October 17, 2024 – As part of our long-term commitment to supporting global medical device manufacturing, STERIS Applied Sterilization Technologies (AST) is pleased to announce that the Seriate, Italy microbiology laboratory has achieved ISO 17025 accreditation.

The ISO 17025 accreditation ensures that the laboratory meets the stringent requirements for competence, impartiality, and consistent operation. It signifies that the testing methods are globally recognized, and that STERIS adheres to the highest international standards.

With the addition of the Seriate, Italy facility, STERIS AST now has ISO 17025 accredited laboratories in China, Germany, Ireland, Malaysia, UK, and the USA. To view a copy of our certificate, please go here.

Our team of professionals at the Seriate laboratory can provide:

• Consultancy services on microbiological issues and good manufacturing practices
• Bacterial endotoxin testing
• Bioburden testing
• Biological indicator testing
• Environmental monitoring
• EO residual testing
• Irradiation validation services
• Sterility testing
• Assistance with the Interpretation of results
• Guidance on testing methodologies
• Assistance with compliance to ISO 11137, ISO 11135, and ISO 17141.

In addition to the laboratory, our Seriate facility offers electron beam processing. Go here to learn more about the Seriate facility.

About STERIS

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services. For more information, visit www.steris.com.

The post STERIS SERIATE, ITALY MICROBIOLOGY LABORATORY RECEIVES ISO 17025 ACCREDITATION appeared first on STERIS AST.

• Supports cannabis industry with additional radiation processing capacity
• Compliments existing E-beam and gamma processing in Canada

October 3, 2024 – As part of our commitment to ensuring patient and consumer safety, STERIS is pleased to announce the construction of a new electron beam processing facility in Edmonton, Alberta, Canada. The new site will be dedicated to processing cannabis products grown and distributed in Canada.

The expansion of services in Canada supports our commitment to providing a global technology-neutral service offering that includes radiation and gas processing options, now and well into the future. In addition to the new location in Edmonton, STERIS provides E-beam processing services for cannabis at our London, Ontario facility and gamma irradiation processing through our facility in Whitby, Ontario.

Demand for both medical and recreational cannabis in Canada has accelerated our plans for expanding radiation processing capacity to ensure the safety of those who use or consume these products. The continued expansion of processing options throughout our global network allows us to support Customers with both routine services and processing redundancy.

About STERIS

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services. For more information, visit www.steris.com.

The post STERIS ANNOUNCES NEW ELECTRON BEAM PROCESSING FACILITY IN EDMONTON, ALBERTA, CANADA appeared first on STERIS AST.

• Supports cannabis industry with additional radiation processing capacity
• Complements exists gamma processing services offered in Canada

July 11, 2024 – As part of our commitment to ensuring patient and consumer safety, STERIS is pleased to announce the construction of a new electron beam processing facility in London, Ontario, Canada. The new site will be dedicated to processing cannabis products grown and distributed in Canada.

The expansion of services in Canada supports our commitment of providing a global technology-neutral service offering that includes radiation and gas processing options, now and well into the future. In addition to the new location in London, STERIS provides gamma irradiation processing through our existing facility in Whitby, Ontario.

Demand for both medical and recreational cannabis in Canada has accelerated our plans for expanding radiation processing capacity to ensure the safety of those who use or consume these products. The continued expansion of processing options throughout our global network allows us to support Customers with both routine services and processing redundancy.

About STERIS
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services. For more information, visit www.steris.com.

The post STERIS ANNOUNCES NEW ELECTRON BEAM PROCESSING FACILITY IN LONDON, ONTARIO, CANADA appeared first on STERIS AST.

• Programs promote effective worksite-based safety and health
• Acceptance represents STERIS’s 13^th facility to receive VPP Star status

July 8, 2024 – STERIS Applied Sterilization Technologies is pleased to announce that the U.S. Occupational Safety and Health Administration (OSHA) has accepted its Whippany, New Jersey operations into the agency’s prestigious Voluntary Protection Programs (VPP) at the Star Level.

The VPP recognize employers and workers who have implemented effective safety and health management systems and maintain injury and illness rates below national Bureau of Labor Statistics averages for their respective industries. The highest award offered by the VPP, the Star Award is reserved for participants that consistently exceed OSHA standards, thereby making them models for their industry. There are approximately six million worksites in the United States under OSHA jurisdiction, and approximately 1,700 of those sites are certified in the VPP.

