Millipore Integritest Exacta Operating And Maintenance Manual Download Page 259

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Millipore System Documentation Set

260

Operating and Maintenance Manual

Publication XITXSP121 P Rev.A

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Summary of Contents for Integritest Exacta

Page 1: ...Millipore Biopharmaceutical Division Operating and Maintenance Manual Integritest Exacta Instrument MILLIPORE Publication XITXSP121 P...

Page 2: ...Topics in this Manual...

Page 3: ...Millipore System Documentation Set 4 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 4: ...49 SECURITY SETUP 59 MANAGING USER ACCESS 71 INSTRUMENT SETUP 79 FILTER EDITOR 91 INTEGRITEST EXACTA INSTRUMENT TESTS 103 TEST EDITOR 111 RUNNING A TEST 123 PRINTING 133 PRINTER MAINTENANCE AND TROUBL...

Page 5: ...Millipore System Documentation Set 6 Operating and Maintenance Manual Publication XITXSP121 P Rev A REFERENCES 263 GLOSSARY 267 INDEX 273...

Page 6: ...re Corporation Prep Scale Helicon Solvex Aerex Aervent Opticap Prostak HydroCorr and Optiseal are trademarks of Millipore Corporation or an affiliated company Calendar Widgets is a trademark of Sherid...

Page 7: ......

Page 8: ...Using Help for the Integritest Exacta Instrument...

Page 9: ...Millipore System Documentation Set 10 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 10: ...related to individual screens designed to answer specific questions related to current tasks To access the help screens Click on the help icon that is located on each screen The Context Help that corr...

Page 11: ......

Page 12: ...Getting Started...

Page 13: ...Millipore System Documentation Set 14 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 14: ...de Plane and Mouse Buttons 20 PHYSICAL CONNECTIONS 25 PHYSICAL CONNECTIONS 25 What you need for installation 25 Electrical Connections 26 Power Cord Assembly 26 Power Requirements 27 Pneumatic Connect...

Page 15: ...Millipore System Documentation Set 16 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 16: ...cation is not intended as a reference source for Windows NT or any other software which is outside the scope of Millipore s scope of supply Do not attempt to upgrade or reinstall standard versions of...

Page 17: ...ns the following materials Integritest Exacta Instrument Operating and Maintenance Manual Envelope for Registration Information Certificate of Quality Declaration of Conformity Inlet Tubing Assembly M...

Page 18: ...t the power cord to the instrument Turn on the instrument Note During power up the instrument will display messages for entering the system BIOS and Windows NT setup These functions are for Millipore...

Page 19: ...e left and right buttons serve the same functions as a standard mouse See Figure 1 for the location of the glide plane and mouse buttons The glide plane can facilitate cursor movement across the scree...

Page 20: ...Hardware Connections...

Page 21: ...Millipore System Documentation Set 22 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 22: ...sembly 26 Power Requirements 27 Pneumatic Connections 28 Gas Supply Requirements 28 Gas Inlet Connection 28 To Gas Supply 28 To Instrument 28 Exhaust Connections 29 Connecting Disconnecting the exhaus...

Page 23: ...Millipore System Documentation Set 24 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 24: ...for installation Screwdriver approximately 1 8 or 3 x 40 mm slotted to tighten serial and parallel port connectors optional Diagram Key A Side Plate Pneumatic Connections See Figure 4 B Floppy Drive C...

Page 25: ...designed for conversion to standard 10BASE T connection Optional Fuse access 2 amp slow blow delayed action 250v 5 x 20 mm System on off Power switch Parallel LPT1 parallel port for external Line Pri...

Page 26: ...cted Contact a qualified electrician for additional assistance To connect the power cord to the instrument locate the power input connection on the rear panel of the instrument Align the notch in the...

Page 27: ...at the inlet gas be filtered with an external coalescing filter Gas Inlet Connection To Gas Supply Do not remove the gas inlet filter or damage to the instrument may result Connect a regulated supply...

Page 28: ...ed on the right side of the instrument is where the system is exhausted after a test is complete This can be routed away from the work area using OD tubing if desired Press the tubing firmly into the...

Page 29: ...firmly against the outlet connector stem and release it when you hear it click into place Do not grasp the flared section when making a connection This section must be able to slide freely into place...

Page 30: ...T line housing you cannot attach the tubing assembly to the housing inlet which is located below the filter If the tubing assembly and instrument valve are not installed at the top of the housing dur...

Page 31: ...llipore System Documentation Set 32 Operating and Maintenance Manual Publication XITXSP121 P Rev A Figure 8 Cutting the Tubing 2 Insert the tubing into the connector Figure 5 3 Seat the tubing Figure...

Page 32: ...First Log On...

Page 33: ...Millipore System Documentation Set 34 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 34: ...ode 39 Check Security Log 39 Clear Security Log 39 Log Off Administrator 39 Stop Instrument 40 TAB 2 SYSTEM ADMIN 41 User Registration Utility 41 Event Log Utility 41 Automatic Logout Utility 42 TAB 3...

Page 35: ...Millipore System Documentation Set 36 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 36: ...emporary password Administrator will allow you initial access to the system This password should be changed as soon as possible and the user names and passwords for any personnel who may need access t...

Page 37: ...for the system administrator It serves as a map for all essential administrative tasks It consists of 3 tabbed menus accessed by the corresponding function keys F1 F2 and F3 or by clicking on the tabs...

