Millipore Integritest Exacta Operating And Maintenance Manual
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Millipore Integritest Exacta Operating And Maintenance Manual

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Millipore Biopharmaceutical Division
Operating and Maintenance Manual
®
Integritest
Exacta Instrument
MILLIPORE
Publication XITXSP121 P

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Summary of Contents for Millipore 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 Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 4: Table Of Contents

    Integritest Exacta Filter Integrity Test Instrument TOPICS USING HELP FOR THE INTEGRITEST EXACTA INSTRUMENT ........9 GETTING STARTED ..................13 HARDWARE CONNECTIONS ................21 FIRST LOG ON ....................33 STARTING/STOPPING THE INSTRUMENT ............49 SECURITY SETUP.....................59 MANAGING USER ACCESS ................71 INSTRUMENT SETUP ..................79 FILTER EDITOR....................91 INTEGRITEST EXACTA INSTRUMENT TESTS .............103...
  • Page 5 Millipore System Documentation Set REFERENCES ....................263 GLOSSARY ....................267 INDEX ......................273 Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 6 PKUnzip is a registered trademark of PK Ware Inc. HEPA is a registered trademark of HEPA Corporation. Note: This Manual is intended as a reference for the Integritest Exacta instrument with version 3.0.X software. Different software revisions may or may not contain features and/or graphic representations that differ from the content in this manual.

  • Page 8: Using Help For The Integritest Exacta Instrument

    Using Help for the Integritest Exacta Instrument...
  • Page 9 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 10 Integritest Exacta Filter Integrity Test Instrument USING HELP FOR THE INTEGRITEST EXACTA INSTRUMENT Software for the Integritest Exacta unit includes Context sensitive online help: Context-sensitive help • related to individual screens • designed to answer specific questions related to current tasks To access the help screens •...

  • Page 12: Getting Started

    Getting Started...
  • Page 13 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 14 Integritest Exacta Filter Integrity Test Instrument CHAPTER CONTENTS INTRODUCTION ..................17 The Integritest Exacta Manual ...............17 Before you start...................17 Scope of Supply ..................18 Make sure your package contains the following materials: ......18 IMPORTANT TASKS TO PERFORM BEFORE POWER UP.......19 Power up....................19 Printer preparation ................19...
  • Page 15 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 16 This publication is to be used as a reference for the Exacta instrument hardware and the pertinent Millipore software. This publication 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.
  • Page 17 Millipore office nearest you. The addresses and telephone numbers for Millipore local and worldwide offices are listed in the section titled Contacting Millipore on page 255 and in the Millipore Catalogue. Your representative will guide you through the appropriate steps for replacing damaged or missing items.
  • Page 18 Note: During power up, the instrument will display messages for entering the system BIOS and Windows NT setup. These functions are for Millipore Service use only, and are not accessible by the end user. For security purposes, the keyboard is locked during power up.

  • Page 19: Figure 1: Keyboard

    Millipore System Documentation Set Diagram Key: A. Printer Online/Offline D. Left Mouse Button B. Printer Paper Feed E. Right Mouse Button C. Function Keys (F1-F12) F. Glide Plane Figure 1: Keyboard Glide Plane and Mouse Buttons The built-in glide plane serves the same function as a standard mouse. To use, gently slide your fingertip along the glide plane in the direction you wish to move the cursor.

  • Page 20: Hardware Connections

    Hardware Connections...
  • Page 21 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 22 Integritest Exacta Filter Integrity Test Instrument CHAPTER CONTENTS PHYSICAL CONNECTIONS ...............25 What you need for installation ..............25 Electrical Connections .................26 Power Cord Assembly ................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 exhaust tubing........29...
  • Page 23 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 24: Figure 2: Integritest Instrument (Bottom Rear View)

    Integritest Exacta Filter Integrity Test Instrument PHYSICAL CONNECTIONS What you need 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.

  • Page 25: Figure 3: Rear Panel

    Housing Temp Housing Gas Temperature Sensor, optional Network Watertight Ethernet network connector designed to connect to a Millipore Adapter. The Millipore Adapter is 6-ft. watertight cable designed for conversion to standard 10BASE-T connection. (Optional) Fuse access 2 amp, slow blow (delayed action), 250v, 5 x 20 mm...
  • Page 26 Integritest Exacta Filter Integrity Test Instrument stripped and tinned leads, for connection to the desired power plug (certified attachment plug cap.) Install a certified attachment plug cap, with suitable electric ratings, in accordance with local safety standards. If a plug is to be installed, the following connections should be made: •...

  • Page 27: Figure 4: Side Panel

    To Instrument • Slide quick disconnect fitting of Integritest Exacta inlet tubing assembly onto the connector stem labeled Air Inlet. • Grasp the rear of the connector and push it firmly against the connector stem. Do not grasp the flared section when making a connection.

  • Page 28: Figure 5: Connecting And Disconnecting Exhaust Tubing

    • Verify that the tubing assembly is firmly attached to the outlet connector. If you can easily detach the tubing assembly from the Integritest Exacta instrument, you have not connected it properly. Repeat steps 1 and 2 above until you achieve a firm connection.
  • Page 29 • Verify that the tubing assembly is firmly attached to the outlet connector. If you can easily detach the tubing assembly from the Integritest Exacta instrument if it is not connected properly. Repeat steps 1 and 2 above until you achieve a firm connection (see Figure 5).

  • Page 30: Figure 6: Inlet And Outlet Tubing Connections

    • Gently pull the tubing away from the instrument. (see Figure 5). WARNING: Proper Installation is required When installing the Integritest Exacta instrument, you must attach the outlet tubing assembly and instrument valve to the top of the filter housing. The filter housing must be perpendicular to the floor (Figure 7).

  • Page 31: Figure 8: Cutting The Tubing

    Millipore System Documentation Set Figure 8: Cutting the Tubing 2. Insert the tubing into the connector (Figure 5). 3. Seat the tubing (Figure 5) Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 32: First Log On

    First Log On...
  • Page 33 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 34: Chapter Contents

    Integritest Exacta Filter Integrity Test Instrument CHAPTER CONTENTS CHAPTER CONTENTS................35 INTRODUCTION ..................37 CONTROL MENU SCREEN................38 TAB 1 - EXACTA..................39 Restart In Normal Mode...............39 Restart In Archive Mode ...............39 Check Security Log................39 Clear Security Log ................39 Log Off Administrator ................39 Stop Instrument ...................40 TAB 2 –...
  • Page 35 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 36: Introduction

    Integritest Exacta Filter Integrity Test Instrument INTRODUCTION When the instrument is first powered up, the computer boots up, and the system will prompt you to push Ctrl+Alt+Del in order to log in. The Windows NT Logon screen will appear. The user name “Administrator”...

  • Page 37: Control Menu Screen

    Millipore System Documentation Set CONTROL MENU SCREEN The Control Menu is the starting point 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. The Exacta tab (F1) is shown in Figure 10.

  • Page 38: Tab 1 - Exacta

    Integritest Exacta Filter Integrity Test Instrument TAB 1 - EXACTA This control allows the administrator access to the instrument. For information on instrument configuration, please see the section titled Setup Options on page 83. Upon initial access to the instrument, the user will be prompted to fill out a registration form.

