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LEADING PORTFOLIO OF DIFFERENTIATED SERVICES & PRODUCTS
Three Companies. One Focus.
Safeguarding Global Health™
Nelson Labs TM | Nordion® | Sterigenics®
What I want to cover today
• Safety briefing on COVID-19
• A quick introduction about myself
• Sotera Health and it’s trajectory so far
• Nelson labs
o Aim of it’s offering
o E&L specifically
PG #
Coronavirus (COVID-19) update
Sotera Health is committed to protecting employees, visitors and all communities where we operate in ensuring their safety.
The situation is evolving quickly …. We have implemented preventive measures in Europe including a tracking of travels for our employees but also for visitors. Thanks to have completed this form in advance allowing you to be present here today.
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If you would be confirmed as affected by COVID-19 in the next 2 weeks, we would like you to inform immediately our EMEAA COVID Contact points :
Béatrice Decelle (EHS) +32.477.55.94.45 [email protected]
Inge Vanwittenbergh (HR) +32.473.85.67.14 [email protected]
What are the symptoms of COVID-19?
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The COVID-19 makes people sick usually with a mild to moderate upper respiratory tract illness, similar to a common cold.
Its symptoms include a runny nose, cough, sore throat, headache and a fever that can last for a couple of days.
For those with a weakened immune system, the elderly and the very young, there is a chance the virus could cause a lower, and much more serious, respiratory tract illness like a pneumonia or bronchitis.
Consulting with family medical provider is key to ensure any person receives proper treatment.
What are the most important preventive measures ?
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• Appointed as Senior Vice President Nelson Labs EMEAA in June 2019, transitioned Q4 2019
• 13+ years with Sterigenics, managed the Sterigenics EMEAA busniess over the last 8+ years – highlights:
o Globalization of the organisation
o Facility expansions, including greenfields
o M&A
o Strong focus (1) EHS, (2) Quality and (3) financial perfomrance of the EMEAA region
• Before that, worked in 2 other industries:
o Paper Tissue - 10 years / Scott Paper -> Kimberly-Clark
o IT industry - 6 years / Xircom-> Intel
• Belgian National, worked mostly internationally (Western Europe, EE, Russia, Middle East)
• Master Degree in Finance & Administration
A few words about myself....
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Over 70 Years of Providing Innovative, Safe Sterilization Solutions to Customers
1999-2004 1978-1999 1925-1978 2004-2011
1978: Sterigenics International (then known as Radiation Sterilization) opened its first gamma facility in Tustin, California
Customer acceptance of Gamma irradiation grows steadily over two decades
1992: Sterigenics became the first contract sterilization company to receive ISO 9002 certification
Griffith Laboratories invented the EO sterilization process in the mid-1930s
EO gas sterilization process starts to be utilized in the healthcare industry
1999: Belgium-based Ion Beam Applications acquired both Griffith and Sterigenics
Two companies merged to form IBA’s Sterilization and Ionization Division
March 2014: FTSI acquisition
August 2014: Nordion acquisition
October 2014: Gammarad acquisition
2014
1 4
2 5
7 2011: GTCR
acquired Sterigenics
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1998: Sterigenics International goes public on the NASDAQ as “STER”
3 2004: IBA’s
Sterilization and Ionization division acquired by Silverfleet Capital and PPM American Capital Partners
Company History
2015 2014 2004-2011 1999-2004 1978-1999 1925-1978
2015: GTCR Brings WP in as an Equity Partner
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Before Nelson Labs became part of the family….
Contract Steriliser in 2004
M&A in 2014-2016
Where we are today
Company Vision & Values
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At Sotera Health, our vision is to be the leading provider of mission-critical solutions to improve global health. In fulfilling our vision, all of our actions are driven by our Company Values each and every day.
Sotera Health, what does it mean as a company?
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Safeguarding Global Health TM
Expert Lab Testing and Consulting Gamma Technologies (GT)
Safeguarding Global Health – with every test we complete.
Safeguarding Global Health – with every critical isotope we supply.
Comprehensive Sterilization Services
Safeguarding Global Health – with every product we sterilize.