Page 38: ...ine has been placed in Archive Mode Restart In Archive Mode This control puts the instrument into its Archive Mode The Archive Mode is used to access non current data For more information on Archiving...

Page 39: ...ation Set 40 Operating and Maintenance Manual Publication XITXSP121 P Rev A Stop Instrument This tool is used to shut down the system For more information on powering down see the section titled Instr...

Page 40: ...User Registration Utility is used to manage all of the instrument user accounts Clicking on this will bring up the Windows NT User Manager interface See the section titled Setting Up User Accounts on...

Page 41: ...ity allows the administrator to set a time limit of inactivity before the system goes into screensaver mode The screensaver mode is password protected ensuring that if a user walks away for the set le...

Page 42: ...y pressing the F3 key and it appears as in Figure 13 Figure 13 Control Menu screen Tools Tab The tools in tab 3 are each outlined below Backup Utility is used to backup data on the instrument s 3 disk...

Page 43: ...kup and Restore functions please see the section titled Backup and restore on page 163 Figure 15 Restore screen Fingerprint Unit Utility is a utility by which calibration data is stored as a unique at...

Page 44: ...s Printers Utility will open the Windows NT Printers selection window The window will contain all configured printers The default printer will have a checkmark next to it as shown in Figure 17 To set...

Page 45: ...nced with networking computers in an NT environment should attempt to network the instrument See the section titled Networking the Exacta Instrument on page 175 for more details Warning 21 CFR Part 11...

Page 46: ...Maintenance Manual First Log On 47 Figure 18 Windows NT Network window Time and Date Utility allows the user to set local or other Date and Time settings in the Windows standard Date Time Properties w...

Page 47: ...Figure 20 Regional Settings Properties Fingerprint Unit Utility is a utility by which calibration data is stored as a unique attribute to the individual system It is primarily used by Millipore quali...

Page 48: ...Starting Stopping the Instrument...

Page 49: ...Millipore System Documentation Set 50 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 50: ...ity Test Instrument Operating and Maintenance Manual Starting Stopping the Instrument 51 CHAPTER CONTENTS STARTING THE INSTRUMENT 53 INSTRUMENT SHUTDOWN 56 Procedure 56 PRODUCT REGISTRATION 57 Process...

Page 51: ...Millipore System Documentation Set 52 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 52: ...appear automatically after the instrument powers up For most users the System Startup Screen as shown in Figure 22 will appear after logging into Windows NT Click on the icon to bring up the Exacta L...

Page 53: ...l Publication XITXSP121 P Rev A Figure 22 System Startup Screen Figure 23 Login screen The user name is that of the user who logged in at the Windows NT prompt and is in read only format No password i...

Page 54: ...f the screen To start and use the instrument click on the button Note If this is the first time you have entered the system the product registration screen will appear See the section titled Product R...

Page 55: ...s procedure may result in irretrievable loss of data and or damage to the instrument Please shut down the instrument using the following procedure Procedure 1 Go to the Log On screen or the Main Menu...

Page 56: ...lowing information will be collected and stored in the database Company Name Address Country Telephone Number Fax Number Key Contact Integritest Exacta Serial Number found on rear of instrument Date I...

Page 57: ...e completed form to Millipore Customer Service After completing or dismissing product registration the Main Menu will appear as shown in Figure 26 Figure 26 Main Menu screen The Main Menu screen as sh...

Page 58: ...Security Setup...

Page 59: ...Millipore System Documentation Set 60 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 60: ...ance Manual Security Setup 61 CHAPTER CONTENTS SETTING UP USER ACCOUNTS 63 Administrator 63 Procedure 63 Overview of the User Manager 64 TO CREATE A NEW USER ACCOUNT 65 MANAGING ACCOUNT POLICY 67 Befo...

Page 61: ...Millipore System Documentation Set 62 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 62: ...nces to the Administrator in this manual refer to the NT User Administrator the only user with the username Administrator The Exacta Instrument has TWO access configuration areas NT The system uses Wi...

Page 63: ...rs group The Manager allows for the adding and removal of local user accounts the adding and removal of users from groups and working with passwords The NT User administrator can set account policies...

Page 64: ...type a user name In Full Name type the user s complete name In Description type a description of the user or the user account In both Password and Confirm Password type a password of up to 14 charact...

Page 65: ...user account repeat steps 2 through 6 Note A user name cannot be identical to any other user or group name of the computer being administered It can contain up to 20 uppercase or lowercase characters...

Page 66: ...Maximum Password Age Minimum Password Age Minimum Password Length Password Uniqueness 4 You may also click Password Never Expires Allow Changes Immediately Permit Blank Password Do Not Keep Password...

Page 67: ...ng is strong enough and that their policy conforms to regulations within their industry for example 21 CFR Part 11 This example policy can be made stronger by increasing the required length or diversi...

Page 68: ...cause numerous password cracking programs exist that can run through millions of possible word combinations in seconds A complex password that cannot be broken is useless if you cannot remember it For...

Page 69: ......

Page 70: ...Managing User Access...

Page 71: ...Millipore System Documentation Set 72 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 72: ...est Instrument Operating and Maintenance Manual Managing User Access 73 CHAPTER CONTENTS INTRODUCTION 75 Modify User Categories 75 Modify User Category Access Levels 76 Add Users 76 Enter a User 77 De...

