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Integritest



Exacta Filter Integrity Test Instrument

Operating and Maintenance Manual

Data Management

153

DATA MANAGEMENT FEATURES OF THE INTEGRITEST EXACTA INSTRUMENT

Filter Database and Filter Editor

•

Pre-loaded Millipore filter specifications

•

Can add user filter specifications to database–only one entry required

•

Revision tracking

Test Database and Test Editor

•

Unlimited number of tests can be programmed and stored

•

Test programs can be modified

•

Revision 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 test data can be backed up to a 3.5” floppy disk drive

•

Data Functions

•

display

•

print test data

•

Calibration and leak test data are automatically stored on the internal hard drive

•

only the most recent calibration and leak test data are stored

Configurable Operator Input

•

Data inputs (such as lot number) required by operators just prior to running a test can

be configured to reflect user preferences

•

A second signature on printouts can be configured

Содержание Integritest Exacta

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

Страница 2: ...Topics in this Manual...

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

Страница 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...

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

Страница 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...

Страница 7: ......

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

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

Страница 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...

Страница 11: ......

Страница 12: ...Getting Started...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 20: ...Hardware Connections...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 32: ...First Log On...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 48: ...Starting Stopping the Instrument...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 58: ...Security Setup...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 69: ......

Страница 70: ...Managing User Access...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 78: ...Instrument Setup...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 90: ...Filter Editor...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 101: ......

Страница 102: ...Integritest Exacta Instrument Tests...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 109: ......

Страница 110: ...Test Editor...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 122: ...Running a Test...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 131: ......

Страница 132: ...Printing...

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

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

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

Страница 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...

Страница 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...

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

Страница 139: ......

Страница 140: ...Printer Maintenance and Troubleshooting...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 147: ......

Страница 148: ...Data Management...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 171: ......

Страница 172: ...Networking...

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

Страница 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...

Страница 175: ......

Страница 176: ...Maintenance and Calibration...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 199: ......

Страница 200: ...Troubleshooting...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 214: ...Error Messages...

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

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

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 225: ......

Страница 226: ...Instrument Repair...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 232: ...Warranty...

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

Страница 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...

Страница 235: ......

Страница 236: ...Integritest Exacta Specifications...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 246: ...Interface Conventions...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 253: ......

Страница 254: ...Contacting Millipore...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 262: ...References...

Страница 263: ......

Страница 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...

Страница 265: ......

Страница 266: ...Glossary...

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

Страница 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...

Страница 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...

Страница 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...

Страница 271: ......

Страница 272: ...Index...

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

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

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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