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Why Monitor?

Why Monitor?. Provide information for regulators Verify critical environmental conditions to maximize yield and quality Monitor and capture data of product quality Alert personnel of significant changes or problems in these critical measurements

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Why Monitor?

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  1. Why Monitor? • Provide information for regulators • Verify critical environmental conditions to maximize yield and quality • Monitor and capture data of product quality • Alert personnel of significant changes or problems in these critical measurements • Generate reports and summaries for external customers to meet contract goals

  2. Why FMS? • Helps assure that the environment surrounding the process and product is in good control throughout the operations • Signals responsible personnel to take corrective action at any deviation from the acceptable range • Provides historical records to prove to customer or regulatory authorities that control of critical areas has been maintained during the process.

  3. Hach FMS Solutions • Project Management Software Particle Counters Accessories Service and Support

  4. Project Management systematic process system design industry guidelines global professional dedicated team

  5. Project Management • Systematic process of steps • Assess, specify, implement, commission, support • Process tailored to meet specific situation • System design • Get what you need—project scope, layout and functional specifications defined • Based on industry guidelines • ISO, GMP, GAMP • Global professional, dedicated team • Local support • Software integrators, system engineers, calibration/test technicians

  6. FMS Pharmaceutical Installations • Over 250 sites worldwide including:

  7. Software • Met One FMS Online Met One Lite

  8. Software • Glue for your FMS—holds system together • Range of solutions • Reliable quality code • Application-specific • Compatible with instrumentation • Air particle counters • Alarm indicators • Environmental sensors • Analog inputs • Digital inputs/outputs • Turn data into useful information

  9. Software Types—Quick Comparison

  10. Software Types—Quick Comparison

  11. Met One FMS Online Benefits • Validation/Documentation Support Tools • Saves time and money • Reduce validation time by 50 % to 60% • Each node can have a unique operator view • Operator can focus on his area or task • Rapid communication of system status • Batch driven data collection • Data capture, display, retrieval and reporting based on user assigned IDs

  12. Met One FMS Online Benefits • Customized operator view • Operator can quickly understand if parameters are within limits • Provides opportunity for a cohesive FMS system • Accepts measurements from many sources • Focused information can be sent to different departments • Transform data into meaningful information • Trend analysis • Preparation of historical reports • Automatic batch report generation

  13. Met One FMS Online Features • Supports 21 CFR Part 11 X • Facility maps X • Validation support tools X • Email messaging X • Network: real-time displays Remote Access • Connect to other databases ODBC • Alarm limit lines on graphs X • More than 8 pens on graph X • Update manifold sequencesX

  14. 21 CFR Part 11 and Validation • Access and Security • Audit Trail of Changes • Data Availability • Revision Controls • Digital Signatures • Data Security • System Validation Tools • IQ/OQ • Document Generator • Validation Test Log

  15. Create Custom User Displays • Facility maps • Unlimited number • Create diagram or import from existing drawings • Equipment diagrams or photos • JPG, GIF or other formats • Help operator visualize sensor position

  16. Met One FMS Online Software Versions • Standalone • Basic, Professional • Network Versions • Remote Access – 5 users • Remote Access – unlimited • Remote Access versions • Remote Access – 5 users on multiple computers • 5 active seats at any moment • Remote Access – unlimited

  17. Sample Configuration Diagrams • Simple networked system • Networked system with Ethernet Counters • Met One FMS Online Remote Access • Met One FMS Online Standalone via local network or • remote • Met One FMS Online Standalone

  18. Met One FMS Online Options • Met One FMS Online Alert • Multiple recipients for each alarm message • Modem dial out—pagers and voice messaging • Voice messages—PA systems or computer • Met One FMS Online Recall • Historical reporting to another computer(s) • License required for each computer • Historical information; not "real-time”

  19. Met One FMS Lite • Features and Benefits • Configure a compliant monitoring system in minutes utilizing an easy-to-use wizard. • Monitors up to 20 locations on a single screen • Provide secure operations using Windows user names and passwords • Includes system validation documents • Reporting and data export • Supports alarm panels • Supports digital IO and analog environmental sensors (RH/Temp, Delta P)