Page 73: ...Millipore System Documentation Set 74 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 74: ...gned privileges See the section titled Setting Up User Accounts on page 63 for more information on this subject Note Users that are configured in Windows NT but are NOT assigned privileges in the User...

Page 75: ...1 operator 2 For each user category select the boxes under the user number to the right of each task that user will be allowed to perform 3 Click to cancel the changes and restore the previous user c...

Page 76: ...e Manual Managing User Access 77 Figure 33 User Management Screen Enter a User 1 Click to enter a user 2 Add a user name in the field as shown 3 Enter the users full name optional 4 Enter details rela...

Page 77: ...lick to open to the User Management Screen Figure 32 8 Select the logon name for this user 9 Modify the user s full name by entering the desired changes 10 Modify the details related to this user opti...

Page 78: ...Instrument Setup...

Page 79: ...Millipore System Documentation Set 80 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 80: ...ibration Screen 85 Step 1 Choosing Language 85 Procedure 85 Step 2 Configure Operator Input Screen 86 Procedure 86 Step 3 Choosing the Default Printer 87 Step 4 Choose a Report Format 88 Procedure 88...

Page 81: ...Millipore System Documentation Set 82 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 82: ...up Procedures are conducted in multiple locations Table 3 Table 3 Instrument Setup Locations Setup Locations Corresponding Setup Operations Print Setup Screen Interface Language Operator Input Test Re...

Page 83: ...4 Operating and Maintenance Manual Publication XITXSP121 P Rev A Accessing the Print Setup Screen Figure 34 Main Menu 1 From the Main Menu Figure 34 click to access the System Utilities Screen Figure...

Page 84: ...om the Setup Calibration Screen Click the Shortcut to go directly to the Print Setup Screen Step 1 Choosing Language One instrument Catalogue numbers XITXACTP1 and XITXACTP1U allows operation in any o...

Page 85: ...input is added the user will be prompted to enter a value in the corresponding field prior to running a test 2 Modifying the Operator Input legends Customizing operator input legends so they meet a us...

Page 86: ...hecked Mandatory Unchecked Optional 4 Select to have a second signature line print out on all reports 5 Select to print out reports automatically when tests have been completed 6 Click if you wish to...

Page 87: ...mat is available Procedure 1 Go to the Print Setup Screen and select the Reports Tab F4 Figure 39 Figure 39 Print Setup Screen Tab F4 Reports 2 Select a report type from the list 3 For each report typ...

Page 88: ...Main Menu From the Main Menu click to access the Setup Calibration Screen Figure 40 Setup Calibration Screen B From the Print Setup Screen Click the shortcut to go directly to the Setup Calibration s...

Page 89: ...2 Figure 40 2 For the current instrument enter the serial number found on the rear of the instrument 3 Next enter the instrument description Step 7 Use Temperature Compensation Go to the Setup Calibra...

Page 90: ...Filter Editor...

Page 91: ...Millipore System Documentation Set 92 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 92: ...t Instrument Operating and Maintenance Manual Filter Editor 93 CHAPTER CONTENTS INTRODUCTION 95 Accessing the Filter Editor Screen 95 ADDING A NEW FILTER SPECIFICATION 96 General Procedure 96 Modifyin...

Page 93: ...Millipore System Documentation Set 94 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 94: ...ded or existing specifications can be edited Each specification is revision controlled with 1 A revision number that indicates whether the specification is a user defined specification or a Millipore...

Page 95: ...ate Wetting Fluid for this specification Note Each filter wetting fluid combination requires a unique entry For example an Aervent 10 inch gas filter Catalogue number CTGR 71 TP1 can be HydroCorr test...

Page 96: ...if it is a 30 inch filter enter 3 and if it is a 40 inch filter enter 4 For all other filters enter 1 for example a 5 inch cartridge a 4 inch capsule a TFF cassette would all require 1 to be entered F...

Page 97: ...of tests available see Table 6 for this filter type Table 6 Available Tests Available Test Selected Visible Tabs Bubble Point F2 F3 F4 Diffusion F2 F3 F5 Enhanced Bubble Point F2 F3 F4 F5 HydroCorr F2...

Page 98: ...Therefore Diffusion test times will vary The Diffusion Test Time is a default that will time out a test if the instrument is unable to measure an acceptable value within the default time Diffusion Pr...

Page 99: ...ory Enter a value from 100 ml to 4000 ml HydroCorr Test Time Mandatory Enter a value from 5 60 minutes Unlike the diffusion test the HydroCorr test does run for the predetermined test time that is ent...

Page 100: ...when a test is saved Modifying an Existing Filter Specification 1 Go to the Main Menu and click to go to the Filter Editor Screen Figure 41 Choose Tab F2 General Figure 41 2 Use the pull down menu to...

Page 101: ......

Page 102: ...Integritest Exacta Instrument Tests...

Page 103: ...Millipore System Documentation Set 104 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 104: ...ntegritest Exacta Instrument Tests 105 CHAPTER CONTENTS CAPABILITIES OF THE INTEGRITEST EXACTA INSTRUMENT 107 TEST PROCEDURES OF THE INTEGRITEST EXACTA INSTRUMENT 108 Diffusion Test Steps 108 Bubble P...

Page 105: ...Millipore System Documentation Set 106 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 106: ...ntegritest Exacta Instrument Tests 107 CAPABILITIES OF THE INTEGRITEST EXACTA INSTRUMENT The Integritest Instrument conducts the following tests on hydrophilic and hydrophobic filters to determine a f...