  • Page 39: Stop Instrument

    Millipore System Documentation Set Stop Instrument This tool is used to shut down the system. For more information on powering down, see the section titled Instrument Shutdown on page 56. Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 40: Tab 2 - System Admin

    Integritest Exacta Filter Integrity Test Instrument TAB 2 – SYSTEM ADMIN Tab 2 of the Control Menu screen is accessed by clicking on the tab itself or by pressing the F2 key, and it appears as in Figure 12. Figure 12: Control Menu screen, System Admin Tab The tools in tab 2 are each outlined below: User Registration Utility is used to manage all of the instrument user accounts.

  • Page 41: Automatic Logout Utility

    Millipore System Documentation Set Automatic Logout Utility 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 length of time the system will require a password for reentry.

  • Page 42: Tab 3 - Tools

    Integritest Exacta Filter Integrity Test Instrument TAB 3 - TOOLS Tab 3 of the Control Menu screen is accessed by clicking on the tab itself or by 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 ½”...

  • Page 43: Restore Utility

    It is primarily used by Millipore qualified technicians and engineers for the purposes of manufacturing the unit and for certain service related functions.

  • Page 44: Superuser Access

    Printers other than the internal printer are the responsibility of the end user and are outside of Millipore’s scope of supply. External printers may be connected via the LPT1 port (see Figure 3: Rear Panel, Item F on page 26). Printers may be installed by Windows NT qualified personnel according to the manufacturers specifications.

  • Page 45: Network Utility

    Millipore System Documentation Set Printers on a network may also be utilized (See the section titled Networking the Exacta Instrument on page 175 for more details). Figure 17: Windows NT Printer Selection window Network Utility will bring up the Windows NT Network window as shown in Figure 18.

  • Page 46: Time And Date Utility

    Integritest Exacta Filter Integrity Test Instrument 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 window as shown in Figure 19. Figure 19: Date/Time Properties window Operating and Maintenance Manual First Log On...

  • Page 47: Regional Settings Utility

    It is primarily used by Millipore qualified technicians and engineers for the purposes of manufacturing the unit and for certain service related functions.

  • Page 48: Starting/Stopping The Instrument

    Starting/Stopping the Instrument...
  • Page 49 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 50 Integritest Exacta Filter Integrity Test Instrument CHAPTER CONTENTS STARTING THE INSTRUMENT ..............53 INSTRUMENT SHUTDOWN ...............56 Procedure...................56 PRODUCT REGISTRATION ................57 Processing Registration information ............58 Operating and Maintenance Manual Starting/Stopping the Instrument...
  • Page 51 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 52: Starting The Instrument

    Integritest Exacta Filter Integrity Test Instrument STARTING THE INSTRUMENT The Windows NT Logon screen (see Figure 21) will 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.

  • Page 53: Figure 22: System Startup Screen

    Millipore System Documentation Set 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 is necessary at this point as it has already been provided at NT login.
  • Page 54 Integritest Exacta Filter Integrity Test Instrument If the user wishes to log back out, they may click on the icon at the top-right of 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.

  • Page 55: Instrument Shutdown

    Millipore System Documentation Set INSTRUMENT SHUTDOWN To maintain the integrity of the software, it is important that the software be shut down before the instrument is turned off. This is a Windows NT requirement that must be adhered to. Warning: Failure to follow this procedure may result in irretrievable loss of data and/or damage to the instrument.

  • Page 56: Product Registration

    • Telephone Number • Fax Number • Key Contact • Integritest Exacta Serial Number (found on rear of instrument) • Date Integritest Exacta Instrument Received • E-mail Address The following fields will be automatically detected and will be stored in the database •...

  • Page 57: Processing Registration Information

    The information that is entered will be stored in the database. • Click to print the completed form. • Using the pre-printed envelope, mail the completed form to Millipore Customer Service. • After completing (or dismissing) product registration, the Main Menu will appear as shown in Figure 26.

  • Page 58: Security Setup

    Security Setup...
  • Page 59 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 60 Integritest Exacta Filter Integrity Test Instrument 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 Before you click OK, review the following guidelines: ......68 Password Guidelines ................68 Operating and Maintenance Manual Security Setup...
  • Page 61 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 62: Setting Up User Accounts

    Integritest Exacta Filter Integrity Test Instrument SETTING UP USER ACCOUNTS Administrator There are many references to Administrators and Administrative access throughout this chapter and the next, and it can get confusing. This is because both Windows NT and the Exacta Instrument contain both Administrator and Administrator Groups.

  • Page 63: Overview Of The User Manager

    Millipore System Documentation Set Figure 27: User Manager window Overview of the User Manager The User Manager is pre-configured with built in accounts for the administrator and for six user levels. These user levels are preconfigured in NT, but are not applicable to the Exacta Instrument.

  • Page 64: To Create A New User Account

    Integritest Exacta Filter Integrity Test Instrument TO CREATE A NEW USER ACCOUNT On the User menu, click New User. Type appropriate information in the dialog box (see Figure 28). Figure 28:New User Dialogue Box • In Username, type a user name. •...

  • Page 65: Figure 29: Group Memberships Window

    Millipore System Documentation Set Figure 29: Group Memberships Window Choose the NT Administrators group (see Figure 29). Click Add. Click OK. Note that all users of the Exacta Instrument must be configured in the NT Administrators group. Remember that this does NOT mean that they are NT User administrators.

  • Page 66: Managing Account Policy

    Integritest Exacta Filter Integrity Test Instrument MANAGING ACCOUNT POLICY 1. On the Policies menu, click Account. 2. The Account Policy window will open (see Figure 30). 3. Enter the values you want under any of the groups: • Maximum Password Age •...

  • Page 67: Before You Click Ok, Review The Following Guidelines

    Millipore System Documentation Set Before you click OK, review the following guidelines: If you enter a value under “Password Uniqueness”, you should also enter a value for “Allow Changes in _ Days” under “Minimum Password Age”. Maximum values for the various options are as follows: •...
  • Page 68 Integritest Exacta Filter Integrity Test Instrument • Your password should not be a “common” word (for example, it should not be a word in the dictionary or slang in common use). Your password should not contain words from any language, because numerous password-cracking programs exist that can run through millions of possible word combinations in seconds.

  • Page 70: Managing User Access

    Managing User Access...
  • Page 71 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 72 Integritest Exacta Filter Integrity Test Instrument CHAPTER CONTENTS INTRODUCTION ..................75 Modify User Categories ...............75 Modify User Category Access Levels............76 Add Users ..................76 Enter a User..................77 Delete All Data for an Existing User............78 Operating and Maintenance Manual Managing User Access...
  • Page 73 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 74: Introduction

    Integritest Exacta Filter Integrity Test Instrument INTRODUCTION The user operations screen allows the system administrator to set user privileges and access levels for the instrument. Windows NT controls system security, and therefore, the usernames to which the privileges are assigned must be configured in the User Manager before they can be assigned privileges.

  • Page 75: Modify User Category Access Levels

    Millipore System Documentation Set Figure 32: User Access Levels Screen Modify User Category Access Levels The numbers (1–5) at the top of each column correspond to a user category (e.g. 1 = operator). For each user category, select the boxes under the user number to the right of each task that user will be allowed to perform.

  • Page 76: Enter A User

    Integritest Exacta Filter Integrity Test Instrument Figure 33: User Management Screen Enter a User Click to enter a user. Add a user name in the field as shown. Enter the users full name (optional). Enter details related to this user (optional). Select a level for this users access privileges Operating and Maintenance Manual Managing User Access...

