system should be closed during operation Access to the back door lock should only be permitted for approved personnel The user should be present at all times during testing Failure to follow ASI s user instructions as outlined in the inSITE Operations Manual may cause disruption in testing system validations or overall functionality Users of th
87. inning of each test The user can also toggle the display units for pressure from available selections any time during each test 36 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific 11 7 SCREEN PANEL QUALIFICATION INFORMATION ENTRY The Qualification Test is used to determine the time required to find a flaw of a given size During the test a series of 3 to 10 non flawed and flawed bags are inflated then settled while the pressure decay is measured over time The differential Qualification Leak Flag between the non flawed and flawed bags determines if a given flaw size can be detected for the room conditions The parameters are then used in the Fine Leak Test r 6 52 22 AM SASI 10 22 2015 dowa j i i QUALIFICATION PETA Mandi Inflation and Integrity Test System INEO EMTKY ACCEPT DEFAULT DEFAULT SETPOINTS SETPOINTS 0 0 a T RECHARGE SPEED 0 0 CHARGE STEP DOWN mbar CHARGE SETPOINT NON FLAWED BAGS SETTLE TIME TEST TIME PRESSURE TOLERANCE Qualification Information Entry FLAWED BAGS This panel below shows the options which are available for User Accounts with an Engineer privilege level or higher This Screen Panel will appear after the user presses the QUALIFICATION TEST button on the
88. ions inSITE Inflation and Integrity Test System Manual 19 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe Y 20 A part of Thermo Fisher Scientific Fine Leak Test The Fine Leak Test is similar to the Gross Leak Test except the unit is configured to detect a fine or smaller leak than the Gross Leak Test during this test cycle The Fine Leak Test also enables the end user to find a gross leak in the Pressure disposable system during Settle cycle similar to Gross Leak Test Inflation Change Setile Test i fine m Pressure Controlled Inflation The inSITE system can be used to inflate a bag prior to use By inflating the bag wrinkles are eliminated and the location and fit of the bag in its container are improved This cycle inflates the bag to a predetermined pressure Liquid Filling Cycle Once a bag is inflated by the Pressure Controlled Inflation Cycle the bag is ready to be used in the process The Liquid Filling Cycle moderates the internal pressure within the bag while fluid is being introduced As the pressure increases with the addition of the process liquid the Liquid Filling Cycle is configured to regulate the open close position of the coaxial value mounted on the inSITE unit Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI
89. low the procedure below Tare the main i e Disposable pressure sensor Press the TARE button on the HMI touchscreen and make sure the inlet tube filter attached to the pressure sensor is open to the atmosphere and not under any pressure influence e Once the TARE operation is complete assemble the tube filter attachment to the tri clover air supply outlet on the right side of the cabinet Clamp the supply line after the disposable pressure sensor and press the START button e Ifthe pressure at the permanent and disposable sensor are within 1 0 mbar remove the pinch clamp and proceed to the integrity test Original Instructions inSITE Inflation and Integrity Test System Manual 27 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific a 7 09 08 AM SASI 10 22 2015 inSITE Inflation and Integrity Test System jahan CONFIRM mbar Pressure Confirm Test Start Once the Pressure Confirm test is successful the user can proceed to the gross leak test by pressing the PROCEED TO GROSS LEAK TEST button If the Pressure Confirm test fails to meet the requirement the pop up screen will not prompt the proceed button The user will be required to press the MAIN SCREEN button to terminate the Pressure Confirm test for further investigation i 2 43 36 PM SASI 10 27 2015
90. ls inflate the test bag and the inSITE unit will determine if a fine leak is present 11 9 1 Fine Leak Select Operator Maintenance This panel below shows the options which are available for User Accounts with any of the four privilege levels Validated Setup Press this button to select from previously saved fine leak test setup parameter files 8 52 27 AM ASI E FINE LEAK mow inSITE Inflation and Integrity Test System SELECT LOGGED IN AS o VALIDATED SETUP Fine Leak Select Operator Maintenance 11 9 2 Fine Leak Select Engineer Administrator This panel below shows the options which are available for User Accounts with an Engineer privilege level or higher Note the Edit Process Validations button is the only addition from the previous lower level privilege Press this button to edit or add process validation parameters r 7 17 55 AM SASI 10 22 2015 i tdw inSITE Inflation and Integrity Test System Pelee LOGGED IN AS aadmin VALIDATED SETUP Fine Leak Select Engineer Administrator 52 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific 11 10 SCREEN PANEL FINE LEAK INFORMATION ENTRY This panel below shows the options which are available for User Accounts with any of the