Page 107: ...bble point specification if the diffusion test pressure was not entered into the filter editor Allow the pressure to stabilize Increment pressure until bubble point is determined Increase pressure to...

Page 108: ...cification Increase pressure in increments proportional to 2 5 psi 1 psi for IPA tests until bubble point is reached This proportionally reduces the step size as pressure gets further away from minimu...

Page 109: ......

Page 110: ...Test Editor...

Page 111: ...Millipore System Documentation Set 112 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 112: ...est Instrument Operating and Maintenance Manual Test Editor 113 CHAPTER CONTENTS INTRODUCTION 115 Test Editor Features 115 Using the Test Editor 115 ACCESSING THE TEST EDITOR SCREEN 118 Program a New...

Page 113: ...Millipore System Documentation Set 114 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 114: ...Programming a test in the test editor is very easy Normally only four entries are required because the filter integrity test specifications have already been entered into the filter database The test...

Page 115: ...ation Tab F2 Select a test from the list When a filter is chosen the allowable tests for that filter appear in the Test Type dialog box Number of Cartridges Yes Optional Default value is commonly used...

Page 116: ...l to modify field when programming a new test Instructions Notes Test Time Yes Optional Default value is commonly used Location Tab F4 Type in a new default test time if desired Do not enter a test ti...

Page 117: ...REEN Go the Main Menu Click to go to the Test Editor Screen Figure 46 Figure 46 Test Details Screen Tab F2 General Program a New Test 1 Go to the Test Details screen Figure 46 2 Click to program a new...

Page 118: ...housing type description optional This is a text field that appears on the printout 10 If you wish to define a preset upstream gas volume select to enable that option see Figure 47 and enter the appro...

Page 119: ...Details Screen F3 Options Note All of the grayed fields on the Test Details Screens are retrieved from the filter database for the specific filter selected on Tab F2 except for the System Specificatio...

Page 120: ...you wish to cancel the changes 14 Or click to save the changes 15 The revision information is automatically updated when a test is saved Note If more information is required about a specific filter c...

Page 121: ...22 Operating and Maintenance Manual Publication XITXSP121 P Rev A 2 Change any of the modifiable entries 3 Click to cancel the changes 4 Or click to save the changes The revision information is automa...

Page 122: ...Running a Test...

Page 123: ...Millipore System Documentation Set 124 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 124: ...Instrument Operating and Maintenance Manual Running a Test 125 CHAPTER CONTENTS PROCEDURE 127 Elements of the Test Progress Screen 129 Icon Functions 129 Test Progress Graph 130 Red Line 130 Blue Line...

Page 125: ...Millipore System Documentation Set 126 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 126: ...Highlight the test to be run Note This screen indicates whether the unit is AVAILABLE for running tests The unit may not be available if a user has locked out the instrument for maintenance if the in...

Page 127: ...t information to be associated with this test in the User Defined Fields Note The operator inputs are user defined and will vary There may be from 0 4 input fields in addition to the Notes dialog box...

Page 128: ...ns will vary Icon Functions While a test is running the following icons are active Table 11 Icon Functions Icon Description When it appears Function Terminate Test Icon While a test is running Stops t...

Page 129: ...n measurement gas flow vs time water flow during HydroCorr measurement water flow vs time during the bubble point determination gas flow vs pressure Table 12 Typical Test Times and Values Reported Tes...

Page 130: ...ting a diffusion gas flow or HydroCorr water flow measurement FIND BUBBLE POINT Indicates that the instrument is determining the bubble point ENDING Indicates that a test has been completed PRINTING A...

Page 131: ......

Page 132: ...Printing...

Page 133: ...Millipore System Documentation Set 134 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 134: ...Integritest Exacta Filter Integrity Test Instrument Operating and Maintenance Manual Printing 135 CHAPTER CONTENTS INTRODUCTION 137 Printing Reports 137 SAMPLE REPORTS 139...

Page 135: ...Millipore System Documentation Set 136 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 136: ...ata Management Screens Via print icon Yes Test Report for the stored test data that has been chosen Calibration Reports Setup Calibration Screen Tab F3 for Pressure Calibration Tab F4 for Temperature...

Page 137: ...nual Publication XITXSP121 P Rev A Available Printouts Where Printing Occurs How to Print Print Preview Available Y N What is printed toolbar top of screen User Lists User Management Screen Via print...

Page 138: ...Integritest Exacta Filter Integrity Test Instrument Operating and Maintenance Manual Printing 139 SAMPLE REPORTS Figure 52 Sample Report Printout...

Page 139: ......

Page 140: ...Printer Maintenance and Troubleshooting...

Page 141: ...Millipore System Documentation Set 142 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 142: ...Maintenance Manual Printer Maintenance and Troubleshooting 143 CHAPTER CONTENTS PRINTER MAINTENANCE AND TROUBLESHOOTING 145 Changing the Paper 145 Replacing the Ink Cartridge 146 Priming the HP print...

Page 143: ...Millipore System Documentation Set 144 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 144: ...end of the paper on the new roll to form a clean edge 3 Position the new paper roll so that the paper can be inserted into the printer Figure 53 4 Insert the end of the roll between the print guide ta...

Page 145: ...dge according to the Hewlett Packard instructions Included below 4 Place the new cartridge in the holder The front of the cartridge should face the front of the Integritest Exacta instrument 5 Make su...