VPP participant sites experience 50 percent fewer lost workday injuries than would be expected of a similar facility with an “average” safety program and recognize participants for their dedication to safety excellence.

The Whippany location will remain OSHA Star certified for three years. At the end of the three-year period, STERIS must submit annual self-evaluations of the program and apply for recertification.

This is an outstanding distinction for STERIS and the Whippany location. Safety Excellence is a core value of STERIS and, through this award, the Whippany facility and its employees will join the other STERIS members of the VPP Family to serve as a model for our global operations.

The Whippany facility is the sixth location in the Applied Sterilization Technologies network, and the 13th STERIS facility overall to receive the VPP Star status.

The post STERIS WHIPPANY, NEW JERSEY FACILITY ACCEPTED INTO OSHA VPP PROGRAMS AT STAR LEVEL appeared first on STERIS AST.

• Supports medical device manufacturing in Asia with additional ethylene oxide processing capacity
• Complements existing radiation and gas processing facilities in China, Malaysia, and Thailand

July 5th, 2024 – As part of our long-term commitment to supporting global medical device manufacturing, STERIS is pleased to announce a new ethylene oxide (EO) processing facility in Singapore through a strategic partnership with TOMOE SHOKAI CO., Ltd (“TOMOE”). The addition of the EO facility to the STERIS network complements our existing electron beam, gamma, X-ray, and microbiological testing services in Kuala Ketil, Kulim, Port Klang, and Rawang, Malaysia; Chonburi, Thailand; and Suzhou, China.

Additional EO processing capacity in Asia furthers our commitment to ensuring patient safety through a technology-neutral service offering that includes radiation and gas processing options, now and well into the future.

Our global EO offering includes Sustainable EO^® sterilization services, which provides Customers with strategies to reduce the EO sterilant used in the sterilization process to achieve the prescribed Sterility Assurance Level. The program includes innovative approaches to EO sterilization, such as cycle design, validation strategy, and process challenge device design, all focused on reducing EO residuals on healthcare products.

The addition of EO capacity in Singapore allows for increased technology-neutral processing options in the APAC region and throughout our global network, and allows us to support Customers with both routine services and processing redundancy.

About STERIS

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services. For more information, visit www.steris.com.

The post STERIS ANNOUNCES NEW ETHYLENE OXIDE PROCESSING FACILITY IN SINGAPORE appeared first on STERIS AST.

• Supports medical device and pharmaceutical manufacturing with additional irradiation processing capacity
• Provides a comprehensive technology-neutral radiation service offering at the Libertyville campus

June 24, 2024 – As part of our long-term commitment to supporting global medical device manufacturing, STERIS is pleased to announce the completed expansion of its existing Libertyville II, Illinois gamma processing facility to include X-ray processing.

The expansion of the Libertyville II facility furthers our commitment of ensuring patient safety through a technology-neutral service offering that includes radiation and gas processing options, now and well into the future.

In addition to X-ray and gamma processing at Libertyville II, our Libertyville campus includes a second gamma processing facility, an on-site microbiological laboratory, our Radiation Technology Center, and is home to our Radiation TechTeam® technical professionals. The combination of a dedicated technology center, technical support for radiation processing, and laboratory services in one location results in a seamless transfer of validation and dose work into our production processing locations.

Increased demand in medical device and pharmaceutical manufacturing has accelerated our plans for global expansion. The addition of accelerator-based radiation processing options throughout our global network allows us to support Customers with both routine services and processing redundancy.

About STERIS

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services. For more information, visit www.steris.com.

The post STERIS ANNOUNCES COMPLETION OF LIBERTYVILLE, ILLINOIS EXPANSION TO INCLUDE X-RAY PROCESSING appeared first on STERIS AST.

• Supports medical device manufacturing with additional radiation processing capacity
• Complements existing EO, E-beam, gamma and X-ray services Asia

 April 8, 2024 – As part of our long-term commitment to supporting global medical device manufacturing, STERIS is pleased to announce the expansion of its existing Suzhou, China EO processing facility to include X-ray processing.

The expansion of the Suzhou facility furthers our commitment of ensuring patient safety through a technology-neutral service offering that includes radiation and gas processing options, now and well into the future.

In addition to the Suzhou, China facility, we support medical device manufacturing in Asia through our electron beam, ethylene oxide, gamma and X-ray processing sterilization services in Kuala Ketil, Kulim, Port Klang and Rawang, Malaysia; and Chonburi, Thailand.

