STERIS Laboratories
STERIS Applied Sterilization Technologies is a global provider of contract sterilization, laboratory testing, and product and packaging testing services, supporting medical device and pharmaceutical manufacturers with a technology-neutral sterilization services offering. The company is committed to creating a healthier and safer world through innovative healthcare and life science products and services, emphasizing infection prevention, regulatory compliance, and quality standards. With over 60 facilities worldwide, STERIS offers services including gamma, electron beam, X-ray, ethylene oxide, vaporized hydrogen peroxide, and steam sterilization, along with equipment, control systems, and radiation dosimetry. The company also provides validation, testing, and support services to ensure safety, efficacy, and regulatory compliance.
Industries
Nr. of Employees
small (1-50)
Products
Integrated sterilization equipment and control systems
Accelerators, product handling systems (conveyors) and automation solutions for sterilization processing facilities.
Dosimetry supplies and measurement services
Dosimeter usage and reporting based on alanine pellet and Perspex/red Perspex dosimeters to quantify absorbed ionizing radiation.
Tissue Sterilization Services
Contract sterilization services for human, animal, and synthetic tissues intended for transplantation or medical use, using low temperature terminal sterilization modalities such as gamma, E-beam, X-ray radiation, ethylene oxide, and vaporized hydrogen peroxide (VHP).
Tissue Testing Services
STERIS provides tissue testing services using dedicated testing equipment to process a wide range of tissue samples including bovine, equine, porcine, and human tissue.
Bioburden Testing Services
Contract testing service measuring microbial contamination levels on or in a product, developed and validated for each individual product/device type to ensure accuracy and repeatability.
Biological Indicators (BIs)
Test systems with microorganisms of known high resistance deposited onto a substrate, used for sterilization validations and routine product release primarily for gaseous sterilization technologies for medical devices and pharmaceuticals.
Integrated sterilization equipment and control systems
Accelerators, product handling systems (conveyors) and automation solutions for sterilization processing facilities.
Dosimetry supplies and measurement services
Dosimeter usage and reporting based on alanine pellet and Perspex/red Perspex dosimeters to quantify absorbed ionizing radiation.
Tissue Sterilization Services
Contract sterilization services for human, animal, and synthetic tissues intended for transplantation or medical use, using low temperature terminal sterilization modalities such as gamma, E-beam, X-ray radiation, ethylene oxide, and vaporized hydrogen peroxide (VHP).
Tissue Testing Services
STERIS provides tissue testing services using dedicated testing equipment to process a wide range of tissue samples including bovine, equine, porcine, and human tissue.
Bioburden Testing Services
Contract testing service measuring microbial contamination levels on or in a product, developed and validated for each individual product/device type to ensure accuracy and repeatability.
Biological Indicators (BIs)
Test systems with microorganisms of known high resistance deposited onto a substrate, used for sterilization validations and routine product release primarily for gaseous sterilization technologies for medical devices and pharmaceuticals.
Services
Outsourced sterilization processing using radiation, gas and steam modalities for medical device, pharmaceutical and consumer products.
Microbiological, analytical, product and package testing and validation to support sterilization qualification and release decisions.
Dosimetry measurement and monitoring services using alanine and Perspex dosimeters to support radiation processing control and validation.
Expert technical support throughout sterilization design and validation, including engineering runs and process qualification.
Supply and integration of sterilization equipment, accelerators and product handling/automation systems for processing facilities.
Assistance with FDA device and drug establishment registration, product listing submissions and mechanisms to reference sterilization master files.
Outsourced sterilization processing using radiation, gas and steam modalities for medical device, pharmaceutical and consumer products.
Microbiological, analytical, product and package testing and validation to support sterilization qualification and release decisions.
Dosimetry measurement and monitoring services using alanine and Perspex dosimeters to support radiation processing control and validation.
Expert technical support throughout sterilization design and validation, including engineering runs and process qualification.
Supply and integration of sterilization equipment, accelerators and product handling/automation systems for processing facilities.
Assistance with FDA device and drug establishment registration, product listing submissions and mechanisms to reference sterilization master files.
Expertise Areas
- Contract sterilization services
- Laboratory testing and validation
- Radiation dosimetry
- Regulatory compliance and FDA interactions
Key Technologies
- Gamma irradiation
- Electron beam irradiation
- X-ray irradiation
- Ethylene oxide sterilization