Page 146: ...he instrument See Figure 3 Back Panel Diagram on page 26 Parallel port is F 4 Connect the Centronics connector to the printer 5 Turn on the printer then turn on the Integritest instrument 6 External p...

Page 147: ......

Page 148: ...Data Management...

Page 149: ...Millipore System Documentation Set 150 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 150: ...OF ELECTRONIC TEST DATA 154 Accessing the Manage Test Data Screen 154 Data Search 154 Simple Query Procedure 154 Advanced Query Procedure 155 Printing Stored Test Data Procedure 157 ARCHIVING 159 Int...

Page 151: ...Millipore System Documentation Set 152 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 152: ...sion tracking Database and Operation Logs Activities are logged with user identification date and time Electronic Test Data Filter test data is automatically archived on the internal hard drive Filter...

Page 153: ...s Accessing the Manage Test Data Screen From the Main Menu click to access the System Utilities Screen Figure 35 Click to access the Manage Test Data Screen Figure 55 Figure 55 Manage Test Data Screen...

Page 154: ...use the arrow keys to scroll one unit at a time 8 Click All tests conducted in the chosen time period will appear on the screen Advanced Query Procedure Go to the Manage Test Data Screen 1 Click to c...

Page 155: ...selected Choose All Filters to include all of the available filters in the search 7 Select a test name from the list One or more tests may be selected Choose All Test Names to include all of the avai...

Page 156: ...required in the search select No Label Selected and go to step 11 10 Select the desired value s from the Values list 11 Press Enter or click to continue The Manage Test Data Figure 55 screen will app...

Page 157: ...gure 59 Print Preview Screen 5 From the Print Preview Screen click to print the report associated with the data file chosen Note The Archived files can only be retrieved for printing and viewing when...

Page 158: ...is is explained in detail in this section The data once archived is accessible for viewing and or printing To accomplish this the system must be restarted in Archive Mode This is also covered in this...

Page 159: ...e system reaches mandatory reboot any test in progress will be aborted no test report will be generated and all data from the test in progress will be lost After reboot a yellow message box will appea...

Page 160: ...Once in Archive Mode select The Archive Selection Menu as shown in Figure 63 will come into view Figure 63 Archive Selection Menu 4 You may now double click to select the archive of your choice or exi...

Page 161: ...eturn the user to the Archive Selection Menu to allow another selection Selecting will close the archive selection program and continue normal operation Note When the instrument starts in archive mode...

Page 162: ...3 floppy disk inserted in the Exacta unit You should also have extras in case the backup requires more than one diskette 2 Select the data set that you would like to back up The files included in eac...

Page 163: ...rformed The following chart shows what the file types are used for Table 15 Backup File Types File Type Explanation integra mdb Microsoft Data Base file This is the server database ltclient mdb Micros...

Page 164: ...ception to this is the Complete Backup and Audit Files which allows an auditor to unzip and view the data See the section in this chapter titled Auditing Files for information on recovering data on an...

Page 165: ...Warning Insert the disk and select and the window as shown in Figure 68 will appear or choose or If you choose or the system will prompt you to insert the last disk of a set as in Figure 67 Figure 67...

Page 166: ...ating and Maintenance Manual Data Management 167 Figure 68 Restore File List 2 If the correct file set is displayed select The instrument will restore the data and display the Restore Complete prompt...

Page 167: ...n select Complete Backup and Audit Files see Figure 65 2 Follow the on screen instructions to complete the data transfer to floppy disk 3 The disk can be accessed from another computer It will contain...

Page 168: ...p www winzip com Figure 71 Files Unzipped for Audit Note You cannot access most of the files as they appear in the WinZip window They are encrypted and must be properly extracted by auditor exe to be...

Page 169: ...XITXSP121 P Rev A Figure 72 Auditor extraction 8 Auditor will default to the folder that it is in for an extraction location and automatically locates the files on the floppy drive 9 Select OK and th...

Page 170: ...extract the files and alert you when it has finished see Figure 74 The files can now be opened for review Figure 74 Auditor Extraction Completed 11 The file types extracted are opened with the follow...

Page 171: ......

Page 172: ...Networking...

Page 173: ...Millipore System Documentation Set 174 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 174: ...the instrument side The other end terminates with a standard RJ45 Ethernet connector for ease of setup The embedded Windows NT platform provides the administrator with standard TCP IP network setup fe...

Page 175: ......

Page 176: ...Maintenance and Calibration...

Page 177: ...Millipore System Documentation Set 178 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 178: ...SURE TRANSDUCER CALIBRATION INTERNAL CALIBRATION 187 Calibration Criteria 187 Calibration curve fits 187 Calibration Adjustment Decisions 187 Calibration Setup 188 Calibration Procedure 188 TEMPERATUR...

Page 179: ...Millipore System Documentation Set 180 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 180: ...system also provides a pressure calibration check called an Internal Calibration only applicable to pressure calibration which is conducted without an external reference In this process the primary t...

Page 181: ...28kPa 0 33 psi 2 28kPa Pressure Regulator 0 45 psi 3 10kPa 0 45 psi 3 10kPa Conversion Factor 1psi 6 89kPa 1kPa 0 145psi Calibration curve fits Each of the transducers has a linear relationship vs a r...