  20. Met One FMS Lite • System Description • Continuous measurement of particle counts • Remote start/stop of particle counters • Alarm output to indicator devices • Audit trail recording • Secure user interface • Trend views of live and historical data • Tabular reports of historical data • 21 CFR part 11 compliant

  21. Particle Counters remote particle counters sequential particle counters portable particle counters

  22. Why use a Particle Counter ? • FDA cGMP or EU GMP compliance • Particle monitoring is required • Verify results of changes in cleanroom design • Addition or reduction of ceiling filters • Changes to shields or walls around equipment • Test for extent and nature of particles generated • Monitor operator as stoppers are added • Check conveyor belts for shedding

  23. Factors Determining Sampling Points • Size of cleanroom • Critical nature of the process • Nature of the airflow (turbulent or unidirectional) • Industry norms • Regulatory guidelines / requirements

  24. Cleanroom Standards

  25. Airborne Particle Counters • Types • Remotes 6000 / 7000 • Portables 3400 / 3411 • Sequential 2432 (with 3400) ISO 21501 compliant

  26. Remote Counters Address… • Transient events occur in the best designed cleanrooms • Lack of confidence in control of environment • Manual methods inefficient—Operator must be in the right place at the right time • Continuous sampling improves likelihood of recording transient events

  27. Benefits of Remote Counters • Detect transient events using continuous sampling • Mount close to sample point for optimum results • Operate 24/7/365 • Optimize disinfection and minimize outgassing • Place in critical areas without compromising the environment

  28. Long Life Laser Technology • 10+ years average lifespan • Longer laser life = lower cost of ownership • 3 years standard and up to 5 year extended warranty

  29. Portable and Sequential Counters • Increased frequency of sampling compared to manual methods • Enhanced quality and quantity of particle data • Sequential monitoring samples several locations with one central counter • Trend cleanliness levels for QA or external customers • Designed for 24/7/365 operation

  30. Comparison of Particle Counting Methods

  31. Accessories sampling probes environmental sensors I/O systems power and vacuum wall plates communications analog inputs and outputs

  32. Accessories • One source for complete system monitoring • Complete connectivity between FMS sensors and alarms • Environmental control • Optimum sampling • Communication links • Flexibility of configuration • Mounting options to permanently or temporarily place in awkward areas

  33. Types of Accessories • Environmental sensors • Temperature • Relative humidity • Differential pressure • Air velocity • Sampling probes • Isokinetic • Various materials • Mounting options

  34. Types of Accessories • Communications • Protocol converters • Example: USB to RS-485, Ethernet to RS-485 • Analog inputs and control outputs • Analog inputs • Digital inputs • Alarm indicators

  35. Types of Accessories • I/O Systems • Programmable Logic Controller (PLC) • PD I/O modules • Wall plates and junction boxes • Connection to power, vacuum and other utilities • Power and vacuum • Power supplies • Vacuum pumps

  36. Support Services full service agreement validation maintenance/calibration audits/data analysis training support

  37. Support Services • Full Service Agreement (FSA) • Repair, maintenance, calibration and validation • Total confidence in the performance of your instruments • Significantly reduce instrument downtime, labor and stocking of needless spare and consumable parts. • Maintenance/calibration contract • Eliminate the hassle of performing your own regular maintenance • Extend the operational life of your system • Validation • Meet regulations and expand resources • IQ/OQ documentation

  38. Support Services • Audits/data analysis • Improve your processes and procedures • Enhance information flow • Optimize your operations; save time and money • Training • Refresh learning and expand knowledge to keep up with current practices • Support • Prompt, effective response to questions and service needs

  39. FMS Summary • Met One offers… • The experience needed to manage your project • The data collection and management systems you require • “Best in class” particle counters • A wide spectrum of accessory items • A global support team for long term, expert service

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