0% found this document useful (0 votes)
13 views

Envigil™ Lite Cleanroom Monitoring Systems: Affordable and Easy Compliance For Small Aseptic Production

Uploaded by

marlen
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
13 views

Envigil™ Lite Cleanroom Monitoring Systems: Affordable and Easy Compliance For Small Aseptic Production

Uploaded by

marlen
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 2

Data Sheet

enVigil™ Lite
Cleanroom Monitoring
Systems
Affordable and easy compliance
for small aseptic production

Features and Benefits

Configures a compliant monitoring system


in minutes using an easy-to-use intuitive wizard
enVigil Lite Facility Monitoring Software allows you to configure a
fully featured particle monitoring system in minutes using a simple,
intuitive wizard. The drop down menu allows for the cleanroom class
or grade to be selected for FDA cGMP or EU GMP compliance. For
example, choosing “Grade A” automatically loads the pass/fail criteria
in accordance with the EU GMP Annex 1.

Monitors up to 20 locations on a single screen Consolidated Alarms Display


enVigil Lite presents a simple and consistent user interface for
controlling all MET ONE particle counters and indicating their current
state. Clicking on an indicator reveals the historical data trend, alarms
or tabular data for the individual counter. In addition to the individual
reports, a global audit report is available showing login activity and
any changes to the configuration. As a result, enVigil Lite delivers
the information you need to maintain compliance without tedious
configuration and documentation.

Provides secure operation using Windows


user names and passwords
enVigil Lite is password protected and employs an automatic audit
trail logging system that enables 21 CFR Part 11 compliance
out of the box.
Particle Trends Display

Includes system verification documents


enVigil Lite also includes documentation templates to address the
enVigil Lite is ideal for smaller FMS installations
system functional design specification (DQ), as well as installation
consisting of 20 or fewer monitoring locations.
and operational acceptance testing (IQ/OQ). Using this pre-printed
The primary advantage of enVigil Lite is that it
document set, system verification can be completed without the
provides a turnkey software solution without
need to recreate the documents.
requiring expensive customization.

Reporting and data export


enVigil Lite offers a clear status overview with one click access to
trends, concise alarm reports and data export to Microsoft® Excel®.
Reports can be printed with a single click, and include signature boxes
allowing them to be used for batch sign off.

®
Specifications
At Hach, it’s about learning
from our customers and
System Description providing the right answers.
• Continuous measurement of particle counts When it comes to the things
• Remote start/stop of particle counters that touch our lives...
• Vacuum control
• Alarm output to indicator devices Keep it pure.
• Audit trail recording Make it simple.
• Secure user interface Be right.
• Alarm indication via color change on the operator screen
• Alarm acknowledgment via operator screen
• Trend views of live and historic data
• Tabular reports of historic data For current price information,
• Reconciled alarm reports technical support, and ordering
• Compliance with 21 CFR Part 11 with respect to electronic records assistance, contact the Hach
• Supports up to 160 inputs for Analog/Digital sensors office or distributor serving
(differential pressure, temperature, air velocity, etc.) your area.

In the United States, contact:


Languages
• French HACH COMPANY World Headquarters
• German P.O. Box 389
• Spanish Loveland, Colorado 80539-0389
U.S.A.
• Italian
Telephone: 800-227-4224
Fax: 970-669-2932
Supported Hardware E-mail: [email protected]
• Up to 20 each MET ONE 6000/7000/3400 series particle counters www.hach.com/metone
• Up to 20 alarm indicators, alarm beacons and/or alarm displays
• 1 single, or up to 20 individual vacuum controllers U.S. exporters and customers in Canada,
• Supports modules for analog and digital inputs and outputs in several configurations Latin America, sub-Saharan Africa, Asia,
and Australia/New Zealand, contact:
For configurations requiring more than 20 counters, contact your local Hach sales representatives
HACH COMPANY World Headquarters
P.O. Box 389
Computer System Requirements Loveland, Colorado 80539-0389
• Configured as standalone system or network supported U.S.A.
• Microsoft Windows XP® or Vista® OS Telephone: 970-669-3050
Fax: 970-461-3939
• Monitor resolution 1280 x 800 pixels
E-mail: [email protected]
• CD-ROM drive www.hach.com/metone
• USB port for security key www.hach-latinoamerica.com
• Ethernet port
In Europe, the Middle East, and
Ordering Information Mediterranean Africa, contact:
200-600-7005 Up to 5 Particle Counters
HACH LANGE GmbH
200-600-7010 6 to 10 Particle Counters Willstätterstraße 11
200-600-7015 11 to 15 Particle Counters D-40549 Düsseldorf
200-600-7020 16 to 20 Particle Counters GERMANY
Tel: +49 (0) 211 5288-0
Fax: +49 (0) 211 5288-143
E-mail: [email protected]
www.hach-lange.com

Lit. No. 5246


B10 Printed in U.S.A.
©Hach Company, 2010. All rights reserved.
In the interest of improving and updating its equipment, Hach Company reserves the right to alter specifications to equipment at any time. ®

You might also like