• Provider of mission critical sterilization services
• 46 Facilities, 13 countries • Offers all major sterilization
technologies: Gamma Irradiation, Ethylene Oxide & Electron Beam
• End markets include Medical Devices, Pharma, & Food
Provider of microbiological and analytical
testing services in 13 global lab locations
Offer 900+ tests across the product lifecycle,
from initial design, to product validation,
extractables and leachables testing, and ongoing
quality control
Acquisitions of Toxikon Europe and Gibraltar
Labs expands lab services
Consulting services for regulatory submissions
support, product changes, detentions, and
rejection notices
End markets include Medical Devices, Pharma,
and Tissue
Global leader in Cobalt-60 (“Co-
60”) supply
‒ Co-60 is the key input for
Gamma sterilization
‒ Established market leader
Gamma Facilities North America
West Memphis, AR Corona, CA Gilroy, CA Hayward, CA Tustin, CA Gurnee, IL Schaumburg, IL Charlotte, NC Haw River, NC Rockaway, NJ Salem, NJ Lewis Center, OH Fort Worth, TX Mulberry, FL Hidalgo, Mexico
South America Cotia, Brazil Jarinu, Brazil
Europe Fleurus, Belgium Minerbio, Italy
Asia Bangkok, Thailand
EO Facilities North America
Los Angeles, CA Ontario, CA Atlanta, GA Willowbrook, IL Charlotte, NC Santa Teresa, NM Queensbury, NY Grand Prairie, TX Salt Lake City, UT Mexico City, Mexico Toronto, Ontario
Central America Coyol City, CR
Europe Petit-Rechain, Belgium Somercotes, England Rantigny, France Wiesbaden, Germany
Asia Shanghai, China
Global Headquarters Cleveland, OH
Nordion Facilities North America
Laval, Quebec Ottawa, Ontario
Europe South Oxfordshire, England
Nelson Labs North America
Fairfield, NJ (2) Itasca, IL Ontario, CA Salt Lake City, UT Mexico City, Mexico
Europe Leuven, Belgium Petit-Rechain, Belgium Espergaerde, Denmark Somercotes, England Rantigny, France Wiesbaden, Germany
Asia Shanghai, China
E-Beam Facilities North America
San Diego, CA South America
Jarinu, Brazil Europe
Espergaerde, Denmark Asia
Shanghai, China Bangkok, Thailand
Sotera Health Global Facilities Network
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Sotera Health serves 5,000+ customers across 63 facilities in 13 countries
Nelson Labs has 13 global lab facilities to meet customer requirements
Nelson Global Facilities
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Our global network enables us to serve customers where they need us – when they need us. We perform over 700 rigorous microbiological and analytical laboratory tests across the medical device, pharmaceutical, and tissue industries. With the addition of Nelson Labs Europe and Gibraltar Laboratories, our 13 global locations are comprised of eight fully integrated laboratories within Sterigenics’ sterilization facilities and five stand-alone laboratories.
STAND-ALONE LABS
• Europe Espergaerde, Denmark Petit-Rechain, Belgium Rantingy, France Somercotes, England Wiesbaden, Germany
INTEGRATED LABS
• North America Ontario, CA Mexico City, Mexico
• Asia Shanghai, China
• Nelson Labs – Global Headquarters Salt Lake City, UT
• Itasca, IL – Center of Excellence
• Nelson Labs NV – European Center of Excellence Leuven, Belgium
• Gibraltar Laboratories, Inc. – Newly Acquired Fairfield, NJ
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End-to-End Solutions That Customers Need & Regulatory Bodies Mandate
• New product design file review
• Product R&D testing, performance evaluation and validation
• Test plans, protocols, and written justifications for method selections
• Analytical Chemistry
• Facility validations
• In-process controls
• Environmental monitoring
• Surface & equipment cleaning validations
• Water systems validation
• Sterilization validations for reusable, reprocessed, and single-use devices
• Failure investigations
• Biocompatibility
• Extractables & leachables
• Sterilization validation
• Product validation
• Packaging validation
• Regulatory support for submissions
• Bioburden
• Particulates
• Bacterial endotoxin
• BI sterility
• Sterility lot release for Pharma and Biologics
• Virology/Molecular Biology
• Analytical Chemistry
• Stability Testing
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Nelson Labs Europe Nelson Labs acquired European division of
Toxikon Corporation in October 2017.
The acquisition created the leading global extractables and leachables lab testing platform to serve the pharmaceutical and medical device industries.
AVAILABLE TESTING SERVICES
Nelson Labs Europe Services
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• Extractables & Leachables for Pharmaceutical Containers
• Extractables & Leachables for Medical Devices
• Material Characterization Screens for Raw Materials
• Combination Products Testing
• Impurities Identification in Drug Components and APIs
• Stability Studies – Pharmaceutical
• Method Development – Pharmaceutical
• Cleaning and Disinfection Validation
• Microbiological Testing
Glad to be here
…Enjoy the seminar!