Page 182: ...Full Scale 0 100 psig Note You can order a reference gauge direct from Millipore catalogue no XITXSP114 Calibration Setup 1 Connect the Integritest Exact inlet tubing to the instrument and to a regula...

Page 183: ...rt calibration with external referee points 4 The following dialog box will appear 5 Enter the reference gauge identification number This will be included on the calibration printout 6 The instrument...

Page 184: ...which should stabilize at 0 almost immediately 7 Input the values recorded by the gauge for each calibration pressure Note For each of the calibration pressures the instrument will measure 7 points b...

Page 185: ...11 At the completion of the external calibration an internal calibration computation is automatically performed to match the secondary pressure transducer and pressure regulator to the primary transd...

Page 186: ...compares the referee values of the primary transducer against the transducer readings of the secondary and regulator at 6 points across the full scale of the transducers readings are taken at 0 20 40...

Page 187: ...cess the Setup Calibration Screens 2 Click Tab F3 to open the Pressure Calibration Screen 3 Click to start an internal calibration 4 The instrument will automatically begin to collect data for each ca...

Page 188: ...Exacta Filter Integrity Test Instrument Operating and Maintenance Manual Maintenance and Calibration 189 Note If the test must be stopped before completion click to terminate the internal calibration...

Page 189: ...nternal temperature sensor readings at three points across the operating range of the sensor 4 60 C A regression analysis is performed to determine a line of best fit and a measure of the quality of t...

Page 190: ...strument See Figure 2 on page 25 for location Disconnect the internal temperature sensor from the pneumatic module and pull it through the opening in the bottom of the Integritest Exacta Set up three...

Page 191: ...mperature Calibration 3 The following dialog box will appear 4 Enter the reference gauge identification number This will be included on the calibration printout 5 Place the internal temperature sensor...

Page 192: ...nsor Upon input the instrument will take the 8th reading 8 Repeat this process for each of the three calibration temperatures 9 After the third calibration a Bath 4 dialogue screen will appear Hit the...

Page 193: ...nance Manual Publication XITXSP121 P Rev A 12 If the test must be stopped before completion click to terminate the internal calibration in progress 13 Reconnect the internal temperature sensor to the...

Page 194: ...the test period Note Verify that the temperature plug is installed See Item E Figure 2 page 25 Note The leak test time is adjusted based on the inlet gas pressure The higher the test pressure the shor...

Page 195: ...Figure 77 Setup and Calibration Tab F5 Leak Testing 3 Click to start an internal leak test The leak test will run automatically and will display a progress window as shown in Figure 78 Figure 78 Leak...

Page 196: ...Integritest Exacta Filter Integrity Test Instrument Operating and Maintenance Manual Maintenance and Calibration 197 5 Click to print a leak test report Figure 79 Leak Test Report Example...

Page 197: ...rument s cooling fan exhaust It is recommended that the filter be replaced every 6 months The actual replacement frequency will vary depending on the cleanliness of the environment where the instrumen...

Page 198: ...the filter should be replaced The instrument can still be used if the desiccant is exhausted however the filter will no longer remove moisture from the gas supply Procedure 1 Make sure that the inlet...

Page 199: ......

Page 200: ...Troubleshooting...

Page 201: ...Millipore System Documentation Set 202 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 202: ...Procedure 205 Possible Failure Modes 206 Exacta Gross Leak Criteria 207 Gross Leak detection during the diffusion flowrate step 207 Gross Leak detection prior to sizing 208 EXACTA GROSS LEAK TROUBLES...

Page 203: ...Millipore System Documentation Set 204 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 204: ...or lower bubble point values Bubble Point Diffusion Rewet the filter using flow thru wetting See Millipore Wetting Insert for specific instructions Improper filter drying resulting in high HydroCorr t...

Page 205: ...the Integritest Exacta instrument and into a functional power outlet If the fuse is blown there may be a serious internal problem Call Millipore Technical Service see page 255 for help Program for th...

Page 206: ...nt test The second criterion is performed twice during a filter test prior to system sizing and after the diffusion flowrate is determined In a bubblepoint test the second criterion is checked only on...

Page 207: ...14 7 V However since the actual volume is unknown the table below lists the assumed volumes Table 25 Assumed Volume Used for Leak Detection Filter Classification Q spec mL min Assumed volume mls Hydr...

Page 208: ...ing Verify that the correct test is being run with the appropriate parameters Check all pneumatics connections to the Integritest Exacta instrument and make sure all connections are firmly attached Ca...

Page 209: ...ime Maximum Cartridge Diffusion Rate 14 7 Upstream Volume 5 Prior to monitoring the pressure drop in the housing allow the housing to stabilize for about 5 minutes at the diffusion test pressure 6 Aft...

Page 210: ...emperature while a test is being conducted If the gas in the housing is cooled during an integrity test the volume occupied by the gas will decrease also This will lead to a pressure drop in the housi...

Page 211: ...of the computer e g Disk Drives memory keyboard monitor are responding to commands If the Integritest Exacta instrument fails to boot correctly contact Millipore Technical Service Calibration The syst...

Page 212: ...ve Press the F4 function key or use the mouse to click on the valve Green valve is open Red valve is closed Exhaust valve Press the F5 function key or use the mouse to click on the valve Green valve i...

Page 213: ...System Documentation Set 214 Operating and Maintenance Manual Publication XITXSP121 P Rev A Screen Component Graphic Operation Notes Primary transducer The Primary transducer measures absolute pressur...

