Millipore Integritest Exacta, Operating And Maintenance Manual

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Integritest

Exacta Filter Integrity Test Instrument
Operating and Maintenance Manual Getting Started
17
INTRODUCTION
The Millipore Integritest Exacta instrument is designed to conduct on-site bubble point,
diffusion and HydroCorr tm tests on a wide range of membrane filter systems. Both
hydrophobic and hydrophilic membrane filters can be tested with the Integritest Exacta
instrument. Testing is not limited to Millipore filter products.
The Integritest Exacta instrument conducts filter integrity tests on the upstream side of the
filter system, ensuring sterility of downstream connections.
The system is equipped with a customized* Windows NT operating system which has been
validated for its use with the instrument. The system is capable of tracking and managing
data and test results, and is compliant with 21CFR Part 11 guidelines for data security.
It is the responsibility of the end user to maintain compliance with this and any other data
security rules and regulations. It is recommended that the user be familiar with Windows
NT and its capabilities before attempting to perform NT administrative duties on the
system. 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.
Do not attempt to upgrade or reinstall standard versions of NT. Changes to the operating
system or the system applications software will void the warranty.
*Windows NT software modules not needed for operation of this system have been
removed.
The Integritest Exacta Manual
This manual contains all the information you need to install, operate, program and
maintain the lntegritest Exacta instrument. It assumes you have a basic understanding of
the bubble point and diffusion integrity tests. Sections of the manual that refer to advanced
operations assume that the user is familiar with the operation of IBM-compatible personal
computers and Microsoft
®
Windows NT applications. Knowledge of PC’s and Windows is
not necessary for basic operations such as programming and running a filter test. For
detailed information on integrity testing, contact Millipore.
Before you start
1.
Unpack the inner shipping container.
2.
Carefully remove the instrument from the inner packaging without damaging the
shipping materials.
3.
Store the packaging in a dry area for future use. (The instrument must be properly
repackaged in a Millipore certified shipping container if it is ever returned to
Millipore for servicing.)
4.
Place the instrument on a flat surface (such as a stable bench or cart), which all
four rubber feet will firmly contact.