Certificate of Registration
QUALITY MANAGEMENT SYSTEM - ISO 13485:2016 & EN ISO 13485:2016
This is to certify that: Sotera Health LLC
2015 Spring Road
Suite 650
Oak Brook
Illinois
60523
USA
Holds Certificate Number: MD 741791
and operates a Quality Management System which complies with the requirements of ISO 13485:2016 & EN ISO
13485:2016 for the following scope:
The provision of contract ethylene oxide and radiation sterilization services fulfilling applicable
quality management system requirements within EN ISO 11135:2014 & EN ISO 11137-1:2015.
The provision of contract nitrogen dioxide sterilization services.
Chemistry, microbiology, consulting and associated laboratory services for the sterilization
industry.
For and on behalf of BSI:
Graeme Tunbridge, Senior Vice President Global Regulatory & Quality
Original Registration Date: 2021-02-09 Effective Date: 2024-03-27
Latest Revision Date: 2024-10-04 Expiry Date: 2027-03-26
Page: 1 of 9
This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract.
An electronic certificate can be authenticated online.
Printed copies can be validated at www.bsigroup.com/ClientDirectory
Information and Contact:
BSI Group The Netherlands B.V., John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands | Tel: +31 20 3460 780
BSI Group The Netherlands B.V. is registered in The Netherlands under number 33264284 | A Member of the BSI Group Holdings B.V.
Certificate No: MD 741791
Location Registered Activities
Sotera Health LLC The provision of contract ethylene oxide and radiation
2015 Spring Road sterilization services fulfilling applicable quality management
Suite 650 system requirements within EN ISO 11135:2014 & EN ISO
Oak Brook 11137-1:2015.
Illinois Chemistry, microbiology, consulting and associated laboratory
60523 services for the sterilization industry.
USA
Sterigenics UK Ltd The provision of contract ethylene oxide sterilization services
Cotes Park Lane and associated laboratory services fulfilling applicable quality
Somercotes management system requirements within EN ISO
Alfreton 11135:2014.
DE55 4NJ Chemistry, microbiology and associated laboratory services
United Kingdom for the sterilization industry.
Sterigenics US, LLC The provision of contract ethylene oxide sterilization services
4900 Gifford Avenue fulfilling applicable quality management system requirements
Los Angeles within EN ISO 11135:2014.
California
90058
USA
Sterigenics US, LLC The provision of contract gamma radiation sterilization
3125 Wichita Court services fulfilling applicable quality management system
Fort Worth requirements within EN ISO 11137-1:2015.
Texas
76140
USA
Sterigenics US, LLC The provision of contract ethylene oxide sterilization services
2971 Olympic Industrial Drive SE fulfilling applicable quality management system requirements
Suite 116 within EN ISO 11135:2014.
Atlanta
Georgia
30339
USA
Sterigenics US, LLC The provision of contract ethylene oxide sterilization services
10821 Withers Cove Park Drive fulfilling applicable quality management system requirements
Charlotte within EN ISO 11135:2014.
North Carolina
28278
USA
Original Registration Date: 2021-02-09 Effective Date: 2024-03-27
Latest Revision Date: 2024-10-04 Expiry Date: 2027-03-26
Page: 2 of 9
This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract.
An electronic certificate can be authenticated online.
Printed copies can be validated at www.bsigroup.com/ClientDirectory
Information and Contact:
BSI Group The Netherlands B.V., John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands | Tel: +31 20 3460 780
BSI Group The Netherlands B.V. is registered in The Netherlands under number 33264284 | A Member of the BSI Group Holdings B.V.
Certificate No: MD 741791
Location Registered Activities
Sterigenics US, LLC The provision of contract ethylene oxide sterilization services
5725 W. Harold Gatty Drive fulfilling applicable quality management system requirements
Salt Lake City within EN ISO 11135:2014.
Utah
84116
USA
Sterigenics US, LLC The provision of contract ethylene oxide sterilization services
2400 Airport Road fulfilling applicable quality management system requirements
Santa Teresa within EN ISO 11135:2014.
New Mexico
88008
USA
Sterigenics US, LLC The provision of contract ethylene oxide sterilization services
84 Park Road fulfilling applicable quality management system requirements
Queensbury within EN ISO 11135:2014.
New York
12804
USA
Sterigenics US, LLC The provision of contract ethylene oxide sterilization services
1302 Avenue T fulfilling applicable quality management system requirements
Grand Prairie within EN ISO 11135:2014.