  • Page 77: Delete All Data For An Existing User

    Millipore System Documentation Set Click to save the configuration data for this user. Modify Data for an Existing User. Click to open to the User Management Screen (Figure 32). Select the logon name for this user. Modify the user’s full name by entering the desired changes.

  • Page 78: Instrument Setup

    Instrument Setup...
  • Page 79 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 80 Integritest Exacta Filter Integrity Test Instrument CHAPTER CONTENTS SETUP OPTIONS ..................83 General Setup Procedures..............83 Accessing the Print Setup Screen ............84 From the Setup & Calibration Screen: ..........85 Step 1. Choosing Language ..............85 Procedure...................85 Step 2. Configure Operator Input Screen ..........86 Procedure...................86 Step 3.
  • Page 81 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 82: Setup Options

    Integritest Exacta Filter Integrity Test Instrument SETUP OPTIONS The setup options define many of the general operating and testing parameters for the Instrument. These include configurations for setting up the following areas: • Language Interface • Operator Input Screen • Default Printer Selection •...

  • Page 83: Accessing The Print Setup Screen

    Millipore System Documentation Set Accessing the Print Setup Screen Figure 34: Main Menu 1. From the Main Menu (Figure 34), click to access the System Utilities Screen (Figure 35). Figure 35: System Utilities Screen Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 84: From The Setup & Calibration Screen

    Integritest Exacta Filter Integrity Test Instrument 2. Click to open the Print Setup screen (Figure 36). Figure 36: Print Setup Screen, Tab F3, Language From the Setup & Calibration Screen: Click the Shortcut to go directly to the Print Setup Screen. Step 1.

  • Page 85: Step 2. Configure Operator Input Screen

    3. Click to save the selected language. Step 2. Configure Operator Input Screen The Integritest Exacta instrument allows the user to customize specific aspects of the test print out. These include: 1. Adding 0–4 Operator Inputs to the test procedure.

  • Page 86: Step 3. Choosing The Default Printer

    Integritest Exacta Filter Integrity Test Instrument 2. Enter up to four Operator Input legends, which will print on Test Reports. If a legend is not required, simply leave the corresponding dialog box empty. 3. Select whether the Operator Input legends will be optional or mandatory entries. Legend Status Checked Mandatory...

  • Page 87: Step 4. Choose A Report Format

    The following procedure explains how to select the preferred report format. To use the Integritest Exacta’s internal printer the “Internal” format must be chosen so that the printout is configured for the 3-inch internal printer. For external printers the choice of 8.5” x 11” or A4 format is available.

  • Page 88: Accessing The Setup & Calibration Screen

    Integritest Exacta Filter Integrity Test Instrument Or click to save the changes. Accessing the Setup & Calibration Screen A. From the Main Menu: From the Main Menu, click to access the Setup & Calibration Screen. Figure 40: Setup & Calibration Screen B.

  • Page 89: Procedure

    Millipore System Documentation Set • kPag Procedure Go to the Setup & Calibration Screen and select the Instrument Setup Tab F2 (Figure 40). Select . From the pull-down menu, set the Pressure units to be used for testing. Step 6. Enter Instrument Description Go to the Setup &...

  • Page 90: Filter Editor

    Filter Editor...
  • Page 91 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 92 Integritest Exacta Filter Integrity Test Instrument CHAPTER CONTENTS INTRODUCTION ..................95 Accessing the Filter Editor Screen ............95 ADDING A NEW FILTER SPECIFICATION............96 General Procedure................96 Modifying an Existing Filter Specification..........101 Operating and Maintenance Manual Filter Editor...
  • Page 93 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 94: Introduction

    Each specification is revision controlled with: 1. A revision number that indicates whether the specification is a user-defined specification or a Millipore specification. 2. Revision date. 3. The name of the user who modified the filter data.

  • Page 95: Adding A New Filter Specification

    Filter” and input a valid checksum value. This will result in a revision number of the format Mxxx. If you do not check the “Millipore Filter” box or do not have a valid checksum the revision number will indicate that it is a “User” filter specification with a format of Uxxx.

  • Page 96: Figure 42: Filter Editor, Tab F3, Filter Size

    Integritest Exacta Filter Integrity Test Instrument Figure 42: Filter Editor, Tab F3, Filter Size 11. Enter the appropriate data for the filter being entered. 12. Use Table 5 as a guide. Table 5: Filter Selection Table Entry Optional or Instructions Notes Mandatory Filter Size...

  • Page 97: Figure 43: Filter Editor, Tab F4, Filter Bubble Point Specifications

    Millipore System Documentation Set 13. Enter the filter integrity test specifications. Only specifications for “Available Tests” selected are required to be entered. If a test type is not selected then the tab will be grayed out and cannot be accessed. Select the tabs related to the type of tests available (see Table 6) for this filter type.

  • Page 98: Figure 44: Filter Editor, Tab F5, Filter Diffusion Specifications

    Integritest Exacta Filter Integrity Test Instrument Table 8: Tab F5, Diffusion Test Entries Entry Optional or Instructions Notes Mandatory Diffusion Test Mandatory Enter a value The Diffusion test does not run for a Time from 6–60 predetermined test time. It runs until a minutes stable, accurate diffusion measurement is achieved, or the...

  • Page 99: Table 9: Tab F6, Hydrocorr Test Entries

    Millipore System Documentation Set Table 9: Tab F6, HydroCorr Test Entries Entry Optional or Instructions Notes Mandatory Minimum Gas Mandatory Enter a value from It is important to control the Volume 50 ml to 2000 ml initial gas volume during a HydroCorr test.

  • Page 100: Modifying An Existing Filter Specification

    Integritest Exacta Filter Integrity Test Instrument Figure 45: Filter HydroCorr Specifications 14. Click to cancel the changes. 15. Click to save the changes. 16. The revision information is automatically updated when a test is saved. Modifying an Existing Filter Specification 1.

  • Page 102: Integritest Exacta Instrument Tests

    Integritest Exacta Instrument Tests...
  • Page 103 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 104 Integritest Exacta Filter Integrity Test Instrument CHAPTER CONTENTS CAPABILITIES OF THE INTEGRITEST EXACTA INSTRUMENT .......107 TEST PROCEDURES OF THE INTEGRITEST EXACTA INSTRUMENT....108 Diffusion Test Steps: ................108 Bubble Point Test Steps ..............108 Enhanced Bubble Point Test Steps............108 The HydroCorr Test Steps..............109...
  • Page 105 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 106 Integritest Exacta Filter Integrity Test Instrument CAPABILITIES OF THE INTEGRITEST EXACTA INSTRUMENT The Integritest Instrument conducts the following tests on hydrophilic and hydrophobic filters to determine a filter’s integrity: • Bubble Point Test • Diffusion • Enhanced Bubble Point •...
  • Page 107 Millipore System Documentation Set TEST PROCEDURES OF THE INTEGRITEST EXACTA INSTRUMENT Diffusion Test Steps: 1. System check 2. Clear housing of excess fluid • Apply ½ of the test pressure to the housing. 3. Determine upstream gas volume 4. Pressurize the system to the test pressure •...
  • Page 108 2. Determine upstream gas volume to perform a gross leak check. 3. The system stabilizes at a constant pressure for a predetermined length of time. 4. The system calculates the appropriate flow rate from the pressure-drop measurement. Operating and Maintenance Manual Integritest Exacta Instrument Tests...