91. lta P s for each will determine the allowable variance buffer zone is the established point of time for the Qualification Leak Flag This also establishes the validated pass fail point criteria 22 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe N A part of Thermo Fisher Scientific 11 1 4 Main Administrator This panel below shows the options which are available for User Accounts with a Administrator privilege level Note the Event History button and the Administrative Settings are the only additions from the previous lower level privilege e Event History Press this button to navigate to EVENT HISTORY that contains log records for all traceable events Log records maintain the compliance to 21 CFR Part 11 guidelines e Administrative Setup Press this button to navigate to administrative setup Including the shutdown of HMI to access Windows operating system Choose one of the available options depending on the user s privilege level to advance to the various procedures Ai 1 43 27 PM SASI 10 21 2015 Shutdowl inSITE Inflation and Integrity Test System vet SinSITE INFLATION amp INTEGRITY TEST SYSTEM GROSS FINE LEAK TEST TES LEAK TEST PRESSURE ADMINISTRATIVE LIQUID CONTROLLED A pa 6 FILLING INFLATION ref CYCLE Main Screen Pa
92. mbol 0 to I opening the vent In case the vent is opened manually the VACUUM button would also be enabled for vacuuming operation Vacuum When the VACUUM button is on it would turn the box displayed on the top right corner of the button to green and replace the symbol 0 to I When completed press the VACUUM and VENT buttons displayed on the same location Stop The Stop button can be pressed at any time to terminates the Fine Leak Test The user can toggle the display units for temperature from available selections prior the beginning of each test The user can also toggle the display units for pressure from available selections any time during each test Original Instructions inSITE Inflation and Integrity Test System Manual 57 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific 11 11 1 Fine Leak Test Results Six different outcomes are possible upon the completion of the Fine Leak Test Pass Test Fail Test Settle Time Failure Ambient Temperature Failure PendoTECH Sensor Disconnected PendoTECH Transmitter Failure Pass Test The pressure decay observed in the test unit during the settle cycle is stable and did not decay more than the predetermined limit Test Begin Time Displays the date time when the Inflate button was pressed on the Fine
93. nd Integrity Test System Manual 17 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific 11 INSITE SCREEN PANELS The inSITE Inflation and Integrity Test System has a series of screen panels to guide the user through the process of each test that the unit is capable of performing There are also user privilege levels set which allow specific screen panels to have limited access Please view the flow chart below to better understand inSITE s screen panels and the privilege levels assigned to them Liquid Fillin Pressure a B Controlled Fine Leak Test Cycle f Inflation i P52 Liquid Filling Pressure P 34 Fine Leak eae Controlled Select Inflation P24 3 5L 5000L Test Validated Setup Gross Leak P26 Fine Leak info P53 info Entry Entry Gross Leak P27 P55 Fine Leak Test Test P21 Maintenance P 67 P25 ARRA Gross Leak Qualification Edit Process Setup Test Validations Gross Leak P 33 Qualification P 37 Fine Leak P61 Setup info Entry Setup DOArwWUMVO Qualification P 39 Validation P62 Validation P 63 Test Recall Save Administrative Event History P7 i Setup Validation P 69 Delete Administrative P 65 Setup 18 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TES
94. nel Administrator Original Instructions inSITE Inflation and Integrity Test System Manual 23 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe Y A part of Thermo Fisher Scientific 11 2 SCREEN PANEL GROSS LEAK SELECT The Gross Leak Select Screen Panel will appear after pressing the GROSS LEAK TEST button on the Main screen panel The user will then attach the test bag to the unit input the required information on the following panels initiate the test bag and the inSITE unit will determine if a gross leak is present 11 2 1 Gross Leak Select Operator Maintenance This panel below shows the options which are available for User Accounts with all four privilege levels The Gross Leak Select panel displays a list of bag sizes on which to perform the gross leak test procedure 5 L 5 000 L Press the button with the corresponding bag size range to preform the Gross Leak Test ref 11 4 5 20 L Press this button to perform the Gross Leak test on a bag from 5 to 20 Liters 21 100 L Press this button to perform the Gross Leak test on a bag from 21 to 100 Liters 101 250 L Press this button to perform the Gross Leak test on a bag from 101 to 250 Liters 251 500 L Press this button to perform the Gross Leak test on a bag from 251 to 500 Liters 501 1 000 L Press this button to perform the Gross Leak test on a bag from
