Enhanced MET ONE 3400 Series
Portable Airborne Particle
Counters
November 15, 2010
1
MET ONE
Leader in Airborne
Particle Counting
Introduction to MET ONE 3400 Series
• Flexible Communications
– Wireless, Ethernet, Serial, USB
• OPC Server Enabled Open
Communication Architecture
– Seamless integration into YOUR System
Software
– LIMS
• Industry Standard for Ease of Use
– Easy area, location, parameter
configuration
•
21 CFR Part 11 Compliance
– Secure multi-level log on
•
Cleanroom Classification Wizard
– A few clicks to compliance!
Solutions from
simple, manual
printout operation
to multiple data
integration options
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MET ONE
Leader in Airborne
Particle Counting
Flexible Communications - Wireless
Optional Wireless
802.11 b/g based I/O
for FMS connectivity
MET ONE
Leader in Airborne
Particle Counting
USB connectivity for data
retrieval / communications
3
Wouldn’t Paperless
Be Nice?
Start / stop
sampling
File the print
out
Yes
Tear the
print out
Review the
data
20 years of
paper
storage
Paste the
printout to a
sheet
Need to
retrieve
data?
Yes
Are there
excursions?
Yes
Yes
Photocopy
or scan the
print out
No
Generate
manual
reports
Is data
entry
accurate?
Enter data
into Lims
No
Manual
retrieval
Enter
correct data
4
MET ONE
Leader in Airborne
Particle Counting
Hach Eliminates
Paper & Wasted Time
Start / stop
sampling
File the print
out
Yes
Tear the
print out
Review the
data
20 years of
paper
storage
Paste the
printout to a
sheet
Need to
retrieve
data?
Yes
Are there
excursions?
Yes
Yes
Photocopy
or scan the
print out
No
Generate
manual
reports
Is data
entry
accurate?
Enter data
into Lims
No
Manual
retrieval
Enter
correct data
5
MET ONE
Leader in Airborne
Particle Counting
Traditional Printout / Spreadsheets
-- Basic Data Printouts --
Paper-based procedures, data acquisition, data entry and reporting
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MET ONE
Leader in Airborne
Particle Counting
Automate data collection, entry, analysis
& reporting
Eliminates all of these!
• Manual handling of paper tape
• Manual processing of sampling recipe
• Manual entry & validation of results
• Storage space for about 20 years of data
• Data entry errors
• Difficulty of accessing historical data
• Separate reports for alarms & excursions
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MET ONE
Leader in Airborne
Particle Counting
Automate data collection, entry, analysis
& reporting
Six choices
•
Download utility [PortAll]
•
Mobile EM with wireless transfer to server [MODA]
•
OPC Server standalone
•
OPC Server into 3rd Party software such as LIMS, SCADA, etc
•
Standalone for small systems, up to 20 counters [enVigil Lite]
•
UVO software for Process Monitoring and EM
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MET ONE
Leader in Airborne
Particle Counting
Hach PortAll Version 2.4 Software
•
Organize, archive and report particle count data
– Intuitive, easy-to-use software
•
Paperless, secure data transfer in a 21 CFR Part 11 environment
– Supports Ethernet, wireless and serial communications
– Supports encrypted file transfer via memory stick
•
Easy Report Generation
– Create ISO 14644, EU GMP Annex 1 and FS209E Cleanroom Reports
– Export reports to locked PDF file format suitable for LIMS archival
MET ONE Compliance Workflow Software
Direct Paperless Data Acquisition
The MET ONE CWS software provides
seamless integration with the MET ONE 3400
series airborne particle counters eliminating
the need for paper tape output, saving,
valuable operator time and reducing the risk
of error.
