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Software Particle Counters AccessoriesSupport Services
Project Management
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Software Particle Counters AccessoriesSupport Services
Project Management
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
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Software Particle Counters AccessoriesSupport Services
Project Management
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.
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Software Particle Counters AccessoriesSupport Services
Project Management
Hach FMS Solutions
Project Management
Software
Particle Counters
Accessories
Service and Support
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Software Particle Counters AccessoriesSupport Services
Project Management
Project Management
systematic process
industry guidelines
global professional dedicated team
system design
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Software Particle Counters AccessoriesSupport Services
Project Management
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 definedBased on industry guidelines
• ISO, GMP, GAMPGlobal professional, dedicated team
• Local support• Software integrators, system engineers, calibration/test
technicians
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Software Particle Counters AccessoriesSupport Services
Project Management
FMS Pharmaceutical Installations
Over 250 sites worldwide including:
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Software Particle Counters AccessoriesSupport Services
Project Management
Software
Met One FMS Online
Met One Lite
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Software Particle Counters AccessoriesSupport Services
Project Management
SoftwareGlue for your FMS—holds system togetherRange of solutionsReliable quality codeApplication-specificCompatible with instrumentation
• Air particle counters• Alarm indicators • Environmental sensors• Analog inputs• Digital inputs/outputs
Turn data into useful information
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Software Particle Counters AccessoriesSupport Services
Project Management
Software Types—Quick ComparisonMet One
Lite
Met One FMS Online
Basic Professional Remote Access 5
Remote Access Unlimited
21 CFR Part 11 X X X X
Facility maps X X X X
Validation support tools X X X X
Email messaging X X X X
Network: real-time displays X X
Microsoft® Windows® operating system X X X X X
Connectivity to other databasesX X X X
Alarm limit lines on graphs X X X X X
More than 4 pens on graphs X X X X X
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Software Particle Counters AccessoriesSupport Services
Project Management
Software Types—Quick ComparisonMet One
Lite
Met One FMS Online
Basic Professional Remote Access 5
Remote Access
UnlimitedUpdate manifold sequences X X X X
Number of sample points <20 350 4096 4096 4096
Number of instant graphs 1 Unlimited Unlimited Unlimited UnlimitedNumber of simultaneous graphs 1 Unlimited Unlimited Unlimited Unlimited
Statistical measurement X X X X XStatistical alarms X X X X XAlarm delays X X X XManual entry measurement X X X XWeb-based client Option Option
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Software Particle Counters AccessoriesSupport Services
Project Management
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
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Software Particle Counters AccessoriesSupport Services
Project Management
Met One FMS Online Benefits
Customized operator view• Operator can quickly understand if parameters
are within limitsProvides opportunity for a cohesive FMS system
• Accepts measurements from many sources• Focused information can be sent to different
departmentsTransform data into meaningful information
• Trend analysis• Preparation of historical reports• Automatic batch report generation
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Software Particle Counters AccessoriesSupport Services
Project Management
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 sequences X
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Software Particle Counters AccessoriesSupport Services
Project Management
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
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Software Particle Counters AccessoriesSupport Services
Project Management
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
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Software Particle Counters AccessoriesSupport Services
Project Management
Met One FMS Online Software VersionsStandalone
• Basic, ProfessionalNetwork Versions
• Remote Access – 5 users• Remote Access – unlimited
Remote Access versionsRemote Access – 5 users on multiple computers• 5 active seats at any moment
Remote Access – unlimited
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Software Particle Counters AccessoriesSupport Services
Project Management
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
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Software Particle Counters AccessoriesSupport Services
Project Management
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”
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Software Particle Counters AccessoriesSupport Services
Project Management
Met One FMS LiteFeatures 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)
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Software Particle Counters AccessoriesSupport Services
Project Management
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
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Software Particle Counters AccessoriesSupport Services
Project Management
Particle Counters
remote particle counters
portable particle counters
sequential particle counters
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Software Particle Counters AccessoriesSupport Services
Project Management
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
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Software Particle Counters AccessoriesSupport Services
Project Management
Factors Determining Sampling Points
• Size of cleanroom• Critical nature of the process• Nature of the airflow (turbulent or unidirectional)• Industry norms• Regulatory guidelines / requirements
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Software Particle Counters AccessoriesSupport Services
Project Management
6 1,000 M4.5
9
7 10,000 M5.5
8 100,000 M6.5
4 10 M2.5
5 100 M3.5
2
3 1 M1.5
ISO 14644-1 FED STD 209E
1
ISO Class English Metric
CLASS Number of Particles per Cubic Meter by Micrometer Size
0.1 um 0.2 um 0.3 um 0.5 um 1 um 5 um
ISO 1 10 2
ISO 2 100 24 10 4
ISO 3 1,000 237 102 35 8
ISO 4 10,000 2,370 1,020 352 83
ISO 5 100,000 23,700 10,200 3,520 832 29
ISO 6 1,000,000 237,000 102,000 35,200 8,320 293
ISO 7 352,000 83,200 2,930
ISO 8 3,520,000 832,000 29,300
ISO 9 35,200,000 8,320,000 293,000
Cleanroom Standards
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Software Particle Counters AccessoriesSupport Services
Project Management
Airborne Particle Counters
Types• Remotes
6000 / 7000
• Portables3400 / 3411
• Sequential 2432 (with 3400)
ISO 21501 compliant
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Software Particle Counters AccessoriesSupport Services
Project Management
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
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Software Particle Counters AccessoriesSupport Services
Project Management
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
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Software Particle Counters AccessoriesSupport Services
Project Management
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
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Software Particle Counters AccessoriesSupport Services
Project Management
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
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Software Particle Counters AccessoriesSupport Services
Project Management
0
10
20
30
40
50
60
70
80
90
100
Flexibility Initial Cost Daily Labor Calibration Quality of data
Manual
Sequential
Continuous
Comparison of Particle Counting Methods
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Software Particle Counters AccessoriesSupport Services
Project Management
Accessories
environmental sensors
sampling probes
analog inputs and outputs
communications
I/O systems
wall plates power and vacuum
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Software Particle Counters AccessoriesSupport Services
Project Management
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
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Software Particle Counters AccessoriesSupport Services
Project Management
Types of Accessories
Environmental sensors• Temperature• Relative humidity• Differential pressure• Air velocity
Sampling probes• Isokinetic• Various materials• Mounting options
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Software Particle Counters AccessoriesSupport Services
Project Management
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
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Software Particle Counters AccessoriesSupport Services
Project Management
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
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Software Particle Counters AccessoriesSupport Services
Project Management
Support Services
audits/data analysis
full service agreement
support
maintenance/calibration
training
validation
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Software Particle Counters AccessoriesSupport Services
Project Management
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
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Software Particle Counters AccessoriesSupport Services
Project Management
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 practicesSupport
• Prompt, effective response to questions and service needs
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Software Particle Counters AccessoriesSupport Services
Project Management
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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Software Particle Counters AccessoriesSupport Services
Project Management