95. on ii Label pop up is displayed over ALARM window iii Label is printed iv Label pop up hides v ALARM window is visible again Fine Leak Test a Inflate Charge Cycle i Resets to beginning of the test il Allowed to restart the test when AC power is resumed b Settle Cycle i Test continues as normal until UPS battery is on c Test Cycle i Test continues as normal until UPS battery is on ii Label pop up is displayed over ALARM window iii Label is printed Qualification Test a Inflate Charge Cycle i Resets to beginning of the test ii Allowed to restart the test when AC power is resumed b Settle Cycle i Test continues as normal until UPS battery is on c Idle i Test continues as normal until UPS battery is on d End of Test i Test continues as normal until UPS battery is on ii Label pop up is displayed over ALARM window iii Label is printed iv Label pop up hides v ALARM window is visible again A part of Thermo Fisher Scientific Pressure Controlled Inflation a Inflate Charge Cycle i Resets to beginning of the test ii Allowed to restart the test when AC power is resumed b Pressure Confirm i Idle 1 No effect il Inflate 1 Resets to Idle 2 Allowed to restart the test when AC power is resumed iii Confirm complete 1 No effect c Vacuum Function in Progress i Vacuum stops and the VACUUM button are disabled ii Does not restart when alarm is acknowledged and cleared
96. on the completion of the Gross Leak Test Pass Test Fail Test Ambient Temperature Failure PendoTECH Sensor Disconnected PendoTECH Transmitter Failure Pass Test The pressure decay observed in the test unit during the settle cycle is stable and did not decay more than the predetermined limit e Test Begin Time Displays the date time when the Inflate button was pressed on the Gross Leak Test panel to begin the test e Operator ID Displays the User ID used to login to the inSITE unit e Job Number Displays the job number as entered by the user e Product ID Displays the Product ID as entered by the user e Tank ID Displays the Tank ID as entered by the user e Field 4 This field is an additional custom field that can be used for other product specifications In case this field was used it will display the information added by the user e Charge Set Point mbar Displays the pressure value set as a charge set point by the user in Administrative Setup e Charge Time secs Displays the charge time as determined by the Gross Leak Process Validation Setup of the test selection e Settle Time secs Displays the settle time as determined by the Gross Leak Process Validation Setup of the test selection e Pressure Tolerance Displays the Pressure Tolerance determined by the Gross Leak Process Validation Setup of the test selection e Flaw Size p Displays the Flaw Size as determined by the Gross Leak Process Valid
97. ors PREET have complete and u ZH Backup Operators Backup Operators can override secu AOGA Toper Properties 0 e a Distributed COM Qe Event LogRead General d l Guests Jes qusrs ae Al Network Configu T JE Performance Loc d Performance Mo Derin ene o J Power Users i dl Remote Desktop Jel Replicator Members del Users JE aaAdministrator Jel aaPowerUsers Z aaReplicationUs JE aaUsers Jel Acronis Remote gel ASBSolution JE HelpLibraryUpde Admin Be TEng Changes to a user s group Add Remove are not effective until a Pee aT Se SQLServer 2005 peat oie user logs on Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific 10 3 12 Step 12 Privilege Group Details Completed Enter the new user Account ID as shown and press the OK button on the bottom of the pop up Jel Administrators Backup Operators mes Bil oper opens ee 21x oa P rti y 7 x Hl Distributed COM piiki ai ie a Event Log React Specter 2 x Guests Sedect tis ies tie Administrators have complete and u Backup Operators can override SECU Seis _IUSRS Zl Network Configu JE Performance Log del Performance Mo JE Power Users Jel Remote Desktop JE Replicator de Users JE aaAdministrator Jel aaPowerUsers
98. owered US and IN1006 Single Channel AC Powered Europe Y A part of Thermo Fisher Scientific 10 3 2 Step 2 Select Administrative Setup The Main Screen Panel is displayed after the user logs in Choose the ADMINISTRATIVE SETUP button from the available list to proceed to the next screen SASE 10 21 2015 RSN wesen inSITE Inflation and Integrity Test System LOGGED IN AS aadmin INFLATION amp INTEGRITY TEST SYSTEM GROSS LEAK TEST PRESSURE CONTROLLED INFLATION MAINTENANCE 10 3 3 Step 3 Select HMI Shutdown Choose the HMI Shutdown button on the top right corner of the screen This will shut down the HMI screen and allow the access to the Windows A 1 53 40 PM ASI 10 21 2015 Shutdown i i ADMINISTRATIVE PARAF eee Inflation and Integrity Test System CETOP USER FIELD TITLE 1 amp 2 CANNOT BE BLANK Maximum of 15 Characters SOFTWARE REVISION Timeout Setpoint JOB NUMBER 9999 9999 Will Disable Timeout 0 PRODUCT ID TEMP DEVIATION STATIC TITLE ic o TANK ID I ENABLE REMOTE TARE USER FIELD TITLE 4 V ENABLE VACUUM M CE 50 Hz Version DELETE VALIDATIONS 12 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe N A part of Thermo Fisher Scientific 10 3 4 Step 4 USB Drive Insert
