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Millipore Integritest Exacta User Manual

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

Table of Contents

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Millipore Integritest Exacta Specifications

General IconGeneral
BrandMillipore
ModelIntegritest Exacta
CategoryTest Equipment
LanguageEnglish

Summary

Copyright Notices

Trademark Notices

Lists registered trademarks of Millipore Corporation and other companies.

Using Help

Context-sensitive help

Explains the instrument's context-sensitive online help features.

Getting Started

Introduction

Provides an overview of the Integritest Exacta instrument and its capabilities.

Important Tasks Before Power Up

Critical tasks to perform before powering up the instrument.

Physical Connections

Electrical Connections

Details the instrument's electrical connections and ports.

Power Requirements

Specifies the voltage, frequency, and power requirements for the instrument.

Pneumatic Connections

Details the instrument's pneumatic connections for gas supply.

First Log On

Introduction

Describes the initial power-up and logon process for the instrument.

Control Menu Screen

Introduces the Control Menu as the starting point for administrative tasks.

Starting/Stopping the Instrument

Starting the Instrument

Guides the user through the initial startup procedure for the instrument.

Instrument Shutdown

Provides instructions for safely shutting down the instrument's software.

Security Setup

Setting Up User Accounts

Explains how to configure user accounts and access levels for the instrument.

Managing Account Policy

Covers the configuration of password policies and account lockout settings.

Managing User Access

Modify User Categories

Describes how to set user privileges and access levels for the instrument.

Instrument Setup

Setup Options

Details the various general operating and testing parameters for the instrument.

Choosing the Default Printer

Guides on selecting the default printer for the instrument.

Step 5. Choose Pressure Units

Details how to select pressure units for testing.

Filter Editor

Introduction

Introduces the Filter Editor as a database for test specifications.

Adding a New Filter Specification

Details the procedure for entering new filter specifications into the database.

Integritest Exacta Instrument Tests

Capabilities of the Integritest Exacta Instrument

Lists the types of tests the instrument can perform.

Test Procedures of the Integritest Exacta Instrument

Details the procedures for performing various tests.

Test Editor

Introduction

Introduces the Test Editor for creating and modifying test programs.

Program a New Test

Details the process for creating a new test program.

Running a Test

Procedure

Outlines the steps for running a test on the instrument.

Printing

Printing Reports

Details the types of printouts available and how to generate them.

Printer Maintenance and Troubleshooting

Printer Maintenance and Troubleshooting

Covers procedures for maintaining and troubleshooting the printer.

Connecting an External Printer

Details the procedure for connecting an external printer.

Data Management

Data Management Features of the Integritest Exacta Instrument

Lists the features related to managing data on the instrument.

Data Management Procedures

Covers procedures for maintaining electronic test data.

Backup and Restore

Covers the procedures for backing up and restoring data.

Networking

21 CFR Part 11 Compliance

Addresses compliance considerations when networking the unit.

Maintenance and Calibration

External Calibration

Explains the on-site calibration process against a reference standard.

Internal Calibration

Describes the pressure calibration check conducted without an external reference.

Routine Maintenance—Replaceable Components

Lists user-replaceable components and their maintenance.

Troubleshooting

General Troubleshooting Procedure

Outlines a systematic approach to diagnosing and solving problems.

Exacta Gross Leak Troubleshooting Procedure

Provides a structured approach to troubleshooting gross leaks.

Diagnostic Tools

Introduces tools for diagnosing instrument issues.

Error Messages

Test Status Errors

Explains error conditions detected during test operation.

Instrument Repair

Millipore Technical Service

Information on contacting technical support for assistance.

Integritest Exacta Specifications

Performance Specifications

Provides performance data for the instrument's tests.

Physical Characteristics

Lists the physical dimensions, weight, and electrical specifications.

Equipment Maintenance & Safety

Covers safety precautions and maintenance aspects.

Interface Conventions

Dialog Boxes

Explains the use and appearance of dialog boxes for data entry.

List Boxes

Explains how to select items from list boxes.

Contacting Millipore

Contacting Millipore The U.S.

Provides contact information for Millipore Customer Service in the U.S.

Millipore Worldwide

Lists contact details for Millipore offices globally.

References

Recommended HydroCorr Gas Volumes

Lists recommended gas volumes for HydroCorr tests based on filter size.

Glossary

Bubble Point Test

Explains the Bubble Point test procedure and its critical role.

Diffusion Test

Explains the diffusion test and its significance.

Index

Table of Figures

List of all figures included in the manual with their page numbers.

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