Texas
75050
USA
Sterigenics US, LLC The provision of contract gamma radiation sterilization
344 Bonnie Circle services fulfilling applicable quality management system
Corona requirements within EN ISO 11137-1:2015.
California
92878
USA
Sterigenics US, LLC The provision of contract gamma radiation sterilization
711 East Cooper Court services fulfilling applicable quality management system
Schaumburg requirements within EN ISO 11137-1:2015.
Illinois
60173
USA
Original Registration Date: 2021-02-09 Effective Date: 2024-03-27
Latest Revision Date: 2024-10-04 Expiry Date: 2027-03-26
Page: 3 of 9
This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract.
An electronic certificate can be authenticated online.
Printed copies can be validated at www.bsigroup.com/ClientDirectory
Information and Contact:
BSI Group The Netherlands B.V., John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands | Tel: +31 20 3460 780
BSI Group The Netherlands B.V. is registered in The Netherlands under number 33264284 | A Member of the BSI Group Holdings B.V.
Certificate No: MD 741791
Location Registered Activities
Sterigenics US, LLC The provision of contract gamma radiation sterilization
305 Enterprise Drive services fulfilling applicable quality management system
Lewis Center requirements within EN ISO 11137-1:2015.
Ohio
43035-9418
USA
Sterigenics US, LLC The provision of contract gamma radiation sterilization
1401 Morgan Circle services fulfilling applicable quality management system
Tustin requirements within EN ISO 11137-1:2015.
California
92780
USA
Sterigenics US, LLC The provision of contract gamma radiation sterilization
1003 Lakeside Drive services fulfilling applicable quality management system
Gurnee requirements within EN ISO 11137-1:2015.
Illinois
60031
USA
Sterigenics US, LLC The provision of contract gamma radiation sterilization
2311 Lincoln Avenue services fulfilling applicable quality management system
Hayward requirements within EN ISO 11137-1:2015.
California
94545
USA
Sterigenics US, LLC The provision of contract gamma radiation sterilization
1148 Porter Avenue services fulfilling applicable quality management system
Haw River requirements within EN ISO 11137-1:2015.
North Carolina
27258
USA
Sterigenics US, LLC The provision of contract gamma radiation sterilization
75 Tilbury Road services fulfilling applicable quality management system
Salem requirements within EN ISO 11137-1:2015.
New Jersey
08079
USA
Original Registration Date: 2021-02-09 Effective Date: 2024-03-27
Latest Revision Date: 2024-10-04 Expiry Date: 2027-03-26
Page: 4 of 9
This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract.
An electronic certificate can be authenticated online.
Printed copies can be validated at www.bsigroup.com/ClientDirectory
Information and Contact:
BSI Group The Netherlands B.V., John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands | Tel: +31 20 3460 780
BSI Group The Netherlands B.V. is registered in The Netherlands under number 33264284 | A Member of the BSI Group Holdings B.V.
Certificate No: MD 741791
Location Registered Activities
Sterigenics US, LLC The provision of contract gamma radiation sterilization
5900 Obata Way, Suite A services fulfilling applicable quality management system
Gilroy requirements within EN ISO 11137-1:2015
California
95020
USA
Sterigenics US, LLC The provision of contract gamma radiation sterilization
108 Lake Denmark Road services fulfilling applicable quality management system
Rockaway requirements within EN ISO 11137-1:2015.
New Jersey
07866
USA
Sterigenics US, LLC The provision of contract gamma radiation sterilization
1700 College Blvd services fulfilling applicable quality management system
West Memphis requirements within EN ISO 11137-1:2015.
Arkansas
72301
USA
Sterigenics Radiation Technologies, LLC The provision of contract electron beam radiation sterilization
7695 Formula Place services fulfilling applicable quality management system
San Diego requirements within EN ISO 11137-1:2015.
California
92121
USA
Sterigenics S.de R.L de C.V. The provision of contract gamma radiation sterilization
Calle Norte 7 s/n services fulfilling applicable quality management system
Parque Industrial Tepeji requirements within EN ISO 11137-1:2015.
Tepeji del Rio de Ocampos
Edo. de Hidalgo
CP 42850
Mexico
Sterigenics (Thailand) Ltd. The provision of contract gamma radiation sterilization
109/16 Eastern Seaboard Industrial services fulfilling applicable quality management system
Estate (Rayong), Moo 4 T. Pluakdaeng requirements within EN ISO 11137-1:2015.