Page 214: ...Error Messages...

Page 215: ...Millipore System Documentation Set 216 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 216: ...Integritest Exacta Filter Integrity Test Instrument Operating and Maintenance Manual Error Messages 217 CHAPTER CONTENTS TEST STATUS ERRORS 219 General Messages 222...

Page 217: ...Millipore System Documentation Set 218 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 218: ...xacta unit certain error conditions are tested for and if found the test is terminated and an error status message is reported on the test progress screen In addition there is a more detailed text des...

Page 219: ...Failed Param Low Range Check Failed minimum boundary value for the input value listed 5 INPUT TOO HIGH Failed Param High Range Check Failed maximum boundary value for the input value listed 6 NETWORK...

Page 220: ...f a stored test requests a revision number that is different from the test being requested 13 NO TEST Requested Test Unavailable Error condition that occurs at the initiation of a test If the test tha...

Page 221: ...ot found in the filter database Both the filter catalogue number and revision number needs to match that being requested 21 NO HC INPUTS HC Inputs Not Found Specific to a HydroCorr test the HydroCorr...

Page 222: ...d An Invalid Referee Value Was Entered External Calibration Dialog Box The referee temperature specified is out of range Invalid Temperature Value Entered External Calibration Dialog Box The referee p...

Page 223: ...strument Not Available Equipment Setup Error Last Test Status External Pressure Calibration Failure Code Equipment Setup The instrument is not currently available Instrument Not Available Equipment Se...

Page 224: ...e Fields Mentioned Filter Editor is an invalid character Check the Fields Mentioned Filter Editor Database error Database Error during Load Test Editor The filter revision update has been undone The t...

Page 225: ......

Page 226: ...Instrument Repair...

Page 227: ...Millipore System Documentation Set 228 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 228: ...st Exacta Filter Integrity Test Instrument Operating and Maintenance Manual Instrument Repair 229 CHAPTER CONTENTS MILLIPORE TECHNICAL SERVICE 231 Returning the Instrument to Millipore 231 SPARE PARTS...

Page 229: ...Millipore System Documentation Set 230 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 230: ...the Instrument to Millipore Contact Millipore Technical Service to obtain a Return Authorization number and instructions Package the Integritest Exacta Instrument in its original container If you do n...

Page 231: ...K CABLE INCLUDES NETWORKING GUIDELINES PUBLICATION XITXSP194 G XITXSP194 NETWORKING GUIDELINES PUBLICATION XITXSP194 G ITX PRINTER CABLE XITXSP206 POWER CORD 115 V XITX SP141 POWER CORD 240 V XITXSP14...

Page 232: ...Warranty...

Page 233: ...Millipore System Documentation Set 234 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 234: ...tion the applicable product or part thereof provided the customer notifies Millipore promptly of any such breach If after exercising reasonable efforts Millipore is unable to repair or replace the pro...

Page 235: ......

Page 236: ...Integritest Exacta Specifications...

Page 237: ...Millipore System Documentation Set 238 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 238: ...est 241 The HydroCorr Test 241 PHYSICAL CHARACTERISTICS 242 Dimensions 242 Weight 242 Electrical Specifications 242 Fuse Rating 242 Input and Output connections 242 Computer 242 Operating Environment...

Page 239: ...Millipore System Documentation Set 240 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 240: ...nch high cartridge systems The instrument is also capable of conducting diffusion tests on Tangential Flow Filtration TFF systems The instrument is validated to measure flow rates up to 2500 ml min Ta...

Page 241: ...on Category II specifications Fuse Rating 2 amp slow blow delayed action 250v 5 x 20 mm Input and Output connections 1 RS 232 422 COM Port Serial port 1 Parallel port DB 25 pin External printer 1 Sens...

Page 242: ...nsing Air Pressure 40 110psi 10 275 758 kPa 10 Indoor Use Pollution Degree 2 Altitude 0 9000 ft 0 2743 m Cleaning The instrument may be cleaned or sanitized by wiping it with a dilute solution of blea...

Page 243: ...s for emissions immunity and low voltage safety EMC Directive Electromagnetic emissions The Integritest Exacta instrument meets the emission standards of EMC Directive EN55011 Immunity to external ele...

Page 244: ...you do not follow these instructions you may risk electric shock Two identical warning labels are located inside of the instrument in areas adjacent to the power supply These labels use an orange bac...

Page 245: ...ts all requirements of the Canadian Interference Causing Equipment Regulations Cet appareil num rique de la class B respecte toutes les exigences du Reglement sur le mat riel brouilleur du Canada This...

Page 246: ...Interface Conventions...

Page 247: ...Millipore System Documentation Set 248 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 248: ...t Operating and Maintenance Manual Interface Conventions 249 CHAPTER CONTENTS INTERFACE CONVENTIONS 251 Dialog Boxes 251 Data Entry Windows 251 List Boxes 251 Pull down Menus 252 Check Boxes 252 Optio...

Page 249: ...Millipore System Documentation Set 250 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 250: ...r within the screen window 2 Click the left mouse button to make a selection 3 Enter type data 4 Click the left mouse button to complete the selection List Boxes It s often quicker to select a value f...

Page 251: ...oxes 1 Select by clicking the cursor to select a yes no option 2 Click the left mouse button within the checkbox to select a yes option the blank checkbox indicates that the filter is not hydrophobic...