99. panel below shows the options which are available for User Accounts with a Engineer privilege level or higher The Save Validation Parameters Screen Panel appears when the user presses the SAVE VALIDATION PARAMETERS button on the Fine Leak Setup Screen Panel This panel displays a list of previously saved Process Validation parameter sets and empty locations to save new PV parameter sets Press this button to save the current parameters as a new validation parameter file This button would not be visible until a Process Validation Number is entered Pressing a PV NUMBER button selects and saves the current set of Process Validation parameter to that location The controls on this panel operate as follows PV Number Displays the label of the set of Process validation numbers Press the appropriate button to select AND OVERWRITE the corresponding set of Process Validation s Product ID Displays the Product ID of the corresponding PV Number Tank ID Displays the Tank ID of the corresponding PV Number Return To Setup Press this button to return to the Fine Leak Setup panel Next Set Select Navigates to the next page of 20 saved PV parameter files to recall This button title can be customized per the customer s selection as defined in administrative setup panel l ri s 7 20 36 AM _Main screen SASL 10 22 2015 inSITE Inflation and Integrity Test System Ypres ag LOGGED IN AS aadmin PY NUMBER PRODUCT ID TANK ID P
100. pare parts inventory 14 1 LIST OF SPARE PARTS DESCRIPTION ASI PART NUMBER MANUFACTURER ee Meee ie Bar Code Scanner 30 IN 1009 GRYPHON GD4330 BK 1 Printer 30 IN 1013 Primera PX450 1 General Polyester Air Filter 30 IN 1022 McMaster Carr 2122K183 1 Printer Labels LB 01204 Primera Technology Inc 075860 082 1 Printer Cartridge LB 01203 Primera Technology Inc 53376 1 Please refer to the manufacturer s manuals for all spare parts as needed 15 WARRANTY The inSITE Equipment from ASI is covered under a 1 Year Limited Warranty ASI will not be liable under any warranty expressed or implied in any amount greater than the price of the product sold 16 CUSTOMER CARE CONTACT INFORMATION Your ASI equipment has been designed to provide you with years of reliable and dependable performance To ensure that you maintain maximum performance over the years we offer a complete package of customer services including e Original Quality Replacement Parts e Factory Repair Service e Field Service e Process Application Assistance e Preventive Maintenance Programs e Training Programs ASI maintains complete manufacturing records of all ASI equipment and will repair your unit to meet the original specifications If required units can be updated to the very latest technologies in materials and design We wish you much success with your new ASI equipment and thank you for your confidence in our equipment The entire ASI
101. plays the Charge Time as determined by the selected Fine Leak Test Process Validation e Settle Time secs Displays the Settle Time as determined by the selected Fine Leak Test Process Validation e Pressure Tolerance Displays the Pressure Tolerance determined by the selected Fine Leak Test Process Validation Test Time secs Displays the Fine Leak Test Time as determined by the selected Fine Leak Test Process Validation e Fine Leak Flag mbar Displays the Fine Leak Flag as determined by the selected Fine Leak Test Process Validation e Flaw Size u Displays the smallest flaw size that the system will test as determined by the Selected Fine Leak Test e Charge Step Down mbar Displays the pressure offset from the Charge Set Point to restart blower as determined by the selected Fine Leak Test Process Validation These button titles can be customized per the customer s selection as defined in administrative setup panel f 7 23 25 AM tsin sereen SASL 10 22 2015 FINE LEAK mae inSITE Inflation and Integrity Test System INF ENTRY LOGGED IN AS aadmin JOB NUMBER SELECT 60 0 Mower CHARGE SPEED PROCESS VALIDATION dS 34000 0000 FROM LIST 26 o BLOWER RECHARGE SPEED PROCESS VALIDATION NUMBER 1 500 1935 UUU oe CHARGE TIME PRODUCT ID 120 SECONDS as em ECH seme mo TOLERANCE ee as ID B0404 eee 1000 ERCON FINE LEAK FLAG 2 49 mbar PROCEED TO 250 naw sz
102. r the Blower Charge Speed Blower Recharge speed and Charge step down as determined by the bag size selection Accept Press this button to accept default setup Blower Charge Speed Hz Press these buttons to set the initial blower frequency as an inflation cycle begins for the first time on each test unit The user is allowed to readjust this setting even during the inflation cycle as necessary Blower Recharge Speed Hz Press these buttons to set the recharge blower frequency once the pressure of the test unit reaches to the step down set point The purpose of the low recharge frequency is to prevent any overshoot from the actual set point during charge time inflation The user is allowed to readjust this setting even during the inflation cycle as necessary Charge Step Down mbar Press these buttons to readjust the pressure inflation set point to toggle between charge and recharge blower set points The user is allowed to readjust this setting even during the inflation cycle as necessary 34 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific Confirm Confirm Pressure Sensor Prior to conducting the Gross Leak Test the user should make sure the pressure sensor attached to the test unit is placed away from any heat source and subje