  • Page 110: Test Editor

    Test Editor...
  • Page 111 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 112 Integritest Exacta Filter Integrity Test Instrument CHAPTER CONTENTS INTRODUCTION ..................115 Test Editor Features ................115 Using the Test Editor................115 ACCESSING THE TEST EDITOR SCREEN ..........118 Program a New Test................118 Modify an Existing Test...............121 Operating and Maintenance Manual Test Editor...
  • Page 113 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 114: Introduction

    Integritest Exacta Filter Integrity Test Instrument INTRODUCTION The Test Editor is a database containing filter test programs created by the user. New test programs can be added or existing test programs can be modified. Each program is revision controlled with a: •...
  • Page 115 Millipore System Documentation Set Entry Value Mandatory or Instructions Notes required in optional to modify field? field when Yes/No programming a new test? Filter Catalogue Mandatory Location: Locate filters by either Number Tab F2 scrolling through the list Select a filter using the arrow bars or from the list.
  • Page 116 Integritest Exacta Filter Integrity Test Instrument Entry Value Mandatory or Instructions Notes required in optional to modify field? field when Yes/No programming a new test? Test Time Optional Location: Do not enter a test time Default value is Tab F4 of less than 6 minutes.

  • Page 117: Accessing The Test Editor Screen

    Millipore System Documentation Set ACCESSING THE TEST EDITOR SCREEN 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.
  • Page 118 Integritest Exacta Filter Integrity Test Instrument 6. Using the ‘Test type’ pull-down menu, select the type of test that will be conducted. 7. Enter the number of filter cartridges to be tested. The default is 1. If only one filter is to be tested, no entry is required. 8.

  • Page 119: Figure 47: Test Details Screen, F3, Options

    Millipore System Documentation Set Figure 47: Test 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 Specification Box where the Diffusion or the HydroCorr specification is multiplied by the number of cartridges entered on Tab F2.

  • Page 120: Modify An Existing Test

    Integritest Exacta Filter Integrity Test Instrument Figure 48: Test Details Screen - F4: Specifications 12. Modify the Test Time (optional). 13. Click if 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, click to view the filter specifications from the Filter Editor.
  • Page 121 Millipore System Documentation Set 2. Change any of the modifiable entries. 3. Click to cancel the changes. 4. Or click to save the changes. The revision information is automatically updated when a test is saved. Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 122: Running A Test

    Running a Test...
  • Page 123 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 124 Integritest Exacta Filter Integrity Test Instrument CHAPTER CONTENTS PROCEDURE ..................127 Elements of the Test Progress Screen ...........129 Icon Functions ..................129 Test Progress Graph ................130 Red Line:..................130 Blue Line:...................130 Test Status Box and Data Display..........130 Operating and Maintenance Manual Running a Test...
  • Page 125 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 126: Figure 49: Test Selection Screen

    Integritest Exacta Filter Integrity Test Instrument PROCEDURE 1. From the Main Menu, click to go to the Test Selection Screen (Figure 49). Figure 49: Test Selection Screen 2. Click your cursor in the list box labeled “select a test”. 3. Highlight the test to be run. Note: This screen indicates whether the unit is “AVAILABLE”...

  • Page 127: Figure 50: Operator Input Screen

    Millipore System Documentation Set Figure 50: Operator Input Screen 5. Enter any test 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’...

  • Page 128: Figure 51: Test Progress: Check

    Integritest Exacta Filter Integrity Test Instrument Figure 51: Test Progress: CHECK Elements of the Test Progress Screen Note: During the Testing Cycle, the appearance of the screen and the availability of icons will vary. Icon Functions While a test is running the following icons are active. Table 11: Icon Functions Icon: Description...

  • Page 129: Table 12: Typical Test Times And Values Reported

    Millipore System Documentation Set Test Progress Graph The test progress graph will vary depending on the type of test being conducted and the particular test step being executed during the test sequence. Red Line: (See Figure 51, red line is non-bold) The red line indicates the internal tank pressure (pressure vs.
  • Page 130 Integritest Exacta Filter Integrity Test Instrument Status Message: Meaning CLEAR Appears when the “clearing upstream” section of a test is occurring. The “clearing upstream” phase of the test is when residual fluid is eliminated from the system by pressurizing the system and pushing it through the filter.

  • Page 132: Printing

    Printing...
  • Page 133 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 134 Integritest Exacta Filter Integrity Test Instrument CHAPTER CONTENTS INTRODUCTION ..................137 Printing Reports.................137 SAMPLE REPORTS ...................139 Operating and Maintenance Manual Printing...
  • Page 135 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 136: Table 14: Print Variables

    Integritest Exacta Filter Integrity Test Instrument INTRODUCTION For information about the following topics, see the section titled Setup Options on page 83. Some points of interest concerning Printing in this manual include the following: Adding an External Printer............pg. 45 Configurable Operator Input Options........pg. 86 Choose a Default Printer ............pg.
  • Page 137 Millipore System Documentation Set Available Where Printing How to Print: Print Preview What is printed? Printouts: Occurs: Available? Y/N toolbar (top of screen) User Lists User Via print icon on Current users and Management toolbar (top of their passwords. Screen...

  • Page 138: Figure 52: Sample Report Printout

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

  • Page 140: Printer Maintenance And Troubleshooting

    Printer Maintenance and Troubleshooting...
  • Page 141 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 142 Integritest Exacta Filter Integrity Test Instrument CHAPTER CONTENTS PRINTER MAINTENANCE AND TROUBLESHOOTING........145 Changing the Paper ................145 Replacing the Ink Cartridge..............146 Priming the HP printer cartridge ............146 CONNECTING AN EXTERNAL PRINTER ............147 Procedure..................147 Operating and Maintenance Manual Printer Maintenance and Troubleshooting...
  • Page 143 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 144: Printer Maintenance And Troubleshooting

    Integritest Exacta Filter Integrity Test Instrument PRINTER MAINTENANCE AND TROUBLESHOOTING To Rear of Instrument To Front of Instrument Diagram Key: A. Paper Roll Rod Guides D. Paper Roll Rod B. Retaining Clip E. Print Guide Tab C. Ink Cartridge Figure 53: Internal Printer Changing the Paper 1.

  • Page 145: Replacing The Ink Cartridge

    4. Place the new cartridge in the holder. The front of the cartridge should face the front of the Integritest Exacta instrument. 5. Make sure the cartridge is seated in the holder. 6. Raise the plastic retaining clip to lock the cartridge in place.

  • Page 146: Connecting An External Printer

    Integritest Exacta Filter Integrity Test Instrument CONNECTING AN EXTERNAL PRINTER Procedure 1. Connect an external printer to the Integritest Exacta instrument with a standard parallel cable. 2. Make sure both the printer and the instrument are off. 3. Connect the 25-pin connector to the parallel port of the instrument. (See Figure 3- Back Panel Diagram on page 26.

