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0% found this document useful (0 votes)
17 views9 pages

LS - Smart - Facilities - Environmental Control - New

DOCUMENT

Uploaded by

rkinspires
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Smart Facilities solutions

We help our customers create future-ready pharmaceutical manufacturing and biotech facilities

ENVIRONMENTAL CONTROL

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Smart Facilities
Safer and more available environment

Asset Performance Management


The most comprehensive solution for a
Building Management
maximum economic return of your assets
Provide the best conditions for your
manufacturing operations

Server Rooms management


Provide self contained and secure computing
environment for your on-premise applications
Environmental Control
Make sure your production environment
comply with requirements and regulations

Power Safety & Availability


Standardization, site assessment, and
predictive maintenance for Electrical
Distribution

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Environmental Control (1/3)
Make sure your production environment comply with requirements and regulations.

Control and monitoring of storage and production


environments are very important within the
Life Sciences Industry.
The FDA, MHRA, EMEA and other regulatory bodies
require accurate measurement and storage of
environmental parameters and, if the storage medium
is electronic, the methods used must comply with FDA
21 CFR Part 11.

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Environmental Control (2/3)
Make sure your production environment comply with requirements and regulations.
The Solutions:
• Our solutions are based on scalable, cost-effective
architectures to suit the application
• Optional redundancy can include the processor,
I/O, power, communications, servers and
historians, offering high process availability
• Data recorded in a tamper-resistant, high-integrity
format with store-and-forward functionality, for
reliable regulatory auditing

Laboratory Control System

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Environmental Control (3/3)
Make sure your production environment comply with requirements and regulations.

The Benefits
• Solutions based on scalable cost-effective
architectures to suit the application
• Optional redundancy can include the processor,
I/O, power, communications, servers and
historians, offering high availability of the process
• Data recorded in a tamper resistant, high integrity
format with store-and-forward functionality, offers
high data reliability for regulatory auditing purpose

Learn more

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Major Medicine
Customer Challenge Multinational medical devices,
Manufacturer, France • Environmental Monitoring System (EMS), for
manufacturing site in France producing dry form
pharmaceutical and consumer
Reducing validation time for a BMS and EMS packaged goods manufacturer
products
solution
• Segregate BMS and EMS: EMS must be compliant
with 21 CFR Part 11 Requirements (DATA
INTEGRITY ALCOA). Implemented in line with GAMP
5 guidelines
For Life Sciences
The Solution
• Eurotherm T2750 PAC based EMS
Apps,
• AVEVA System Platform running independently from
Analytics,
BMS Aveva* System
& Services Platform
Customer Benefits
• Data recorded at point of measurement aids storage
reliability
Edge
• Store & Forward technology helps to improve reliability
Control
of data archiving by automatically backfilling missing Eurotherm 2750
data PAC
• Eurotherm project team GAMP 5 and data integrity
know-how
• All GMP related monitoring situated within separate Connected
EMS so validation of BMS no longer required Products

The Results : Life is On with…


reducing *The Schneider Electric industrial software business and AVEVA have merged to trade
validation time, CAPEX and OPEX COST as AVEVA Group plc, a UK listed company. The Schneider Electric and Life is On
trademarks are owned by Schneider Electric and are being licensed to AVEVA by
Schneider Electric.”

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New
Vaccine Manufacturer,
Customer Challenges Vaccine development
India • Our customer required a robust, reliable and (eg. COVID-19) requires robust EMS for
scalable monitoring solution for COVID-19 vaccine
21CFR Part 11 compliant EMS solution manufacturing facility
24/7 Data Integrity, traceability and
• To commence production within 3 months regulatory compliance
• To Integrate Eurotherm solution with Dream
Report and customer preferred 3rd party HMI
For Life Sciences
Our Solution EcoStruxure™ for Life Sciences
• 3 X Eurotherm Environment Monitoring Systems
(“EMS”) compliant with 21 CFR Part 11 and FDA Apps, EcoStruxure -ready
regulations for new manufacturing facility for Analytics, Data Review er with
COVID-19 Vaccine Dream Report
& Services software analytics
• 1000+ Analog , 850+ Digital, 25 versadac™
Scalable Data Recorders 4 x 6180XIO Recorders,
HMI’s and Control Panel
• Eurotherm Data Reviewer with Dream Report Edge
software analytics Control
3rd Party HMI
Customer Benefits
• Fast delivery of first system within timescales
• Proven solution with Eurotherm Data Management
solution (6000 series and versadac™ Recorder) Connected
with 21 CFR Part 11 enables Data Integrity and Products versadac™ 6180XIO
T2750
Traceability of environmental conditions PAC Scalable Data Graphic
Recorder Recorder
• Digitized reporting via Data Reviewer with Auditor
and Dream Report integration

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Customer Challenges New
Pharmaceutical • Produce a COVID vaccine in April 2021
Manufacturer, France • Upgrade the Environmental Monitoring System (EMS) Cold chain of the covid-
of plant to be compliance with FDA 21CFR Part11
• Measure and record the temperature of mobile 19 vaccine needs to be
Data integrity ALCOA+ tracking solution production pallets : Tracking operations monitored and tracked for
• Deliver the project (technical study and negotiations regulation compliance.
include) in less than 4 months.

Our Solution for EMS For Life Sciences


• Microsoft Windows Server Server station
• Eurotherm Review
Report
• Dream Report software Apps,
&
• 12 x Eurotherm Eycon 10 Analytics,
History access
• 1 x Eurotherm T2750 Programmable Automation & Services
Controller
• 11 x QR Code Scanner
• 1 x Mobile QR Code Scanner (Bluetooth) Batch
• 40 x wireless sensors information
Edge
• Design and electrical installation of cabinet &
Control
Data
recording T2750 & EYCON 10 &
Customer Benefits Radio receiver QR Code Scanner
• A validated EMS that meets the FDA 21 CFR Part 11
compliance requirements
Connected
Measures:
• Data Integrity ALCOA+ Tracking solution Temperature
Products
• Technical study and delivery of the ISPE GAMP5 &
Engineered project in a very short time Hygrometry Mobile Sensors & Fixed sensors
• Record temperatures on mobile installations QR Code Scanner
• Scalable solution for future plant installations

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