103. s 6 6 5 inSITE Testing 7 17 Sample of EC Declaration of Conformity 83 7 Safety Requirements 8 8 Machine Installation 8 9 Handling and Lifting Recommendations 9 1 APPLICABLE DOCUMENTS 10 Operating Procedures 10 10 1 Power Up 10 The following supporting documents are available upon request 10 2 Operation 10 l l E E seta 11 e Pressure Transducer Calibration TD 30 IN 001 e Thermocouple Calibration TD 30 IN 002 11 inSITE Screen Panels 18 l E 19 e ASI inSITE P amp ID 30 IN 1050 11 gt Gross leak Solec 24 e Electrical Schematics US 30 IN 1051 11 3 Gross Leak Information Entry 26 e Electrical Schematics EU 30 IN 1052 11 4 Gross Leak Test 2 s inSITE FAT N A 11 5 G Leak Set 33 PA inSITE ESTOP N A 11 6 Pressure Controlled Inflation 34 11 7 Qualification Information Entry 37 11 8 Qualification Test 39 11 9 Fine Leak Select 52 11 10 Fine Leak Information Entry Do 11 11 Fine Leak Test 55 2 SCOPE 11 12 Fine Leak Setup 61 This document details the setup operation and maintenance of the inSITE Inflation and Integrity Test System 2 www aasisus com INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe 3 GENERAL MACHINE DESCRIPTION GROSS AND FINE LEAK INTEGRITY TESTING As the value of processes increase with each step downstream the value of sterility and leak detection become even more critical The confiden
104. s button to enter the Fine Leak Flag e Blower Recharge Speed Hz Press these buttons to set the recharge blower frequency once the pressure of the test unit reaches to the step down set point The purpose of the low recharge frequency is to prevent any overshoot from the actual set point during charge time inflation e Bag Size Press this button to enter the Bag Size e Flaw Size Press this button to enter the Flaw Size e Charge Step Down mbar Press these buttons to re adjust the pressure inflation set point to toggle between charge and recharge blower set points This button title can be customized per the customer s selection as defined in administrative setup panel Original Instructions inSITE Inflation and Integrity Test System Manual 61 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific e Recall Validation Parameters The panel below shows the options which are available for User Accounts with an Engineer privilege level or higher The Recall Validation Parameters Screen Panel appears when the user presses the RECALL VALIDATION PARAMETERS button on the Fine Leak Setup Screen Panel Press this button to recall previously saved validation parameters The Validation Recall panel displays a list of previously saved Process Validation PV parameter sets Pressing a PV NUMBER button
105. selects and loads that set of Process Values The controls on this panel operate as follows PV Number Displays the label of the set of Process validation numbers Press the appropriate button to select the corresponding set of Process Validation e Product ID Displays the Product ID of the corresponding PV Number Tank ID Displays the Tank ID of the corresponding PV Number e Return To Setup Press this button to return to the Fine Leak Setup panel Next Set Select Navigates to the next page of 20 saved PV parameter files to recall This button title can be customized per the customer s selection as defined in administrative setup panel Note The edited process validation parameters are NOT saved until the user has selected a parameter file on the Process Validation Save Select panel tea LS ma 7 27 40 AM naim sereen SASL 10 22 2015 Shutdown i i I VALIDATION mon PAE Sea Inflation and Integrity Test System DECAL ET AA PY NUMBER FRODUCT ID TANK ID PV NUMBER PRODUCT ID TANK ID EHHH Do4 M0405 D0405 Rl ROE ACUL e E yr P FE E m je Fine Leak Setup Validation Recall Parameters 62 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific e Save Validation Parameters This
106. splays the start time of the Settle cycle Test End Time Displays the end time of the Settle cycle Result Seconds Displays the duration between test start and test end time in seconds Test Start Pressure mbar Displays the pressure observed at the start of the settle cycle Test End Pressure mbar Displays the pressure observed at the end of the settle cycle Charge Speed Hz Displays the Blower frequency as determined by the Fine Leak Process Validation Setup of the Test Selection Recharge Speed Hz Displays the Blower frequency as determined by the Fine Leak Process Validation Setup of the Test Selection Charge Step Down mbar Displays the pressure offset from the Charge Set Point to restart blower as determined by the Fine Leak Process Validation Setup of the Test Selection Test Result Displays the final Test Result of the Fine Leak Test These button titles can be customized per the customer s selection as defined in administrative setup panel SinSITE e INFLATION amp INTEGRITY TEST SYSTEM 11 12 2014 TEST BEGIN TIME 5 35 28 PM OPERATOR ID aadmin JOB NUMBER 37000 0000 PRODUCT ID B101234 I TANK ID TK 01010 FIELD 4 BLANK PROCESS VALIDATION 01 TARGETS CHARGE SETPOINT 25 mbar CHARGE TIME 30 SECS SETTLE TIME 60 SECS PRESSURE TOLERANCE 10 FLAW SIZE 50 p TEST TIME 60 SECS FINE LEAK FLAG 2 50 mbar BESSSSS SSSSSSSRE8 ee Pel TISE PM Wii Wiel 5 36 25 PM iiaiai 5 76 59 P