  • Page 148: Data Management

    Data Management...
  • Page 149 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 150 Integritest Exacta Filter Integrity Test Instrument CHAPTER CONTENTS DATA MANAGEMENT FEATURES OF THE INTEGRITEST EXACTA INSTRUMENT ......................153 Filter Database and Filter Editor............153 Test Database and Test Editor ............153 Database and Operation Logs ............153 Electronic Test Data................153 Configurable Operator Input..............153 DATA MANAGEMENT PROCEDURES (MAINTENANCE OF ELECTRONIC TEST DATA) ....................154...
  • Page 151 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 152: Data Management Features Of The Integritest Exacta Instrument

    Integritest Exacta Filter Integrity Test Instrument 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 •...

  • Page 153: Data Management Procedures (Maintenance Of Electronic Test Data)

    Millipore System Documentation Set DATA MANAGEMENT PROCEDURES (MAINTENANCE OF ELECTRONIC TEST DATA) Filter test data are automatically stored electronically on the internal hard drive. The user can search, display and print this data on demand. Also, the filter test data can be transferred to a 3.5”...

  • Page 154: Advanced Query Procedure

    Integritest Exacta Filter Integrity Test Instrument 2. Enter a starting date. 3. Highlight the month, date, or year. 4. Enter the date values (or use the arrow keys to scroll one unit at a time) 5. Enter an ending date. 6.

  • Page 155: Figure 57: Advanced Query Screen 2, Filter & Test Selection

    Millipore System Documentation Set Figure 57: Advanced Query Screen 2, Filter & Test Selection 6. Select a filter name from the list box. One or more filters may be selected. Choose “All Filters” to include all of the available filters in the search.

  • Page 156: Printing Stored Test Data Procedure

    Integritest Exacta Filter Integrity Test Instrument Figure 58: Advanced Query Screen 3, Operator Input Selection Note: The Third Query Screen utilizes the user configurable operator inputs to search on. For example, if the test printout has been configured to require the Product Batch Number before a test is conducted, Product Batch Number can become a searchable parameter.

  • Page 157: Figure 59: Print Preview Screen

    Millipore System Documentation Set Figure 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 the instrument is in Archive Mode.

  • Page 158: Archiving

    Integritest Exacta Filter Integrity Test Instrument ARCHIVING Introduction Archiving is performed to free resources by reducing the current database size. Archiving can be performed automatically by the instrument at shutdown if the total database size has exceeded 10 megabytes (equivalent to approximately 150 tests). If a user or series of users exceed 12 megabytes database size, the system will prompt the operator to restart the instrument in order to archive.

  • Page 159: Viewing Archives

    Millipore System Documentation Set Figure 61: Database Size Red Warning Message A red warning message appears when the database size warrants a mandatory reboot. This indicates that the database has exceeded 15 megabytes of system memory. This is equivalent to approximately 225 tests.

  • Page 160: Figure 63: Archive Selection Menu

    Integritest Exacta Filter Integrity Test Instrument 2. Select . This utility starts the instrument in Archive Mode. 3. Once in Archive Mode, select . The Archive Selection Menu as shown in Figure 63 will come into view. Figure 63: Archive Selection Menu 4.

  • Page 161: Restarting In Normal Mode

    Millipore System Documentation Set Figure 64: Archive Confirmation Prompt 6. At the confirmation prompt: • Selecting will stop Normal Operation mode and re-start the instrument using the selected archive. • Selecting will return the user to the Archive Selection Menu to allow another selection.

  • Page 162: Backup And Restore

    Integritest Exacta Filter Integrity Test Instrument BACKUP AND RESTORE The backup and Restore functions are found on tab F3 of the administrators Control Menu screen. If you are unfamiliar with these screens, see the section titled Control Menu Screen on page 38.

  • Page 163: Filter And Test Definitions Only

    Millipore System Documentation Set Filter and Test Definitions Only • Itclient.mdb Archived Test Results Only • archive\*_integra.mdb Complete Backup and Audit Files • integra.mdb • Itclient.mdb • *.log • *.evt • archive\*_integra.mdb • XceedZip.dll • auditor.exe There are several file types that the system will save when the different backups are performed.

  • Page 164: Restoring Data From Backup Disks

    Integritest Exacta Filter Integrity Test Instrument Figure 65: Backing up data to Floppy Diskette You cannot view the contents of these files on other computers. This ensures that the data is not modified in any way. Only an Exacta instrument can read from the backup disk. (The exception to this is the Complete Backup and Audit Files, which allows an auditor to unzip and view the data).

  • Page 165: Figure 66: No Disk Warning

    Millipore System Documentation Set Figure 66: No Disk Warning Insert the disk and select and the window as shown in Figure 68 will appear, or choose If you choose , the system will prompt you to insert the last disk of a set as in Figure 67.

  • Page 166: Figure 68: Restore File List

    Integritest Exacta Filter Integrity Test Instrument 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 as shown in Figure 69. Figure 69: Restore Complete Prompt Operating and Maintenance Manual Data Management...

  • Page 167: Auditing Files

    Millipore System Documentation Set AUDITING FILES An auditor may recover files from diskette on a computer other than that on the Exacta Instrument in compliance with 21 CFR Part 11 procedures. These files must be unzipped in order to be viewed. Once unzipped, the files cannot be re-zipped in a format that the instrument will recognize.

  • Page 168: Figure 71: Files Unzipped For Audit

    Integritest Exacta Filter Integrity Test Instrument Note: WinZip is used as an example, as it is a commonly used utility. PKUnzip ® or other disk-spanning compression utilities will work as well. A free trial version of WinZip is available for download from http://www.winzip.com/ Figure 71: Files Unzipped for Audit Note: You cannot access most of the files as they appear in the WinZip window.

  • Page 169: Figure 72: Auditor Extraction

    Millipore System Documentation Set 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 the files to be extracted will be shown (see Figure 73).

  • Page 170: Figure 74: Auditor Extraction Completed

    Integritest Exacta Filter Integrity Test Instrument 10. The system will prompt you as to whether to continue. Select OK. The Auditor will extract the files, and alert you when it has finished (see Figure 74). The files can now be opened for review.

  • Page 172: Networking

    Networking...
  • Page 173 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 174 Therefore, establishing a network and all connections to a network are outside of Millipore’s scope of supply. Validation of the network, network connections, and network functionality are also outside of Millipore’s scope of supply.

  • Page 176: Maintenance And Calibration

    Maintenance and Calibration...
  • Page 177 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 178 Integritest Exacta Filter Integrity Test Instrument CHAPTER CONTENTS BACKGROUND/INTRODUCTION ............181 External Calibration................181 Internal Calibration ................181 Calibration Approach ................181 Calibration Frequency Recommendations ..........181 PRESSURE TRANSDUCER CALIBRATION—EXTERNAL CALIBRATION ...182 Calibration Criteria ................182 Calibration curve fits: ..............182 Calibration Adjustment Decisions: ..........182 Recommended Reference Pressure Gauge...........183 Calibration Setup ................183 Calibration Procedure ...............183 PRESSURE TRANSDUCER CALIBRATION—INTERNAL CALIBRATION ...187...
  • Page 179 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 180: Background/Introduction

    Internal Calibration The Integritest Exacta 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 transducer is considered the reference and is compared against the secondary transducer and the electronic pressure regulator.

  • Page 181: Pressure Transducer Calibration-External Calibration

    Note: Millipore recommends the use of a Setra™ Model #370 referee transducer or the equivalent thereof. See the subsection in this chapter titled “Recommended Reference Pressure Gauge”...

