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Enhanced MET ONE 3400 Series Portable Airborne Particle Counters

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

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Enhanced MET ONE 3400 Series Portable Airborne Particle Counters

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

  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 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 Eliminates all of these!

  8. Automate data collection, entry, analysis & reporting 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 Six choices

  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 Optional Met One OPC Server Customer Database (LIMS, etc) Business network Sensor Control & OPC Server Sensor network Portables accessed via MODBUS / TCP Database Historical data only Data from portables Crystal Reports Paperdata & PDF files via Crystal Reports

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

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

  14. 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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  16. 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” Meets ISO 21501-4 Calibration Standard

  17. Air Particle Counter CalibrationISO 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”

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

  19. Met One 3400Portable Air Counter 19

  20. Intuitive User Interface! • 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 Test wizard for standards compliance

  21. Intuitive User Interface! • 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. Improved group management

  22. Intuitive User Interface! • 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 21 CFR Part 11 compliance: unique user log in

  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. 10 Users 50 Users

  40. Standard Shipment Includes

  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. 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 New Enhanced MET ONE 3400

  44. Automation Solutions ●= only data storage and report generation, NVP sampling controlled by 3400 Series Wizards

  45. Thank you !!Joe GecseyChris Syrengelas 45

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