107. ss Leak Select Screen Panel aaa o 1 45 32 PM SASL 10 21 2015 TAFE inSITE Inflation and Integrity Test System GROSS LEAK SETUP LOGGED IN AS aadmin CHARGE SETPOINT CHARGE CHARGE TIME SETTLETIME PRESSURE BLOWER SETPOINTS Hz STEP DOWN SECONDS SECONDS TOLERANCE FLAW SIZE y CHARGE RECHARGE mbar vee Je A wes oe fiom e e fli i e s E ae eo Da Ee E e ws am J fame fine e Screen Panel Gross Leak Test Setup The Gross Leak Setup panel is the panel that contains all of the controls for the user to edit from various validation parameters of the gross leak test setup Each bag size can be configured with unique validation parameters Each of the controls is described below Charge Set Point mbar Sets the default inflation pressure Charge Time secs Press these buttons to setup edit charge time in seconds The charge time is the amount of time to inflate the bag to the required pressure set point During this cycle the blower may start and stop several times Settle Time secs Press these buttons to setup edit settle time in seconds The settle phase is the time allowed for the volume of the bag to change and stabilize due to stresses introduced by pressurization The adiabatic temperature also stabilizes during the settle phase During this period blower would be idle and no additional air would be added to the bag The unit will monitor the pressure in the bag during this period an
108. sure measurement sensor in raw un scaled units for 5 seconds Then reset the Input min with an average and Input Max with a proportional value to keep the difference between the two values equal as it was prior to pressing the zero button Once this process is complete the Actual mbar Reading displays zero mbar Vent If necessary the user can also press the VENT button to vent the air out from the bag without making any disconnections When the VENT button is pressed it will turn the box displayed on the top right corner of the button to green and replace the symbol 0 to ae opening the vent In case the vent is opened manually the VACUUM button would also be enabled for vacuuming operation e Vacuum When the VACUUM button is on it would turn the box displayed on the top right corner of the button to green and replace the symbol 0 to I When completed press the VACUUM and VENT buttons displayed on the same location The user can toggle the display units for temperature from available selections prior the beginning of each test The user can also toggle the display units for pressure from available selections any time during each test Note Please refer to TD 30 IN 001 and TD 30 IN 002 to perform the pressure transducer and Thermocouple calibrations 1 52 30 PM 10 21 2015 MAINTENANCE inSITE Inflation and Integrity Test System LO EDTA AS sadin ACTUAL MBE EIT I
109. t pallet jack hoists slings cables straps hooks eyebolts shackles etc should be of adequate capacity inspected regularly and in good condition Never use corroded cracked or bent tools e When using spread slings never permit the sling angle to the horizontal be less than 45 Only use the shoulder eyebolts that are properly seated De rate the sling and all lifting components used according to the sling angle respective to the horizontal e Personal safety equipment such as eye shields safety shoes etc must be used e When lifting use care to prevent sliding e Provide a spacious cleared area around the equipment during maintenance Never stand under or near lifted equipment Original Instructions inSITE Inflation and Integrity Test System Manual 9 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe Y A part of Thermo Fisher Scientific 10 OPERATING PROCEDURES CAUTION Before operating this machine confirm that it has been installed and set up properly This means that the machine has all correct utilities connected and is ready to power up Ref 8 0 10 1 POWER UP Turn on the electrical power by turning the power switch on The machine controllers will boot up load and run the system software This may take a few minutes The HMI Touchscreen will display the Login Screen as shown on page 11 10 2 OPERATION
110. t default setup This button title can be customized per the customer s selection as defined in administrative setup panel Original Instructions inSITE Inflation and Integrity Test System Manual 37 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe A part of Thermo Fisher Scientific e Blower Charge Speed Hz Press this button to set the initial blower frequency as an inflation cycle begins for the first time on each test unit The user is allowed to readjust this setting even during the inflation cycle as necessary e Blower Recharge Speed Hz Press this button to set the recharge blower frequency once the pressure of the test unit reaches to the step down set point The purpose of the low recharge frequency Is to prevent any overshoot from the actual set point during charge time inflation The user is allowed to readjust this setting even during the inflation cycle as necessary e Charge Step Down mbar Press this buttons to readjust the pressure inflation set point to toggle between charge and recharge blower set points The user is allowed to readjust this setting even during the inflation cycle as necessary e Proceed to Qualification Test After all information is entered the PROCEED TO QUALIFICATION TEST button will appear highlighted and the test can be initiated Press this buttons to proceed to the Qualification Test Scr