  • Page 182: Recommended Reference Pressure Gauge

    Note: Use of long tubing sets or multiple fittings may degrade the accuracy of the referee gauge. Millipore recommends that a tubing set no more than 60cm (2ft.) in length with no additional fittings be used for this purpose.

  • Page 183: Figure 75: Pressure Calibration

    Millipore System Documentation Set Figure 75: Pressure Calibration 2. Click Tab F3 to open the Pressure Calibration Screen. (Figure 75). 3. Click to start 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.
  • Page 184 Integritest Exacta Filter Integrity Test Instrument Note: After the request, wait 10-15 seconds, or until the referee pressure has stabilized to 0.01psi with no change. The exception to this is for the 0psi calibration pressure, which should stabilize at 0 almost immediately. 7.
  • Page 185 Millipore System Documentation Set 10. The calibration coefficients 1, 2, 3 and the regression coefficient for each transducer will be updated automatically if adjustments are necessary. 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 transducer.

  • Page 186: Pressure Transducer Calibration-Internal Calibration

    Integritest Exacta Filter Integrity Test Instrument PRESSURE TRANSDUCER CALIBRATION—INTERNAL CALIBRATION The secondary pressure transducer and regulator are compared against the primary pressure transducer across the full operating span of the transducers (0–98 psig). The calibration is conducted by an automated procedure that requires different operator inputs from those required to start the calibration.

  • Page 187: Calibration Setup

    Millipore System Documentation Set Calibration Setup Connect the Integritest Exacta inlet tubing to the instrument and to a regulated compressed gas (nitrogen or air) source. Set the inlet gas pressure to 100 psig (689kPa). Note: For an internal calibration, external tubing is not required and valves need not be closed.
  • Page 188 Integritest Exacta Filter Integrity Test Instrument Note: If the test must be stopped before completion, click to terminate the internal calibration in progress. Operating and Maintenance Manual Maintenance and Calibration...

  • Page 189: Temperature Sensor Calibration

    Millipore System Documentation Set TEMPERATURE SENSOR CALIBRATION The temperature sensor is calibrated against an external referee temperature sensor. The referee gauge should be traceable to the NIST (National Institute of Standards Testing) or equivalent. The calibration is conducted with an automated procedure that prompts the user through the calibration process.

  • Page 190: Recommended Reference Temperature Sensor

    • 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 water baths, one at each of the three test temperatures shown in Table...

  • Page 191: Figure 76: Temperature Calibration

    Millipore System Documentation Set Figure 76: Temperature 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 and the referee temperature sensor in the first bath, and allow about 3 minutes for equilibration.
  • Page 192 Integritest Exacta Filter Integrity Test Instrument 7. The instrument will take 7 temperature readings from the internal temperature sensor and then prompt the operator to enter the value from the referee sensor. Upon input, the instrument will take the 8 reading 8.
  • Page 193 Millipore System Documentation Set 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 pneumatic module. 14. Re-install the Temperature Sensor Plug. Operating and Maintenance Manual...

  • Page 194: Internal Leak Testing

    Connect the supplied Loop-Back Tubing Assembly (Part Number XITXLBTA). Note that this assembly will only connect to ports C and D of Figure 4 (see page 28). • Connect the Integritest Exacta inlet tubing to the instrument and to a regulated compressed gas (nitrogen or air) source. •...

  • Page 195: Figure 77: Setup And Calibration, Tab F5, Leak Testing

    Millipore System Documentation Set 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 Test Progress Report 4.

  • Page 196: Figure 79: Leak Test Report Example

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

  • Page 197: Routine Maintenance-Replaceable Components

    The filter is not required to operate the Integritest Exacta instrument. If filtration of the cooling fan exhaust is not necessary, the user can choose to remove the fan filter and operate the instrument without it.

  • Page 198: Inlet Tubing Gas Filter Replacement

    Main Fuse Replacement The main fuse should never require replacement unless there is a major electrical surge from the electrical source. If the fuse needs replacement, the Millipore approved fuse must be used. (2 Amp Slow-Blow, 250V, 5-20mm, Millipore Part No. P80037) Procedure 1.

  • Page 200: Troubleshooting

    Troubleshooting...
  • Page 201 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 202 Integritest Exacta Filter Integrity Test Instrument CHAPTER CONTENTS INTRODUCTION ..................205 General Troubleshooting 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 TROUBLESHOOTING PROCEDURE ......209 Instrument ..................209 Hardware ..................209 Filter ....................210...
  • Page 203 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 204: Introduction

    If there is an instrument operation issue, check the following: • Make sure that the Integritest Exacta instrument is plugged into a properly grounded wall outlet and that there is power to that outlet. • Check all pneumatic connections to the Integritest Exacta instrument and make sure all connectors are firmly attached.

  • Page 205: Possible Failure Modes

    (see page 195) or the Hardware Diagnostics section(see page 212). Integritest Exacta unit does not turn on. • Make sure the power cord is plugged into the rear of the Integritest Exacta instrument and into a functional power outlet. •...

  • Page 206: Exacta Gross Leak Criteria

    • This may result from a software conflict causing the cursor not to respond. Press the Ctrl-Alt-Delete keys simultaneously. Close the program that is not responding. Shut down and restart the Integritest Exacta unit. ( See the section titled Starting/Stopping the Instrument on page 49 for more details).

  • Page 207: Gross Leak Detection Prior To Sizing

    Millipore System Documentation Set Gross Leak detection prior to sizing Prior to sizing, the system detects gross leaks by comparing the measured pressure drop against the pressure drop that would be expected if a leak flowrate is set at twice the filter diffusion specification.

  • Page 208: Exacta Gross Leak Troubleshooting Procedure

    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. Cap off the outlet tubing at the stainless steel disk test adapter.

  • Page 209: Filter

    1. Prior to conducting either a manual test or a pressure hold test, re-wet the filter following Millipore’s recommended wetting procedure. (See the Wetting Instructions insert enclosed with the filter.) 2.

  • Page 210: Environmental

    Integritest Exacta Filter Integrity Test Instrument Environmental The final factor that can cause a “Gross Leak” error message to appear is an unstable environmental temperature 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 housing unrelated to gas diffusing through the filter membrane.

  • Page 211: Diagnostic Tools

    DIAGNOSTIC TOOLS Self-diagnostics When the Integritest Exacta unit is turned on, the computer BIOS runs a self-diagnostics program that tests its internal circuitry. This test checks that the major components 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.

  • Page 212: Table 26: Diagnostics Screen Component Identification

    Integritest Exacta Filter Integrity Test Instrument Table 26: Diagnostics Screen Component Identification Screen Component Graphic Operation Notes Pressure Regulator Type in a pressure between 35 and 100 psig. Inlet valve Press the F2 function Green valve is open: key or use the mouse to click on the valve.
  • Page 213 Millipore System Documentation Set Screen Component Graphic Operation Notes Primary transducer The Primary transducer measures absolute pressure (e.g. Psia) Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 214: Error Messages

    Error Messages...
  • Page 215 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 216 Integritest Exacta Filter Integrity Test Instrument CHAPTER CONTENTS TEST STATUS ERRORS ................219 General Messages ................222 Operating and Maintenance Manual Error Messages...
  • Page 217 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 218: Figure 82: Example Of An Error Message Box

    Integritest Exacta Filter Integrity Test Instrument TEST STATUS ERRORS During the operation of the Integritest Exacta 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.

