FACILITY MONITORINGSYSTEM (FMS)
SOLUTIONSPARTICLE MONITORING FOR GMP COMPLIANT
PHARMACEUTICAL MANUFACTURING

MET ONE Facility Monitoring System Solutions

On-line and Portable Particle Counters

Continuous and routine environmental monitoring has never been easier ormore powerful. Beckman Coulter Life Sciences offers a full suite of cleanroom
Facility Monitoring System (FMS) products to enable EU GMP Annex 1, FDA,
and your internal quality system compliance. Utilizing high quality MET ONE air
particle counters, Beckman Coulter FMS integration software packages are easy
to install, set up, validate, and operate. Utilizing years of experience in setting up
complete FMS solutions around the world, our team will work with you to delivera fully operational system on schedule and within your budget.

With innovative designs specifically tailored to address the requirements of thepharmaceutical industry, MET ONE particle counters feature full ISO 21501
compliance in accordance with ISO 14644 standard adoption for all calibration
parameters. Based on open-architecture communications, they integrate easily
with your preferred systems. To make manual monitoring more efficient,
MET ONE portable counters feature testing wizards and automatic, paperlessdata transfer compliant with 21 CFR Part 11. All our counters support 0.5 μm
and 5.0 μm size channels per regulatory requirements and can support 4 to 6
channels to meet industrial cleanroom monitoring requirements.

PARTICLE MONITORING COMPLIANCEMET ONE 3400 SERIES• Nonviable and viable particle monitoring compliant with EU GMP
Annex 1 and FDA 21 CFR Part 11• Available in 28.3, 50, and 100 LPM flow rates that can sample
a full cubic meter of air in as little as 10 minutes.

• Built in Audit Logging• Custom reports to record results• High performance: 0.3/0.5 μm sensitivity counter designed for
ISO 21501 compliance for data accuracy and repeatability• IQ/OQ documentation for simple validation• Flexible communications: ethernet, USB, WiFi and Serial

SCALABLE SOLUTIONS• Small scale, rapidly deployed pre-packaged software and hardware
for isolators and small production line
• Batch workflow system for one or more production lines with several
monitoring points• Custom workflow optimized solutions for monitoring complex
production methods across several production lines

Product Offerings
1. EnVigil PNP
2. UVO+ Standard
3. UVO+ Custom

EASE OF USE• Graphical user interfaces available on the system or via remote
access terminals• Ease of use: Intuitive wizards reduce workload for classificationand compliance• 21 CFR Part 11 Compliance: allows secure USB memory
stick data transfer• Configurable for: portable, on-line or batch use

MET ONE 6000 SERIES• High performance: 0.3/0.5 μm sensitivity counter designed for
ISO 21501 compliance for data accuracy and repeatability• Easy to integrate: multiple communication options allow easy
integration into existing FMS systems• Long life laser diode: reduced downtime and reduced
cost of ownership• Built-in flow meter: ensure data is valid during validationand monitoring• Enhanced end user notification via built in LED:
added assurance of correct sensor operation,
invaluable fault finding tool

• Color coded indication of system status• Alarms clearly identified for acknowledgement• Single click reports to generate auditable records for compliance

2 |Characterized By Ingenuity | 3

On-line and Portable Air Particle Counters

MET ONE Facility Monitoring System: Paperless - Compliance

MET ONE 6000P SERIES• All the enhanced features on the 6000 series counters
and an integrated pump system• Microprocessor controlled flow
• Reduced installation cost - no expensive distributed
vacuum system required• Flexible installation options - remote areas where
vacuum isn’t available

MET ONE 7000 SERIES• High performance: 0.3/0.5 μm sensitivity counter
designed for ISO 21501 compliance for data accuracy
and repeatability

Go from here...
to here...Paperless• Protected sensor: NEMA enclosure with sealed connectors
and flow shut-off valve protects counter internals from
accidental exposure to harmful disinfecting chemicals• Enhanced end user notification via built in LED: added
assurance of correct sensor operation, invaluable fault
finding tool
• Easy to integrate: multiple communication options allow
easy integration into existing FMS systems• Long life laser diode: reduced downtime and reduced costof ownership• Built-in flow meter: ensure data is valid during validationand monitoring

MET ONE MANIFOLD PARTICLE COUNTING SYSTEM• Sampling locations: allows a single 3400 series particle
counter to monitor as many as 32 locations• Continuous flow: uses a high-volume pump for continuous
flow of air through all ports so particles are not lost due tofallout or surface adhesion

4 |MET ONE UVO+ solutions set the standard of scalable on-line particle monitoring
systems. Whether you run limited, short term aseptic manufacturing or multiple
production lines of high-volume filling suites our MET ONE UVO+ platform
adjusts to your specific requirements. Use wireless portables or dedicated on-line
sensors, add environmental sensors or mix them all in a batch-driven style ofoperation. MET ONE UVO+ manages all data for Grade A sterile areas, including
cleanroom classification, pre-production environmental qualification and aseptic
on-line manufacturing.