Page 252: ...e option button would indicate that the access level is selected a blank option button indicates that the access level is not selected History Tables History Tables are list boxes the contents of whic...

Page 253: ......

Page 254: ...Contacting Millipore...

Page 255: ...Millipore System Documentation Set 256 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 256: ...ing and Maintenance Manual Contacting Millipore 257 CHAPTER CONTENTS CONTACTING MILLIPORE THE U S 259 Products Ordered in the U S for Shipment Overseas 259 Products Ordered in Countries Other Than the...

Page 257: ...Millipore System Documentation Set 258 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 258: ...800 645 5439 Attention Customer Service Write Millipore Corporation 80 Ashby Road Bedford MA 01730 Attention Customer Service Products Ordered in the U S for Shipment Overseas Call Fax or Write Milli...

Page 259: ...SP Tel 011 5548 7011 Fax 011 5548 7923 CANADA Life Sciences Division Millipore Canada Ltd 36 Antares Drive Suite 280 Nepean Ontario K2E 7W5 Tel 1 800 645 5476 Fax 1 800 645 5439 CANADA BioPharmaceutic...

Page 260: ...Tel 09 804 5110 Fax 09 256 5660 FRANCE Millipore S A BP 307 78054 Saint Quentin Yvelines Cedex Tel 01 30 12 7000 Fax 01 30 12 7180 GERMANY Millipore GmbH Hauptstra e 87 65760 Eschborn Tel 06196 494 0...

Page 261: ...33 PUERTO RICO Millipore Cidra Inc P O Box 11977 Cidra P R 00739 1977 Tel 787 273 8495 Fax 787 747 6553 SINGAPORE Millipore Singapore Pte Ltd 31 Kaki Bukit Road 3 06 08 11 Techlink Singapore 417818 Te...

Page 262: ...References...

Page 263: ......

Page 264: ...one 10 inch element 100 600 300 two 10 inch elements one 20 inch cartridge or two 10 inch cartridges 200 700 450 three 10 inch elements one 30 inch cartridge or three 10 inch cartridges etc 300 1000 6...

Page 265: ......

Page 266: ...Glossary...

Page 267: ...Millipore System Documentation Set 268 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 268: ...ly Default Password Administrator Default User Name Administrator Double click To rapidly press and release a mouse button twice without moving the mouse Double clicking carries out an action such as...

Page 269: ...al initial gas volume is outside of this range the accuracy of the test could be compromised An error message will result and the test will stop HydroCorr Test Time The HydroCorr test time defines the...

Page 270: ...In this case no upstream gas sizing will occur The instrument will use the value that has been designated manually in the Preset upstream Gas Volume screen element to perform its test calculations Up...

Page 271: ......

Page 272: ...Index...

Page 273: ...Millipore System Documentation Set 274 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 274: ...Integritest Exacta Filter Integrity Test Instrument Operating and Maintenance Manual Index 275 CHAPTER CONTENTS INDEX 277 TABLE OF FIGURES 283 TABLES 285...

Page 275: ...Millipore System Documentation Set 276 Operating and Maintenance Manual Publication XITXSP121 P Rev A...

Page 276: ...Calibration 181 CALIBRATION TEMPERATURE SENSOR 190 CE APPROVAL 244 Changing the Paper 145 Check Boxes 252 Choose Pressure Units See Setup Choose Pressure Units Cleaning 243 Compliance 21 CFR Part 11...

Page 277: ...Specification 96 General Procedure for Adding a New Filter Specification 96 Fingerprint 44 Fuse Replacement 199 G Gas Filter Replacement 199 Gas Inlet Connection 28 Gas Supply Requirements 28 Getting...

Page 278: ...ing 195 List Boxes 251 Log On 33 M Main Menu 38 160 163 MAINTENANCE 198 Maintenance Safety 245 MILLIPORE TECHNICAL SERVICE 231 Millipore Web site 262 Millipore contacting Products Ordered in Countries...

Page 279: ...Printer Choose 87 Screen 87 Printer preparation 19 Print Variables 137 PRINTER MAINTENANCE 145 Printing Reports 137 Product Registration Product Registration Card screen 57 Registration information 58...

Page 280: ...Units 89 Default Printer 137 Choose 87 Screen 87 General Procedures 83 Instrument Description 90 Language 85 Operator Input 86 Options 83 Print Setup 84 Temperature Compensation 90 Setup and Calibrat...

Page 281: ...t Of Calibration 222 Requested Test Data Unavailable 221 Requested Test Unavailable 221 Setup Inputs Not Found 222 Test Execution General Failure 220 Test Procedure Not Found 221 User Aborted Test 222...

Page 282: ...s 48 Figure 21 Windows NT Logon screen 53 Figure 22 System Startup Screen 54 Figure 23 Login screen 54 Figure 24 Shut Down Screen 56 Figure 25 Product Registration Card Dialog Screen 57 Figure 26 Main...

Page 283: ...Figure 61 Database Size Red Warning Message 160 Figure 62 Warning Message after reboot 160 Figure 63 Archive Selection Menu 161 Figure 64 Archive Confirmation Prompt 162 Figure 65 Backing up data to F...

Page 284: ...ackup File Type Indicators 168 Table 17 Transducer Specifications 182 Table 18 Calibration Adjustment Decisions a 182 Table 19 Transducer Specifications 187 Table 20 Calibration Adjustment Decisions b...

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