  • Page 219: Table 27: Status Error Messages

    Millipore System Documentation Set Table 27: Status Error Messages Status Status Window Short Description Detailed Description Error Message MATH ERROR General General error in operation Failure Used to convey errors occurring during operation that include, improper set up parameters, computational errors, etc.
  • Page 220 Integritest Exacta Filter Integrity Test Instrument Status Status Window Short Description Detailed Description Error Message UNDEFINED Test Procedure At the time of execution, the test being asked for TEST Not Found is checked against the tests stored within the internal database to ensure that the test is properly defined and available for use.
  • Page 221 Millipore System Documentation Set Status Status Window Short Description Detailed Description Error Message CALIBRATE Out Of This error indicates that the transducer or Calibration pressure regulator is out of calibration when compared to the manufacturer specifications. A mechanical adjustment or replacement is required.

  • Page 222: Table 28: General Error Messages

    Integritest Exacta Filter Integrity Test Instrument Table 28: General Error Messages Scope/Screen Message Cause Global Could not read access Database Communication Error values from Database. Using default values. Global Could not store access level Unable to Store the Access Levels changes on the server.
  • Page 223 Millipore System Documentation Set Scope/Screen Message Cause Node Admin Changes have been made. Changes have not been saved Save them? Utilities The instrument is not Instrument Not Available currently available. HW Diagnostics Pressure setting invalid. Invalid Pressure Value Entered Defaulting to 0...
  • Page 224 Integritest Exacta Filter Integrity Test Instrument Scope/Screen Message Cause Global No current form. Failed Attempt to Change Screen Global Form stack overflow. Too Many Forms Loaded Advanced Query Please enter a range of days Please enter a range of days where where the end date is after the end date is after the start date.

  • Page 226: Instrument Repair

    Instrument Repair...
  • Page 227 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 228 Integritest Exacta Filter Integrity Test Instrument CHAPTER CONTENTS MILLIPORE TECHNICAL SERVICE..............231 Returning the Instrument to Millipore ...........231 SPARE PARTS LIST..................232 Operating and Maintenance Manual Instrument Repair...
  • Page 229 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 230 Integritest Exacta Filter Integrity Test Instrument MILLIPORE TECHNICAL SERVICE To help you get the best performance from your Millipore products, the Technical Support staff is available to provide prompt, reliable assistance. Before calling for assistance, know the software version and instrument serial number for the Integritest Exacta—see Contacting Millipore (page 255) for contact information.

  • Page 231: Table 29: Spare Parts And Accessories

    ITX HARD DRIVE W SOFTWARE, O/S, JAPANESE XITXSP172 P Note: The above list is not a comprehensive listing of all spare parts and accessories. Please contact your local Millipore representative should you require spare parts that are not listed here. Operating and Maintenance Manual...

  • Page 232: Warranty

    Warranty...
  • Page 233 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 234 In the event of a breach of the foregoing warranty, Millipore's sole obligation shall be to repair or replace, at its option, the applicable product or part thereof, provided the customer notifies Millipore promptly of any such breach.

  • Page 236: Integritest Exacta Specifications

    Integritest Exacta Specifications...
  • Page 237 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 238 Input and Output connections ............242 Computer ..................242 Operating Environment ...............243 Cleaning ..................243 CE APPROVAL CHARACTERISTICS ............244 Scope ..................244 EMC Directive ................244 Low-Voltage Directive (Safety) ............244 EQUIPMENT MAINTENANCE & SAFETY ...........245 Safety Warnings ................245 Safety and Electromagnetic Compliance..........246 Operating and Maintenance Manual Integritest Exacta Specifications...
  • Page 239 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 240: Performance Specifications

    Integritest Exacta Filter Integrity Test Instrument PERFORMANCE SPECIFICATIONS Bubble Point Test The Integritest Exacta instrument performs accurate Bubble Point tests on filter systems ranging from 47 mm disk filters to 3-round by 30-inch high cartridge systems. Table 30:Bubble Point Test Performance Specifications...

  • Page 241: Physical Characteristics

    Millipore System Documentation Set PHYSICAL CHARACTERISTICS Dimensions Table 33: Dimensions Height 8 inches 21cm Width 19 inches 49cm Depth 21 inches 54cm Weight • ≤ 40lb. (≤ 18kg) Electrical Specifications • Voltage Range - 100–240 VAC • Frequency - 50–60 Hz •...

  • Page 242: Operating Environment

    The instrument may be cleaned or sanitized by wiping it with a dilute solution of bleach or sodium hydroxide. Avoid long exposure of the instrument enclosure with any cleaning solution. Follow with clear water. This equipment can be safely operated only in a manner explicitly defined in this Manual. Operating and Maintenance Manual Integritest Exacta Specifications...

  • Page 243: Ce Approval Characteristics

    IEC 801-3 Radiated RF (27 - 500 MHz @ 3 volts/meter). • IEC 801-4 Fast Transient Burst (via the power cord). Low-Voltage Directive (Safety) • The Integritest Exacta instrument meets the Low-Voltage Directive, 72/23/EEC and is tested to the standard EN61010 Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 244: Equipment Maintenance & Safety

    In addition, a yellow caution label, designed to reduce the chance of entry into the unit, conforms with international standards. Symbols related to pneumatic and electric connectors are identified on the side and rear panels. Operating and Maintenance Manual Integritest Exacta Specifications...

  • Page 245: Safety And Electromagnetic Compliance

    Millipore System Documentation Set Figure 84: Caution Label Safety and Electromagnetic Compliance • The Integritest Exacta instrument, fully configured with all accessories, meets the requirements of the EMC Directive 89/336/CEE and Low Voltage (safety) directive 72/23/EEC. • This Class B digital apparatus meets all requirements of the Canadian Interference—...

  • Page 246: Interface Conventions

    Interface Conventions...
  • Page 247 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 248 Integritest Exacta Filter Integrity Test Instrument CHAPTER CONTENTS INTERFACE CONVENTIONS ..............251 Dialog Boxes ..................251 Data Entry Windows ................251 List Boxes..................251 Pull-down Menus ................252 Check Boxes..................252 Option Buttons and Option Groups............252 History Tables ...................253 Operating and Maintenance Manual Interface Conventions...
  • Page 249 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 250: Interface Conventions

    Integritest Exacta Filter Integrity Test Instrument INTERFACE CONVENTIONS Dialog Boxes There are several types of dialog box in which to enter data. Background color indicates whether data may be entered. Background Color Data entry allowed Sample White Gray Data Entry Windows Select by moving the cursor to the window and entering (typing) data.

  • Page 251: Pull-Down Menus

    Millipore System Documentation Set Pull-down Menus Select by moving the cursor to highlight an entry. 1. Place your cursor over the down arrow to the right of the pull-down menu. 2. Click the left mouse button to open the pull-down window.

  • Page 252: History Tables

    Integritest Exacta Filter Integrity Test Instrument • a check in the 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 which are the most recent entries. An example is the History Box listing up to six of the most recent Operators of the Instrument.