Characterized By Ingenuity | 5

Scalable Software Solutions

MET ONE UVO+
• Windows-based SCADA (Supervisory Control and Data Acquisition) software based on the use of a real-time
database• Configure a compliant monitoring system inminutes utilizing an easy-to-use wizard• Completely customizable user interface (map of your facility, area or tool)• Monitors up to 20 locations on a single screen• Monitor up to hundreds of locations simultaneously• Supports 21 CFR Part 11 compliance, enabling secure data management• Provide secure operations using Windows usernames and passwords• Integrated secure audit trail• Includes system validation documents• Single user or client-server system• Reporting and data export• Advanced alarming (with acknowledgment), reporting, data display (value tables, trend charts)• Supports alarm panels• Batch-driven data capture, display and reporting• Supports digital IO and analog environmental
sensors (RH/Temp, Delta P)• Industry standard communications protocols (analog, digital, serial, modbus RTU/TCP, OPC)

6 |enVigil PnP

MET ONE DATA MANAGEMENT SERVER• Compatible with all MET ONE air particle counters• Enables capture of enhanced features beyond justparticle counts (flow, calibration dates, location,
batch IDs etc.)• Compatible with most OPC clients• Enable secure data integration to your ERP, BMS,
LIMS or other enterprise network solution• SQL database enables simple integration andreport building (simple reporting available directlyfrom the system)

Characterized By Ingenuity | 7

MET ONE Hardware
MET ONE 3400 PORTABLE AIR PARTICLE COUNTERS
ISO 21501 compliant portable battery-powered air particle counters offered with 0.3 or 0.5 micron sensitivity
at air flow rates up to 100 liters per minute provide you with the confidence that your cleanroom is fully
ISO 14644 compliant.

MET ONE
Solution

MET ONE 6000 SERIES REMOTE PARTICLE COUNTERS
ISO 21501 compliant fixed mount air particle counters offered with 0.3 or 0.5 micron sensitivity at air flow rates up to
28.3 liters per minute provide you with continuous monitoring capabilities that easily integrate with external software
for workflow automation. These units can be integrated into a central vacuum system or provided with an internal
pump for ease of installation.

MET ONE
3400 Simply
Paperless

MET ONE 7000 SERIES REMOTE PARTICLE COUNTERS
All the benefits of the MET ONE 6000 Series remote particle counters available in a NEMA enclosure with sealed
connectors and internal flow shut off valve to prevent unintended contamination when the system is not sampling.

VIABLE AIR SAMPLING HEADSMET ONE
Data
Management
System• Secure PDF straightfrom the counter• Easy to parse text filestraight from thecounter• Automatic transfer via
S/FTP to your server• Enables 21 CFR Part 11
Compliance• Easy to operate User
Interface for small scale
systems• Single click reports
enVigil PnP• Automatic audit
logging

Get 21 CFR Part 11 compliant secure records directly from your portable air particle as an easily parsed CVS or XML
format or via a secure PDF. Available as a field upgrade to your 3400 series air particle counter. Offers direct uploadof files via secure FTP protocol or via USB thumb drive download.

• Enables 21 CFR Part 11
compliance• Batch optimized User
Interface for running up
to several lines from asingle display
UVO+
Standard

enVigil PnP

Yes

250

N/A

Yes

10

10

Yes

• Custom reports andalarms• Integrated electronic
signatures for starting,stopping, alarms

28

28

Yes

250

Defined withyour input
based on the
User
Requirement
Specification• Simple 24/7
monitoring, logging,
and reporting• Provide user alarms
on screen or via email
or text message• Export raw data to
Excel for further
analysis• Batch optimized User
Interface for running
up to several lines
from a single display• Custom reports andalarmsMonitors up to 10 non-viable air particle counters and 10 viable air sampling heads for rapid set up and configurationof a small FMS for use in biosafety containment hoods and on aseptic fill lines. Provides 21 CFR Part 11 compliant
security and audit trail with one click reporting.

• Integrated audit trail

UVO+ STANDARD• Workflow optimized user interface customized toyour specific needs

Monitors up to 28 non-viable air particle counters and 28 viable air sampling heads for work flow optimized
operation of batch production filling lines and processes. Allows for electronic signature on customized reports.
Enables 21 CFR Part 11 compliant security and audit trail.

• Custom reports, alarms, emails, or other externalinterfaces (i.e. machine controls)

Work with MET ONE FMS engineers to customize UVO+ to your specific workflow needs. Define custom reports,
user interfaces, alarm conditions, reports, emails, and external machine interfaces to automate your workflow andeliminate the possibility of human error. Implement electronic signatures with LDAP / Active Directory integration tosimplify user management. Enables 21 CFR Part 11 compliant security and audit trail.

N/A• Provides OPC tags for industrial automation
integration• Ideal for biosafetycontainment hoods

UVO+ CUSTOM

Portable to 999
locations

IQ/OQ
Available• Easy access to quality
data• Stores data in a SQL database for simple retrieval orreport generation

MET ONE 3400 WITH SIMPLY PAPERLESS

Connects to remote and portable MET ONE air particle counters to automatically gather records, store them in asecure SQL database, and provide access to them via SQL or OPC connections to outside software. Also offers
automatically generated custom reports to facilitate 24/7 monitoring output.

