Page–1 Software Particle Counters Accessories SupportServicesProjectManagement

Page–2 Software Particle Counters Accessories SupportServicesProjectManagement 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

Page–3 Software Particle Counters Accessories SupportServicesProjectManagement 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.

Page–4 Software Particle Counters Accessories SupportServicesProjectManagement Hach FMS Solutions Project Management Software Particle Counters Accessories Service and Support

Page–5 Software Particle Counters Accessories SupportServicesProjectManagement Project Management systematic process industry guidelines global professional dedicated team system design

Page–6 Software Particle Counters Accessories SupportServicesProjectManagement 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

Page–7 Software Particle Counters Accessories SupportServicesProjectManagement FMS Pharmaceutical Installations Over 250 sites worldwide including:

Page–8 Software Particle Counters Accessories SupportServicesProjectManagement Software Met One FMS Online Met One Lite

Page–9 Software Particle Counters Accessories SupportServicesProjectManagement 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

Page–10 Software Particle Counters Accessories SupportServicesProjectManagement Software Types—Quick Comparison Met One Lite Met One FMS Online BasicProfessional Remote Access 5 Remote Access Unlimited 21 CFR Part 11 XXXX Facility maps XXXX Validation support tools XXXX messaging XXXX Network: real-time displays XX Microsoft® Windows® operating system XXXXX Connectivity to other databases XXXX Alarm limit lines on graphs XXXXX More than 4 pens on graphs XXXXX

Page–11 Software Particle Counters Accessories SupportServicesProjectManagement Software Types—Quick Comparison Met One Lite Met One FMS Online BasicProfessionalRemote Access 5 Remote Access Unlimited Update manifold sequences XXXX Number of sample points < Number of instant graphs 1Unlimited Number of simultaneous graphs 1Unlimited Statistical measurement XXXXX Statistical alarms XXXXX Alarm delays XXXX Manual entry measurement XXXX Web-based client Option

Page–12 Software Particle Counters Accessories SupportServicesProjectManagement 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

Page–13 Software Particle Counters Accessories SupportServicesProjectManagement 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

Page–14 Software Particle Counters Accessories SupportServicesProjectManagement Met One FMS Online Features Supports 21 CFR Part 11 X Facility maps X Validation support tools X 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 sequences X

Page–15 Software Particle Counters Accessories SupportServicesProjectManagement 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

Page–16 Software Particle Counters Accessories SupportServicesProjectManagement 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

Page–17 Software Particle Counters Accessories SupportServicesProjectManagement 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

Page–18 Software Particle Counters Accessories SupportServicesProjectManagement 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

Page–19 Software Particle Counters Accessories SupportServicesProjectManagement Simple Networked System CLIENT# 1 Room A CLIENT# 2 Room B CLIENT# 3 Room C CLIENT# 4 Room D PLC / POD Counter with manifold Met One Serial 6015 or similar Remote Counters Server/client with database 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 USB to RS-485 Convertor

Page–20 Software Particle Counters Accessories SupportServicesProjectManagement Networked System with Ethernet Counters CLIENT# 1 Room A Counter with manifold Ethernet Remote Counters Met One 7015 or similar Server/client with database 7015 POD CLIENT# 2 Room B EtherNet POD 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

Page–21 Software Particle Counters Accessories SupportServicesProjectManagement Met One FMS Online Remote Access Access to real-time data via Local Network or from Remote Site 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 Met One FMS Online Server FMS Alerts

Page–22 Software Particle Counters Accessories SupportServicesProjectManagement Met One FMS Online Remote Access Analog inputs such as RH and Temp Digital signal outputs for alarm lights or audible alarms 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 Met One FMS Online RA Server Particle Counters

Page–23 Software Particle Counters Accessories SupportServicesProjectManagement Met One FMS Online Standalone 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 Analog inputs such as RH and Temp Digital signal outputs for alarm lights or audible alarms Particle Counters Met One FMS Online Standalone Server

Page–24 Software Particle Counters Accessories SupportServicesProjectManagement 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”

Page–25 Software Particle Counters Accessories SupportServicesProjectManagement 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)

Page–26 Software Particle Counters Accessories SupportServicesProjectManagement 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

Page–27 Software Particle Counters Accessories SupportServicesProjectManagement remote particle counters portable particle counters sequential particle counters

Page–28 Software Particle Counters Accessories SupportServicesProjectManagement 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

Page–29 Software Particle Counters Accessories SupportServicesProjectManagement Factors Determining Sampling Points Size of cleanroom Critical nature of the process Nature of the airflow (turbulent or unidirectional) Industry norms Regulatory guidelines / requirements

Page–30 Software Particle Counters Accessories SupportServicesProjectManagement Cleanroom Standards

Page–31 Software Particle Counters Accessories SupportServicesProjectManagement Airborne Particle Counters Types Remotes 6000 / 7000 Portables 3400 / 3411 Sequential 2432 (with 3400) ISO compliant

Page–32 Software Particle Counters Accessories SupportServicesProjectManagement 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

Page–33 Software Particle Counters Accessories SupportServicesProjectManagement 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

Page–34 Software Particle Counters Accessories SupportServicesProjectManagement 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

Page–35 Software Particle Counters Accessories SupportServicesProjectManagement 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

Page–36 Software Particle Counters Accessories SupportServicesProjectManagement Comparison of Particle Counting Methods

Page–37 Software Particle Counters Accessories SupportServicesProjectManagement Accessories environmental sensors sampling probes analog inputs and outputs communications I/O systems wall plates power and vacuum

Page–38 Software Particle Counters Accessories SupportServicesProjectManagement 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

Page–39 Software Particle Counters Accessories SupportServicesProjectManagement Types of Accessories Environmental sensors Temperature Relative humidity Differential pressure Air velocity Sampling probes Isokinetic Various materials Mounting options

Page–40 Software Particle Counters Accessories SupportServicesProjectManagement 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

Page–41 Software Particle Counters Accessories SupportServicesProjectManagement 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

Page–42 Software Particle Counters Accessories SupportServicesProjectManagement Support Services audits/data analysis full service agreement support maintenance/calibration training validation

Page–43 Software Particle Counters Accessories SupportServicesProjectManagement 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

Page–44 Software Particle Counters Accessories SupportServicesProjectManagement 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

Page–45 Software Particle Counters Accessories SupportServicesProjectManagement 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

Page–46 Software Particle Counters Accessories SupportServicesProjectManagement