Project
Management
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Software
Particle Counters
Accessories
Support
Services
Project
Management
Software
Particle Counters
Accessories
Support
Services
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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Project
Management
Software
Particle Counters
Accessories
Support
Services
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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Project
Management
Hach FMS Solutions
Project Management
Software
Particle Counters
Accessories
Service and Support
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Software
Particle Counters
Accessories
Support
Services
Project
Management
Software
Particle Counters
Project Management
systematic process
system design
industry guidelines
global professional dedicated team
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Accessories
Support
Services
Project
Management
Software
Particle Counters
Accessories
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
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Support
Services
Project
Management
Software
Particle Counters
FMS Pharmaceutical Installations
Over 250 sites worldwide including:
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Accessories
Support
Services
Project
Management
Software
Particle Counters
Software
Met One FMS Online
Met One Lite
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Accessories
Support
Services
Project
Management
Software
Particle Counters
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
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Accessories
Support
Services
Project
Management
Software
Particle Counters
Support
Services
Accessories
Software Types—Quick Comparison
Met One
Lite
21 CFR Part 11
Basic
X
Facility maps
Validation support tools
Met One FMS Online
X
X
Email messaging
X
Professional
Remote
Access 5
Remote Access
Unlimited
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Network: real-time displays
Microsoft® Windows® operating
system
X
Connectivity to other databases
X
X
X
X
X
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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Project
Management
Software
Particle Counters
Accessories
Support
Services
Software Types—Quick Comparison
Met One FMS Online
Met One
Lite
Update manifold sequences
Basic
Professional
Remote
Access 5
Remote
Access
Unlimited
X
X
X
X
Number of sample points
<20
350
4096
4096
4096
Number of instant graphs
1
Unlimited
Unlimited
Unlimited
Unlimited
Number of simultaneous graphs
1
Unlimited
Unlimited
Unlimited
Unlimited
Statistical measurement
X
X
X
X
X
Statistical alarms
X
X
X
X
X
Alarm delays
X
X
X
X
Manual entry measurement
X
X
X
X
Option
Option
Web-based client
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Project
Management
Software
Particle Counters
Accessories
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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Support
Services
Project
Management
Software
Particle Counters
Accessories
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
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Support
Services
Project
Management
Software
Particle Counters
Accessories
Met One FMS Online Features
•
•
•
•
•
•
•
•
•
Supports 21 CFR Part 11
Facility maps
Validation support tools
Email messaging
Network: real-time displays
Connect to other databases
Alarm limit lines on graphs
More than 8 pens on graph
Update manifold sequences
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X
X
X
X
Remote Access
ODBC
X
X
X
Support
Services
Project
Management
Software
Particle Counters
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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Accessories
Support
Services
Project
Management
Software
Particle Counters
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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Accessories
Support
Services
Project
Management
Software
Particle Counters
Accessories
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
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Support
Services
Project
Management
Software
Particle Counters
Accessories
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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Support
Services
Project
Management
Software
Particle Counters
Accessories
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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Support
Services
Project
Management
Software
Particle Counters
Accessories
Support
Services
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)
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Project
Management
Software
Particle Counters
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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Accessories
Support
Services
Project
Management
Software
Particle Counters
Particle Counters
remote particle counters
sequential particle counters
portable particle counters
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Accessories
Support
Services
Project
Management
Software
Particle Counters
Accessories
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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Support
Services
Project
Management
Software
Particle Counters
Accessories
Support
Services
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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Project
Management
Software
Particle Counters
Accessories
Support
Services
Cleanroom Standards
CLASS
ISO 14644-1 FED STD 209E
Number of Particles per Cubic Meter by Micrometer Size
ISO Class
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
ISO 6
1,000,000
237,000
2
102,000
3
1
M1.5
4
10
M2.5
5
100
M3.5
6
1,000
M4.5
7
10,000
M5.5
100,000
M6.5
29
8,320
293
ISO 7
352,000
83,200
2,930
ISO 8
3,520,000
832,000
29,300
8
35,200,000 8,320,000
293,000
9
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Metric
1
35,200
ISO 9
English
Project
Management
Software
Particle Counters
Accessories
Support
Services
Airborne Particle Counters
Types
• Remotes
6000 / 7000
• Portables
3400 / 3411
• Sequential
2432 (with 3400)
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ISO 21501 compliant
Project
Management
Software
Particle Counters
Accessories
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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Support
Services
Project
Management
Software
Particle Counters
Accessories
Support
Services
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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Project
Management
Software
Particle Counters
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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Accessories
Support
Services
Project
Management
Software
Particle Counters
Accessories
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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Support
Services
Project
Management
Software
Particle Counters
Accessories
Support
Services
Comparison of
Particle Counting Methods
100
90
Manual
80
70
Sequential
60
Continuous
50
40
30
20
10
0
Flexibility
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Initial Cost
Daily Labor
Calibration
Quality of data
Project
Management
Software
Particle Counters
Accessories
sampling probes
environmental sensors
I/O systems
wall plates
power and vacuum
communications
analog inputs and outputs
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Accessories
Support
Services
Project
Management
Software
Particle Counters
Accessories
Support
Services
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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Project
Management
Software
Types of Accessories
Environmental sensors
• Temperature
• Relative humidity
• Differential pressure
• Air velocity
Sampling probes
• Isokinetic
• Various materials
• Mounting options
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Particle Counters
Accessories
Support
Services
Project
Management
Software
Particle Counters
Accessories
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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Support
Services
Project
Management
Software
Particle Counters
Accessories
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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Support
Services
Project
Management
Software
Particle Counters
Support Services
full service agreement
validation
maintenance/calibration
audits/data analysis
training
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support
Accessories
Support
Services
Project
Management
Software
Particle Counters
Accessories
Support
Services
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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Project
Management
Software
Particle Counters
Accessories
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
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Support
Services
Project
Management
Software
Particle Counters
Accessories
Support
Services
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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Project
Management
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Software
Particle Counters
Accessories
Support
Services