21 CFR Part 11 Compliance
now part of LONZA
MET ONE
Leader in Airborne
Particle Counting
10
Hach integrates portable counters to your
LIMS using our OPC Server
Optional
Met One OPC Server
Business network
Sensor Control
& OPC Server
Customer
Database
Sensor network
Portables accessed via
MODBUS / TCP
(LIMS, etc)
Database
Historical data only
Data from portables
Paper data & PDF files
via Crystal Reports
Crystal
Reports
11
MET ONE
Leader in Airborne
Particle Counting
Automate Data
collection with
Met One 3400
Automate Data
Analysis &
Reporting
Automate Data
Entry
Connect via Ethernet
Or
Customer
Database
(LIMS, etc)
Connect via wireless
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MET ONE
Leader in Airborne
Particle Counting
Low-cost, Simple enVigil Lite 2
for Aseptic Production Monitoring
Ethernet
RS-485
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MET ONE
Leader in Airborne
Particle Counting
13
Complete Facility Monitoring Systems for
Integration of Portable and Fixed Counters
Client # 1
Fill Line A
Client # 2
Fill Line B
Ethernet
RS-485
Server/client with
database
Ethernet or RS-485
Grade C & D
monitoring
Fill Line B
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MET ONE
Leader in Airborne
Particle Counting
15
MET ONE
Leader in Airborne
Particle Counting
15
Meets ISO 21501-4 Calibration Standard
Designed to fully comply with ISO 21501-4 calibration standard for data
accuracy and consistency between counters
“The purpose of ISO 21501 is to
provide a calibration procedure and
verification method for particle
counters, so as to minimize the
inaccuracy in the measurement
result by a counter, as well as the
differences in the results measured
by different instruments”
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MET ONE
Leader in Airborne
Particle Counting
Air Particle Counter Calibration
ISO 21501 and ISO 14644 - the link to GMP
•
Regulators inspect to EU GMP, which
calls up ISO14644
•
Next revision ISO14644 will refer to
ISO21501-4
•
ISO 21501-4 states – “Instruments that
conform to this part of ISO 21501 are
used for the classification of air
cleanliness in cleanrooms and
associated controlled environments in
accordance with ISO 14644-1”
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MET ONE
Leader in Airborne
Particle Counting
ISO 21501 Calibration Standard
• Improved compliance
– Removes ambiguity by providing a single internationally recognized
standard method for calibration
– Harmonization between ISO and GMP guidance
• Improved unit-to-unit reproducibility
– All particle counters are referenced to a “gold” standard
• Improved counting accuracy
– Reduces false alarms in Grade A areas
All current Met One particle counters from Hach may be calibrated
using ISO 21501 at your facility
For further information go to: www.iso21501.com
Or email: iso21501@hach.com
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MET ONE
Leader in Airborne
Particle Counting
Met One 3400
Portable Air Counter
19
MET ONE
Leader in Airborne
Particle Counting
19
Intuitive User Interface!
Test wizard for standards compliance
•
Wizard to conduct pass/fail test for
ISO, EU-GMP Annex I, FS 209E
and BS5295 standards
•
No expertise in standards required.
Few clicks to compliance
•
The wizard guides an operator step
by step to sample data, process
data and product reports
20
MET ONE
Leader in Airborne
Particle Counting
Intuitive User Interface!
Improved group management
•
Group is a collection of desired
sampling parameters
•
New group can be created or
existing group can be loaded
•
A location can be added to or
removed from a group
•
‘Settings’ button allows preselecting sampling parameters
such as sampling time, delay, hold
time, count and environmental
alarm, etc.
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MET ONE
Leader in Airborne
Particle Counting
Intuitive User Interface!