Increased demand in medical device manufacturing has accelerated our plans for global expansion. The addition of accelerator-based radiation processing options throughout our global network allows us to support Customers with both routine services and processing redundancy.

About STERIS

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. For more information, visit www.steris.com.

The post STERIS ANNOUNCES EXPANSION OF SUZHOU, CHINA FACILITY TO INCLUDE X-RAY PROCESSING appeared first on STERIS AST.

• Supports medical device manufacturing with additional radiation processing capacity
• Complements existing EO, E-beam and gamma services in Asia

April 2, 2024 – As part of our long-term commitment to supporting global medical device manufacturing, STERIS is pleased to announce the completed expansion of its existing Chonburi I, Thailand facility to include X-ray processing. The addition of X-ray processing compliments the existing gamma irradiation services offered at the Chonburi I site, as well as the gamma services at the Chonburi II facility.

The expansion of the Chonburi I, Thailand facility furthers our commitment of ensuring patient safety through a technology-neutral service offering that includes radiation and gas processing options, now and well into the future.

In addition to the Chonburi facilities, we support medical device manufacturing in Asia through our electron beam, ethylene oxide, and gamma processing sterilization services in Kuala Ketil, Kulim, Port Klang, and Rawang, Malaysia; and Suzhou, China.

Increased demand in medical device manufacturing has accelerated our plans for global expansion. The addition of accelerator-based radiation processing options throughout our global network allows us to support Customers with both routine services and processing redundancy.

About STERIS

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention.

WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services.

For more information, visit www.steris.com.

The post STERIS ANNOUNCES COMPLETED EXPANSION OF CHONBURI, THAILAND FACILITY NOW INCLUDES X-RAY PROCESSING appeared first on STERIS AST.

• Innovative FDA program advances alternatives for radiation and EO sterilization of medical devices
• Facilitates more timely changes to alternative sterilization methods, processes, or sites

November 7, 2023. STERIS is pleased to announce that its Applied Sterilization Technologies (AST) business has been accepted to participate in the U.S. Food and Drug Administration (FDA) Radiation Sterilization Master File Pilot Program (Pilot Program), first announced by the FDA in April 2023.  STERIS’s participation in the Radiation Pilot Program complements its prior acceptance into the Ethylene Oxide (EO) Master File Pilot Program in 2021.

The FDA developed the Radiation Sterilization Master File Pilot Program in response to global supply chain constraints and to support supply chain resiliency. The voluntary Pilot Program allows companies that sterilize single-use PMA-approved medical devices using gamma radiation or EO to submit master files when making certain changes, including:

• Changing sterilization processing locations or adding processing redundancy
• Switching from one sterilization technology to another (i.e, changing from gamma to X-ray)
• Implementing other processes to incentivize and expedite actions to further assure sterilization safety, such as lowering the gamma radiation dose

Eligible participants making any of the changes described above at a STERIS AST facility may be eligible to reference the Master File submitted by STERIS in a Letter of Intent/Letter of Authorization, rather than a PMA supplement. Please reference our FAQ document for more information.

“The FDA’s Pilot Programs align with the STERIS MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. Following our prior acceptance into the EO Master File Pilot Program, we are excited to be the only contract sterilization provider accepted into both the EO and radiation programs,” comments Ken Kohler, vice president and general manager, STERIS AST Americas. “The Pilot Programs support our efforts to provide sterilization supply chain resiliency through a technology-neutral processing option that utilizes both radiation and gas technologies.”

STERIS will be hosting an educational webinar on the FDA’s Pilot Program, providing an overview of the initiative, its impact on our Customers, device eligibility and process. Go here to register for the webinar, which will be held on Thursday, November 30 at 11:00am EST. For more information regarding the program, please go here to view our frequently asked questions.

About STERIS

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. For more information, visit www.steris.com.

The post STERIS ACCEPTED AS FIRST COMPANY TO PARTICIPATE IN THE FDA RADIATION STERILIZATION MASTER FILE PILOT PROGRAM appeared first on STERIS AST.

Global OTOG Day is a day to celebrate achievements and recognition of our people, individuals, and teams, who go over and above on a daily basis to achieve our goals. The day is full of fun, food, and team activities!

Our facilities use Global OTOG Day to host a range of activities including volunteering in the community, sustainability initiatives including clean-ups and gardening, as well as team building activities.

The post STERIS AST HOSTS A DAY OF “ONE TEAM ONE GOAL” CELEBRATION appeared first on STERIS AST.