A. Pluakdaeng, Rayong Province
21140
Thailand
Original Registration Date: 2021-02-09 Effective Date: 2024-03-27
Latest Revision Date: 2024-10-04 Expiry Date: 2027-03-26
Page: 5 of 9
This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract.
An electronic certificate can be authenticated online.
Printed copies can be validated at www.bsigroup.com/ClientDirectory
Information and Contact:
BSI Group The Netherlands B.V., John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands | Tel: +31 20 3460 780
BSI Group The Netherlands B.V. is registered in The Netherlands under number 33264284 | A Member of the BSI Group Holdings B.V.
Certificate No: MD 741791
Location Registered Activities
Sterigenics US, LLC The provision of contract gamma radiation sterilization
10811 Withers Cove Park Drive services fulfilling applicable quality management system
Charlotte requirements within EN ISO 11137-1:2015.
North Carolina
28278
USA
Sterigenics Shanghai ETO Ltd. The provision of contract ethylene oxide sterilization services
No. 333, Shuang Hui Road and associated laboratory services fulfilling applicable quality
Yang Shan Free Port management system requirements within EN ISO
Shanghai 11135:2014.
201308
China
Sterigenics Shanghai E Beam Ltd. The provision of contract electron beam irradiation
No. 588, Chuantu Road, Chuan Sha, sterilization services and associated laboratory services
Pudong fulfilling applicable quality management system requirements
Shanghai within EN ISO 11137-1:2015.
201202 Chemistry, microbiology and associated laboratory services
China for the sterilization industry.
Sterigenics Belgium (Fleurus) SA The provision of contract gamma radiation sterilization
Zoning Industriel de Fleurus services fulfilling applicable quality management system
Avenue De L'Esperance 17 requirements within EN ISO 11137-1:2015.
Fleurus, Hainaut
B-6220
Belgium
Sterigenics Germany GmbH The provision of contract ethylene oxide sterilization services
Kasteler Straße 45 and associated laboratory services fulfilling applicable quality
Wiesbaden management system requirements within EN ISO
65203 11135:2014.
Germany Chemistry, microbiology and associated laboratory services
for the sterilization industry.
Sterigenics Belgium The provision of contract ethylene oxide sterilization services
(Petit- Rechain) SA and associated laboratory services fulfilling applicable quality
Zoning Industriel de Petit-Rechain management system requirements within EN ISO
Avenue Andre Ernst 21 11135:2014. The provision of contract nitrogen dioxide
sterilization services and associated laboratory services.
Verviers, Liege
B-4800 Chemistry, microbiology and associated laboratory services
Belgium for the sterilization industry.
Original Registration Date: 2021-02-09 Effective Date: 2024-03-27
Latest Revision Date: 2024-10-04 Expiry Date: 2027-03-26
Page: 6 of 9
This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract.
An electronic certificate can be authenticated online.
Printed copies can be validated at www.bsigroup.com/ClientDirectory
Information and Contact:
BSI Group The Netherlands B.V., John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands | Tel: +31 20 3460 780
BSI Group The Netherlands B.V. is registered in The Netherlands under number 33264284 | A Member of the BSI Group Holdings B.V.
Certificate No: MD 741791
Location Registered Activities
Sterigenics Denmark A/S The provision of contract electron beam irradiation
Aa Louis-Hansens Alle 11 sterilization services and associated laboratory services
Espergaerde, Region Sjaelland fulfilling applicable quality management system requirements
DK-3060 within EN ISO 11137-1:2015.
Denmark Chemistry, microbiology and associated laboratory services
for the sterilization industry.
Sterigenics SAS The provision of contract ethylene oxide sterilization services
8 Rue Parmentier and associated laboratory services fulfilling applicable quality
Rantigny management system requirements within EN ISO
60290 11135:2014.
France Chemistry, microbiology and associated laboratory services
for the sterilization industry.
Sterigenics Costa Rica S.R.L. The provision of contract ethylene oxide sterilization services
Zona Franca PROPARK fulfilling applicable quality management system requirements
Calle Principal, Edificio 10 within EN ISO 11135:2014.
El Coyol
Alajuela
20101
Costa Rica
Sterigenics US, LLC The provision of contract ethylene oxide sterilization services
687 S. Wanamaker Avenue fulfilling applicable quality management system requirements
Ontario within EN ISO 11135:2014.