21 CFR Part 11 compliance: unique user log in
•
Multiple level of user accounts
– Basic (no log in)
– Operator
– Administrator
•
No limits to number of log in
accounts
•
An administrator can create
operator level user account and
assign selective access rights and
group access
22
MET ONE
Leader in Airborne
Particle Counting
Screen Shot - Area/Location Setup
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MET ONE
Leader in Airborne
Particle Counting
Screen Shot – Alarm Settings
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MET ONE
Leader in Airborne
Particle Counting
Screen Shot – Sample Setup
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MET ONE
Leader in Airborne
Particle Counting
Screen Shot – Main Operation Screen
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MET ONE
Leader in Airborne
Particle Counting
Screen Shot – Viewing Past Test Runs
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MET ONE
Leader in Airborne
Particle Counting
Screen Shot – Print Center
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MET ONE
Leader in Airborne
Particle Counting
Screen Shot – Export Data to Thumb Drive
29
MET ONE
Leader in Airborne
Particle Counting
Screen Shot – System Status Screen
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MET ONE
Leader in Airborne
Particle Counting
Copy Programming from Unit-to-Unit
Just 15 seconds to replicate
31
MET ONE
Leader in Airborne
Particle Counting
Case Study:
Sanofi, Swiftwater PA
Delivering on our claims regarding
the Flexibility of the Met One 3400
32
MET ONE
Leader in Airborne
Particle Counting
Create Batch ID
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MET ONE
Leader in Airborne
Particle Counting
Beep Functionality
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MET ONE
Leader in Airborne
Particle Counting
Definition of Alarms
35
MET ONE
Leader in Airborne
Particle Counting
Select from six user configurable
reasons for the alarm
36
MET ONE
Leader in Airborne
Particle Counting
Gas Selection
User option to select the gas to be analyzed (Air, N2, Ar, He, CO2)
that applies a correction factor to the flow rate calculation.
37
MET ONE
Leader in Airborne
Particle Counting
Storage of Partial Data
The Storage of Partial Data, enabled by the user, will automatically
store aborted samples (manually stopped or due to Flow Error.)
38
MET ONE
Leader in Airborne
Particle Counting
10 Users
50 Users
39
MET ONE
Leader in Airborne
Particle Counting
Standard Shipment Includes
Item Number
Description
1
3400 series particle counter
2
Rechargeable Battery (1 unit)
3
AC adapter
4
Power cord US
5
Power cord EU
6
Thermal printer paper (2 rolls)
7
Clamp, isokinetic probe holder
8
Tripod, isokinetic probe holder
9
Isokinetic probe
10
Extension tubing for isokinetic probe
11
Zero count filter
12
RS 485 connector assembly
13
USB drive (1 unit)
14
Intake cleaning brush
15
Wireless antenna for optional Wi-Fi Unit
16
Stylus for touch screen interface
40
MET ONE
Leader in Airborne
Particle Counting
MET ONE will program your
Air Particle Counters
41
MET ONE
Leader in Airborne
Particle Counting
MET ONE will set-up your Air Particle Counters
After programming your new fleet of particle counters – we will hand
you your new set of keys to your site specific programming
42
MET ONE
Leader in Airborne
Particle Counting
New Enhanced MET ONE 3400
•
Flexible Communications
•
– Wireless, Ethernet, serial and USB
•
Compliance Setup Wizard
– A few clicks to compliance for
ISO14644, EU GMP Annex 1 and
FS 209E
•
Seamless connectivity to data
management software
– OPC server enabled open
communication architecture
•
Intuitive user interface
– Easy area, location, operating
parameter
21CFR Part 11 compliance
– Secure multi-level logon, secure
data transfer
•
Unit-to-unit accuracy and
reproducibility
– Assured through ISO 21501
compliance
•
Long continuous operation
– Dual hot-swappable batteries
•
Now available in 1 CFM, 50 LPM
and 100 LPM flow rates
– Optimized for your application
43
MET ONE
Leader in Airborne
Particle Counting
Automation Solutions
PortAll
enVigil Lite
OPC Server
UVO
Cleanroom Classification
●
●
●
Environmental Monitoring
●
●
●
■
■
■
Aseptic Production Monitoring
● = only data storage and report generation, NVP sampling controlled by 3400 Series Wizards
44
MET ONE
Leader in Airborne
Particle Counting
Thank you !!
Joe Gecsey
Chris Syrengelas
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MET ONE
Leader in Airborne
Particle Counting
45