  • Page 254: Contacting Millipore

    Contacting Millipore...
  • Page 255 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 256 Integritest Exacta Filter Integrity Test Instrument 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 U.S.: ......260 Millipore Worldwide ................260 Contact our Web site.................262 Operating and Maintenance Manual...
  • Page 257 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 258: Contacting Millipore The U.s

    Millipore Corporation 80 Ashby Road Bedford, MA 01730 Attention: Customer Service Products Ordered in the U.S. for Shipment Overseas: Call, Fax or Write Millipore International Customer Service Call: 1-800-MILLIPORE, ext. 8622 (Monday-Friday, from 7 a.m. to 5 p.m. Eastern Time)

  • Page 259: Products Ordered In Countries Other Than The U.s

    Millipore System Documentation Set Products Ordered in Countries Other Than the U.S.: To Place an Order or to receive Technical Assistance or Additional Information, call your nearest Millipore office. Millipore Worldwide COUNTRY CONTACT ADDRESS TEL NUMBER FAX NUMBER AUSTRALIA Millipore Australia 9A Byfield Street North Tel .1 800 222...
  • Page 260 Integritest Exacta Filter Integrity Test Instrument COUNTRY CONTACT ADDRESS TEL NUMBER FAX NUMBER CZECH Millipore spol. Ricanova 2116900 Tel.02-2051 Fax 02-2051 REPUBLIC s.r.o. Praha 6 3841 4298 DENMARK Millipore A/S Odinsvej 9-19, st. 2600 Tel.70 10 00 Fax 70 10 13 Glostrup E.

  • Page 261: Contact Our Web Site

    Tel. (822) 551- Fax (822) 551- Co. Ltd. Terminal Building 159- 0990 0228 6, Samsung-Dong Kangnam-ku Seoul 135- MALAYSIA Millipore Asia Ltd. Suite 3.03 Wisma KT Tel. 603- Fax 603- No. 14 Jalan 19/1 7571322 7571711 46300 Petaling JayaSelangor MEXICO Millipore S.A.
  • Page 262 References...

  • Page 264: Table 34: Recommended Hydrocorr Gas Volumes

    Integritest Exacta Filter Integrity Test Instrument REFERENCES Recommended HydroCorr Gas Volumes Table 34: Recommended HydroCorr Gas Volumes Filter Size Initial System Gas Preferred Initial System Volume Range (cm Gas Volume (cm 50 mm capsule (such as Aervent-50) 20–60 Millidisk cartridge (10–40 stack) 30–100 4-inch capsule (such as Opticap) 30–100...
  • Page 266 Glossary...
  • Page 267 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 268 Integritest Exacta Filter Integrity Test Instrument GLOSSARY Bubble Point Pressure Bubble point is based on the fact that liquid is held in the pores of a filter by surface tension and capillary forces. The Bubble Point Pressure is the minimum pressure required to overcome these forces and force liquid out of the pores of a membrane filter.
  • Page 269 The Enhanced Bubble Point test is a combination of a diffusion test followed by a bubble point test to determine if a filter is integral. The Enhanced Bubble Point test is the test recommended by Millipore for most applications. Exceptions to this are;...
  • Page 270 Integritest Exacta Filter Integrity Test Instrument Preset Upstream Gas Volume Tests are designed to measure upstream gas volume automatically. However, a user can define upstream gas volume manually. 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.
  • Page 272 Index...
  • Page 273 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 274 Integritest Exacta Filter Integrity Test Instrument CHAPTER CONTENTS INDEX ....................277 TABLE OF FIGURES.................283 TABLES....................285 Operating and Maintenance Manual Index...
  • Page 275 Millipore System Documentation Set Operating and Maintenance Manual Publication XITXSP121 P Rev.A...

  • Page 276: Index

    Integritest Exacta Filter Integrity Test Instrument INDEX Access Levels ........................76 ACCOUNT POLICY ......................67 Add Users........................76 Administrator ........................63 Advanced Query Procedure ..................155 Archive Mode .......................39 Auditing Files ......................168 Automatic Logout ......................42 BACKUP......................43, 44, 163 Bubble Point Test Steps ....................108 Calibration .........................181 CALIBRATION TEMPERATURE SENSOR ......................190 CE APPROVAL ......................244...
  • Page 277 Millipore System Documentation Set Enhanced Bubble Point Test Steps .................108 Errors Error Messages........................215 Event Log ........................41 Exhaust Connections .....................29 External Calibration.....................181 EXTERNAL PRINTER .....................147 Fan Filter Replacement ....................198 Files Saved .........................164 Filter Editor ........................91 Accesing the Filter Editor Screen....................95 Adding a New Filter Specification....................96 General Procedure for Adding a New Filter Specification ............96...
  • Page 278 Integritest Exacta Filter Integrity Test Instrument Physical Characteristics ......................242 Integritest Exacta Tests ....................107 Interface Conventions ....................247 Internal Calibration .....................181 INTERNAL LEAK TESTING ....................195 Keyboard Features ......................19 Glide Plane........................19, 20 Language ..................See Setup, Language Leak Testing........................195 List Boxes........................251 Log On ........................33 Main Menu....................38, 160, 163...
  • Page 279 Millipore System Documentation Set Spare Parts..........................232 Parts - Replaceable......................198 Password Guidelines .....................68 Pneumatic Connections ....................28 Power Cord Assembly ....................26 Power Requirements ......................27 Pressure ........................269 Bubble Point..........................269 Calibration........................184, 188 PRESSURE TRANSDUCER CALIBRATION ...............182, 187 Priming the HP printer cartridge ..................146 Print Default Printer Choose..............................87...
  • Page 280 Integritest Exacta Filter Integrity Test Instrument Returning the Instrument to Millipore ............... See Warranty ROUTINE MAINTENANCE...................198 Running a Test ......................127 Icon Functions ........................129 Test Progress Graph ......................130 Safety.........................246 Security Log ........................39 SERVICE ........................231 Setup ........................83, 85 Accessing the Setup & Calibration Screen ..................89 Choose a Report Format ......................88...
  • Page 281 Hardware Diagnostics ..........................212 Self-diagnostics............................212 Failure Modes ........................206 General ..........................205 User Access ........................269 USER ACCOUNTS ......................63 User Category Access Levels ..................76 User Manager.......................64 Warranty ........................233 Returning the Instrument to Millipore ..................231 Packaging ..............................17 Operating and Maintenance Manual Publication XITXSP121 P Rev.A...
  • Page 282 Integritest Exacta Filter Integrity Test Instrument TABLE OF FIGURES Figure 1: Keyboard ................. 20 Figure 2: Integritest Instrument (bottom rear view)........25 Figure 3: Rear Panel ................26 Figure 4: Side Panel................28 Figure 5: Connecting and Disconnecting exhaust tubing ......29 Figure 6: Inlet and Outlet Tubing Connections .........
  • Page 283 Millipore System Documentation Set Figure 47: Test Details Screen, F3, Options..........120 Figure 48: Test Details Screen - F4: Specifications ........121 Figure 49: Test Selection Screen ............127 Figure 50: Operator Input Screen ............128 Figure 51: Test Progress: CHECK ............129 Figure 52: Sample Report Printout ............
  • Page 284 Integritest Exacta Filter Integrity Test Instrument TABLES Table 1: Electrical Connections..............26 Table 2: Password Characters ..............68 Table 3: Instrument Setup Locations ............83 Table 4: Temperature Compensation............90 Table 5: Filter Selection Table ..............97 Table 6: Available Tests ................98 Table 7: Tab F4, Bubble Point Test Entries..........

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