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

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

Flexible Communications - Wireless Optional Wireless 802.11 b/g based I/O for FMS connectivity USB connectivity for data retrieval / communications

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

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

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

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

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

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

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

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

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

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

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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”

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” 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 21501 is the new standard and it is related to ISO14644 and the GMP. 17

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 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 21501 calibration on site, at your facility. For further information go to: www.iso21501.com Or email: iso21501@hach.com

Met One 3400 Portable Air Counter 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

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.

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

Screen Shot - Area/Location Setup

Screen Shot – Alarm Settings

Screen Shot – Sample Setup

Screen Shot – Main Operation Screen

Screen Shot – Viewing Past Test Runs

Screen Shot – Print Center

Screen Shot – Export Data to Thumb Drive

Screen Shot – System Status Screen

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

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

Create Batch ID

Beep Functionality

Definition of Alarms

Select from six user configurable reasons for the alarm

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.

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.)

50 Users 10 Users

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

MET ONE will program your Air Particle Counters

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

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

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

Thank you !! Joe Gecsey Chris Syrengelas 45