111. the records displayed on the Event History panel is 1 000 The user may be required to navigate through several screens to locate and review records outside the current display range 7 30 49 AM SASI 10 22 2015 dwl inSITE Inflation and Integrity Test System oint HISTORY LOGGED IN AS aadmin V Duration Last 15 Minutes Last Hour Last 2 Hours Last 8 Hours l Start Date and Time l End Date and Time 10 22 2015 07 30 46 AM 10 22 2015 07 29 17 AM 10 22 2015 07 29 06 AM 10 22 2015 07 29 05 AM 10 22 2015 07 28 13 AM 10 22 2015 07 28 03 AM 10 22 2015 07 27 35 AM 10 22 2015 07 27 34 AM 10 22 2015 07 27 33 AM 10 22 2015 07 27 32 AM 10 22 2015 07 23 43 AM 10 22 2015 07 22 50 AM 10 22 2015 07 22 49 AM 10 22 2015 07 21 07 AM 10 22 2015 07 21 05 AM 10 22 2015 07 21 04 AM 10 22 2015 07 20 30 AM 10 22 2015 07 18 20 AM 10 22 2015 07 17 50 AM 10 22 2015 07 17 49 AM 10 22 2015 07 17 47 AM 10 22 2015 07 17 42 AM 10 22 2015 07 14 53 AM 10 22 2015 07 13 00 AM 10 22 2015 07 12 57 AM 10 22 2015 07 12 56 AM WindowName WindowName WindowName WindowName WindowName WindowName WindowName WindowName WindowName WindowName WindowName WindowName WindowName WindowName WindowName WindowName WindowName WindowName WindowName WindowName Last Day Last Week LIQUID FILLING CYCLE MAIN VALIDATION RECALL 1 20 FINE LEAK SETUP FINE LEAK SELECT MAIN FINE LEAK TEST FINE LEAK INFO ENTRY VALIDATION SELECT 1 20 FINE LEAK INFO
112. ton It would close the coaxial valve and speed up the pressure build up in the test unit Immediately stop the liquid filling pump or re adjust to a slower speed 8 MACHINE INSTALLATION Perform the following steps to initially install the machine Carefully uncrate the machine Remove all guard door clamps and or packing material that was installed for transportation of the machine Incoming Inspection Carefully review the product for damage Check the product and components against the parts list Items included with the machine Pressure Transducer Bar Code Scanner Printer inSITE Flaw Tube Set Kit including 100 250 500 700 and 1 000 Micron Flaws USB Drive containing electrical manual E Stop and other important administrative tools Back Door Panel Keys 8 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe Yki A part of Thermo Fisher Scientific e Any damage should be reported to the carrier and manufacturer immediately e If the shipment is not complete please contact ASI Customer Care immediately ASI CUSTOMER CARE 163 Research Lane Millersburg PA 17061 1 717 692 2104 or 1 800 724 4158 e Unlock wheel caster locks e Place the machine in the desired location on the factory floor e Verify that the main disconnect is in t
113. ue to monitor the actual pressure of the test unit A GROSS LEAK in TEST INFLATION amp INTEGRITY TEST SYSTEM 3 17 2015 TEST BEGIN TIME 10 37 47 AM OPERATOR ID Training Administrat JOB NUMBER 34500 0000 PRODUCT ID B101234 I TANK ID TK 01010 0 00 10 37 47 000 AM 10 37 57 800 AM 10 38 08 600 AM 10 38 19 400 AM 10 38 30 200 AM 10 38 41 000 A 317 2015 7 y7 317205 3112015 317 2015 1172015 317205 TARGETS BAG INFLATOR SCL BestFit 00 00 00 01 378 CHARGE SETPOINT 25 mbar TEST RESULTS PENDOTECH TRANSMITTER FAILURE CHARGE TIME 30 SECS SETTLE TIME 60 SECS TEST START TIME 10 38 24 AM PRESSURE TOLERANCE 10 TEST END TIME 10 38 41 AM FLAW SIZE 100 p RESULT SECONDS 17 SECS CHARGE SPEED 24 5 Hz TEST START PRESSURE 25 42 mbar RECHARGE SPEED 24 5 Hz TEST END PRESSURE 0 00 mbar CHARGE STEP DOWN 25 0 mbar PendoTECH Transmitter Failure Gross Leak Test Result Label 32 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe 115 A part of Thermo Fisher Scientific SCREEN PANEL GROSS LEAK TEST SETUP This panel below shows the options which are available for User Accounts with a Engineer privilege level or higher The Gross Leak Test Setup Screen Panel will appear after the user presses the GROSS LEAK SETUP button on the Gro
114. w screen showing all archived labels including the latest test results label as shown below P 2 48 46 PM SASI 10 27 2015 inSITE Inflation and Integrity Test System QUAHFITATION jo x gO F Computer gt Local Disk A gt z Name Date Unspecified 86 gml Computer t Local Disk A amp Local Disk C _ Events csv FE FineLeak_20151009115634 pdf SU qualTest_20151009113654 pdf FE QualTest_20151009113636 pdf QL_TREND_DATA_20151009105917 csv QL_DATA_20151009105917 csv FE crossLeak_20151009103456 pdf FE GrossLeak_20150924182925 pdf FE GrossLeak_20150924181911 pdf Select a file to preview FE crossLeak_20150924175253 pdf BU GrossLeak_20150924174412 pdf FE GrossLeak_20150924174042 pdf Tag FE GrossLeak_20150924171435 pdF F crossLeak_20150924165608 pdf FE GrossLeak_20150924164614 pdf FE GrossLeak_20150924163053 pdf FE GrossLeak_2015092416 1442 pdf FE crossLeak_20150924155646 pdf J5 TEMPERA TUR c 5 86 items SSS 3 Si Qualification Test PDF Access Pop Up Window e Print Once the PDF file is saved the user can print the results to the onboard printer by pressing this button ref 11 8 1 Vent If necessary the user can also press the VENT button to vent the air out from the bag without making any disconnections When the VENT button is pressed it will turn the box displayed on the top right corner of the button to green and replace the symbol 0 to I openin
