1. Enhanced MET ONE 3400 Series Portable Airborne Particle Counters
November 15, 2010

2. 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

3. Flexible Communications - Wireless
Optional Wireless b/g based I/O for FMS connectivity
USB connectivity for data retrieval / communications

4. 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
Manual retrieval
Is data entry accurate?
Enter data into Lims
Enter correct data No

5. 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
Manual retrieval
Is data entry accurate?
Enter data into Lims
Enter correct data No

6. Traditional Printout / Spreadsheets -- Basic Data Printouts --
Paper-based procedures, data acquisition, data entry and reporting

7. 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

8. 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

9. 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

10. 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

11. Hach integrates portable counters to your LIMS using our OPC Server
Customer
Database
(LIMS, etc)
Business network
Historical data only
Optional
Met One OPC Server
Sensor Control & OPC Server
Sensor network
Portables accessed via MODBUS / TCP
Database
Data from portables
Crystal Reports
Paper data & PDF files via Crystal Reports

12. Automate Data collection with Met One 3400
Automate Data Analysis & Reporting
Automate Data Entry
Connect via Ethernet
Customer
Database
(LIMS, etc) Or
Connect via wireless

13. Low-cost, Simple enVigil Lite 2 for Aseptic Production Monitoring
Ethernet
RS-485 13

14. Server/client with database
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
Example of a complex system
UVO or Envigil FMS.
Remote class A/B
Portable classification
Manifold class C/D
T°C/RH%/velocity/DP = 4/20ma sensor driven through a converter
One server connected to many client PC’s
All in one!
Ethernet or RS-485
Grade C & D monitoring
Fill Line B

15. 15

16. Meets ISO 21501-4 Calibration Standard
Designed to fully comply with ISO calibration standard for data accuracy and consistency between counters
“The purpose of ISO 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”

17. 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 ISO
ISO states – “Instruments that conform to this part of ISO are used for the classification of air cleanliness in cleanrooms and associated controlled environments in accordance with ISO ”
Calibration is the act of determining which voltage corresponds to a particle of a given size. Recently, ISO has developed a standard method for calibrating a optical air particle counter. ISO is the new standard and it is related to ISO14644 and the GMP. 17

18. 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 at your facility
So, the major benefits of ISO21501 include:
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
And, Hach is the ONLY company that can deliver a fully ISO calibration on site, at your facility.
For further information go to: Or

19. Met One 3400 Portable Air Counter19

20. 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

21. 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 pre-selecting sampling parameters such as sampling time, delay, hold time, count and environmental alarm, etc.

22. 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

23. Screen Shot - Area/Location Setup

24. Screen Shot – Alarm Settings

25. Screen Shot – Sample Setup

26. Screen Shot – Main Operation Screen

27. Screen Shot – Viewing Past Test Runs

28. Screen Shot – Print Center

29. Screen Shot – Export Data to Thumb Drive

30. Screen Shot – System Status Screen

31. Copy Programming from Unit-to-Unit
Just 15 seconds to replicate

32. Case Study: Sanofi, Swiftwater PA
Delivering on our claims regarding the Flexibility of the Met One 3400

33. Create Batch ID

34. Beep Functionality

35. Definition of Alarms

36. Select from six user configurable reasons for the alarm

37. 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.

38. 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.)

39. 50 Users
10 Users

40. 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

41. MET ONE will program your Air Particle Counters

42. 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

43. 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 compliance
Long continuous operation
Dual hot-swappable batteries
Now available in 1 CFM, 50 LPM and 100 LPM flow rates
Optimized for your application

44. 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

45. Thank you !! Joe Gecsey Chris Syrengelas45