• Automatic transfer via
S/FTP to your server

Recommended
Maximum
Viable Sampling
Locations• Secure System for data storage and access

MET ONE DATA MANAGEMENT SYSTEM

8 |Industrial Application

Recommended
Maximum
Nonviable
Sampling
Locations• Gathers data from multiple portable and remote air
particle counters

Active microbial air sampling can be added to MET ONE FMS solutions using fixed location sampling heads that
accept 90 mm petri dishes and sample on a schedule set by the user. Flow rate control guarantees a cubic meteris sampled.

MET ONE Software

Pharmaceutical
Application• Enables 21 CFR Part 11
compliance

UVO+
Custom• Electronic signatures with LDAP integration
available for any point in the workflow process• Integrated audit trail with user defined
audit points

250• Enables 21 CFR Part 11 compliance

Characterized By Ingenuity | 9

Full Range of Accessories & Service Solutions

Compliance Experts

COMPLIANCE SERVICES

The MET ONE brand has years of experience meeting regulatory requirements and assisting ourcustomers with particle monitoring systems solutions. Before published regulatory guidance,
we were helping companies meet the recommendations of individual regulators. As new standards
and regulations emerged, we have guided the industry and regulatory community toward practicalimplementations.

From assistance with SOP development for manual monitoring, to full validation documentation
packages for automated systems, Beckman Coulter Life Sciences ensures that your particle monitoring
program is fully compliant. We assist with URS planning, provide validation documents (IQ/OQ), andguide you through the validation testing process to final sign-off.

SYSTEM DEVELOPMENT SERVICES
When your requirements include automated monitoring, our dedicated Systems Team ensuressmooth implementation.
Our service covers each phase of system deployment:• Project management• System requirement definition and design• Software configuration

When your requirements include automated monitoring, our dedicated Systems Team ensures smooth
implementation.
Beckman Coulter Life Sciences provides many services to help you stay abreast of current regulations:• Regional Life Science User Group seminars• Compliance Webinars• On-site consulting and seminars for your particular needs
We can help you design the right particle monitoring program for improved compliance accuracy
and productivity.

• Validation documentation• System installation and commissioning

SYSTEM INTEGRATION SERVICESOur Systems Team are also experts at integrating our instruments with your existing Enterprise
Information Systems, LIMS, or Building Management System.
Let us eliminate:• Data silos and validation for multiple systems• Multiple reports by including non-viable and viable particle data with all other production data
• Maintenance and upgrades for multiple monitoring systems

ENVIRONMENTAL SENSORS & SYSTEM ACCESSORIES
Beckman Coulter offers a wide spectrum of accessory items to complete and perfect your facility
monitoring system• Relative humidity and temperature sensors• Air velocity sensors• Differential pressure sensors

On-site Service
With our large global network of local service offices, we are the only company that can deliver fullycompliant on-site service for your instruments, including full ISO 21501-4 calibrations. Each of ourautomated monitoring solutions can report the calibration status of each instrument and proactively
notify you of upcoming calibrations to ensure full service compliance of all batch production andenvironmental monitoring measurements.
Our service agreements program provides proactive pre-scheduled on-site calibration andmaintenance services, including discounts for any repairs.

Visit beckman.com/metone to learn more.

• IO modules for connecting to existing sensors, door switches, tool interrupts, etc.
• Ethernet switches, touch-screen NEMA computers etc.
• Distributed vacuum systems• Distributed DC power systems• Variety of isokinetic sample probe options• Multi-function alarm and stacklight modules

10 |Characterized By Ingenuity | 11

Why work with Beckman Coulter Life Sciences?
Our application experts have surveyed the market, looked at existing
workflows and integrated our solutions at customer sites around the world.
Let us help you ensure your environmental monitoring is fully compliant byleveraging our experience and our workflow solutions.
• Our products are designed to support GMP compliance.*• We offer PROService, an internet-based application that uses a
proprietary data pipeline to remotely connect to our systems in yourlabs to help maximize instrument uptime and service efficiency.
• We’re a Danaher company, with the Danaher Business System (DBS)
at its core. DBS is a proven model for achieving success. It drives every
aspect of our culture and performance. We use DBS to guide what wedo, measure how well we execute, and create options for doing evenbetter. Let us help you apply DBS to your cleanroom.
Interested in talking to someone? Visit www.beckman.com/contact-us
Learn more about MET ONE FMS solutions at beckman.com/metone
Beckman Coulter Life Sciences designs, manufactures, sells, services,and markets instrument systems, reagents and services that enable new
discoveries in biology-based research and development. Our products areused in the forefront of drug discovery, development and manufacturing.
We offer an extensive range of products including: centrifugation, flow
cytometry, particle characterization and counting, cell counting, andlaboratory automation.

The MET ONE 3400 series, MET ONE 6000 series, MET ONE 6000P series, and MET ONE 7000 Series aredesigned to support GMP compliance.
© 2019 Beckman Coulter, Inc. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter
product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc.
in the United States and other countries.

For Beckman Coulter’s worldwide office locations and phone numbers, please visit “Contact Us” at beckman.com
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