115. wered US and IN1006 Single Channel AC Powered Europe b Alarm State ACK i Audible buzzer is silenced when ACKNOWLEDGE button is pressed ii ALARM window is displayed 1 Banner is displayed with the following a PendoTECH pressure transmitter failure 2 ACKNOWLEDGE button is disabled ASL ae Shutdown j i GROSS LEAK inSITE Inflation and Integrity Test System TEET LOGGED IN AS Training Administrator Time State Tag Comment 10 27 2015 11 15 59 AM ACK PENDOTECH PRESSURE TRANSMITTER FAILURE Acknowledge c Alarm State UNACK_RTN i Audible buzzer is silenced ii ALARM window is displayed 1 Banner is displayed with the following a PendoTECH pressure transmitter failure If the ACKNOWLEDGE button is pressed iii ALARM window is no longer displayed ASI 10 27 2015 tall Shutdown inSITE Inflation and Integrity Test System pa tae LOGGED IN AS Training Administrator Time State Tag Comment 10 27 2015 11 12 17 AM UNACK_RTN PENDOTECH PRESSURE TRANSMITTER FAILURE 10 27 2015 11 06 44 AM UNACK PENDOTECH PRESSURE TRANSMITTER FAILURE Acknowledge 80 Original Instructions inSITE Inflation and Integrity Test System Manual A part of Thermo Fisher Scientific INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe Fine Gross Quantification Tests Pressure Controlled Inflation Maintenance a Inflate Charge Cycle i
116. wing tests on a single use bag up to 5 000 L depending on the User Account s privilege level 6 5 1 Pressure Decay Testing Pressure decay refers to the change of pressure P inside a pressurized containment during a leak test The test is an inflation test in which a bag is pressurized to a preset level After the bag system has stabilized the decay in pressure over time is evaluated to determine if a leak is present ASI chose the pressure decay method of testing due to its sensitive results and practicality at the point of use In comparison to alternative methods of leak detection pressure decay yields quantitative information and measurable data points that can be recorded and upon which decisions can be made The sensitivity of pressure decay testing is dependent upon three factors the size of the bag the change in temperature and the amount of time allotted for the test Any variances in these conditions can affect test results making it important to have a consistent environment and setup for each test There are four distinct phases to the pressure decay testing process listed below each step is unique to pressure decay and ultimately makes the placement and filling cycle easier for the user and gentler to the bag Inflation Cycle The Inflation Cycle is the period of time in which the bag system is being pressurized to a predetermined test pressure through an onboard blower The air is forced through a 0 2 micron um ster
117. y to initiate the test press the INFLATE button The system will run through the test and indicate a pass or fail at the conclusion PDF Access Once the test is completed the test results will be automatically saved as a PDF file Press this button to open a window screen showing all archived PDF labels including the latest test results label as shown below 2 47 35 PM 10 27 2015 FINE LEAK TEST _ Cvents csv FL Fined atk _20 15 10091 15634 pat Li quattect_20151009112654 pdF So QuatTest_20151009213636 pdF QL_TREND_DATA_20151009105917 csv _ L_DATA_20151009209917 c8y FAD Grosel enk_20 151009 103456 pdf LL GrowsLeak_20150924182925 pdl Di croseLesk_2019092418191Lodf PL Grosset eak_20150924175253 pdf FL GroseLeak_20150924174412 pdl Li crosscesk_20150924174042 9df M Grossi eak_20 150424171435 paf FL GrowsLeak_20150924165608 pd TH GrossLesk_20150924164 14 0df AD Gross eak_20 150924 163053 pdf BS Grosevesk_20180929101942 pdf HD GrossLesk_20150924155646 pdf TEMPERATUR 77 0 ea Fine Leak Test PDF Access Pop Up Window Print Once the PDF file is saved the user can print the results to the onboard printer by pressing this button ref 11 11 1 Vent If necessary the user can also press the VENT button to vent the air out from the bag without making any disconnections When the VENT button is pressed it will turn the box displayed on the top right corner of the button to green and replace the sy
118. ystem ITADmin and all privileges of ITEng Security level and below Engineer Change SELECT system set points perform Qualification Tests and all privileges of ITMaint ITEng Security level and below Maintenance Take manual control of system valve s and blower and all privileges of ITOper ITMaint Security level and below Operator TOper Select start and stop inflation and integrity tests Print Test Results 10 Original Instructions inSITE Inflation and Integrity Test System Manual INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC Powered US and IN1006 Single Channel AC Powered Europe N A part of Thermo Fisher Scientific 10 3 NEW USER ACCOUNT SETUP The user has the ability to create new accounts and apply one of the four user privileges to that account Please follow the steps below to setup a new user account 10 3 1 Step 1 Login Login to the inSITE Inflate and Integrity Test System using the temporary user name and password provided with the new machine User Name aadmin Password AlPassword he 8 20 20 AM SASI 10 22 2015 Shutdown inSITE Inflation and Integrity Test System woes SinSITE INFLATION amp INTEGRITY TEST SYSTEM LOGIN SCREEN USER NAME PASSWORD Original Instructions inSITE Inflation and Integrity Test System Manual 11 INSITE INFLATION AND INTEGRITY TEST SYSTEM USER MANUAL CASI Models IN1005 Single Channel AC P

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