California
91761
USA
Sterigenics S.de R.L de C.V. The provision of contract ethylene oxide sterilization services
James Watt No. 22 fulfilling applicable quality management system requirements
Parque Industrial Cuamatla within EN ISO 11135:2014.
Cuautitlan Izcalli
Edo. de Mexico
CP 54730
Mexico
Sterigenics US, LLC The provision of contract gamma radiation sterilization
502 Prairie Mine Road services fulfilling applicable quality management system
Mulberry requirements within EN ISO 11137-1:2015.
Florida
33860
USA
Original Registration Date: 2021-02-09 Effective Date: 2024-03-27
Latest Revision Date: 2024-10-04 Expiry Date: 2027-03-26
Page: 7 of 9
This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract.
An electronic certificate can be authenticated online.
Printed copies can be validated at www.bsigroup.com/ClientDirectory
Information and Contact:
BSI Group The Netherlands B.V., John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands | Tel: +31 20 3460 780
BSI Group The Netherlands B.V. is registered in The Netherlands under number 33264284 | A Member of the BSI Group Holdings B.V.
Certificate No: MD 741791
Location Registered Activities
Sterigenics UK Limited The provision of contract gamma radiation sterilization
Seymour Link Road services fulfilling applicable quality management system
Woodthorpe, Mastin Moor requirements within EN ISO 11137-1:2015
Chesterfield
S43 3FG
United Kingdom
Sterigenics Italy Spa The provision of contract gamma radiation sterilization
via Marzabotto, 4 services fulfilling applicable quality management system
Minerbio requirements within EN ISO 11137-1:2015.
Bologna
40061
Italy
Sterigenics EO Canada, Inc. The provision of contract ethylene oxide sterilization services
400 Ambassador Dr. fulfilling applicable quality management system requirements
Mississauga within EN ISO 11135:2014.
Toronto
Ontario
L5T 2J3
Canada
Sterigenics Jarinu SP Brasil The provision of contract gamma and electron beam radiation
Avenida do Progresso, 900 services fulfilling applicable quality management system
Ponte Alta requirements within EN ISO 11137-1:2015.
Jarinu
São Paulo
13240-00
Brasil
Sterigenics Cotia SP Brasil The provision of contract gamma radiation sterilization
Av. Cruzada Bandeirantes, 290 services fulfilling applicable quality management system
Vila Jovina requirements within EN ISO 11137-1:2015.
Cotia
São Paulo
06705-140
Brasil
Sterigenics Radiation Technologies The provision of contract electron beam radiation sterilization
Canada, Inc. services fulfilling applicable quality management system
1425 Kebet Way requirements within EN ISO 11137-1:2015.
Port Coquitlam
British Columbia
V3C 6L3
Canada
Original Registration Date: 2021-02-09 Effective Date: 2024-03-27
Latest Revision Date: 2024-10-04 Expiry Date: 2027-03-26
Page: 8 of 9
This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract.
An electronic certificate can be authenticated online.
Printed copies can be validated at www.bsigroup.com/ClientDirectory
Information and Contact:
BSI Group The Netherlands B.V., John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands | Tel: +31 20 3460 780
BSI Group The Netherlands B.V. is registered in The Netherlands under number 33264284 | A Member of the BSI Group Holdings B.V.
Certificate No: MD 741791
Location Registered Activities
Sterigenics Radiation Technologies IN, The provision of contract electron beam radiation sterilization
Inc. services fulfilling applicable quality management system
4394 East Park 30 Drive requirements within EN ISO 11137-1:2015.
Columbia City
Indiana
46725
USA
Sterigenics S.de R.L. de C.V. Chemistry, microbiology and associated laboratory services
Benjamín Franklin S/N lote 41-43 for the sterilization industry.
Parque Industrial Cuamatla
C.P. 54730
Cuautitlán Izcalli
Estado de México
Mexico
Original Registration Date: 2021-02-09 Effective Date: 2024-03-27
Latest Revision Date: 2024-10-04 Expiry Date: 2027-03-26
Page: 9 of 9
This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract.
An electronic certificate can be authenticated online.
Printed copies can be validated at www.bsigroup.com/ClientDirectory
Information and Contact:
BSI Group The Netherlands B.V., John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands | Tel: +31 20 3460 780
BSI Group The Netherlands B.V. is registered in The Netherlands under number 33264284 | A Member of the BSI Group Holdings B.V.
