why monitor?

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Software Particle Counters Accessories Support Services

Project Management

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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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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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Project Management

Hach FMS Solutions

Project Management

Software

Particle Counters

Accessories

Service and Support

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Project Management

Project Managementsystematic process

industry guidelines

global professional dedicated team

system design

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Project Management

Project ManagementSystematic 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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Project Management

FMS Pharmaceutical Installations

Over 250 sites worldwide including:

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Project Management

Software

Met One FMS Online

Met One Lite

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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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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 XFacility maps X X X XValidation support tools X X X XEmail messaging X X X X

Network: real-time displays X XMicrosoft® Windows® operating system X X X X X

Connectivity to other databases X X X X

Alarm limit lines on graphs X X X X XMore than 4 pens on graphs X X X X X

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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 UnlimitedStatistical 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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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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Project Management

Met One FMS Online BenefitsCustomized 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

departmentsTransform data into meaningful information

• Trend analysis• Preparation of historical reports• Automatic batch report generation

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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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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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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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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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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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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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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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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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Project Management

Particle Counters

remote particle counters

portable particle counters

sequential particle counters

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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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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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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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Project Management

Airborne Particle Counters

Types• Remotes

6000 / 7000

• Portables3400 / 3411

• Sequential 2432 (with 3400)

ISO 21501 compliant

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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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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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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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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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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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Project Management

Accessories

environmental sensors

sampling probes

analog inputs and outputs

communications

I/O systems

wall plates power and vacuum

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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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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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Project Management


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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Project Management


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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Project Management

Support Services

audits/data analysis

full service agreement

support

maintenance/calibration

training

validation

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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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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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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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Project Management

why monitor?

Documents

fms onlinemet

fms online standalone

remote met

remote access met

system engineers

quality monitor

room aclient

room cclient